药物信息协会(DIA)第五届中国年会 患者关爱与药物安全 5th DIA China Annual Meeting Patient Safety - A Sustained Focus from Scientific Ideas to Innovative Medicines 中国 · 北京国际会议中心 Beijing International Convention Center, China 2013年5月12日—— 会前专题研讨会 2013年5月13-15日—— 会议、展览和壁报 May 12, 2013 - Pre-conference Workshops May 13-15, 2013 - Conference, Exhibition and Posters FINAL PROGRAM 会议手册www.diachina.org合办单位: 中国医药国际交流中心 30 2013年5月12日 星期日 | 会前专题研讨会 07:30-16:00 一层,注册台 会议注册 08:30-17:30 二层,201B 专题研讨一(全天) 运用数据分析技术监控和评价临床研究质量和结果 二层,201C 专题研讨二(全天) 原料药和制剂的稳定性要求与实践 二层,201D 专题研讨三(全天) 肿瘤临床试验中的数据管理 二层,203C 专题研讨四(全天) 从药物监管角度看MedDRA (ICH国际医学用语词典) 在临床试验药物安全和药物警戒方 面的应用 二层,201A 专题研讨五(全天) 全球性药物临床试验的原则和案例研究 三层,307 专题研讨六(全天) 药品安全和原料药: 全球对原料药的监管及法律的要求和实践 10:00-10:30 一层,展厅 茶歇 12:00-13:00 二层,二号厅 午餐 15:00-15:30 一层,展厅 茶歇 2013年5月13日 星期一 | 会议日程(第一天) 07:30-16:00 一层,注册台 会议注册 13:30-17:30 一层,展厅 展览和壁报开放 13:30-17:15 二层,一号厅 开幕式及全体大会 促进药物创新,保障患者安全 主旨嘉宾:桑国卫 中国药学会理事长 中国工程院院士 风险管理计划:促进创新确保患者安全 主旨嘉宾:Patrizia A. CAVAZZONI 医学博士 辉瑞全球研发中心高级副总裁 全球安全负责人及成熟产品药政事务部负责人 艾滋病病毒携带者治疗药物现状和期待 主旨嘉宾:孟林 北京爱之方舟感染者信息支持组织负责人 中国艾滋病病毒携带者联盟秘书处协调员 中国全球基金项目国家协调委员会非工委代表 15:30-16:00 一层,展厅 茶歇 17:30-19:30 一层,展厅/二层, 二号厅 欢迎招待会 — 中国之夜 DIA中国五周年庆典 2013年5月14日 星期二 | 会议日程(第二天) 07:30-16:00 一层,注册台 会议注册 08:30-17:30 一层,展厅 展览和壁报开放 08:30-10:00 一层,5 C+F T 1-1 成功的全球临床试验 – 优化利益,降低风险 一层,5 A+B+G+H T 2-1 固定剂量复方制剂(FDCs)在中国及全球的发展 一层,5 D+E T 3-1 上市批准前的药物警戒 – 探索研究 二层,201 A T 4-1 安全性信号检测和效益/风险定量评估(一) 二层,201 B+C T 5-1 确保细胞/基因疗法和血液制品的创新和安全 二层,201 D T 6-1 仿制药与参比制剂之比较与评价 – 仿制药质量一致性评价 (一) 二层,203 C T 7-1 开发适用于中国及全球的创新性中药 10:00-10:30 一层,展厅 茶歇 10:30-12:00 一层,5 C+F T 1-2 临床试验中各方的协调与沟通 一层,5 A+B+G+H T 2-2 生物类似药新的监管:挑战与机遇 一层,5 D+E T 3-2 产品批准上市后的药物警戒 – 长期的任务 二层,201 A T 4-2 安全性信号检测和效益/风险定量评估(二) 二层,201 B+C T 5-2 流感大流行应急准备原则以及批准上市后疫苗生产的变更 会议活动交流活动会场通知会议一览 31 二层,201 D T 6-2 仿制药与参比制剂之比较与评价 – 仿制药质量一致性评价 (二) 二层,203 C T 7-2 中药开发的案例分析与实践 12:00-13:30 二层,一号厅 午餐 2013年5月14日 星期二 | 会议日程(第二天·续) 13:30-15:00 一层,3号会议厅 国家食品药品监督管理总局 (CFDA) 专场会:中国药品上市前和上市后的安全监管 二层,201 B+C T 5-3 细胞药物和生物类似药的研发 - 机遇及监管要求 二层,201 D T 8-1 肿瘤诊断和治疗模式的改变对药物研发的影响 15:00-15:30 一层,展厅 茶歇 15:30-17:30 一层,3号会议厅 国家食品药品监督管理总局 (CFDA) 专场会:中国药品上市前和上市后的安全监管 二层,201 B+C T 5-4 中国与全球的疫苗产品认证和肝炎新疫苗研发 二层,201 D T 8-2 肿瘤靶向创新药物研发策略 17:30-19:30 二层,二号厅 讲者/嘉宾招待酒会 2013年5月15日 星期三 | 会议日程(第三天) 07:30-16:00 一层,注册台 会议注册 08:30-17:30 一层,展厅 展览和壁报开放 08:30-10:00 一层,5 C+F T 1-3 GCP诊所 一层,5 A+B+G+H T 2-3 & T 3-3 新药临床试验/IND阶段的风险与受益权衡 一层,5 D+E T 4-3 Meta分析及其在药品开发中的应用 二层,201 D T 6-3 中美植物药监管展望 二层,201 B+C T 9-1 药物毒理:从动物试验到人体试验 二层,201 A T 10-1 科技进展对临床数据管理的影响 二层,203 C T 11-1 医疗器械的创新、监管及研发投资 (一) 10:00-10:30 一层,展厅 茶歇/ 壁报展抽奖活动 10:30-12:00 一层,5 C+F T 1-4 从质量保证的角度谈药物警戒 一层,5 A+B+G+H T2-4 & T3-4 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价 一层,5 D+E T 4-4 药物研发中的定量科学 二层,201 D T 6-4 全球生物制药法规的发展 – CMC视角 二层,201 B+C T 9-2 GLP法规;数据的质量和完整性 二层,201 A T 10-2 安全数据管理 – 数据管理者的职责 二层,203 C T 11-2 医疗器械的创新、监管及研发投资 (二) 12:00-13:30 二层,一号厅 午餐 / DIA学术沙龙交流活动 13:30-15:00 一层,5 C+F T 1-5 临床研究机构面临的机遇与挑战 一层,5 A+B+G+H T 2-5 在中国开发治疗用生物制品 – CMC视角 一层,5 D+E T 3-5 为患者的利益平衡效益和风险 二层,201 D T 12-1 如何建立双赢关系 二层,201 B+C T 9-3 药物研发的毒理评价和风险评估 二层,201 A T 10-3 数据标准在临床研究中的应用和成功案例 (一) 二层,203 C T 14 药物流行病学的最佳实践和药物安全 15:00-15:30 一层,展厅 茶歇 15:30-17:30 一层,5 C+F T 1-6 中国伦理委员会的职责和发展 一层,5 A+B+G+H T 2-6 创新的标签说明书中心体系在亚洲的应用及与国际体系的整合 一层,5 D+E T 3-6 制定风险管理计划有益于患者吗? 二层,201 D T 12-2 合同研究机构对确保药品安全所起的作用 二层,201 B+C T 13 上市后和实际环境中的药物研究 二层,201 A T 10-4 数据标准在临床研究中的应用和成功案例 (二) 15:30 - 16:15 二层,203 C T 15 药品追溯体系建设—药品电子监管 会议活动交流活动会场通知会议一览 32 会前专题研讨 (全天) 08:30-17:30 运用数据分析技术监控和评价临床研究质量和结果 08:30-17:30 原料药和制剂的稳定性要求与实践 08:30-17:30 肿瘤临床试验中的数据管理 08:30-17:30 从药物监管角度看MedDRA (ICH国际医学用语词典) 在临床试验药物安全和药物警戒方面的应用 08:30-17:30 全球性药物临床试验的原则和案例研究 08:30-17:30 药品安全和原料药: 全球对原料药的监管及法律的要求和实践 2013年5月12日 星期日 | 会前专题研讨 目标听众 以下临床研究领域的人员: ? 临床管理和运作 ? 临床信息技术与计算机处理技术 ? 临床试验数据监查(临床监查,医疗监控) ? 数据保障和数据质控 ? 临床信息学 ? 药品法规 ? 数据管理和设计 ? 电子临床服务商管理 ? 药物研发 议程 第一节 | 临床研究管理的生物信息工具 I ? 早期研究探索阶段的数据审核 第二节 | 临床研究管理的生物信息工具 II ? 数据质量审查过程 ? 受试者数据跟踪 ? CDISC标准数据结构及应用方法 第三节 | 应用先进的报告和分析方法提高临床研发的效能 ? 临床研发效率和质量的提高 ? 资源调配 ? 研究计划的制定和决策 第四节 | 对全球数据进行有效的数据管理和信息发掘 – WHO全球药品监测中 心(UMC)的视角 I ? 用于信息发掘的信号检测和方法 ? 数据转化为信息: 标准化词典和术语的重要性 第五节 | 对全球数据进行有效的数据管理和信息发掘 – WHO全球药品监测中 心(UMC)的视角 II ? 如何运用WHO药物词典对临床试验和安全性数据进行编码 (全天) 专题研讨 一08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 B 运用数据分析技术监控和评价临床研究质量和结果 讲授专家 刘川 博士 Medidata Solutions Worldwide 大中华地区发展总监 Eric S. Herbel 美国Integrated Clinical Systems公司总裁 Yutaka Sato 日本Medidata Solutions公司方案建设部顾问 Madeleine Krieg 注册药师 瑞典Uppsala监测中心产品经理 Maria Lindquist 博士 瑞典Uppsala监测中心总监兼首席执行官 专题研讨介绍 过去的十年中,临床试验的周期和复杂性在不断增加,但药物研发经费却呈现 缩减之态,开发方无法在更长期和更复杂的试验中投入更多的资金.因此,寻 求更高效和创新的方法来进行临床研究显得迫在眉睫.本研讨会将讨论临床研 究数据分析的典型方法和最佳实践范例.议题包括支持临床试验医疗监控运行 的数据分析技术类型,风险监控所用CDISC数据结构,以及临床试验阶段和上 市后临床研究的试验管理.本研讨会也将讨论基于数据积累的临床数据审核各 种方法、临床研究计划制定以及决策.此外,涵盖的话题还包括如何实现更好 的资源调配以提高临床研发的效能和质量、受试者数据审查的益处、异常数据 检测的方法以及如何进行信号检测. 目的 ? 了解应用生物信息工具进行临床数据评价的时机和方法. ? 了解的已出现的新方法,侧重于"病人鉴别/深度发掘"的报告、图解和数 据系统中受试者信息的交互作用. ? 了解如何进一步提高临床研发的效能和质量. ? 掌握数据信息转化以便更好调配资源并进行风险决策. ? 学会运用全球性词典对临床试验和安全性数据进行编码. 33 (全天) 专题研讨 二08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 C 原料药和制剂的稳定性要求与实践 讲授专家 阮忠士 博士 美国百时美施贵宝公司分析研发部副总监 卜欣 博士 美国百时美施贵宝公司分析和生物分析部高级研究员 专题研讨介绍 稳定性是医药产品的重要质量属性;因此,遵循当前药物规范的稳定性试验方 案对药物开发和新药注册至关重要.稳定性试验方案的成功实施要求对全球的 药品监管规定、稳定性方法与最佳实践范例有全面的了解.本研讨会将概述美 国食品药品监督管理局(FDA)、国际协调组织(ICH)和世界卫生组织(WHO)对药 品的稳定性要求,并从监管和技术层面上探讨如何设计高效、规范的全球化药 物稳定性试验方案. 目的 ? 了解稳定性试验方案在药物开发过程中的重要性 ? 遵循ICH/WHO与全球的药物规范设计稳定性研究方案 ? 高效地实施稳定性试验方案 ? 了解稳定性检测方法的重要性 ? 全球技术转移的管理 ? 解读稳定性试验数据 目标听众 ? 研发及管理人员 ? 法规监管人员 ? 质量保证和质量控制专业人员 ? 合同研究机构和生产企业 ? 学术研究机构 议程 第一节 | 药物稳定性的监管要求概述 ? 稳定性在药物开发过程中的重要性 ? cGMP药物稳定性要求概述 ? ICH药物稳定性指南 ? 全球化药物稳定性试验方案的要求 ? 药品保存期的确定 第二节 | 药品稳定性的技术方面实践 ? 稳定性检测方法的建立 ? 强制降解研究的设计 ? 试验方法的验证和技术转移 ? 稳定性数据的评估 第三节 | 案例讨论 (全天) 专题研讨 三08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 D 肿瘤临床试验中的数据管理 讲授专家 颜崇超 博士 辉瑞(中国)研究开发有限公司 数据管理部门技术运营负责人 徐莉 医学博士,工商管理硕士 美国辉瑞公司肿瘤业务部, 肿瘤中国策略规划、贯彻和全球运作部副总裁 陈丽娟 新加坡 InVentiv Health Clinical 亚太区临床研究执行总监 张薇 辉瑞(中国)研发有限公司数据管理部门治疗领域经理 吴沭陵 辉瑞(中国)研发有限公司临床数据管理部门经理 王娟 辉瑞(中国)研发有限公司临床数据(肿瘤组)管理员 伍晓华 默沙东研发(中国)临床数据管理副总监 专题研讨介绍 在中国临床研究中,肿瘤临床试验占相当大的比重.本研讨会由两部分组成, 将分别介绍肿瘤临床试验的基础知识以及肿瘤临床试验各阶段中数据管理的具 体操作. 目的 ? 介绍肿瘤临床试验的基础知识 ? 阐述肿瘤临床试验具有特征性的试验设计,疗效评价以及安全性评价 ? 帮助理解肿瘤试验中各个阶段的数据管理的工作,强调病例报告表的设 计、数据清理、实验室数据管理、实体肿瘤测量以及长期试验的管理 ? 讨论肿瘤试验中的最佳操作方法.例如,关键数据点的确定,SAE的处 理以及实验室数据的审查等 目标听众 本次研讨会是为希望了解肿瘤临床试验或者肿瘤临床试验数据管理的专业人员 设置及下列相关领域的人员: ? 临床研究专业人员 ? 临床项目管理人员 ? 临床监查员 ? 统计学人员 ? 试验程序人员 议程 第一节 | 肿瘤学临床研究基础知识 第一部分: 概述 ? 肿瘤药物开发 ? 肿瘤学治疗标准以及相关术语 第二部分: 肿瘤试验的设计和终点 ? 肿瘤临床试验的分期以及类型 ? 肿瘤评价终点(无进展生存期、客观缓解率、总生存期、肿瘤评价标准 1.1) 第三部分: 肿瘤试验进行期 ? 知情同意 ? 现场监查与方案偏离 34 第四部分: 安全监测 ? 不良事件和严重不良事件 ? 不良事件通用术语标准(CTCAE) 第五部分: 案例讨论 第二节 | 肿瘤学数据管理员基础知识 第一部分: 试验启动阶段 ? 肿瘤试验的病例报告表的设计以及数据库的建立 ? 肿瘤学试验的治疗周期 ? 肿瘤学试验中有效性数据的收集与测量 第二部分: 试验进行阶段 ? 试验数据的清理 ? 肿瘤学研究中本地实验室数据与正常范围的处理 ? 支持有关有效性与安全性数据的临床审查 ? 第三方数据的审查对数据管理员的挑战 ? 外部数据的处理和一致性检查 ? 第三部分: 试验结束期 ? 中期分析时数据库临时性的锁定 ? 长期试验的管理与跟踪 第四部分: 肿瘤试验的最佳实践 ? 肿瘤试验中的关键数据点 ? 了解必要数据和最佳数据 ? SAE 处理 ? 实验室数据审核 ? 肿瘤测量 (全天) 专题研讨 四08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,203 C 从药物监管角度看MedDRA(ICH国际医学用语词典)在临床试验药物 安全和药物警戒方面的应用 讲授专家 Anna ZHAO-WONG 医学博士 美国MedDRA Maintenance and Support Services Organization副总监 Sonja BRAJOVIC 医学博士 美国FDA药物审评和研究中心 监测和流行病学办公室 MedDRA协调员 专题研讨介绍 本次研讨会将重点放在MedDRA在临床试验安全性和药物警戒方面的应用, 包括监管方面的观点.内容含有如何按照ICH认可的《MedDRA编码:考虑 要点》和《MedDRA数据检索和显示:考虑要点》指南文件统一精确地使 用MedDRA术语编码、检索、显示临床药物安全信息数据的方法,如何使用 MedDRA标准分析查询工具(SMQs)帮助识别,检测药物安全信号.同时还将 介绍美国FDA不良事件报告系统(FAERS)的实施,描述标准术语在药品安全数 据编码和分析中使用.鼓励参加者带有关MedDRA编码、数据检索/分析的问 题参加交流和讨论. 目的 ? 描述如何使用MedDRA术语进行不良事件数据编码 ? 阐述检索和分析MedDRA编码数据的策略及其在临床药物安全性和药物 警戒中的应用 ? 了解美国FDA如何使用MedDRA对FDA不良事件报告系统(FAERS)数据 进行上市后药物警戒.并在新药审评中将其运用于对临床试验安全性数 据的分析 目标听众 本次研讨会是为以下有MedDRA基本知识并想探索其在临床药物安全和药物 警戒中应用的专业人士设计的: ? 药物警戒和临床研究的专业人员 ? 临床数据管理人员 ? 医学写作者 ? 法规及监管人员 议程 第一节 | MedDRA简介 第二节 | MedRA编码和ICH认可的《MedDRA编码: 考虑要点》 ? 《MedDRA编码: 考虑要点》简介 ? 从美国FDA视角通过编码示例分析数据质量问题 ? 编码练习 ? 问答与互动 第三节 | MedDRA数据分析和ICH认可的《MedDRA数据检索和显示: 考虑要 点》 ? 《MedDRA数据检索和显示: 考虑要点》简介 ? 编写MedDRA查询 ? MedDRA查询编码练习 ? MedDRA标准分析查询工具 ? 自定义搜索 ? 从美国FDA AERS数据库和新药安全审查的例子中看FDA如何使用 MedDRA进行信号检测 ? 问答与互动 第四节 | MedDRA版本更新 (全天) 专题研讨 五08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 A 全球性药物临床试验的原则和案例研究 讲授专家 王武保 博士 默沙东研发(中国)有限公司 生物统计与研究决策科学部 – 亚太区执行总监 寿琼 博士 默沙东研发(中国)有限公司 生物统计与研究决策科学部 – 亚太区资深生物统计师 Hsien-Ming James HUNG 博士 美国FDA药品审评与研究中心生物统计处处长 Sue-Jane Wang 博士 美国FDA药品审评与研究中心生物统计处, 转化科学处副处长 安藤 友纪 日本药物医疗器械监督局生物统计组, 药物评价中心资深生物统计师 专题研讨介绍 近年来,全球性临床试验在药物研发中占有越来越大的比重.ICH指南以及区 域的临床监管指南已经明确阐述了全球性临床试验的基本科学原则.本研讨会 通过心血管、中心神经系统、抗感染、肿瘤和其他治疗领域的案例阐述药物监 管、统计学、临床和运作原则.每一个案例将介绍疾病的背景、临床试验的设 计、药物全球发展的战略、临床试验的结果以及药物监管部门审评的考量. 35 目的 ? 回顾全球性临床试验中药物监管、统计学、临床学和运作的原则 ? 通过实例了解在不同区域开展临床药物研发及注册的策略 ? 通过实例了解不同地区对注册的法规要求 目标听众 以下领域的人员: ? 定量科学 ? 法规监管 ? 制药行业(临床前、上市前、上市后的开发) ? 合同研究组织 ? 政府机关 ? 学术界/研究机构 议程 第一节 | 心血管和中心神经系统案例以及原则 ? 一致性和不一致性的概念 ? 全球和区域临床试验的优势以及挑战 第二节 | 全球和地区药物基因组学试验案例及原则 ? 药物基因组学试验的设计和分析的特点 ? 全球和区域药物基因组学试验的优势以及挑战 第三节 | 亚洲临床试验案例及原则 ? 全球,亚洲和地区临床试验设计的选择以及发展战略 ? 对全球临床试验中总体及区域结果的评估 第四节 | 问答与互动 (全天) 专题研讨 六08:30 - 17:30 (12:00 - 13:00 午餐) | 三层,307 药品安全和原料药: 全球对原料药的监管及法律的要求和实践 欢迎致辞 翁新愚 中国食品药品监督管理总局原药品安全监管司生产监督处处长 苏岭 博士 DIA全球理事会主席 盛德国际律师事务所生命科学战略顾问 Nicole Taylor SMITH 法学博士 美国食品药品监督管理局驻中国办公室副主任 议程 第一节 | 2012年中美原料药法规监管和合作会议回顾总结 Jeffrey GREN 美国商务部健康与消费产品司司长 第二节 | 美国及欧盟对原料药和化学品生产的定义和监管以及原料药在全球 药品安全中的作用 有关欧盟原料药认证新要求和国际合作机遇的讨论 Nicole Taylor SMITH 法学博士 美国食品药物监督管理局驻中国办公室副主任 Patrizia TOSETTI 博士 欧盟委员会健康局科学官 第三节 | 企业对原料药监管的思考 维力士吉 葡萄牙好利安制药科学股份有限公司行政总裁,RX-360 Consortium 机构代表 顾桂国 中国中化帝斯曼制药(淄博)有限公司总经理 第四节 | 中国原料药监管进展概述 翁新愚 中国食品药品监督管理总局原药品安全监管司生产监督处处长 第五节 | 对原料药生产企业的监督检查及针对未受监管的化学原料的执法合作 Piotr KRAUZE 欧洲药品管理局检查部科学行政官 王刚 博士 美国食品药品监督管理局驻中国办公室助理主任 第六节 | 中国、欧盟和美国药典原料药标准的作用 王平 国家药典委员会副秘书长 Susanne KEITEL 博士 欧洲理事会欧洲药品质量局(EDQM)局长 胡江滨 博士 美国药典委员会中华区副总裁 第七节 | 确保原料药质量以及防止销售或出口不受监管或伪造的原料药的法 律和政策 杨晨 盛德国际律师事务所北京办事处合伙人 盛德中国生命科学业务负责人 刘志伟 教授 北京师范大学法学院 刘科 副教授 法学博士 北京师范大学刑事法律科学研究院 何菁 法学博士 安杰律师事务所高级顾问 第八节 | 具体法律和政策建议 主持人 Jeffrey GREN 美国商务部健康与消费产品司司长 翁新愚 中国食品药品监督管理总局原药品安全监管司生产监督处处长 第九节 | 建议与合作措施 第十节 | 总结 36 2013年5月13日 星期一 | 会议日程 (第一天) 现场注册 07:30 - 16:00 开幕式及全体大会 13:30 - 17:15 (茶歇 15:30-16:00) 介绍来宾 蔡伊志 博士 DIA中国区总监 DIA主席致辞 苏岭 博士 DIA全球理事会主席 盛德国际律师事务所生命科学战略顾问 尹力 博士 国家食品药品监督管理总局副局长 DIA志愿者杰出贡献奖颁奖仪式 大会主席致辞 谭凌实 博士 辉瑞全球开发运营副总裁 辉瑞(中国)研究开发有限公司总经理 赵亚军 中国医药国际交流中心主任 主旨嘉宾演讲 促进药物创新,保障患者安全 桑国卫 中国药学会理事长 中国工程院院士 风险管理计划: 促进创新确保患者安全 Patrizia A. Cavazzoni 医学博士 辉瑞全球研发中心高级副总裁, 全球安全负责人及成熟产品药政事务部负责人 艾滋病病毒携带者治疗药物现状和期待 孟林 北京爱之方舟创办者及负责人 中国艾滋病病毒携带者联盟秘书处协调员 中国全球基金项目国家协调委员会非政府工作委席位代表 欢迎招待会 — 中国之夜: DIA中国五周年庆典 17:30 - 19:30 国家食品药品监督管理总局 (CFDA) 专场会 2013年5月14日 星期二 13:30 - 17:30 一层, 三号会议厅 中国药品上市前和上市后的安全监管 会议主持 薛斌 国家食品药品监督管理总局中国医药交流中心副主任 2012年度中国药品审评报告 陈震 博士 国家食品药品监督管理总局药品审评中心化药药学一部副部长 2013年5月14日 星期二 | 会议日程 (第二天) 董江萍 国家食品药品监督管理总局药品注册司化学药品处处长 程刚 国家食品药品监督管理总局药品评价中心,国家药品不良反应监测中心主任助 理37 专题 1 | 临床研究与运作 分会场 T 1-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 C+F 成功的全球临床试验 - 优化利益,降低风险 会议主持 顾薇 百时美施贵宝(中国)投资有限公司临床运营部高级总监 为确保临床试验的成功,患者的安全和风险管理是关键要素.FDA和EMA颁布 了基于风险的监查规范, 中国在参与更多的全球临床同步研发过程中,需将这 些国际原则和规范应用于中国和亚洲国家.本专场将深入讨论实施优良临床 试验的指导原则. 临床试验的成功要素 John Ran Kim 韩国ICON公司亚太区临床研究部副总裁 基于风险的监控 Elaine Hawkings 百时美施贵宝(中国)投资有限公司临床运营部亚太区执行总监 包括中国和亚洲参与的全球临床试验的风险与收益 宫崎 浩一 注册药师 日本第一三共制药公司临床运营副总监 专家讨论 分会场 T 1-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 C+F 临床试验中各方的协调与沟通 会议主持 吴䶮 第一三共(中国)投资有限公司医药开发总部总经理 专家讨论 纵观整个临床试验的关键路径,从研究方案的确定,IEC/IRB审查,研究合 同签署,病人/受试者招募,到安全监测及研究结束,责任各方,如申办者, 主要研究者/研究机构,IEC/IRB和CRO等的合作协调和有效沟通对保证高效 率、高质量的临床试验至关重要. 来自临床研究中心(基地)、伦理委员会、申办方及CRO的各方人员将介绍各 自工作重点领域,以及如何建立通畅的交流沟通机制及协调合作.协调一致 以确保以患者安全和权益为中心的临床研究的高效运作. 专家讨论组 徐仲鍈 教授 香港中文大学公共卫生学院临床研究中心生物统计处处长 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 顾薇 百时美施贵宝(中国)投资有限公司临床运营部高级总监 陈莉 医学博士 ICON中国项目管理部负责人 分会场 T 1-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 C+F GCP诊所 会议主持 陈华 杨森(中国)制药研发质量保证部临床质量监控/药物警戒组总监 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 专家讨论 本专场将讨论在临床试验过程中常见的GCP质量问题.参加讨论的人员包括 涉及临床试验不同领域的专家, 药监局官员,临床试验基地主任,制药公司临 床运营部门的主管及质量保证部门的代表.专家将根据临床研究及监管的经 验交流观点.目的是促进相互的理解,提高临床试验的质量. 专家讨论组 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 戴欣 北京诺华制药有限公司国际临床开发部大中国、亚太、中东及非洲区域高级总监 巫雪莹 辉瑞医疗(中国)临床发展及运营负责人 李庆红 辉瑞医疗(中国)质量保证部亚洲地区负责人 分会场 T 1-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 C+F 从质量保证的角度谈药物警戒 会议主持 李庆红 辉瑞医疗(中国)质量保证部亚洲地区负责人 为保证病人的安全,全球的医药监管部门竭力加强对新药的安全监督和管 理.本专场旨在解读欧盟新药安全监督和管理的最新法规,分享和学习来自 监管部门视察和申办者内部稽查的经验和教训,共同思考如何规划未来,如 何符合法规要求、提高工作有效性及改进药物警戒的流程. 本专场并将侧重介绍欧盟药物警戒法规最新发展、药物警戒视察中常见问 题、企业内部稽查的经验. 欧盟药物警戒法规的最新进展和视察中常见问题 Carrie Scott 英国药品医疗产品监管局GPvP运营经理,资深药物警戒监察员 企业内部药物警戒稽查 Deborah Driscoll 博士 美国辉瑞公司医疗质量保证部副总裁 2013年5月14日 星期二 | 会议日程 (第二天) 2013年5月15日 星期三 | 会议日程 (第三天) 38 分会场 T 1-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 C+F 临床研究机构面临的机遇与挑战 会议主持 李海燕 教授 北京大学第三医院药物临床试验机构主任 北京大学临床研究所副所长 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 近年来,临床研究数量在快速增长,国家药监局也更关注研究质量,不仅通 过对申报项目的现场核查进行监管,同时在机构复核检查中也将此作为重要 内容之一.研究者在承担大量临床研究的同时,还要确保研究质量.面对这 样的挑战,临床研究机构应如何加强管理,为临床试验提供一个高效、有序 的GCP平台.本会场将针对这些问题进行深入的讨论. 高效规范的管理程序对临床试验受试者安全性的保障作用 梁茂植 研究员 华西医院国家药品临床试验机构副主任兼I期临床试验研究室主任 临床药理研究室主任 华西医院国家药物临床试验机构/GCP中心负责人 2012 年临床研究机构的问卷调查及分析 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 在中国药物研发中临床试验机构的作用 李海燕 教授 北京大学第三医院药物临床试验机构主任 北京大学临床研究所副所长 分会场 T 1-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 C+F 中国伦理委员会的职责和发展 会议主持 刘海涛 国际公共卫生学硕士 葛兰素史克(中国)投资有限公司 全球质量合规部 亚太地区临床发展质量保证 部高级顾问 本专场将着重于中国目前的伦理审批和伦理委员会的建设: 优势和挑战. 内容 不仅将侧重于内部架构和系统的建设,并从保护患者安全角度讨论目前伦理 委员会的职责.本专场旨在促进发展高效、高质量伦理审查体系. 通过伦理委员会审查确保患者安全 Cristina E. Torres 博士 菲律宾亚太地区伦理审查委员会亚洲区协调员 伦理审查中的挑战与思考 汪秀琴 教授 博士 江苏省人民医院科技处副处长,伦理委员会副主任委员 台湾伦理委员会基础设施策略规划 — 临床研究之关键主动支持 陈恒德 医学博士 台湾生技整合育成中心医务长 专家讨论 专题 2 | 监管科学 分会场 T 2-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 A+B+G+H 固定剂量复方制剂(FDCs)在中国及全球的发展 会议主持 闫小军 工商管理硕士 拜耳医药保健有限公司全球注册战略发展特药负责人 开发固定剂量复方制剂(FDCs)从公众健康角度来说越来越重要.这类药品被 广泛的应用于治疗例如艾滋病(HIV)、高血压、和口服避孕等疾病,通过科学 合理的组合,复方制剂在临床上可起到增加疗效,减少不良反应的作用.此外,FDC制剂的成本可能要小于同时分别给药.由于减少了病人服用的药片/ 丸等,从而提高了用药依从性. 本专场来自制药企业和医院的讲者将分享全球FDC的发展及其对患者的益 处.药监局审评中心的讲者将分享对复方药物开发的主要考虑. 固定复方制剂: 在中国控制高血压的意义与研究进展 王文 教授 中国医学科学院阜外医院国家心血管病中心 跨国公司如何科学理性地开发FDCs Dan Paulson 博士 美国拜耳医药保健有限公司全球临床负责人 复方药物开发的主要考虑 康彩练 国家食品药品监督管理总局 药品审评中心 化药临床二部高级审评员 分会场 T 2-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 A+B+G+H 生物类似药新的监管: 挑战与机遇 会议主持 周雪娟 赛诺菲(中国)监管事务部总监 自美国2011年颁布了生物类似药指南后,如何进行符合该指南要求的临床研 究已引起各方的关注.本场将讨论生物类似药开发的法规要求和试验设计. 美国FDA生物类似药指南要求 龚兆龙 博士 美国FDA同仁会国际网络成员 前美国FDA新药审评员 百济神州(北京)生物科技有限公司副总裁 生物类似药开发的CMC要求 吴笃恭 博士 法玛特咨询咨询部部长 前美国FDA新药审评质量评估部副处长 前美国FDA ICH Q5E 专家工作组代表 如何管理生物类似药上市后的不良反应监控及相关问题 陈少羽 法学博士 美国FDA同仁会成员 美国科文顿.柏灵律师事务所驻北京合伙人 专家讨论 中国生物类似药监管现状与展望 以上讲者及 王凯玲 美国瑞格律师事务所 中国生命科学首席顾问 39 分会场 T 2-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 A+B+G+H 新药临床试验/IND阶段的风险与受益权衡 会议主持 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 风险与受益评估是监管决策的基础.尽管风险/受益评估在过去的十年中取 得了进展,这一领域在目前仍面临着巨大的挑战,尤其是在所开发药物的受 益还无法确定的新药临床试验(IND)阶段.本专场为风险/受益评估主题的第 一部分,将介绍美国FDA和中国CFDA/CDE的观点. 美国FDA在临床试验阶段对药品受益/风险的权衡 Mark J. Goldberger 医学博士,公共卫生硕士 前美国FDA药品审评与研究中心药品审评四部部长 美国FDA同仁会成员 美国雅培制药法规政策部副总裁 临床试验暂停(Clinical Hold)-美国FDA在新药临床试验阶段进行风险管理的 重要措施 Robert J. Meyer 医学博士 前美国FDA药品审评与研究中心药品审评二部部长 美国FDA同仁会成员 美国弗吉尼亚大学医学院公共卫生科学系副教授,弗吉尼亚州立监管科学中 心主任 美国FDA权衡药品受益/风险的统计学考量 李宁 医学博士 赛诺菲药学与医学政策亚洲区副总裁 中国药品审评中心对临床试验申请的审批 杨志敏 中国药品审评中心化药临床一部副部长 专家讨论 分会场 T 2-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 A+B+G+H 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价 会议主持 Mark J. Goldberger 医学博士,公共卫生硕士 前美国FDA药品审评与研究中心药品审评四部部长 美国FDA同仁会成员 美国雅培制药法规政策副总裁 风险与受益评估是监管决策的基础.不同的监管机构对同一类药品申请有不 同的审评结论和决策.本专场为风险/受益评估主题的第二部分,将介绍 NDA及上市后,如何考量风险和受益,并着重介绍美国专家顾问委员会的作 用. NDA及上市后风险及效益平衡观 Robert J. Meyer 医学博士 前美国FDA药品审评与研究中心药品审评二部部长 美国FDA同仁会成员 美国弗吉尼亚大学医学院公共卫生科学系副教授,弗吉尼亚州立监管科学中 心主任 美国FDA借助外部咨询委员会对新药/NDA进行风险/受益评估 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 风险效益观在上市申请审评中的体现 徐丽娟 台湾卫生署药品食品监督局药品审评中心临床科学处首席执行官 上市后的风险效益再评价 詹思延 教授, 医学博士 北京大学医学部流行病和生物统计系副主任 专家讨论 分会场 T 2-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 A+B+G+H 在中国开发治疗用生物制品 – CMC的视角 会议主持 刘秀凤 美国安进公司北京办事处注册事务和安全部总监 在解决未能满足的医疗需求方面,已知治疗用生物制品正扮演着日益重要的 作用.在中国及时引入新的、安全有效的治疗用生物制品是国内外制药企业 和监管机构的共同目标.在这个专题的演讲和讨论中,来自制药企业和监管 机构的代表将从CMC的视角来分享和讨论如何加速临床研究申请的批准,包 括申报资料准备,顺利启动和完成样品检验,总结和分析所遇到的挑战和机 遇,并提出可能的解决方案. 生物制品临床申请中申报资料的准备和样品检验 程慧旸 博士 嘉和生物药业有限公司医学注册部总监 蔺亚萌 罗氏(中国)制药有限公司政策事务经理 饶春明 中国食品药品检定研究院 生物制品检定所重组药物室主任 专家讨论组 以上讲者及 徐砺新 医学博士 美国FDA药品审评与研究中心 单克隆抗体处,生物科技产品办公室,生物药 品质量评审专家 Anthony Ridgway 博士 加拿大卫生部健康产品和食品局生物和基因疗法处首席监管科学家 分会场 T 2-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 A+B+G+H 创新的标签说明书中心体系在亚洲的应用及与国际体系的整合 会议主持 Rie Matsui 注册药师 日本辉瑞公司WSR国际和全球产品信息部区域标记组亚洲区总监 岸达生 日本药物医疗器械监督局药物安全二处风险管理主任 许多跨国公司使用集中统一的标签说明书模式.支持该模式的核心数据表 (CCDS)由公司总部管理,而本地药品文件和病人使用说明书由所在地的公 司管理.本专场将对CCDS、USPI、EU-SPC等全球标签说明书体系进行综 40 述,并通过亚洲区的实例,探讨发展的前景.本专场还将从确保病人信息安 全的视角,阐述制药产业对全球标签说明书体系的管理. 跨国制药企业的全球药物安全说明书体系 Matthias BOEDDING 教授,医学博士 拜耳(中国)医药保健有限公司, 全球研发北京中心全球药物警戒-风险管理部负责人 一个亚洲区管理药物说明书的创新模式 Rie Matsui 注册药师 日本辉瑞公司WSR国际和全球产品信息部区域标记组亚洲区总监 日本药物说明书的政策法规 岸达生 日本药物医疗器械监督局药物安全二处风险管理主任 美国和欧洲的全球药物说明书流程以及相关组织 Jeffery Ho 英国WCI咨询公司负责人 专题 3 | 药物安全和警戒 分会场 T 3-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 D+E 上市批准前的药物警戒 — 探索研究 会议主持 夏峰 医学博士 美国辉瑞全球研发有限公司 全球安全和法规部 安全评价组医疗总监 药物警戒活动已转向更为早期、主动的风险和潜在效益评估,并成为新药开 发及上市前评估过程中的重要内容.生物学、药理学等基础科学的进步和药 物研发过程中对信息技术的运用已经促成对以往难以获得的更为复杂药物的 开发,并能更早地在药物开发过程中进行全面深入的风险效益评估. 公众对新药安全的加倍关注以及科学新发展促进了创新药开发方、药监部门 和医务工作人员的紧密合作,以制订相关的指南,加强在药物早期开发阶段 的药物警戒和安全风险管理.同时,制药企业也在不断努力适应新的要求以 确保病人安全. 本专场将分享关于评估、决策、沟通和规划的思路和观点,以及一个需对病 人安全有特殊考量的肿瘤临床试验. 从首次人体使用到批准上市:中国创新药开发中的安全性关键要素(评估、决策和 沟通) 张丹 医学博士,公共卫生硕士 方恩医药发展有限公司总裁兼首席执行官 新药上市批准前的安全评估 — 主要考量及案例回顾 陈之键 医学博士,工商管理硕士 阿斯利康(中国)全球药物研发 中国区副总裁兼负责人 专家讨论 ? 药品上市申请的临床安全性审评 ? 上市批准前安全风险评估的实践 ? 个例和整合的药物安全报告 ? 上市批准前的药品安全性信息沟通 分会场 T 3-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 D+E 产品批准上市后的药物警戒 — 长期的任务 会议主持 程刚 国家食品药品监督管理总局药品评价中心,国家药品不良反应监测中心主任 助理 裘行敏 辉瑞(中国)研发中心全球安全和法规部总监 药品监管机构基于新药申请上市时提供的信息批准药品上市.随着药品在不 同患者群中的使用和患者数量的增多,对于该药品的安全性的了解也随之变 化.除了常规的各项上市后安全性监测工作,还需要对某些有特殊安全性考 虑的药品采用额外的药物警戒方法.究竟采用何种最佳方法,取决于药物、 患者群和安全信号.随着主动监测成为药物警戒的发展新领域,严格设计的 观察性研究在实践中已经被大量应用.本专场将深入讨论上市后药品药物警 戒的方法和实际应用. 主动监测 — 上市后药物安全性监测的新机遇 周晓枫 博士 美国辉瑞制药公司 全球安全和药政事务部总监 上市后药物安全性主动监测的5大理由 Andy Stergachis 博士 美国华盛顿大学流行病学及全球卫生学教授 华盛顿大学公共卫生学院全球医药专业主任 "祖父药"一定安全吗?— 苯丙醇胺(PPA)的个案分享 庄易 博士 美国FDA药品审评与研究中心 生物统计处副处长 专家讨论 ? 上市后的安全性研究 — 什么是最佳途径? ? 实际环境中的研究 分会场 T 3-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 A+B+G+H 新药临床试验/IND阶段的风险与受益权衡 (见分会场T2-3) 分会场 T 3-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 A+B+G+H 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价 (见分会场T2-4) 41 分会场 T 3-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 D+E 为患者的利益平衡效益和风险 会议主持 Hugues Berard 医学博士,工商管理硕士 益普生(法国)研发公司副总裁及代理首席医务官 高杲 辉瑞(中国)研究开发有限公司,安全监测及风险管理部副总监 对药物效益风险的评估和权衡贯穿于药品的研发、审评、上市后监测的整个 生命周期.如何建立能被广泛认可的评估模式成为药监部门和制药行业关注 的问题.近年来,不少国家的药品监管部门、制药行业均相继开展药物效益 风险评估方法的研究项目,并取得进展.本专场的讨论旨在: ? 介绍药物效益风险评估方法研究的进展和实施 ? 从制药行业角度探讨当前业界和监管部门采用的评估方法及相应问题 ? 分享制药公司在进行药物研发中进行效益风险分析的方法和实例 ? 探讨如何使各方在科学的评估模式上达成共识,以及其在药物创新中的 作用 效益风险的一体化及代表性: 欧州 PROTECT项目 Juhaeri Juhaeri 博士 美国赛诺菲药物警戒和流行病学部门副总裁及药物流行病学负责人 药物效益风险评估的实施:制药公司合作模式案例分析 Hugues Berard 医学博士,工商管理硕士 益普生(法国)研发公司副总裁及代理首席医务官 以中国为先导的药物研发中的效益 一 风险评估和风险管理 牟骅 博士 和记黄埔医药(上海)有限公司执行副总裁及首席医务官 专家讨论 ? 如何就科学的评估方式达成共识 ? 效益风险评估模式在药物创新中的作用 分会场 T 3-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 D+E 制定风险管理计划有益于患者吗? 会议主持 周凌云 医学博士,公共卫生硕士 赛诺菲全球药物警戒及流行病部 国际药物警戒协调员 茅蕴 工商管理硕士 辉瑞(中国)研究开发有限公司 安全监测及风险管理部总监 有效的风险管理计划已在药物研发和上市阶段发挥重要的作用.然而对于其 可能给医疗系统增加负担并可能限制患者获得药品的争议仍旧存在.风险管 理计划正趋于全球性的协调和统一,但区域的差异需加以考虑,因为不同地 区的患者人群和医疗服务体系的模式会很大程度地影响风险鉴别和分类, 以及 对降低风险工具的选择.有效的风险计划应基于对患者的最佳保护.本专场 重点: ? 介绍侧重于亚洲的全球风险管理计划 ? 介绍CIOMS工作组在有效降低风险方面的进展 ? 分享如何有效应用流行病学研究评估风险最小化手段 ? 讨论风险管理协调统一及工具应用 风险管理计划的全球概况和亚洲特色 William Gregory 美国辉瑞公司安全策略部高级总监 亚洲风险管理:日本的经验 Stewart Geary 医学博士 卫材(日本)全球医学事务副总裁暨首席医学官 观察性试验在风险识别分类以及评估风险最小化工具中的应用实践 Juhaeri Juhaeri 博士 美国赛诺菲公司药物警戒和流行病学部门副总裁及药物流行病学负责人 专题 4 | 统计学 分会场 T 4-1 & T 4-2 | 2013年5月14日 星期二 08:30 - 12:00 二层, 201 A 安全性信号检测和效益/风险定量评估 会议主持 袁维颖 博士 强生药物研发 中国生物统计和统计程序部门总监 曲鹏 博士 辉瑞(中国)研究开发有限公司统计部总监 保护病人的安全在药品开发和医疗中至关重要.辨别潜在性安全信号和效益/ 风险定量评估是安全评价的一个组成部分,统计学在其中起到不可缺少的作 用.本专场从制药界和监管部门两个角度进行探讨. QTc临床试验中的统计考量 庄易 博士 美国FDA药品审评与研究中心 生物统计处副处长 安全性信号检测的序贯GLR检验方法 陈杰 博士 默沙东北京药物研发有限公司生物统计总监 效益和风险的统计考量 Marcia LEVENSTEIN 辉瑞全球研发统计副总裁 安全性信号检测的贝叶斯收缩估计 戴鲁燕 博士 上海勃林格殷格翰药业有限公司 生物统计副总监 药物基因组学的安全性 Sue-Jane WANG 博士 美国FDA药品审评与研究中心生物统计处,转化科学处副处长 专家讨论 分会场 T 4-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 D+E META分析及其在药品开发中的应用 会议主持 Hendrik SCHMIDT 博士 德国勃林格殷格翰药业有限公司 生物统计部 副总监 Meta分析是医学研究和药品开发中应用最广泛的方法之一,例如,产生假 设,判定非劣效性临床试验的界值,以及基于大规模临床试验的治疗效果的 整合分析.但是该方法如果使用不当,其价值就会因各种偏差而减弱.本会 场将推动Meta分析的规范应用并介绍其最新发展. 42 Meta分析在药品安全评估中的应用:统计学挑战与最佳实践范例 George Quartey 博士 美国Genentech公司主任 Meta分析与混合疗法比较数据 — 治疗网络中直接证据和间接证据的测量与 报告:方法、软件和示例 Hendrik Schmidt 博士 德国勃林格殷格翰药业有限公司生物统计部副总监 Meta-回归及其在临床试验中的应用 陈峰 教授, 博士 南京医科大学 公共卫生学院院长 分会场 T 4-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 D+E 药物研发中的定量科学 会议主持 王武保 博士 默沙东研发(中国)有限公司 生物统计和研究决策科学部 – 亚太区执行总监 宋杨 博士 默沙东研发(中国)有限公司 生物统计和研究决策科学部亚太分部 后期研发统 计组首席统计学家 药物研发中的定量科学涵盖了生物统计学、流行病学、卫生经济统计学、科 学应用编程和数据管理等多门学科.这些学科在药物研发领域共同发挥着越 来越大的作用.这些作用不仅体现在战略的制定和实施上,也体现于药监申 请递交和药监决策制定;它不仅反映了发达地区的药物研究现状,也反映了 新兴市场地区的情况.本专场将探讨定量科学专业人员面临的挑战和机遇. 药品研发中的定量科学的新议题 Hsien-Ming James HUNG 博士 美国FDA药品审评与研究中心生物统计处处长 专家讨论 ? 建模与模拟的作用 ? 受益风险定量评估 ? 复杂的临床试验设计 ? 生物标识的预示或预后性 ? 整合分析或Meta分析的效用与缺陷 ? 全球化 专家讨论组 Hsien-Ming James HUNG 博士 美国FDA药品审评与研究中心生物统计处处长 Sue-Jane WANG 博士 美国FDA药品审评与研究中心生物统计处,转化科学处副处长 安藤 友纪 日本药物医疗器械监督局生物统计组, 药物评价中心资深生物统计师 Joan Shen 医学博士 辉瑞(中国)临床发展部高级总监 姚晨 教授 北京大学临床研究所副所长、北京大学第一医院医学统计室主任 黄钦 博士 中国药品审评中心生物统计学部副部长 专题 5 | 疫苗和生物制品 分会场 T 5-1 | 2013年5月14日 星期二 08:30 - 10:00 二层, 201 B+C 确保细胞/基因疗法和血液制品的创新和安全 会议主持 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 本专场将综合介绍中国CFDA/CDE及美国FDA生物制品审评与研究中心对血 液供应、细胞、组织和基因疗法的质量、有效性以及病人安全的监管方法. FDA对细胞/基因疗法药物的安全性和有效性的要求 胡劲捷 博士 FDA同仁会会员 前美国FDA/CBER血液研究和评价办公室,高级审评官员 美国生物咨询公司高级顾问 中国关于细胞/基因疗法安全性及有效性法规方面进展的报告 沈琦 中国食品药品检定研究院生物制品检定所所长 FDA在血液制品安全性方面的职责 胡劲捷 博士 FDA同仁会会员 前美国FDA/CBER血液研究和评价办公室,高级审评官员 美国生物咨询公司高级顾问 专家讨论组 郭秀霞 国家食品药品监督管理总局原药品注册司生物制品处副调研员 常卫红 国家食品药品监督管理总局原药品注册司生物制品处副调研员 分会场 T 5-2 | 2013年5月14日 星期二 10:30 - 12:00 二层, 201 B+C 流感大流行的应急准备原则以及批准上市后疫苗生产的变更 会议主持 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 确保疫苗的安全对于各国监管当局都是困难但又必须履行的职责,目的是为 了促进公众健康,督促生物制药企业承担责任.美国FDA和中国CFDA有多 年的经验.为确保疫苗的安全有效,监管部门不仅鼓励采用新技术以推进高 质量和高效率的生产,也需要通过合适的验证及临床或非临床的实验研究来 证明因此引起的变化没有给产品的安全性和有效性造成不良影响,这是一个 非常艰巨的挑战.本专场将介绍美国和中国关于流感疫苗生产、应急准备和 安全性方面所开展的工作. FDA和WHO流感大流行疫苗的应急准备工作 Sara E. Gagneten 博士 美国FDA生物制品审评与研究中心 病毒产品部 疫苗审评与研究处副处长 43 推进中国疫苗安全性和创新性 罗建辉 中国药品审评中心生物制品药学部副部长 FDA的疫苗申请:有关安全性和上市后变更的法规 Sara E. Gagneten 博士 美国FDA生物制品审评与研究中 心病毒产品部 疫苗审评与研究处副处长 分会场 T 5-3 | 2013年5月14日 星期二 13:30 - 15:00 二层, 201 B+C 细胞药物和生物类似药的研发 - 机遇及监管要求 会议主持 史力 博士 上海泽润生物科技有限公司首席执行官 生物类似药和细胞疗法已进入生物制品开发及临床应用的热点阶段.这些领 域对当前和未来以生物为基础的药品开发发挥着越来越重要的作用.随着新 技术的发展,新的疾病治疗方法包括细胞治疗,在逐渐进入实践,其治疗方 法也在面临技术和监管方面的双重挑战.另外生物类似药进入监管成熟的国 家仍需要做很多工作以满足法规要求.本专场将讨论细胞治疗和生物类似药 开发、质量、安全性和监管要求的现状和机遇. 细胞治疗及发展和现状及其在医学美容治疗中的应用 朱宁文 博士 江苏华亿细胞组织工程有限公司创办人兼首席科学家 按照国际GLP标准对中国新生物医药进行安全评价研究 徐景宏 博士 中国Innostar公司国家上海新药安全评价研究中心副总裁及首席安全官 从监管的角度来看将中国生物类似药引进欧盟的期望和机会 Hoss Dowlat 博士 德国PharmaBio咨询公司政府事务部欧洲-美国区副总裁 分会场 T 5-4 | 2013年5月14日 星期二 15:30 - 17:30 二层, 201 B+C 中国与全球的疫苗产品认证和肝炎新疫苗研发 会议主持 史力 博士 上海泽润生物科技有限公司首席执行官 提高疫苗产品质量及新型疫苗的开发正在中国得到更多的关注.向世界供应 中国制造的疫苗已提上中国疫苗行业的议事日程.世卫组织预认证(PQ)和新 版GMP的实施已经在中国实实在在地展开并取得了实际成果.肝炎疾病是亚 洲包括中国最普遍和严重的疾病之一.本次会议将探讨WHO的PQ实践和肝 炎疫苗的有效性及新发展.本次会议还将回顾开发创新生物医药产品与抗传 染病产品开发的国际合作的机会. 世卫组织对疫苗和生物制品的质量预认证 Nora Dellepiane 博士 世界卫生组织基本药物和医疗产品部疫苗质量和监管组组长,质量安全科学家 滴定法检测甲型肝炎减毒活疫苗 汪萱怡 博士,教授 上海复旦大学医学院 新二代乙型肝炎疫苗的开发:新型佐剂提高疫苗的有效性 Tyler J. martin 医学博士 美国Dynavax总裁和首席医疗官 细胞治疗和生物类似药的开发机会和法规管理上的考虑 Hoss Dowlat 博士 德国PharmaBio咨询公司政府事务部欧洲-美国区副总裁 专题 6 | CMC 分会场 T 6-1 & T 6-2 | 2013年5月14日 星期二 08:30 - 12:00 二层, 201 D 仿制药与参比制剂之比较与评价 — 仿制药质量一致性评价 会议主持 桂敏 博士 百时美施贵宝全球注册科学部 亚太区和中国CMC及运营部总监 陈琦琬 博士 辉瑞全球CMC执行总监 前美国FDA新药审评质量评估部副部长 美国FDA同仁会国际网络成员 国家食品药品监督管理总局(CFDA)2012年开始对2007年前批准的仿制药进 行再评价.该项工作旨在确保药品的安全、有效和质量.如何科学有效地进 行评价?监管部门和制药企业面临着哪些实际挑战?如何解决发现的问题? 本专场将讨论仿制药再评价、分享生物等效性评价和体外溶出度试验的经 验. 国家食品药品监督管理总局仿制药质量一致性评价工作程序 林兰 中国食品药品检定研究院化学药品检定所副所长 参比制剂的选择及溶出度对比试验指南 张启明 中国食品药品检定研究院研究员 体内体外相关性- 挑战与考量 Deepak Hegde 博士 无锡药明康德有限公司配方研发部副总裁 美国药企对仿制药生物等效性和体外溶出度的研究 魏晓雄 医学博士 美国Medpace临床药理部总监 美国FDA同仁会国际网络成员 专家讨论 分会场 T 6-3 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 D 中美植物药监管展望 会议主持 陈琦琬 博士 辉瑞全球CMC执行总监 前美国FDA新药审评质量评估部副部长 美国FDA同仁会国际网络成员 在美国,植物药依照其用途被划分为食品增强剂或药品来监管.美国FDA在2004年发布了关于植物药的指导意见,其涵盖了FDA对临床研究的不同阶段 与新药申请前的CMC方面的建议.该建议使制药业和学术界得以开始药用植 物制品的研究,并在2006年批准了第一例植物药品.本专场将简要回顾植物 药品监管的历史,探讨美国在开发此类药品时所面临的挑战,并与中国长期 以来在中药监管方面的经验做比较. 44 中药产业前景 周俊杰 博士 上海和记黄埔医药有限公司总经理 中药新药研发策略和研发实践 叶祖光 教授 中国中医科学院首席研究员 中药全球化所面临的机遇和挑战 张迅 博士 葛兰素史克(上海)医药研发有限公司副总裁, 全球天然产物事业部负责人 分会场 T 7-2 | 2013年5月14日 星期二 10:30 - 12:00 二层, 203 C 中药开发的案例分析与实践 会议主持 许俊才 上海医药临床研究中心高级副总裁 本专场将通过案例分析讨论中药开发的经验和监管要求,也将讨论"如何制定 中药临床评价的标准". 中药在中国的监管准则和进展 陈易新 国家食品药品监督管理总局 原药品注册司 中药处处长 中国中药临床研究新进展 许俊才 上海医药临床研究中心高级副总裁 专题 8 | 肿瘤靶向药物的研发 合作单位; 美中抗癌协会 分会场 T 8-1 | 2013年5月14日 星期二 13:30 - 15:00 二层, 201 D 肿瘤诊断和治疗模式的改变对药物研发的影响 会议主持 陈之键 医学博士,工商管理硕士 阿斯利康(中国)全球药物研发 中国区副总裁兼负责人 徐莉 医学博士,工商管理硕士 美国辉瑞公司肿瘤业务部, 肿瘤中国策略规划、贯彻和全球运作部副总裁 肿瘤靶向创新药物研发现状概述以及2个成功研发案例的回顾分析 概述和介绍 Maria Koehler 医学博士 美国辉瑞公司肿瘤业务部,临床研究和医学事务部副总裁 案例:基于标志物或靶点的抗肿瘤药物的研发-对合适的人群在合适的时间给 予合适的药物 ? 案例 1 - 克唑替尼:间变性淋巴瘤激酶(ALK)和非小细胞肺癌(NSCLC) Maria Koehler 医学博士 美国辉瑞公司肿瘤业务部,临床研究和医学事务部副总裁 ? 案例 2 - 针对BRAF V600e/k 基因突变的黑色素瘤的BRAF抑制剂治疗 郭军 教授, 医学博士 北京肿瘤医院、北京大学临床肿瘤学院副院长,北京市肿瘤防治研究所 副所长,肾癌黑色素瘤内科主任 国家食品药品监督管总局(CFDA)对中药的监管要求 周跃华 中国药品审评中心中药民族药药学部副部长 美国植物药的监管背景 吴笃恭 博士 PPD法规部总监/资深顾问 美国FDA同仁会国际网络成员 美国植物药品开发所面临的监管挑战 林则全 博士 生物医药咨询公司资深顾问 美国FDA同仁会国际网络成员 专家讨论 分会场 T 6-4 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 D 全球生物制药法规的发展 — CMC视角 会议主持 蔺亚萌 罗氏(中国)技术监管政策部经理 桂敏 博士 百时美施贵宝全球注册科学部 亚太区和中国CMC及运营部总监 过去的十几年中,新技术的发展与应用不断促进生物制药的研发变革.本专 场将介绍全球生物制药产品法规的沿革,以及影响美国和欧盟监管框架的新 监管理念,如贯穿生物制药产品生命周期的工艺验证以及CMC变更管理方案 等.此外还将讨论新ICH Q11指南在生物制药产品原料药研发中的应用,并 结合具体的案例讨论如何将平台工艺应用于生物制药的开发. 美国生物制药监管法规的沿革 徐砺新 医学博士 美国FDA药品审评与研究中心单克隆抗体处,生物科技产品办公室,生物药 品质量评审专家 ICHQ11指南在生物制药原料药研发中的应用 Anthony Ridgway 博士 加拿大卫生部健康产品和食品局 生物和基因疗法处资深监管科学家 模块化病毒验证方法在单克隆抗体平台纯化工艺中的应用 陈琪 博士 美国Genentech公司病毒清除室,蛋白纯化系副总监兼资深科学家 专题 7 | 传统中药 (TCM) 分会场 T 7-1 | 2013年5月14日 星期二 08:30 - 10:00 二层, 203 C 开发适用于中国及全球的创新性中药 会议主持 张迅 博士 葛兰素史克(上海)医药研发有限公司副总裁, 全球天然产物事业部负责人 本专场将介绍关于创新性中药产品开发的研发战略和方法,并将讨论制药企 业致力于借鉴国际临床药物研发技术和标准,研发高质量、受专利保护以及 临床证实的中药新药所面临的机遇和挑战. 45 分会场 T 8-2 | 2013年5月14日 星期二 15:30 - 17:30 二层, 201 D 肿瘤靶向创新药物研发策略 会议主持 陈之键 医学博士, 工商管理硕士 阿斯利康(中国)全球药物研发 中国区副总裁兼负责人 徐莉 医学博士,工商管理硕士 美国辉瑞公司肿瘤业务部, 肿瘤中国策略规划、贯彻和全球运作部副总裁 讨论如何制定高质量、快速、有价值的肿瘤靶向药物开发和注册策略及中国 从参与到主导研发的角色转变. 创新肿瘤靶点识别和验证 杨炜 博士 强生中国上海研发中心研发科学事务部总监 临床研发策略:确定适当目标人群,采用最佳终点指标和研究设计,充分利 用中国优势 牟骅 医学博士 和记黄埔医药(上海)有限公司执行副总裁及首席医务官 中国在参与和领导肿瘤创新药物的发现和研发过程中的角色 周彩存 教授, 博士 同济大学医学院肿瘤研究所所长,肿瘤学系主任 专题 9 | 药物毒理 分会场 T 9-1 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 B+C 药物毒理:从动物试验到人体试验 会议主持 龚兆龙 博士 美国FDA同仁会国际网络成员 前美国FDA新药审评员 百济神州(北京)生物科技有限公司副总裁 讨论新药开发中美国和中国FDA对临床前安全性评价的法规要求,临床前安 全性数据的分析和解释,以及如何用动物数据预测人体的潜在风险和支持法 规申报和决策. 美国FDA临床前安全评价要求 Paul A. Andrews 博士 卫材公司全球法规事务部执行总监 中国CFDA临床前安全评价要求 彭健 博士 赛诺菲(中国)亚太研发中心科学顾问 专家讨论 分会场 T 9-2 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 B+C GLP法规;数据的质量和完整性 会议主持 姚大林 医学博士 美国FDA同仁会国际网络成员 前美国FDA资深药审官,GLP督查官 昭衍新药研究中心有限公司资深副总裁兼首席科学家 从CRO和政府监管机构观点出发,全面阐释与GLP法规相关的临床数据的质 量和完整性,终极目标是保证达到临床项目的安全. 非临床研究管理规范(GLP)的遵循问题对临床前研究的数据质量与完整性的影 响—合同研究组织(CROs)的视角 Jane PEARSE 博士 英国亨廷顿生命科学公司国际市场部特殊项目总监 GLP法规和药物安全性评价对公众健康的重要意义 - FDA 的观念 姚大林 医学博士 美国FDA同仁会国际网络成员 前美国FDA资深药审官,GLP督查官 昭衍新药研究中心有限公司资深副总裁兼首席科学家 专家讨论 以上讲者及 付立杰 博士, 美国毒理科学院院士 SNBL中国事业总经理,中国毒理学会副理事长,亚洲毒理学会副会长 左从林 昭衍新药研究中心有限公司总裁兼CEO 分会场 T 9-3 | 2013年5月15日 星期三 13:30 - 15:00 二层, 201 B+C 药物研发的毒理评价和风险评估 会议主持 付立杰 博士, 美国毒理科学院院士 中国事业总经理,中国毒理学会副理事长,亚洲毒理学会副会长 王英 博士, 美国认证毒理学家 葛兰素史克中国研发中心药物安全评价总监 本专场讨论毒理学在药物研发中的安全评价和风险评估,着重于中国生物药 和中药临床前安全评价,以及技术转让过程中非临床的风险评估. 毒理学的基本概念,危害与风险 付立杰 博士, 美国毒理科学院院士 SNBL中国事业总经理,中国毒理学会副理事长,亚洲毒理学会副会长 干细胞治疗产品的安全性评价 马璟 医学博士 国家上海新药安全评价研究中心研究员 中药的安全性评价及案例研究 王全军 医学博士 国家北京药物安全评价研究中心主任助理 化合物技术转让过程中非临床安全性评估 王英 博士, 美国认证毒理学家 葛兰素史克中国研发中心药物安全评价总监 46 专题 10 | 数据管理和电子临床 分会场 T 10-1 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 A 科技进展对临床数据管理的影响 会议主持 刘川 博士 Medidata Solution大中华地区发展总监 高新技术的发展也使临床研究领域发生变化,如临床试验方案制定和数据获 得与交换方式方法的改变.临床研究在应用高新技术和信息的某些方面相对 落后.因此了解云技术等高科技发展趋势及应用对推动制药业的发展非常重 要.本专场将讨论高新技术给数据管理者带来的益处,及对今后数据管理领 域的影响. 大数据运算 — 理念与实践 Glen de Vries 美国Medidata Solutions公司总裁 生命科学领域的云技术应用 Abhishek BAGGA 印度Cognizant Technology Solutions生命科学研发部临床中心经理 生物信息工具在数据分析和管理中的应用 Eric S. HERBEL 美国Integrated Clinical Systems公司总裁 专家讨论 分会场 T 10-2 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 A 安全数据管理 – 数据管理者的职责 会议主持 刘宗范 默沙东研发(中国)有限公司 全球临床数据管理中心亚太区总监 本专场将介绍如何通过数据验证计划,数据审核过程和医学编码程序确保安 全性数据的质量.经验丰富的讲者与参会者分享管理安全数据的经验,共同 讨论如何应对安全数据管理的挑战. 安全数据的验证及严重不良事件的考虑 陈朝华 辉瑞中国研发中心全球临床数据服务部负责人 I期临床研究的安全性数据管理 徐刚 葛兰素史克(中国)研发数据管理部总监 安全数据管理-编码 Lobo Loo 默沙东数据管理部中国区副总监 专家讨论 分会场 T 10-3 & T 10-4 | 2013年5月15日 星期三 13:30 - 17:30 二层, 201 A 数据标准在临床研究中的应用和成功案例 会议主持 张子豹 博士 PPD生物统计与编程部副总监 邓亚中 工商管理硕士 科文斯(中国)临床数据分析与报告负责人 数据标准一直是药物研发中优化临床研究及提升数据和信息流通水平的热门 话题.本专场将集中研讨标准化带来的价值以及全球实施的不同方法.专 家们将分享成功经验、讨论临床试验中采用数据标准化所遇到的挑战、及CDISC标准化实施及监管要求的最新动态. 从电子健康档案到临床数据库 Demetris ZAMBAS 美国默沙东全球数据管理部执行总监 一个全球CRO实施CDISC标准的经验 李建荣 PPD生物统计和编程亚洲运营部总监 应用CDISC标准的实例:从CDASH 到SDTM 和ADAM 吴崇胜 博士 科文斯(中国)公司生物统计部资深经理 使用CDISC标准以提高临床研究的效率 Ivan Tjong-A-HUNG 医学博士,工商管理硕士 上海霖谷医药科技有限公司总经理 CDISC标准在中国的最新进展 王兰香 诺华制药(中国)有限公司综合信息科学部首席统计师 中国CDISC协调委员会委员 专家讨论 以上讲者及 黄钦 博士 中国药品审评中心生物统计学部副部长 专题 11 | 医疗器械、药械组合产品的创新 分会场 T 11-1 & T 11-2 | 2013年5月15日 星期三 08:30 - 12:00 二层, 203 C 医疗器械的创新、监管及研发投资 会议主持 王凯玲 美国瑞格律师事务所 中国生命科学首席顾问 王春燕 圣犹达医疗用品(香港)有限公司 亚太区临床研究总监 本专场将讨论医疗器械的创新、注册和资金支持.资深专家将介绍CFDA最新 颁布的医疗器械GCP草案,审视风险投资在医疗器械创新和开发中所起的作 用、并进行案例分析. 医疗器械创新 Kok-Hwee NG 博士 圣犹达医疗用品有限公司 创新和策略制作中心设备研发部总监 47 中国医疗器械的GCP草案 岳相辉 国家食品药品监督管理总局 原医疗器械监管司研究评价处 优化医疗器械临床试验 宓现强 教授 中国科学院上海高等研究院 医疗器械创新: 案例分析 王凯玲 美国瑞格律师事务所 中国生命科学首席顾问 风险投资在医疗器械领域的作用 邢菲 医学博士 中国德诚资本投资公司总监 专题 12 | 合同研究机构 分会场 T 12-1 | 2013年5月15日 星期三 13:30 - 15:00 二层, 201 D 如何建立双赢关系 会议主持 蒋皓媛 医学博士 江苏恒瑞制药有限公司执行医疗总监 在药品/器械开发的过程中,企业可能不需要自行承担全部的研发工作.本场 将重点讨论药企寻求外包合作伙伴的考评标准.除费用因素外,药企与CRO 的沟通还包括具体业务要求,科学/医疗方面的专长,特殊领域的技术,定向 职能的合作,甚至是外派专业人员,直至整个项目的外包合作. 案例介绍:如何利用中国收集的安全数据在美国成功地申报IND 李锡明 医学博士 绿叶制药集团全球临床研究和监管事务部副总裁 药物早期临床研究: CRO的选择及协作的机会 吴安凡 博士 罗氏中国早期开发部负责人 案例分析: 企业与CRO合作成功在美国申报IND 王在琪 医学博士 中国默沙东临床研究执行总监 合作中共赢共生 蒋皓媛 医学博士 江苏恒瑞制药有限公司执行医疗总监 分会场 T 12-2 | 2013年5月15日 星期三 15:30 - 17:30 二层, 201 D 合同研究机构对确保药品安全所起的作用 会议主持 宫岩华 中国医药市场协会副理事长,中国医药技术市场协会CRO联合体副主席兼秘 书长, 新药创新和专业化委员会常务副主任 刘佳 爱恩希(北京)医疗科技有限公司 北亚及中国区总经理 本专场将重点探讨合同研究机构如何通过创建合理优化的内部组织结构和发 展在中国的高质量团队来保证研究中病人安全. 在临床试验实施中支持患者安全管理的药物警戒战略同盟 Sheona Stevenson 博士 新加坡INC Research药物警戒部副总监,亚洲区负责人 中国的临床监查: CRO视角下的质量保证 陈丽娟 InVentiv Health Clinical 公司 临床研究中心亚太区执行总监 一个中国本土CRO公司在IPO上市后的业务发展 沙伟郡 杭州泰格医药 事业发展部总监兼项目总监 专家讨论组 以上讲者 专题 13 | 上市后和实际环境中的药物研究 分会场 T 13-1 | 2013年5月15日 星期三 15:30 - 17:30 二层, 201 B+C 上市后和实际环境中的药物研究 会议主持 汤铭 医学博士 上海华斯泰生命策略研究所高级研究员 一个药品批准上市后,科学和医学研究仍在继续.有许多方法和机制可用于 在实际环境中进一步研究和评价该药物的安全与有效性,并发现其潜在的新 用途.本专场将围绕这些方法在国内的应用趋势、实用性、问题和其可能的 解决办法进行讨论. 引言和概述 汤铭 医学博士 上海华斯泰生命策略研究所高级研究员 病人登记 萧燕 医学博士 罗氏(中国)药物研发亚太区中心高级流行病学家 临床研究者启动的试验 ? 案例 I 范帆 博士 赛诺菲(中国)资深医疗总监 ? 案例 II 王伊龙 博士 北京天坛医院神经内科,科研处副处长 48 专题 14 | 药物流行病学的最佳实践和药物安全 分会场 T 14-1 | 2013年5月15日 星期三 13:30 - 15:00 二层, 203 C 药物流行病学的最佳实践和药物安全 会议主持 周伟 医学博士 默沙东默克实验室 流行病学亚太区总监 本专场邀请来自学术界、政府监管部门、及药业著名的药物流行病学家分享 对药物流行病的研究现状、最新进展及比较效益分析的见解. 药物研发和风险控制中药物流行病学基本原理及方法介绍 詹思延 教授, 医学博士 北京大学医学部流行病和生物统计系副主任 药物流行病及药物安全监管法规的进展 颜敏 国家食品药品监督管理总局 药品安全监管司副司长 药物流行病研究的最新进展:电子医疗及保险数据库,及比较效益分析在评 价药物安全和有效性中的应用 陈建炜 博士 台湾大学医院 医学研究科副主任 专题 15 | 中国药品电子监管 分会场 T 15-1 | 2013年5月15日 星期三 15:30 - 16:15 二层, 203 C 药品追溯体系建设 – 药品电子监管 王迎利 国家食品药品监督管理总局 信息中心信息规划处副处长 DIA eLearning Easy Access to Instant Education ? Flexibility to Learn Anytime, Anywhere ? Reduce Travel Costs ? Self-Paced Programs Visit diahome.org/elearning. 49 COMPANY WHITE PAPER SHOWCASE This year, the White Paper Showcase organized by three companies will share their experience, expertise and practices on drug safety and techonology for innovation. Quintiles 13:30 - 15:00 (3rd Floor, 308) Tectonic Transformations: The Future of Biopharma- ceuticals in Asia Amar Kurershi, MD, FRCPC Chief Medical Officer and Head of Drug Development, Quintiles Asia, Singapore Ling Zhen Vice President and General Manager, Quintiles, Greater China Proswell Medical Company 15:30 - 17:30 (3rd Floor, 308) PATIENT SAFETY AND PROACTIVE RISK MANAGEMENT IN CLINICAL TRIAL Establish a Post Marketing Safety System and Standard Procedure to Ensure Product Safety and Proactively Manage Risk ? A comprehensive "End-to-End" safety surveillance system ? Highly specified safety operational and pharmacovigilance processes ? Special designed pharmacovigilance programs support in global post marketing risk benefit assessment Sean Zhao, MD, PhD Vice President, Global Safety, Amylin Pharmaceuticals, Inc. U.S. Head of Pharmacoepidemiology (PV-Epi) Amgen Global Safety Surveillance Process Owner Chairperson of Amgen Safety Policy Committee Subjects Safety in Phase I Clinical Trial ? Category of safety issues ? Unpredictable safety issues ? Case analysis about unpredictable safety issues Bei Hu, PhD Chief Physician, Clinical Pharmacology Research Center, Peking Union Medical College Hospital, China. C3i 13:30 - 15:00 (3rd Floor, 308) Advance Clinical Trials Technology: Best Practices in Deploying Global Word-Class Support for eClinical Applications Discover how site-centric service desk support can provide a comprehensive single point of contact for all technology needs of global clinical sites, ensure accurate data collection and reduce the time spent by the clinical staff on non- clinical activities. Jonathan Song Business Development Director, Asia Pacific Region, C3i, Inc, China Sara DiMinno Project Manager, C3i, Inc, USA 参展商研讨会 本次年会新增参展商研讨会.3家企业将围绕"药品安全,技术创新"分享经 验. 昆泰公司 13:30 - 15:00 (三层 308) 结构性变革:亚洲生物制药企业的未来 Amar Kurershi 博士 昆泰公司亚洲区首席医务官兼药物开发主管 甄岭 昆泰公司大中华区总经理 北京春天医药 15:30 - 17:30 (三层 308) 关注临床试验中受试者用药安全及风险的主动管控 上市后研究体系和产品安全标准程序的建立以及风险的主动管控 ? 安全监管体系对于优化用药安全的重要性 ? 高标准的安全操作和药物警戒体系 ? 国际多中心药物上市后研究的风险利益评估 赵子贤 博士 美国Amylin Pharmaceuticals, Inc. 全球药品安全副总裁 药物流行病学总监(药物警戒-流行病学) 安进公司全球药品安全监查部总监 安进公司药品安全决策委员会主席 从I期临床研究谈谈药物研发早期的安全性问题 ? 安全性的分类 ? 非预期的安全性 ? 非预期安全性的案例分析 胡蓓 博士 中国北京协和医院临床药理中心主任医师 C3i 13:30 - 15:00 (三层 308) 电子临床软件全球部署及支持的最佳实践 讨论客服中心如何为全球临床试验基地提供单点联系的综合技术支持服务, 并确保精确的数据收集,减少试验人员花费在技术及软件方面的时间,提高 临床试验效率. 宋康 科睿特客服科技(大连)有限公司亚太地区业务拓展总监 萨拉 ? 狄米诺 科睿特客服科技 (大连)有限公司项目经理 NEW EXPERIENCES TUESDAY, MAY 14 5月14日 星期二 wednesday, MAY 15 5月15日 星期三 50 SUNDAY, MAY 12, 2013 | Pre-Conference WORKSHOPS ONLY 07:30-16:00 1st Floor, Foyer Registration 08:30-17:30 2nd Floor, 201B Full-Day Workshop 1 Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies 2nd Floor, 201C Full-Day Workshop 2 Drug Substance and Drug Product Stability Requirements and Practices 2nd Floor, 201D Full-Day Workshop 3 Data Management for Oncology Trials 2nd Floor, 203C Full-Day Workshop 4 Applying MedDRA in Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective 2nd Floor, 201A Full-Day Workshop 5 Global Clinical Trials in Drug Development-Principles and Case Studies 3rd Floor, 307 Full-Day Workshop 6 National Drug Safety and Active Pharmaceutical Ingredients (APIs) in China: Development of Recommendations for the Regulation of APIs 10:00-10:30 1st Floor, Exhibition Hall Tea Break 12:00-13:00 2nd Floor, Conference Hall 2 Lunch 15:00-15:30 1st Floor, Exhibition Hall Tea Break MONDAY, MAY 13, 2013 | CONFERENCE Day 1 07:30-16:00 1st Floor, Foyer Registration 13:30-17:30 1st Floor, Exhibition Hall Exhibition and Poster Session Open 13:30-17:15 2nd Floor, Conference Hall 1 Opening Plenary Session ( 15:30-16:00, Tea Break, 1st Floor, Exhibition Hall) Keynote Speech: Encourage Drug Innovation and Ensure Patient Safety Professor Guowei SANG, MD President, Chinese Pharmaceutical Association (CPA) Academician, Chinese Academy of Engineering Risk Management Planning Spurs Innovation and Enables Patient Safety Patrizia A. CAVAZZONI, MD Senior Vice President, Worldwide Safety and Established Products Regulatory, Pfizer Inc. USA Status and Expectations about ARV Treatment for People Living with HIV Lin MENG Director, Ark of Love Information Center General Secretary of China Alliance of People Living with HIV/AIDS Representative of Country Coordinating Mechanism (CCM) of the Global Fund China Programs 17:30-19:30 1st Floor, Exhibition Hall/2nd Floor, Conference Hall 2 Welcome Reception - China Night: DIA China 5th Anniversary Celebration TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 07:30-16:00 1st Floor, Foyer Registration 08:30-17:30 1st Floor, Exhibition Hall Exhibition and Poster Session Open 08:30-10:00 1st Floor, 5 C+F T 1-1 Clinical Excellence When Involving China in Global Clinical Development: Maximize Benefits and Minimize Risks 1st Floor, 5 A+B+G+H T 2-1 Global Trends and China Development Status on Fixed-dose Combinations (FDCs) 1st Floor, 5 D+E T 3-1 Pharmacovigilance during Pre-approval – An Exciting Journey of Investigation 2nd Floor, 201 A T 4-1 Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio- Part I 2nd Floor, 201 B+C T 5-1 Ensuring Innovation and Safety for Cell/Gene Therapy and Blood Products 2nd Floor, 201 D T 6-1 Evaluation of Generic Products vs. Reference Products - The 2007 Conundrum - Part I 2nd Floor, 203 C T 7-1 Development of Novel TCM Products for China and Global Market 10:00-10:30 1st Floor, Exhibition Hall Tea Break 10:30-12:00 1st Floor, 5 C+F T 1-2 Coordination and Communication among Stakeholders of Clinical Trials 1st Floor, 5 A+B+G+H T 2-2 New Biosimilar Regulation: Challenges and Opportunities 1st Floor, 5 D+E T 3-2 Pharmacovigilance during Post-approval - Path to Success 2nd Floor, 201 A T 4-2 Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio- Part II 2nd Floor, 201 B+C T 5-2 Principles for Pandemic Influenza Preparedness and Post-marketing Vaccine Knowledge NetWorking Meeting Information Quick guide to the program 51 Knowledge NetWorking Meeting Information Manufacturing Changes 2nd Floor, 201 D T 6-2 Evaluation of Generic Products vs. Reference Products - The 2007 Conundrum - Part II 2nd Floor, 203 C T 7-2 Case Studies and Good Practices in TCM Development 12:00-13:30 2nd Floor, Conference Hall 1 Lunch TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 (Continued) 13:30-15:00 1st Floor, Conference Hall 3 CFDA Townhall: Pre-marketing and Post-marketing Drug Safety Supervision in China 2nd Floor, 201 B+C T 5-3 Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations 2nd Floor, 201 D T 8-1 Changing Paradigm in Cancer Diagnosis and Treatment - Impact on Drug Development 15:00-15:30 1st Floor, Exhibition Hall Tea Break 15:30-17:30 1st Floor, Conference Hall 3 CFDA Townhall (continued) : Pre-marketing and Post-marketing Drug Safety Supervision in China 2nd Floor, 201 B+C T 5-4 Vaccine Product Qualification and Novel Hepatitis Vaccine Development for China and the World 2nd Floor, 201 D T 8-2 Strategies for Discovery and Development of Target-based Novel Cancer Medicines 17:30-19:30 2nd Floor, Conference Hall 2 Speaker & VIP Reception Wednesday, MAY 15, 2013 | CONFERENCE Day 3 07:30-16:00 1st Floor, Foyer Registration 08:30-17:30 1st Floor, Exhibition Hall Exhibition and Poster Session Open 08:30-10:00 1st Floor, 5 C+F T 1-3 GCP Clinic 1st Floor, 5 A+B+G+H T 2-3 & T 3-3 Balancing Risk and Benefit during IND Period 1st Floor, 5 D+E T 4-3 Overview of Meta - Analysis and Its Application in Drug Development 2nd Floor, 201 D T 6-3 Regulatory Perspectives on Botanical Drug Products in China and the United States 2nd Floor, 201 B+C T 9-1 Pharm/Tox: From Animal to Human 2nd Floor, 201 A T 10-1 Technology Advancement in the Landscape of Clinical Data Management 2nd Floor, 203C T 11-1 Medical Devices: Innovation, Regulation and Investment - Part I 10:00-10:30 1st Floor, Exhibition Hall Tea Break/ Announcement of Poster Price Winners 10:30 - 12:00 1st Floor, 5 C+F T 1-4 Pharmacovigilance - QA Perspective 1st Floor, 5 A+B+G+H T 2-4 & T 3-4 Balancing Risk and Benefit during NDA and Post-marketing Periods 1st Floor, 5 D+E T 4-4 Quantitative Sciences in Pharmaceutical Development (QSPD) 2nd Floor, 201 D T 6-4 Evolution of Global Biotherapeutic Regulations – A CMC Perspective 2nd Floor, 201 B+C T 9-2 GLP Regulatory Compliance for Data Quality and Integrity 2nd Floor, 201 A T 10-2 Data Managers' Roles in Drug Safety 2nd Floor, 203C T 11-2 Medical Devices: Innovation, Regulation and Investment - Part II 12:00 - 13:30 2nd Floor, Conference Hall 1 Lunch / DIA Community Networking 13:30 - 15:00 1st Floor, 5 C+F T 1-5 Challenges and Opportunities at Clinical Trial Sites/Institutions 1st Floor, 5 A+B+G+H T 2-5 Therapeutic Biologic Development in China from CMC Perspective 1st Floor, 5 D+E T 3-5 Benefit-Risk: Getting It Right for Patients 2nd Floor, 201 D T 12-1 How to Build Win-Win Relationship 2nd Floor, 201 B+C T 9-3 Patient Safety: Toxicological Evaluation and Risk Assessment in Pharmaceutical R&D 2nd Floor, 201 A T 10-3 Data Standards in Real World Clinical Research - Part I 2nd Floor, 203C T 14 Pharmacoepidemiology - Drug Safety and Best Practices 15:30 - 17:30 1st Floor, 5 C+F T 1-6 Ethics Committee Roles and Development in China 1st Floor, 5 A+B+G+H T 2-6 Implementation of an Innovative Labeling Hub in Asia and Integration with Global Model 1st Floor, 5 D+E T 3-6 Does Risk Management Planning Benefit Patients? 2nd Floor, 201 D T 12-2 CRO: Value-added Taskforce to Ensure Patient Safety 2nd Floor, 201 B+C T 13 Post-approval and Real World Studies 2nd Floor, 201 A T 10-4 Data Standards in Real World Clinical Research - Part II 15:30 - 16:15 2nd Floor, 203C T 15 Introduction of Drug Electronic Administration Quick guide to the program 53 Full-day 08:30-17:30 Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies 08:30-17:30 Drug Substance and Drug Product Stability Requirements and Practices 08:30-17:30 Data Management for Oncology Trials 08:30-17:30 Applying MedDRA in Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective 08:30-17:30 Global Clinical Trials in Drug Development - Principles and Case Studies 08:30-17:30 National Drug Safety and Active Pharmaceutical Ingredients (APIs) in China: Development of Recommendations for the Regulation of APIs the system. ? To learn approaches for enhancing clinical R&D efficiency and quality ? To master transforming data to knowledge for better resource allocation and risk-based decision making ? To learn the usage of the global dictionaries for coding of clinical trial and safety data Targeted audience Professionals in the following areas: ? Clinical management and operation ? Clinical IT and computing ? Clinical trial data monitoring (CRAs, medical monitoring) ? Data assurance and data quality control ? Clinical informatics ? Regulatory affairs ? Data management and programming ? E-clinical vendor management ? Drug research and development Agenda Session I | Bioinformatic Tools in the Management of Clinical Studies I ? Data review during the discovery phase Session II | Bioinformatic Tools in the Management of Clinical Studies II ? Quality review process ? Patient data tracking ? CDISC standard data structures and approaches Session III | Advanced Reporting and Analysis to Drive Clinical Development Efficiencies ? Clinical R&D efficiency and quality ? Allocation of resources ? Studies planning and decision making Session IV | Effective Data Management and Knowledge Discovery on Global Data – the UMC Perspective I ? Signal detection and other methods for knowledge discovery ? Transforming data to knowledge: the importance of consistent dictionaries and terminologies Session V | Effective Data Management and Knowledge Discovery on Global Data – the UMC Perspective II ? Use of the WHO Drug Dictionaries for coding of clinical trial and safety data Workshop 1 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 B ANALYSIS OF DATA PATTERNS TO MONITOR AND ASSESS OUTCOMES OF CLINICAL STUDIES INSTRUCTORS Daniel LIU, PhD Director, China Development, Medidata Solutions Worldwide, China Eric S. HERBEL President, Integrated Clinical Systems, Inc., USA Yutaka SATO Business Consultant, Solutions Architecture, Medidata Solutions, Japan Madeleine Krieg, RPh Product Manager, Uppsala Monitoring Centre, Sweden Maria Lindquist, PhD Director & CEO, Uppsala Monitoring Centre, Sweden DESCRIPTION Overthepast10years,thedurationandcomplexityofclinicaltrialshavesteadily increased, Pharmaceutical R&D budgets are tighten and less resources on longer and more complex clinical trials have been observed. It becomes more critical to conduct clinical trials with more effective and innovative approaches. This workshop will discuss typical use patterns and best practices for data analysis of clinical studies. Topics include use patterns in support of ongoing medical monitor of clinical trials, use of CDISC data structure for risk-based monitoring, trial management during a clinical trial and post-approval clinical activities. A variety of approaches for reviewing clinical data, study planning, and decision-making based on the data accumulation will be discussed. The workshop will also cover topics such as a better allocation of resources to enhance clinical R&D efficiency and quality, benefits for patient data review, methods for outlier detection, and how to conduct signal detection. Learning objectives ? To understand when and how to use bioinformatic tools in reviewing clinical data. ? To learn typical use patterns that have emerged focusing on the "patient identification/drill-down" reports, graphs, patient profile interactions of SUNDAY, MAY 12, 2013 | PRE-CONFERENCE WORKSHOPS ONLY 54 Workshop 2 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 C DRUG SUBSTANCE AND DRUG PRODUCT STABILITY REQUIREMENTS AND PRACTICES INSTRUCTORS Joan RUAN, PhD Associate Director, Analytical Development Bristol Myers Squibb Co, USA Xin (Amy) BU, PhD Principal Scientist, Analytical and Bioanalytical Development Bristol Myers Squibb Co, USA DESCRIPTION Stability is a crucial quality attribute of pharmaceutical products; therefore, a stability program in compliance with current regulations is critical to all the phases of the drug development process and the new pharmaceutical product registration. Successful execution of stability programs requires a good understanding of global regulatory requirements, stability methodologies, and best practices. This session presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products including regulatory and technical aspects to design global stability programs, which are cost effective and in compliance. Learning objectives ? To understand stability role in the drug development process ? To design stability study based on ICH/WHO and global requirements ? To execute global stability program effectively ? To understand the importance of stability indicating methods ? To manage global technology transfer ? To interpret stability data Targeted audience ? Pharmaceutical R&D scientists and managers ? Regulatory affairs staff ? Quality assurance and quality control professionals ? Contract Research/Manufacturing Organization ? Government health authority ? Academic institution Agenda Session I | Overview of Critical Regulatory Requirements for Drug Stability Program ? Stability role in the drug development process ? Review of cGMP stability requirements ? Review of ICH guidelines for stability ? Requirements for global stability programs ? Assignment of drug product shelf-life Session II | Practice in Technical Aspects of Drug Stability ? Development of stability indicating methods ? Design of forced degradation studies ? Method validation and transfer ? Evaluation of stability data Session III | Discussion - Case Study Workshop 3 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 D DATA MANAGEMENT FOR ONCOLOGY TRIALS Instructors Charles Yan, PhD Technical Operations Lead, Clinical Data Services, Pfizer (China) R&D Center, China Li Xu, MD, MSD, MBA Vice President, Oncology Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer, USA Emily Tan Executive Director, Clinical Research Asia Pacific, InVentiv Health Clinical, Singapore Wei Zhang, MD TA Lead, CDS, Pfizer (China) R&D Center, China Shuling Wu Data Management TA Lead, Pfizer (China) R&D Center, China Juan WANG Data Manger, Oncology Group, CDS, Pfizer (China) R&D Center, China Kiki Wu Associate Director, Clinical Data Management, MSD R&D (China), China DESCRIPTION The full day workshop consists of two sessions: session I (basic) will introduce the fundamentals for professionals new to oncology clinical trials and session II (advanced) will focus on the data management activities at each phase of oncology trials. Learning objectives ? To introduce the basics in cancer definition, diagnosis/treatment, and the stages of oncology trials. ? To specify the characteristics for an oncology trial in design, efficacy endpoints, and safety monitoring. ? To understand data management activities at each phase of the oncology trials by focusing on CRF design, data cleaning, lab data handling, response data measurement, and long-term study management. ? To discuss the best practices in oncology trials regarding the key data points, SAE handling, and lab data review. Targeted audience This workshop is designed for clinical professionals who are new in oncology trials or new in oncology data management. It will also benefit the following professionals: ? Clinical researchers ? Trial project managers ? Trial monitors ? Biostatisticians ? Trial programmers Agenda Session I | Oncology Clinical Trial Basics Part I : Overview ? Drug Development ? Oncology Standards of Care and Related Terminology 55 Part II : Trial Design and Endpoints ? Phases and Types of Oncology Trials ? Endpoints (PFS, ORR, OS, RECIST 1.1) Part III : Trial Conduction ? Informed Consent ? Site Monitoring and Protocol Deviation Part IV : Safety Monitoring ? Adverse Events and Serious Adverse Events ? Common Terminology Criteria for Adverse Events (CTCAE) Part V : Case Study Session II | Basics for Oncology Data Manager Part I : Study Initiation ? Understanding CRF design and database building for oncology trials ? Understanding treatment cycle for oncology studies ? Understanding efficacy data collection and measurement Part II : Study Execution ? Cleaning response data from oncology studies ? Handling local lab data with normal ranges ? Understanding/supporting clinical review on response and toxicity data ? 3rd Party review, challenges to DM ? Handling external data with reconciliation Part III : Study Completion ? Database lock for interim analysis for ongoing oncology studies ? Managing long-term studies with follow-up Part IV : Best Practices for Oncology Trials ? Critical data points in oncology trials ? Data collection: needs vs. nice to have ? SAE handling ? Panic lab test data review ? Tumor response Workshop 4 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 203 C APPLYING MedDRA IN CLINICAL SAFETY AND PHARMACOVIGILANCE PRACTICES: REGULATORY PERSPECTIVE Instructors Anna ZHAO-WONG, MD, PhD, PMP Deputy Director, MedDRA Maintenance and Support Services Organization, USA Sonja BRAJOVIC, MD MedDRA Coordinator, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, USA DESCRIPTION This workshop will focus on the application of MedDRA in clinical safety and pharmacovigilance, including a regulatory perspective. It will provide in- depth coverage of how to consistently and accurately encode clinical data with MedDRA and options to retrieve and present MedDRA-coded data as outlined in the ICH-endorsed "MedDRA Term Selection: Points to Consider" and "MedDRA Data Retrieval and Presentation: Points to Consider" documents. The use of Standardised MedDRA Queries (SMQs) as tools to aid case identification and signal detection will be discussed. The implementation of MedDRA in US FDA Adverse Event Reporting System (FAERS) database will be described, including the current use of the terminology for coding and analysis of safety data. Attendees are encouraged to bring questions about MedDRA coding, data retrieval/analysis to share and discuss. Learning objectives ? To describe the use of MedDRA terminology in coding adverse event data. ? To demonstrate strategies for retrieval and subsequent analysis of MedDRA-coded data in clinical safety and pharmacovigilance. ? To understand how US FDA applies MedDRA in post-market pharmacovigilance utilizing the FDA Adverse Event Reporting System (FAERS) and in analysis of clinical trial safety data in new drug review. Targeted audience This workshop is designed for the following professionals who already have a basic knowledge of MedDRA and wish to explore the implications of its use in clinical safety and pharmacovigilance: ? Pharmacovigilance and clinical research professionals ? Clinical data managers ? Medical writers ? Regulatory affairs professionals Agenda Session I | MedDRA Introduction Session II | MedDRA Coding and the ICH-endorsed Coding Guide: "MedDRA Term Selection: Points to Consider " ? Overview of MedDRA coding and the "MedDRA Term Selection: Points to Consider" document ? Data quality issues from US FDA perspective with coding examples ? Coding exercises ? Question & Answer Session III | Analyzing MedDRA-Coded Data and the ICH-Endorsed Data Retrieval Guide: "MedDRA Data Retrieval and Presentation: Points to Consider" ? Overview of the "MedDRA Data Retrieval and Presentation: Points to Consider" document ? Developing queries using MedDRA ? Query development exercise ? Standardised MedDRA queries ? Customized searches ? FDA approach to MedDRA search strategies for signal detection: examples from FDA AERS database and new drug safety review ? Question & Answer Session IV | MedDRA Versioning Workshop 5 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 A GLOBAL CLINICAL TRIALS IN DRUG DEVELOPMENT – PRINCIPLES AND CASE STUDIES Instructors William WANG, PhD Site Head and Executive Director, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP) Merck Research Laboratories / MSD R&D (China) Co. Ltd., China Qiong Shou, PhD Senior Scientist, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP) Merck Research Laboratories / MSD R&D (China) Co. Ltd., China 56 Hsien-Ming James HUNG, PhD Director, Division of Biometrics I, Office of Biostatistics OTS , Center for Drug Evaluation and Research (CDER), FDA, USA Sue-Jane Wang, PhD Associate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA Yuki Ando Senior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan DESCRIPTION In recent years, there was a significant increase of global clinical trials in pharmaceutical development. ICH guidance and/or local regulatory guidelines have set the basic scientific principles. The purpose of this workshop is to show the regulatory, statistical, clinical and operational principles through case studies in Cardiovascular (CV), Central Neurological System (CNS), anti- infective, oncology, and other therapeutic areas that may involve genomic factors. In each case study we will illustrate the disease, typical trial design, global development strategies, the global or regional clinical trial results, and regulatory review considerations. Learning objectives ? To review the regulatory, statistical, clinical and operational principles in global clinical trials. ? To learn various clinical development strategies for registration with different regulatory agencies through case studies. ? To review regulatory guidelines for regional registration through case studies. Targeted audience Professionals working in the following areas: ? Quantitative science ? Regulatory affairs ? Pharmaceutical industry (preclinical, pre-market, post-market development) ? Contract Research Organizations (CROs) ? Government organizations ? Academia and research institutes Agenda Session I | Principle and Case Examples in the CV/CNS Areas ? Concepts of consistency and inconsistency (e.g. PLATO – acute coronary syndrome trial, and schizophrenia trials) ? Challenges and advantages of global versus regional trial strategy Session II | Principles and Case Examples in Global/Regional Pharmacogenomics Trials ? Special features in design and analysis of pharmacogenomics trials (e.g. cancer, anti-viral, and other drug development influenced by genomic factors) ? Challengesversusadvantagesinglobalversusregionalpharmacogenomics Session III | Principles and Case Examples in Global/Asian Clinical Trials ? Development strategy and selection of trial design - Global/Asian/ Regional ? Evaluation of overall and regional results in global clinical trials Session IV | Panel Discussion Workshop 6 08:30 - 17:30 (12:00 - 13:00 Lunch) 3rd Floor, 307 National Drug Safety and Active Pharmaceutical Ingredients(APIs) in China: Development of Recommendations for the Regulation of APIs Welcome Remarks Xinyu WENG Division Head, Division of Drug Manufacturing Supervision, Department of Drug Safety & Inspection, CFDA, China Ling SU, PhD President, DIA Board of Directors Strategic Advisor, Life Sciences, Sidley Austin LLP, China Nicole Taylor SMITH, JD Assistant Country Director, U.S. FDA, China Office Session I | Summary of the 2012 Roundtable Discussion on the Regulation of APIs and Cooperation Jeffrey GREN Director, Office of Health and Consumer Goods, U.S. Department of Commerce, U.S. Co-chair of JCCT Pharmaceuticals Task Force, USA Session II | Definition and Regulation of APIs and Chemical Manufacturing in the US and EU and the Role of APIs in Global Drug Safety Discussion on the new EU API certification requirements and opportunities for international cooperation. Nicole Taylor SMITH, JD Assistant Country Director, U.S. FDA China Office Patrizia TOSETTI, PhD Policy Officer, DG Health and Consumers, European Commission, France Session III | Industry Perspectives on the Regulation of APIs Guy VILLAX Chief Executive, HOVIONE, Representative of Rx-360, Portugal Gary GU General Manager, DSM Sinochem Pharmaceutical(Zibo) Co., Ltd, China Session IV | Overview of Progress on API Regulation in China The session will discuss the regulation and oversight of APIs and bulk chemical manufacturers in China. Xinyu WENG Division Head, Division of Drug Manufacturing Supervision, Department of Drug Safety & Inspection, CFDA, China Session V | Inspection of API Manufacturing Facilities and Enforcement Cooperation to Address Unregulated Bulk Chemicals Piotr KRAUZE Scientific Administrator, Inspections at European Medicines Agency, United Kingdom Gang WANG, PhD Assistant Country Director, U.S. FDA China Office 57 Registration Open 07:30 - 16:00 Opening Plenary Session 13:30 - 17:15 2nd Floor, Conference Hall 1 (Tea Break 15:30 - 16:00) Introduction Jane CAI, PhD Director, DIA China OPENING REMARKS Ling SU, PhD President, DIA Board of Directors Strategic Advisor, Life Sciences, Sidley Austin LLP, China Li Yin, PhD Vice Minister, China Food and Drug Administration AWARDS CEREMONY WELCOME ADDRESSES Lingshi TAN, PhD Vice President, Pfizer Worldwide Development Operations General Manager, Pfizer (China) R&D Co. Ltd., China Yajun ZHAO Director-General, China Center for Pharmaceutical International Exchange (CCPIE), China KEYNOTE SPEECH Encourage Drug Innovation and Ensure Patient Safety Professor Guowei SANG, MD President, Chinese Pharmaceutical Association (CPA) Academician, Chinese Academy of Engineering Risk Management Planning Spurs Innovation and Enables Patient Safety Patrizia A. Cavazzoni, MD Senior Vice President, Worldwide Safety and Established Products Regulatory, Pfizer Inc. USA Status and Expectations about ARV Treatment for People Living with HIV Lin Meng Director, Ark of Love Information Center, General Secretary of China Alliance of People Living with HIV/AIDS Representative of Country Coordinating Mechanism (CCM) of the Global Fund China Programs welcome Reception-CHINA NIGHT: DIA China 5th Anniversary Celebration 17:30 - 19:30 Exhibition Hall & Conference Hall 2 Session VI | Role of Pharmacopeias Related to APIs in China, EU and US Ping WANG Deputy Secretary General, Chinese Pharmacopoeia Commission, CFDA, China Susanne KEITEL, PhD Director General, Council of Europe, Europe Directorate for Quality of Medicines (EDQM), France John Hu, PhD Vice President and General Manager, US Pharmacopeia, China Session VII | Legal and Policy Considerations to Ensure the Quality of APIs and Prevent the Sale or Export of Unregulated or Falsified APIs Discussion and recommendations to prohibit and deter the manufacture and sale of unregulated bulk chemicals for use in pharmaceutical products, including potential suggestions for revisions to China's Drug Administration Law, criminal code, and other statutes and regulations. Chen YANG, LLM Partner, Sidley Austin Law Office, China Zhiwei LIU Professor, Beijing Normal University, China Ke Liu, JD Associate Professor, Department law school, Beijing Normal University, China Jing HE, JD Senior Consultant, ANJIE Law Firm, China SessionVIII|Development of Specific Legal and Policy Recommend- ations To address the manufacturing, sale and distribution of unregulated or counterfeit/falsified APIs that are intended for use as an API in a finished drug product that either originates from or is consumed in China. Open Discussion: Moderators: Jeffrey GREN Director, Office of Health and Consumer Goods, US Department of Commerce, USA Xinyu WENG Division Head, Division of Drug Manufacturing Supervision, Department of Drug Safety & Inspection, CFDA, China Session IX | Future Cooperation on the Implementation of Recommendations Session X | Next Steps MONDAY, MAY 13, 2013 | CONFERENCE DAY 1 58 Session T 1-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 C+F Coordination and communication among stakeholders of clinical trials Session Chair Yan WU, MD General Manager, Division of Medical and Drug Development, Daiichi Sankyo (China) Holding Co. Ltd., China Round-Table discussion Throughout the whole clinical trial critical path, from protocol development, IEC/IRB review, site contract, patient/subject recruitment, to safety monitoring and site closeout, smooth coordination and effective communication among stakeholders such as sponsor, PI/study site, IEC/IRB and CRO, are essential to ensuring high efficiency and quality of clinical trials. In this session, speakers from clinical trial site, IEC/IRB, sponsor and CRO will share experiences on clinical trial preparation and management from each of their perspectives. All speakers/panelists will engage the audience in discussing how to build up smooth communication and coordination among all stakeholders to yield desired outcomes to all parties. The harmonization will lead to high efficiency in the clinical trial conduct with patient safety and rights in mind. Panelists Benny Chung-Ying Zee, Professor, PhD Director, Division of Biostatistics, School of Public Health and Primary Care, Center of Clinical Trial, The Chinese University of Hong Kong, China Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China Vivian GU Senior Director, Clinical Operations, Bristol-Myers Squibb, China Li CHEN, MD Head of Project Manager, ICON, China CFDA Townhall Tuesday, May 14, 2013 13:30 - 17:30 1st Floor, Conference Hall 3 Pre-marketing and Post-marketing Drug Safety Supervision in China Session Chair Bin XUE Deputy Director, CCPIE, CFDA, China 2012 Drug Review and Evaluation in China Zhen CHEN, PhD Deputy Office Director, Office of New Drug Pharmaceutical Science, CDE, CFDA, China TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 Jiangping DONG Division Head, Division of Pharmaceuticals, Department of Drug Registration, CFDA, China Gang CHENG Assistant Director, National Center for ADR Monitor, Center for Drug Reevaluation, CFDA, China Theme 1 | Clinical Research & Operations Session T 1-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 C+F Clinical Excellence When Involving China in Global Clinical Development: Maximize Benefits and Minimize Risks Session Chair Vivian GU Senior Director, Clinical Operations, Bristol-Myers Squibb, China To ensure the successful operations of clinical trials, we need to identify critical success factors and focus on patient safety and risk management. These are of great interests to pharma companies as well as authorities. After FDA and EMA issued the guidance of risk based monitoring, the principles need to be applied also in China and Asian countries that are more actively involving in global clinical development simultaneously. The in-depth presentations and discussions in this section will provide audience guidance to archive the clinical excellence. Critical Success Factors in Clinical Trials Jong Ran Kim Vice President, Clinical Research of Asia Pacific, ICON, South Korea Risk-Based Monitoring Elaine Hawkings Executive Director, Regional Clincal Operations of Asia Pacific, Bristol-Myers Squibb, China Risk and Benefit When Involving China and Asia in Global Clinical Trials Koichi Miyazaki, RPh Associate Director, Clinical Operation, Daiichi Sankyo, Japan Panel discussion TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 WEDNESDAY, MAY 15, 2013 | CONFERENCE DAY 3 59 Session T 1-5 | Wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 C+F Challenges and Opportunities at Clinical Trial Sites/ Institutions Session Co-Chairs Haiyan LI, Professor, MD Director, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China The amount of clinical trials have increased greatly in recent years, and CFDA has paid more attention to quality than before through inspecting both sites and registration trials. Investigators are facing great challenge to ensure high quality of study conduct while running too many trials. How to cope with the challenge will be discussed in this session. The Guaranteed Role of Efficient Management Program for Subjects Involved Clinical Research Maozhi Liang, Professor Director, GCP Center, West China Hospital of Sichuan University, China A Survey of Clinical Trial Sites and Analysis in 2012 Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China The Role of Clinical Trial Center in Drug Development in China Haiyan LI, Professor, MD Director, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China Session T 1-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 C+F Ethics Committee Roles and Development in China Session Chair: Haitao LIU, MD, MS of International Public Health Senior Advisor, Clinical Development Quality Assurance Asia Pacific, Global Quality and Compliance, GSK R&D, China The session focuses on the current ethical review practice and IEC construction in China: the strengths and challenges. It not only highlights the key areas of IEC construction in terms of infrastructure and system but also examines the existing paradigm defining the roles of EC, in terms of ensuring the protection of patient safety. It aims to develop an efficient review system and promote review quality. Ensuring Patient Safety through Ethics Committee Oversight Cristina E. Torres, PhD Asian Regional Coordinator, Forum for Ethical Review Committees in Asia Pacific (FERCAP), Philippines Challenge and Consideration in Ethical Review Xiuqin Wang, Professor, PhD Deputy Director, Scientific Research Department Vice Chair, IRB, Jiangsu Province Hospital, China Strategic Planning of Ethics Committee Infrastructure in Taiwan – A Critical Proactive Support for Clinical Research Herng-Der Chern, MD, PhD Chief Medical Director, Supra Integration and Incubation Center, Taiwan Panel Discussion Session T 1-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 C+F GCP CLINIC Session Co-Chairs Hannah CHEN, MD Director, CQA/PV China, Jansen Pharm R&D QA, Johnson & Johnson, China Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China Round-Table discussion GCP/ Quality issues that are commonly seen in clinical research will be discussed in this section. Experts from all parties involved in clinical research will provide insights and opinions, aiming to get a better understanding among stakeholders involved in clinical research and to facilitate future quality improvement. Panelists Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China Paul DAI, MD Senior Director, Regional Head of ICRO, AMAC, Greater China Region, Beijing Novartis Pharma Co. Ltd., China Xueying WU Head of Clinical Development and Operations, Pfizer Medical, China Helen LI, MD Director, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China Session T 1-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 C+F Pharmacovigilance - QA perspective Session Chair Helen LI, MD Director, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China Regulators are enhancing their oversight of pharmacovigilance with the ultimate aim to achieve patient safety. What are some of the lessons we have learned and experience gained from pharmacovigilance inspections and sponsor internal audits? Can we plan for the future and build quality and compliance into our quality management system and pharmacovigilance processes? In this section, discussion will focus on recent developments in EU Pharmacovigilance Legislation and common findings from PV inspections, and share one sponsor's experience regarding how to build quality and compliance into the quality system and pharmacovigilance activities. Recent Development in Eu Pharmacovigilance Legislation and Common Findings from Pharmacovigilance Inspections Carrie Scott GPvP Operation Manager, Senior Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), UK Sponsor Internal Pv Audits: Build Compliance and Effectiveness into Pv Process Deborah Driscoll, PhD Vice President, Medical Quality Assurance, Pfizer, USA 60 Theme 2 | Regulatory Science Session T 2-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H Global Trends and China Development Status on Fixed- Dose Combinations (FDCs) Session Chair Wendy Yan, MD Global Regulatory Strategist, Asia Global R&D Center, Bayer Healthcare Co. Ltd., China The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. They are being used in the treatment of a wide range of conditions e.g. HIV, hypertension and oral contraception, etc. There can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. In addition, the cost of an FDC finished pharmaceutical product may be less than that of separate products given concurrently. Improved medication compliance by reducing the pill burden of patients may be difficult to prove, but there could be additional benefit. In this session, speakers from industry and hospital will share the experience of FDC development globally and its benefit to patients, the CDE speaker will share the main consideration of combination drug development. Significance of the Fixed dose Combination (FDC) in Patients with Hypertension Wen WANG, Professor National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, China How MNCs Develop FDCs with Scientific Rationale Daniel PAULSON, PhD Global Clinical Leader, Bayer, USA Main Consideration of Combination Drug Development Cailian Kang Senior Reviewer, Office of Clinical Evaluation II, CDE, CFDA, China Session T 2-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H New Biosimilar Regulation: Challenges and Opportunities Session Chair Kitty Zhou Director, Regulatory Affairs, Sanofi, China Since US FDA released its biosimilar guidance in 2011, the issue surrounding how to conduct a regulatory acceptable study following the guidance becomes very critical. This session will focus on regulatory requirement and trial design of biosimilar development. US FDA Biosimilar Guidance Considerations John Gong, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Vice President, BeiGene (Beijing) Co. Ltd., China CMC Requirements in Biosimilar Product Development Duu-gong WU, PhD Member of FDA Alumni Association International Network (FDAAA) Director, Global Regulatory Affairs, Pharmaceutical Product Development, USA How to Manage Biosimilar Post-market Adverse Event Monitoring and Related Issues Shaoyu CHEN, JD Member of FDA Alumni Association International Network (FDAAA) Partner, Covington & Burling Beijing Office, China Panelists: Biosimilar Regulatory Status and perspective in China Speakers and: Katherine WANG, LLM Chief China Life Sciences Advisor, Ropes & Gray, China Session T 2-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit During IND Period (joint Session) Sessions Chair Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA Risk and benefit assessment is the foundation of any regulatory decision- making. Despite significant progress made in the past decade in risk/benefit framework development, the challenge remains, especially in IND period where the benefit of a potential drug has not been adequately demonstrated. This is the Part I of Risk/Benefit at the FDA and beyond, focusing on FDA's and CFDA/ CDE's approach to manage benefits and risk during IND period. Balancing the Benefits and Risks During IND Period at US FDA Mark J. Goldberger, MD, MPH, FIDSA Former Director, Office of Drug Evaluation IV, US FDA/CDER, Member of FDA Alumni Association, Vice President, AbbVie Regulatory Intelligence and Policy, USA Clinical Hold – An Important Tool of Risk Management During IND at US FDA Robert J. Meyer, MD Former Director, Office of Drug Evaluation II, US FDA/CDER Member of FDA Alumni Association Associate Professor, Public Health Sciences, Director, The Virginia Center for Translational and Regulatory Sciences, School of Medicine, University of Virginia, USA Statistical Considerations for Balancing the Benefits and Risks at US FDA Ning Li, MD, PhD Vice President, Regulatory and Medical Policy, Asia Region, Sanofi, China Approving Clinical Trial Application - Benefits and Risks Considerations at CFDA/CDE Zhimin Yang Deputy Director, Office of Clinical Evaluation I, CDE, CFDA, China Session T 2-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit during NDA and Post-Marketing Periods (joint Session) Sessions Chair Mark J. Goldberger, MD, MPH, FIDSA Former Director, Office of Drug Evaluation IV, US FDA/CDER Member of FDA Alumni Association International Network (FDAAA) Vice President, AbbVie Regulatory Intelligence and Policy, USA 61 Risk and benefit assessment is the foundation of any regulatory decision- making. Despite of the progress made in the past decade, the significant challenge remains as we often witness the different opinions and decisions from regulatory agencies on same applications. This is PART II of Risk/Benefit at the FDA and beyond, focusing on how benefits and risks are weighed during the application review and in the postmarketing period. FDA's use of external experts through a public advisory committee will be highlighted. Overview of Benefit-Risk Assessment During the NDA Review and Post- Marketing Reassessment at US FDA Robert J. Meyer, MD Former Director, Office of Drug Evaluation II, US FDA/CDER Member of FDA Alumni Association Associate Professor, Public Health Sciences, Director, The Virginia Center for Translational and Regulatory Sciences, School of Medicine, University of Virginia, USA Use of Public Advisory Committee in Risk/Benefit Assessment During NDA Review at US FDA Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA Approving Marketing Application - Benefits and Risks Considerations at TFDA/ CDE Lih-Jiuan Hsu, MD Senior Executive Officer, Division of Clinical Science, CDE, TFDA, Taiwan Post-Marketing Reassessment in China Siyan Zhan, MD Professor, Department of Epidemiology, Beijing University Medical School, China Panel Discussion Session T 2-5 | Wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 A+B+G+H Therapeutic Biologic Development in China from CMC Perspective Session Chair Phoenix Liu Director, Regulatory Affairs and Safety, Amgen Inc. Beijing Rep. Office, China Therapeutic biologics play more and more important role to address unmet medical needs. To timely introduce new therapeutic biologics with great efficacy and safety profile to China is also a shared goal of domestic industry, MNCs as well as Health Authorities. The session will focus on the best practice sharing in expediting CTA from CMC perspective, including dossier preparation, testing as well as challenge and recommended solution. Dossier Preparation and Specification Validation during CTA Huiyang Cheng, PhD Director, Preclinical, Clinical and Registration, Genor BioPharm Co. Ltd., China Melly LIN Regulatory Manager, CMC Policy/CMC, Roche (China) Holding Ltd., China Chunming RAO Director, Division of Recombinant Biological Products, NIFDC, China Panel Discussion Panelists: Speakers and: Lixin XU, MD, PhD Product Quality Reviewer, Office of Biotechnology Products, Division of Monoclonal Antibody, CDER, FDA, USA Anthony Ridgway, PhD Senior Regulatory Scientist, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada Session T 2-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 A+B+G+H Implementation of an Innovative Labeling Hub in Asia and Integration with Global Model Session Co-Chairs Rie Matsui, RPh Director, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR International & Global Product Information, Pfizer, Japan Tatsuo Kishi Risk Management Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA) , Japan Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the Headquarters organization while local product documents and patient leaflets are handled by affiliates based in local offices. This session will provide an overview of the Global Labeling System covering the CCDS, USPI and EU-SPC, as well as a case study discussion on the implementation of an Asian regional hub model. Consideration of differences in practice across countries and companies, as well as the prospects for future initiatives around labeling will be discussed. The session will also offer a perspective on how the industry is managing the integration and alignment of global safety and labeling systems and governance to ensure end to end oversight and implementation of patient safety information. Global Safety Labeling in a Multinational Corporation Matthias BOEDDING, Professor, MD, PhD Global Safety Leader, Global Pharmacovigilance – Risk Management, Global R&D Center Beijing, Bayer Healthcare Co. Ltd., China An Innovative Model for Handling Labeling in the Asian Region Rie Matsui, RPh Director, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR International & Global Product Information, Pfizer, Japan Japanese Labeling Regulations Tatsuo Kishi Risk Management Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Global Safety Labeling Process and Organization in US and EU Countries Jeffrey Ho Principal Officer, WCI Consulting Ltd. UK 62 Theme 3 | Drug Safety and Pharmacovigilance Session T 3-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 D+E Pharmacovigilance during Pre-Approval – an Exciting Journey of Investigation Session Chair Feng (Richard) Xia, MD, MS Medical Director, Former Global Pharmacovigilance Lead, Safety Evaluation and Reporting, Worldwide Safety and Regulatory, Pfizer Worldwide R&D, USA Pharmacovigilance has shifted toward earlier, proactive consideration of risks and potential benefits of drugs and has become an important aspect in the development of novel medicinal products, all the way to their market introductions. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also allowed a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines,whichdriveenhancedpharmacovigilanceandsafetyriskmanagement earlier in drug development. On the other hand, the pharmaceutical industry is evolving to actively respond to these new requirements and to ensure the upmost patient safety. This session aims to provide a holistic view of safety in pre-approval stage, introducing the current thinking around pre-approval safety risk assessment, decision making, communication, and planning. The session will also bring practical examples from oncology clinical trials where special considerations about patient safety need to be taken. From FIH to Marketing Authorization: Critical Aspects of Safety in Developing Innovative New Medicinal Products in China (Assessment, Decision Making, and Communication) Dan Zhang, MD, MPH Chairman and CEO, Fountain Medical Development Ltd., China Pre-approval Safety Review for New Drug Application -Key Considerations and Case Review George Chen, MD, MBA Vice President and Head of Global Medicine Development in China, AstraZeneca Global Medicine Development, China Panel Discussion Topics ? Clinical Safety Review for Marketing Applications ? Practical Aspects of Pre-Approval Risk Assessment ? Individual and Aggregate Safety Reports ? Safety Communication During Pre-Approval 63 Session T 3-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 D+E PharmacovigilanceduringPost-Approval-PathtoSuccess Session Co-Chairs Gang CHENG Assistant Director, National Center for ADR Monitor, Center for Drug Reevaluation, CFDA, China Xingmin Qiu, MD Director, World Safety and Regulatory, Pfizer China R&D Center, China The decision to approve a drug is based on the information available at the time of approval. The knowledge related to the safety profile of the product can change over time through expanded use in terms of patient characteristics and the number of patients exposed. In addition to routine post-approval safety monitoring activities, the appropriate pharmacovigilance methods employed for products with special safety concerns need to be applied. The best method chosen can vary with the product, the population, and the safety signal. Rigorously designed and conducted observational studies are recognized as important tools while active surveillance evolves in pharmacovigilance. In this session, the overview, initiatives and practices of these methods for post- approval products will be deeply discussed. Active Surveillance: A New Opportunity Monitoring Safety of Marketed Medical Products Xiaofeng Zhou, PhD, MS Director, Worldwide Safety & Regulatory, Pfizer Inc., USA Five Reasons for Active Surveillance Post-marketing Surveillance Andy Stergachis, PhD, RPh Professor, Epidemiology & Global Health Director, Global Medicines Program, University of Washington, USA Is Grandfather Product Necessarily Safe? – The Experience of Phenylpropanolamine (PPA) Yi Tsong, PhD Deputy Director, Division of Biometrics VI, Office of Biostatistics, CDER, FDA, USA Panel discussion Topics ? Post-Approval Safety Study – Which Way to Go ? "Real World" Study Session T 3-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit during IND Period (joint Session with T2-3) Session T 3-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit during NDA and Post-Marketing Periods (joint Session with T2-4) Session T 3-5 | Wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 D+E Benefit-Risk: getting it right for patients Session Co-Chairs Hugues Berard, MD, MBA Vice President, Deputy Chief Medical Officer, Ipsen R&D, France Gao Gao, MD Associate Director, Worldwide Safety & Regulatory, Pfizer China R&D Center, China Monitoring benefit-risk balance is critical at each stage across the life cycle of drug development, review and post-approval activities. A Benefit-Risk assessment framework is recognized as important from both an agency and a company perspective. It is a rapidly moving field involving a number of ongoing initiatives across regulatory agencies and companies. The session aims to: ? Present the progress made on defining and implementing a benefit-risk methodology framework ? Provide industry perspectives and address the issues within the benefit risk-framework adopted by industry and regulatory authorities ? Share real-life examples on how companies implement different methodologies and their learnings ? Discuss how to achieve a consensus on a scientifically accepted approach for making benefit risk decision and the role of benefit-risk framework in drug innovation Benefit – Risk Integration and Representation: EU PROTECT Juhaeri Juhaeri, PhD AssociateVicePresident, HeadofPharmacoepidemiology, GlobalPharmacoviglance & Epidemiology, Sanofi, USA Practical Considerations When Approaching Benefit-Risk: A Case Study Showing The Benefit of A MAHs Collaborative Approach Hugues Berard, MD, MBA Vice President, Deputy Chief Medical Officer, ISPen R&D, France Benefit-Risk Assessment and Risk Management in Drug Development Initiated from China Hua Mu, MD, PhD Executive Vice President & Chief Medical Officer, Hutchison Medi Pharma, China Panel discussion Topics ? How to achieve a consensus on a scientifically accepted approach for making benefit risk decisions ? The role of benefit-risk framework in drug innovation Session T 3-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 D+E Does Risk Management Planning benefit patients? Session Co-Chairs Lynn Zhou, MD, MPH International Pharmacovigilance Coordinator, PV Affiliate Relations, Global Pharmacovigilance & Epidemiology, Sanofi, China Yun(Jackie) Mao, MD, MBA Director, Worldwide Safety & Regulatory, Pfizer China R&D Center, China Effective risk management planning (RMP) has been playing a critical role in drug development and commercialization, while debates remain that RMP could be burdensome to the healthcare system and potentially limit the access of patients to medicines. On the other hand, global harmonization of RMP is underway but the value of adopting local perspectives is intensively discussed because risk identification/categorization and selection of tools to minimize or mitigate the risk can be largely affected by local patient population and the 64 delivery of the healthcare. The success of a risk management plan should be measured with consideration of value to the patients. This session aims to: ? Provide overview of rmp regulation worldwide with focus on Asia regulation ? Introduce cioms working group ix (effectiveness of risk minimization) ? Share real-life examples on how to use epidemiology study to evaluate effectiveness of risk minimization ? Discuss how to harmonize risk management & toolkit and maintenance as the science of risk management evolves The Global Risk Management Planning Landscape and a Few Asian Perspectives William Gregory Senior Director, Safety Strategy, Policy and Standards, Pfizer, USA Risk Management in Asia: Experience in Japan Stewart Geary, MD Chief Medical Officer, Vice President, Corporate Medical Affairs Headquarters, Eisai Co. Ltd., Japan Observational Study for Risk Characterization and Assessment of Risk Minimization Tools Juhaeri Juhaeri, PhD Associate Vice President, Head of Pharmacoepidemiology, Global Pharmacoviglance & Epidemiology, Sanofi, USA Theme 4 | Statistics Sessions T 4-1 & T 4-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 A Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio Sessions Co-Chairs Weiying YUAN, PhD Site Head of Biostatistics and Programming, China Pharmaceutical Research and Development, Johnson and Johnson, China Roger Qu, PhD Head of Clinical Statistics, Pfizer R&D Center, China Protection of patient safety is paramount in the drug development and medical treatment. Statistics plays an essential role in the identification of potential safety signals and quantification of benefit/risk ratio which is integral part of safety assessment. This session will focus on statistical application in both areas, from both regulatory and sponsor perspective. Statistical Considerations in Thorough QTc Clinical Trials Yi TSONG, PhD Deputy Director, Division of Biometrics VI, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Sequential GLR Tests for Signal Detection Jie Chen, PhD Director, Global Biostatistics, Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd., China Statistical Considerations for Risk/Benefit Assessment Marcia LEVENSTEIN, ScD Vice President and Head of Global Statistics of Specialty Care Business Unit, Pfizer, China Bayesian Shrinkage Estimator for Safety Signal Detection Luyan DAI, PhD Associate Director, Biostatistics, Boehringer Ingelheim Shanghai Pharmaceuticals Co. Ltd., China Safety in Pharmacogenomics Sue-Jane WANG, PhD Associate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA Panel discussion Session T 4-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 D+E Overview of Meta-Analysis and its Application in Drug Development Session Chair Hendrik SCHMIDT, PhD Associate Director, Biostatistics, Boehringer Ingelheim, Germany One of the most commonly used statistical methodologies in medical research and drug development is Meta-analysis, such as hypothesis generating, determination of effect margin for non-inferiority clinical trials, integrated analysis treatment effect based on large number of clinical trials. If conducted inappropriately, its value would be diminished by various sources of biases. This session will promote the good practice of meta-analysis and introduce its recent development. Meta-Analysis in Drug Safety Evaluation: Statistical Challenges and Best Practices/Meta George Quartey, PhD Principal Statistical Scientist, Biostatistics, Genentech, USA Meta-analysis and Mixed Treatment Comparisons - Measuring and Reporting Direct and Indirect Evidence of Treatment Networks: Methodology, Software and Examples Hendrik Schmidt, PhD Associate Director, Biostatistics, Boehringer Ingelheim, Germany Meta-Regression and it's Application in Clinical Trials/Meta Feng Chen, Professor, PhD Dean of School of Public Health, Nanjing Medical University, China Session T 4-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 D+E Quantitative Sciences in Pharmaceutical Development (QSPD) Session Co-Chairs William WANG, PhD Site Head and Executive Director, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP), Merck Research Laboratories / MSD R&D (China) Co. Ltd., China Yang Song, PhD Senior Principal Scientist, Biostatistics, Late Development Statistics, Biostatistics and Research Decision Sciences - Asia Pacific, MSD R&D (China) Co. Ltd., China 65 Quantitative Sciences in the pharmaceutical development encapsulate many disciplines such as biostatistics, epidemiology, health economics statistics, scientific programming, and data management. Collectively these scientific disciplines are playing increasingly important roles in pharmaceutical development. These important roles are reflected not only in strategic design, execution, but also in regulatory submission and regulatory decision making; not only for pharmaceutical development in the developed regions but also in the emerging market regions. This session will examine the top challenges and opportunities facing the quantitative science professionals. Emerging Issues with Quantitative Sciences in Drug Development Hsien-Ming James HUNG, PhD Director, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Panel discussion Topics ? Roles of Modeling and Simulation ? Quantitative Benefit-Risk Assessment ? Complex Clinical Trial Designs ? Predictive or Prognostic Characteristics of Biomarkers ? Utilities and Pitfalls of Integrated or Meta Analyses ? Globalization Panelists: Hsien-Ming James HUNG, PhD Director, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Sue-Jane WANG, PhD Associate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA Yuki Ando Senior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Joan Shen, MD, PhD Senior Director, Clinical Development, Pfizer, China Chen Yao, Professor Vice Director, Peking University Clinical Research Institute Head of Department of Biostatistics, Peking University First Hospital, China Qin HUANG, PhD Deputy Office Director, Office of Biostatistics, CDE, CFDA, China Theme 5 | Vaccines and Biologics Session T 5-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 201 B+C Ensuring Innovation and Safety for Cell/Gene Therapy and Blood Products Session Chair Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network (FDAAA) Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA A comprehensive presentation of the approaches to quality, efficacy and patient safety for the blood supply, cell, tissue, and gene therapies at the US FDA's Center for Biologics Evaluation and Research (CBER) and in CFDA/ Center for Drug Evaluation (CDE). FDA's Requirements for Safety and Efficacy for Cell/Gene Therapies Jinjie Hu, PhD Member of FDA Alumni Association International Network (FDAAA) Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBER Senior Consultant, Biologics Consulting Group, INC., USA China Update: Safety and Efficacy Requirements for Cellular/Gene Therapies Qi SHEN Director, Institute for Biological Product Control, NIFDC, China FDA's Role in Blood Product Safety Jinjie Hu, PhD Member of FDA Alumni Association International Network (FDAAA) Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBER Senior Consultant, Biologics Consulting Group, INC., USA Panelists: Xiuxia GUO Associate Researcher, Division of Biological Products, Department of Drug Registration, CFDA, China Weihong CHANG Associate Researcher, Division of Biological Products, Department of Drug Registration, CFDA, China Session T 5-2 | Tuesday, May 14, 2013 10:30 - 12:00 2nd Floor, 201 B+C Principles for Pandemic Influenza Preparedness and Post- Marketing Vaccine Manufacturing Changes Session Chair Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network (FDAAA) Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA Ensuring safety for vaccines is a difficult but necessary duty of all regulatory agencies to promote public health and responsibilities of the biologics industry. US FDA and China FDA have had many years of experiences to share. Ensuring vaccine safety and effectiveness by balancing the need to encourage the adoption of new technologies to advance quality and efficient manufacturing of vaccines with the need to demonstrate, through appropriate validation and/ or clinical or non-clinical laboratory studies, the lack of adverse effect of the change on the safety and effectiveness of the product remains a challenge. An update on recent US and Chinese activities regarding influenza vaccine production and preparedness and safety will be presented. FDA and WHO Pandemic Influenza Vaccine Preparedness Activities Sara E. Gagneten, PhD Associate Director, Regulatory Policy, Office of Vaccines Research and Review, Division of Viral Products (DVP), CBER, FDA, USA Advancing Vaccine Safety and Innovation in China Jianhui LUO Deputy Office Director, Office of Biological Products, CDE, CFDA, China Vaccine Applications at FDA: Regulations for Safety and Post-Marketing Changes Sara E. Gagneten, PhD Associate Director, Regulatory Policy, Office of Vaccines Research and Review, Division of Viral Products (DVP), CBER, FDA, USA 66 Session T 5-3 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 B+C Cell therapy and biosimilar development, opportunities, and regulatory considerations Session Chair Li Shi, PhD CEO, Shanghai Zerun Biotechnology Co. Ltd., China The new stage of biological product development and usage in treating diseases has been on biosimilars and cell therapeutics. These two areas are playing increasingly important rules in the current and future growth of biological-based pharmacuticals. Cell therapy are facing not only technical but also regulatory challenges. For biosimilars, getting into regulated markets still needs great effort in meeting regulatory requirement. This session will review current status of cell therapy and biosimilar development, quality, safety and regulatory considerations. Cell Therapy Development and Current Status in Its Application for Cosmetic Treatment Ningwen Zhu, MD, PhD CEO, Cell & Tissue Eng, China Safety Evaluation and Research in China for New Biologics by Following the International GLP Standard Gene C. Hsu, PhD, DABT Vice President and CSO, Innostar and National Shanghai Center for New Drug Safety Evaluation and Research, China Expectation and Opportunities of Bringing Biosimilars from China to EU, from Regulatory Point of View Hoss Dowlat, PhD Vice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany Session T 5-4 | Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 B+C Vaccine product qualification and novel hepatitis vaccine development for the world and China Session Chair Li Shi, PhD CEO, Shanghai Zerun Biotechnology Co. Ltd., China Vaccine product qualification and novel vaccine development have both been under much more serious consideration in China. Supplying vaccine made in China to the world has been getting on the agenda of China vaccine industry. WHO PQ activities and new GMP implementation have been a practical task already in China. Hepatitis diseases are among the most awared diseases in Asia countries including China. This session will review WHO PQ practice and hepatitis vaccines from effectiveness and new development point of view. This session will also review opportunities for international collaborations in developing new products for infectious diseases. WHO Prequalification for Vaccines and Biologicals Nora DELLEPIANE, PhD Group Leader of Essential Medicines and Health Products, WHO, Switzerland Accuracy of Titration Method for Detecting Live Attenuated Hepatitis A Vaccine Xuanyi Wang, PhD Professor, Shanghai Medical College, Fudan University, China New Generation of Hepatitis Vaccine Development with Novel Adjuvant for Improving Vaccine Tyler J. martin, MD President and Chief Medical Officer, Dynavax, USA Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations Hoss Dowlat, PhD Vice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany Theme 6 | CMC Sessions T 6-1 & T 6-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 D Evaluation of Generic Products vs. Reference products - the 2007 Conundrum Session Co-Chairs Min GUI, PhD Director, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China Chi-Wan CHEN, PhD Member of FDA Alumni Association International Network (FDAAA) Former Deputy Director, Office of New Drug Quality Assessment, US FDA/ CDER Executive Director, Global CMC, Pfizer, USA CFDA kicked off an initiative in 2012 for the reevaluation of generic products approved before 2007. This initiative aims to ensure safety, efficacy and quality of drug products for patients. How to make ensure a scientifically sound process is in place to achieve the goal? What are the practical challenges faced by the regulatory authority and industry? How to address the identified issues? This session is designed to discuss the generic products reevaluation, experiences in bioequivalence evaluation and in-vitro dissolution tests. CFDA Working Procedures for the Generic Product Reevaluation Initiative Lan Lin Deputy Director, Institute for Chemical Drug Control, NIFDC, China Rule for Reference Product Selection and Guidance on Comparative Dissolution Qiming ZHANG Researcher, NIFDC, China IVIVC-Challenges and Considerations Deepak Hegde, PhD Vice President, Formulation Development Services, WuXi AppTec Co. Ltd., China Bioequivalence and In Vitro Dissolution Studies – A US Industry Perspective Xiaoxiong (Jim) Wei, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Director, Clinical Pharmacology, Medpace, USA Panel discussion 67 Session T 6-3 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 D Regulatory Perspectives on Botanical Drug Products in China and the United States Session Chair Chi-Wan CHEN, PhD Member of FDA Alumni Association International Network (FDAAA) Former Deputy Director, Office of New Drug Quality Assessment, US FDA/ CDER Executive Director, Global CMC, Pfizer, USA A botanical product is regulated as a dietary supplement or drug, depending on its intended use, in the US FDA issued a guidance on Botanical Drug Products in 2004 to outline its recommendations on CMC information for different phases of clinical studies and for pre-NDA consideration. The guidance has enabled the industry and academia to begin studying botanical products for drug use, leading to the approval of the first botanical drug product in the US in 2006. This session will introduce the brief regulatory history of botanical drug products and discuss the challenges in developing such products in the US China's long history and experience in regulating Traditional Chinese Medicines (TCM) will be presented as a comparison. CFDA Requirements for Traditional Chinese Medicines (TCM) Yuehua Zhou Deputy Office Director, Office of Traditional Chinese Medicines, CDE, CFDA, China Botanical Drug Products in the United States – Regulatory Background Duu-gong WU, PhD Member of FDA Alumni Association International Network (FDAAA) Director, Global Regulatory Affairs, Pharmaceutical Product Development, USA Regulatory Challenges in Developing Botanical Drug Products in the United States David LIN, PhD Member of FDA Alumni Association International Network (FDAAA) Senior Consultant, Biologics Consulting Group, USA Panel discussion Session T 6-4 | Wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 D Evolution of Global Biotherapeutic Regulations – A CMC Perspective Session Co-Chairs Melly Lin Regulatory Manager, CMC Policy, Roche (China) Holding Ltd., China Min GUI, PhD Director, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China Over the past decades, the development and application of new technologies have transformed the biotherapeutic product development, and drive the evolution of biotherapeutic regulatory framework. This session will introduce the evolution of global biotherapeutic regulations and the emerging regulatory concepts that will change the regulatory framework in the US & EU, such as life- cycle management approach for process validation, CMC change management protocol, etc. Application of the new ICH Q11 principles in biotherapeutic drug substance development will also be discussed. In addition, this session will cover the platform manufacturing for biotherapeutic development and use cases to demonstrate its application. Evolution of the Biotherapeutic Regulations in USA and Driving Force Behind Lixin XU, MD, PhD Product Quality Reviewer, Office of Biotechnology Products, Division of Monoclonal Antibody, Center for Drug Evaluation and Research (CDER), FDA, USA Application of ICHQ11 Principles in Biotherapeutic Drug Substance Development Anthony Ridgway, PhD Senior Regulatory Scientist, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada Modular Viral Validation for Platform mAb Purification Process Qi Chen, PhD Associate Director and Senior Scientist, Process Virology, Purification Development, Genentech Inc. USA Theme 7 | Traditional Chinese Medicines (TCM) Session T 7-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 203 C Development of Novel TCM Products for China and Global Market Session Chair Xun Zhang, PhD Vice President, Head of Global Natural Product Business Unit, GSK R&D, China This session is to provide an overview of the R&D strategies and activities on the development of novel TCM products, as well as a forum for open discussion of the opportunities and challenges faced by the drug industry in its efforts to convert traditional herbal medicines into high quality, patent-protected, and clinically-proven products using global drug discovery and development technologies and standards. TCM Industry Landscape Junjie Zhou, PhD General Manager, Shanghai Hutchison Pharmaceuticals, China R&D Strategy and Activity for New TCMs Zuguang Ye, Professor Director, TCM Platforms, China National Academy of Sciences, China TCM Globalization Opportunity and Challenge Xun Zhang, PhD Vice President, Head of Global Natural Product Business Unit, GSK R&D, China Session T 7-2 | Tuesday, May 14, 2013 10:30 - 12:00 2nd Floor, 203 C Case Studies and Good Practices in TCM Development Session Chair Jack Xu, MD Senior Vice President, Shanghai Clinical Research Center, China The regulatory requirements, experience, and practices for TCM development will be discussed with case studies at this session. The session will also discuss what criteria should be used for TCM clinical evaluations. 68 Regulatory Guidelines and Updates Yixin CHEN Division Head, Division of TCMs & Ethno-Medicines, Department of Drug Registration, CFDA, China Clinical Research Update about TCMs in China Jack Xu, MD Senior Vice President, Shanghai Clinical Research Center, China Theme 8 | Target-Based Oncology Drug Development Co-Organized By: US Chinese Anti-Cancer Association (USCACA) Session T 8-1 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 D Changing Paradigm in Cancer Diagnosis and Treatment - Impact on Drug Development Session Co-Chairs George Chen, MD, MBA Vice President and Head of Global Medicine Development of China, AstraZeneca Global Medicine Development, China Li XU, MD, MSD, MBA Vice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA This session will overview the current target-based novel cancer drug development and review two successful cases of target-based cancer drug development. Overview and Introduction Maria Koehler, MD, PhD Vice President, Integrated Development Leader and Strategic and Scientific Assessments, Clinical Development and Medical Affairs, Oncology Business Unit, Pfizer Inc., USA Case Study: Integrating Biomarkers into Clinical Trials of New Therapies in Cancer, Right Drug for the Right Patients at the Right Time ? Case 1 - Xalkori for ALK+ NSCLC Maria Koehler, MD, PhD Vice President, Integrated Development Leader and Strategic and Scientific Assessments, Clinical Development and Medical Affairs, Oncology Business Unit, Pfizer Inc., USA ? Case 2 - BRAF Inhibitor for BRAF V600e/k Mut Melanoma Jun GUO, Professor, MD, PhD Director, Department of Kidney & Melanoma Vice President, Peking University Cancer Hospital & Institute, China Session T 8-2 | Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 D Strategies for Discovery and Development of Target- Based Novel Cancer Medicines Session Co-Chairs George Chen, MD, MBA Vice President and Head of Global Medicine Development of China, AstraZeneca Global Medicine Development, China Li XU, MD, MSD, MBA Vice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA This session will discuss the strategies for discovering, developing and registering novel target-based cancer drugs with quality, speed and value. In addition, this session will also discuss what China needs to do to transit from participating to leading target-based cancer drug development. Novel Cancer Target Identification and Validation Jennifer Yang, PhD Director, Science Affairs, Johnson & Johnson Asia R&D Center, China Clinical Development Strategy: Identify Right Target Population, Utilize Optimal Endpoints and Study Designs, and Leverage China Opportunities Hua Mu, MD, PhD Executive Vice President and Chief Medical Officer, Hutchison Medi Pharma, China China's Role in Participating and Leading Discovery and Development of Novel Oncology Medicine Caicun Zhou, Professor, PhD Director, Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, China Theme 9 | Pharm/Tox Session T 9-1 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 B+C Pharm/Tox: From Animal to Human Session Chair John Gong, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Vice President, BeiGene (Beijing) Co. Ltd., China A comprehensive presentation of requirements for preclinical safety evaluations in the US FDA and China CFDA. Discussions will be focused on the following: preclinical safety data analysis and interpretation; extrapolation of animal toxicity findings to humans; and methods on how to use animal data to predict potential human risk and support regulatory decisions. FDA Requirements for Preclinical Safety Evaluations Paul A. Andrews, PhD Executive Director, Global Regulatory Affairs, Eisai Inc. USA CFDA Requirements for Preclinical Safety Evaluations Jian Peng, PhD Scientific Advisor, Asia Pacific R&D, Sanofi, China Panel discussion Session T 9-2 | Wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 B+C GLPRegulatoryComplianceforDataQualityandIntegrity Session Chair Dylan D. Yao, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Senior Vice President and CSO, Joinn Laboratories, Inc., China Comprehensive presentations regarding GLP compliance issues associated with preclinical data quality and integrity from the view point of both CRO and government regulatory agency to ensure subjects safety. 69 GLP Compliance Issues ImpActing Data Quality and Integrity in Preclinical Studies - A Cro's Point of View Jane Pearse, PhD Director, Special Projects, Huntingdon Life Sciences, UK Importance of GLP & Safety Testing to Public Health Mission - A Perspective of FDA Dylan D. YAO, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Senior Vice President and CSO, Joinn Laboratories, Inc. China Panelists Speakers and Lijie FU, PhD, FELLOW ATS General Manager, China Business, Senior Advisor of Regulatory, SNBL Vice President, Chinese Society of Toxicology, China Conglin ZUO, MD President and CEO, Joinn Laboratories, Inc., China Session T 9-3 | Wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 201 B+C Patient safety: toxicological evaluation and risk assessment in pharmaceutical R&D Session Co-Chairs Lijie Fu, PhD, Fellow ATS General Manager, China Business/Senior Advisor of Regulatory, SNBL Vice-President of Chinese Society of Toxicology Charles Y. Wang, PhD, DABT Director, Safety Assessment, GSK R&D, China This session focuses on toxicology in pharmaceutical safety evaluation and risk assessment, specifically the importance of pharmaceutical products and safety evaluation in China, as well as non-clinical risk assessment in compound license-in, which is a primary strategy for Chinese pharmaceutical industry. Hazard vs. Risk - Toxicology Consideration Lijie Fu, PhD, Fellow ATS General Manager, China Business/Senior Advisor of Regulatory, SNBL Vice-President of Chinese Society of Toxicology Drug Safety Assessment for Stem Cell-based Medicinal Products Jing Ma, MD, PhD Director, National New Drug Safety Evaluation and Research Shanghai Center, China Safety Evaluation of Chinese Traditional Medicines: Rhubarb and Its Major Constituents Quanjun Wang, MD, PhD Assistant Director, National Beijing Center for Drug Safety Evaluation and Research, China Non-Clinical Safety Assessment during Compound License-In Charles Y Wang, PhD, DABT Director, Safety Assessment, GSK R&D, China Theme 10 | Clinical Data Management/eClinical Session T 10-1 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 A Technology Advancement in the Landscape of Clinical Data Management Session Chair Daniel LIU, PhD Director, China Development, Medidata Solutions Worldwide, China Technology is changing the clinical research landscape from protocol development, data acquisition and data exchange. Clinical Research is behind other industries in taking advantage of the uses of technology and information so it is important to know the trend such as cloud technology and tools to move the industry forward. This session will discuss the benefit of technologies to data managers and will provide a picture into the future of how it may impact our field. Big Data Computing – Current Concept and Practice Glen de Vries President, Medidata Solutions, USA Suitable Cloud Implementation for Life Sciences Research Abhishek BAGGA Manager, Clinical Systems Center of Excellence, Life Sciences R&D Practice, Cognizant Technology Solutions, India Bioinformatic Tools in Data Analysis and Management Eric S. HERBEL President, Integrated Clinical Systems, USA Panel discussion Session T 10-2 | Wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 A Data Managers' Roles in Drug Safety Session Chair Joanne LIU Director, Global Clinical Data Management & Standard, MSD R&D (China) Center, China This session will provide practical ideas on how to ensure the safety data quality through data validation plan, data review process and medical coding process. Hear from experienced speakers who have been successful in managing safety data and learn more about how you might address key challenges when managing safety data. Considerations in Safety Data Validation and SAE Reconciliation Jessie Chen, MD Head of Clinical Data Services, Pfizer China R&D Center, China Safety Data Management in Phase I Study Gang Xu, MD Director, Data Management, GSK R&D, China Coding in Safety Data Management Lobo Loo Associate Director, China Data Management Center, MSD R&D, China Panel discussion 70 Session T 10-3 & T 10-4 | Wednesday, May 15, 2013 13:30 - 17:30 2nd Floor, 201 A Data Standards in Real World Clinical Research Session Co-Chairs Zibao Zhang, Phd Associate Director, Biostatistics and Programming, PPD, China Yazhong DENG, MBA Head of Clinical Data Analysis and Reporting Organization (CDARO), Covance, China Data Standard is a continued hot topic to streamline clinical research and modernize data and information flow in drug development. This session will focus on the added values of standardization and implementation approaches around the globe. The audience will hear from experts who have been successful in their endeavors and learn how one could address the key challenges of integrating standard into clinical trials. Updates of the CDISC standards implementation and regulatory considerations in China will be shared. From Electronic Health Record to Clinical Database Demetris ZAMBAS Executive Director, Global Data Management & Standards, MSD, USA CDISC Standards Implementation - Experiences from a Global CRO Jianrong LI Director, Biostatistics and Programming Asian Operation, PPD, China Case Studies with CDISC Standards: from CDASH to SDTM and AdaM Victor Wu, PhD Senior Manager, Biostatistics, Covance, China CDISC Standards to Enhance Clinical Trial Efficiency Ivan Tjong-A-Hung, MD, MBA General Manager, Athena Healthcare Consultancy, China Updates of CDISC Standards in China Linda WANG, Master in Health Statistics Principle Biometrician, Integrated Information Sciences Department, Novartis, China China CDISC Coordinating Committee (C3C) Panel discussion Qin HUANG, PhD Deputy Office Director, Office of Biostatistics, CDE, CFDA, China Theme 11 | Innovation on Medical Devices and Combinational Products Sessions T 11-1 & T 11-2 | Wednesday, May 15, 2013 08:30 - 12:00 2nd Floor, 203 C Medical Devices: Innovation, Regulation and Investment Session Co-Chairs Katherine WANG, LLM Chief China Life Sciences Advisor, Ropes & Gray, China Spring WANG, MD Regional Clinical Director, St. Jude Medical, Asia Pacific, Hong Kong, China The session will cover topics of medical device innovation, registration and financing. With participations of senior and experienced experts, speakers will provide comprehensive review of the newly released medical devices GCP guideline by CFDA, innovations, roles of venture capital and cases studies on medical devices. Innovation on Medical Devices Kok-Hwee NG, PhD Director, Instrumentation Development, Center for Innovation and Strategic Collaboration, St. Jude Medical, Inc. USA The Draft GCP on Devices in China Xianghui YUE Division of Research & Reevaluation, Department of Medical Device Supervision, CFDA, China Streamlining Medical Device Clinical Trial Xianqiang Mi, Professor, MD, PhD Shanghai Advanced Research Institute, Chinese Academy of Science, China Medical Device Innovation: A Case Study Katherine WANG, LLM Chief China Life Sciences Advisor, Ropes & Gray, China Role of Venture Capital in Medical Devices Fay Xing, MD Pricipal, Decheng Capital, China Theme 12 | Contract Research Organization Session T 12-1 | Wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 201 D How to build win-win relationship Session Chair Helen JIANG, MD, PhD Executive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China In the journey of drug/device development, companies are not necessary to have all the scientific and operational capability and capacity to undertake all tasks, especially when it is related to patient safety or to the resolution to help patient out of disease suffering. The session will be emphasizing that the outsourcing decision is based on multiple factors besides money, with the aim to outline the various business need for CRO companies, including contribution to science/medicine, special area of service, delegated function services partner, in-sourcing people, and full service outsourced project. How to Leverage Safety Data from Chinese Population to File IND in US Successfully? Simon Li, MD, PhD Vice President, Global Clinic Trials and Regulatory Affair, Luye Pharma, China Early Development: CRO Selection and Partnership Anfan Wu, PhD Head of Early Development, Roche R&D Center (China) Ltd., China Case Study: A Chinese Company Successfully Filed IND in US with CRO Support Zaiqi Wang, MD, PhD Executive Director, Clinical Research, MSD, China Collaboration to Win a Path to Success Helen JIANG, MD, PhD Executive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China 71 Session T 12-2 | Wednesday, May 15, 2013 15:30 - 17:30 2nd Floor, 201 D CRO: Value-added Taskforce to Ensure Patient Safety Session Co-Chairs Yanhua GONG, MD Vice President & Secretary General of CROU (CRO Union), China Association for Pharmaceutical and Medical Technology Exchange, China Jessica Liu, MD General Manager, China/North Asia, INC Research, China The session will discuss how Contract Research Organization (CRO) build infrastructure in China to develop high performance team. Strategic Alliance on Pharmacovigilance to Support Patient Safety Management in Clinical Trial Sheona Stevenson, PhD Associate Director of PVG, Head of Asia-Pacific Region, INC Research, Singapore Clinical Monitoring in China – Assuring Quality from the CRO Perspective Emily Tan Executive Director, Clinical Research Asia Pacific, InVentiv Health Clinical, Singapore The Business Development of a Domestic CRO after IPO Sally Sha, MD Director, Business Development, Project Director, Hangzhou Tigermed Consulting Co. Ltd., China Panel discussion Theme 13 | Post-approval and Real World Studies Session T 13-1 | Wednesday, May 15, 2013 15:30 - 17:30 2nd Floor, 201 B+C Post-approval and Real World Studies Session Chair Ming TANG, MD Principal Scientist, Vital Strategic Research Institute (VSRI), China & USA After a drug is approved for marketing, scientific and medical research continues. Numerous study methodologies and mechanisms are available to further study and evaluate its efficacy and safety in the real word setting as well as to identify its potential new uses. The session will examine the trend, practicality, issues, and possible solutions surrounding the application of these methods in China. Introduction and Overview Ming TANG, MD Principal Scientist, Vital Strategic Research Institute (VSRI), China & USA Patient Registry Yan XIAO, MD, PhD Senior Epidemiologist, Roche Pharma Development Center, Asia Pacific, China Investigator-Initiated Studies: 1. Case I : Frank Fan, PhD Senior Medical Director, Sanofi, China 2. Case II: Yilong Wang, PhD Vice Division Chief, Department of Internal Neurology, Beijing TianTan Hospital, China Theme 14 | Pharmacoepidemiology - Best Practices and Drug Safety Session T 14-1 | Wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 203 C Pharmacoepidemiology - Drug Safety and Best Practices Session Chair Wei Zhou, Md, PhD Director, Epidemiology Asia Pacific Unit, Merck Research Laboratories, China This session is to share the status and progress of pharmacoepidemiology in drug safety and risk management, as well as comparative-effectiveness research. Introduction of Basic Pharmacoepidemiology Principles and Methods in Drug Development and Risk Management Siyan Zhan, Professor, MD, PhD Professor, Department of Epidemiology, Beijing University Medical School, China Regulatory Perspective and Progress of Pharmacoepidemiology and Drug Safety Min YAN Deputy Director General, Department of Drug Safety and Inspection, CFDA, China Recent Progress of Pharmacoepidemiology Research - Using Large Emr and Claim Databases, and Comparative-Effectiveness Research on Drug Safety and Efficacy of Different Treatments and Drugs. Arnold K. CHAN, MD, ScD, FISPE Deputy Director, Medical Research Department, National Taiwan University Hospital, Taiwan Theme 15 | DRUG ELECTRONIC ADMINISTRATION IN CHINA Session T 15-1 | Wednesday, May 15, 2013 15:30 - 16:15 2nd Floor, 203 C Introduction of Drug Electronic Administration Yingli WANG Deputy Director, Division of Information Research & Planning, Information Center, CFDA, China DIA CHINA 7/F, Room 766, Metropolis Tower No.2 Haidian East Third Street, Zhongguancun Xi Zone Haidian District, Beijing, 100080, China Tel: +86.10.6260.2240 DIA@diachina.org DIA worldwide headquarters 800 Enterprise Road, Suite 200, Horsham, PA 19044 DIA regional offices Horsham, Pennsylvania | Washington, DC Basel, Switzerland | Tokyo, Japan | Mumbai, India | Beijing, China
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药物信息协会(DIA)第五届中国年会 患者关爱与药物安全 5th DIA China Annual Meeting Patient Safety - A Sustained Focus from Scientific Ideas to Innovative Medicines 中国 · 北京国际会议中心 Beijing International Convention Center, China 2013年5月12日—— 会前专题研讨会 2013年5月13-15日—— 会议、展览和壁报 May 12, 2013 - Pre-conference Workshops May 13-15, 2013 - Conference, Exhibition and Posters FINAL PROGRAM 会议手册www.diachina.org合办单位: 中国医药国际交流中心 30 2013年5月12日 星期日 | 会前专题研讨会 07:30-16:00 一层,注册台 会议注册 08:30-17:30 二层,201B 专题研讨一(全天) 运用数据分析技术监控和评价临床研究质量和结果 二层,201C 专题研讨二(全天) 原料药和制剂的稳定性要求与实践 二层,201D 专题研讨三(全天) 肿瘤临床试验中的数据管理 二层,203C 专题研讨四(全天) 从药物监管角度看MedDRA (ICH国际医学用语词典) 在临床试验药物安全和药物警戒方 面的应用 二层,201A 专题研讨五(全天) 全球性药物临床试验的原则和案例研究 三层,307 专题研讨六(全天) 药品安全和原料药: 全球对原料药的监管及法律的要求和实践 10:00-10:30 一层,展厅 茶歇 12:00-13:00 二层,二号厅 午餐 15:00-15:30 一层,展厅 茶歇 2013年5月13日 星期一 | 会议日程(第一天) 07:30-16:00 一层,注册台 会议注册 13:30-17:30 一层,展厅 展览和壁报开放 13:30-17:15 二层,一号厅 开幕式及全体大会 促进药物创新,保障患者安全 主旨嘉宾:桑国卫 中国药学会理事长 中国工程院院士 风险管理计划:促进创新确保患者安全 主旨嘉宾:Patrizia A. CAVAZZONI 医学博士 辉瑞全球研发中心高级副总裁 全球安全负责人及成熟产品药政事务部负责人 艾滋病病毒携带者治疗药物现状和期待 主旨嘉宾:孟林 北京爱之方舟感染者信息支持组织负责人 中国艾滋病病毒携带者联盟秘书处协调员 中国全球基金项目国家协调委员会非工委代表 15:30-16:00 一层,展厅 茶歇 17:30-19:30 一层,展厅/二层, 二号厅 欢迎招待会 — 中国之夜 DIA中国五周年庆典 2013年5月14日 星期二 | 会议日程(第二天) 07:30-16:00 一层,注册台 会议注册 08:30-17:30 一层,展厅 展览和壁报开放 08:30-10:00 一层,5 C+F T 1-1 成功的全球临床试验 – 优化利益,降低风险 一层,5 A+B+G+H T 2-1 固定剂量复方制剂(FDCs)在中国及全球的发展 一层,5 D+E T 3-1 上市批准前的药物警戒 – 探索研究 二层,201 A T 4-1 安全性信号检测和效益/风险定量评估(一) 二层,201 B+C T 5-1 确保细胞/基因疗法和血液制品的创新和安全 二层,201 D T 6-1 仿制药与参比制剂之比较与评价 – 仿制药质量一致性评价 (一) 二层,203 C T 7-1 开发适用于中国及全球的创新性中药 10:00-10:30 一层,展厅 茶歇 10:30-12:00 一层,5 C+F T 1-2 临床试验中各方的协调与沟通 一层,5 A+B+G+H T 2-2 生物类似药新的监管:挑战与机遇 一层,5 D+E T 3-2 产品批准上市后的药物警戒 – 长期的任务 二层,201 A T 4-2 安全性信号检测和效益/风险定量评估(二) 二层,201 B+C T 5-2 流感大流行应急准备原则以及批准上市后疫苗生产的变更 会议活动交流活动会场通知会议一览 31 二层,201 D T 6-2 仿制药与参比制剂之比较与评价 – 仿制药质量一致性评价 (二) 二层,203 C T 7-2 中药开发的案例分析与实践 12:00-13:30 二层,一号厅 午餐 2013年5月14日 星期二 | 会议日程(第二天·续) 13:30-15:00 一层,3号会议厅 国家食品药品监督管理总局 (CFDA) 专场会:中国药品上市前和上市后的安全监管 二层,201 B+C T 5-3 细胞药物和生物类似药的研发 - 机遇及监管要求 二层,201 D T 8-1 肿瘤诊断和治疗模式的改变对药物研发的影响 15:00-15:30 一层,展厅 茶歇 15:30-17:30 一层,3号会议厅 国家食品药品监督管理总局 (CFDA) 专场会:中国药品上市前和上市后的安全监管 二层,201 B+C T 5-4 中国与全球的疫苗产品认证和肝炎新疫苗研发 二层,201 D T 8-2 肿瘤靶向创新药物研发策略 17:30-19:30 二层,二号厅 讲者/嘉宾招待酒会 2013年5月15日 星期三 | 会议日程(第三天) 07:30-16:00 一层,注册台 会议注册 08:30-17:30 一层,展厅 展览和壁报开放 08:30-10:00 一层,5 C+F T 1-3 GCP诊所 一层,5 A+B+G+H T 2-3 & T 3-3 新药临床试验/IND阶段的风险与受益权衡 一层,5 D+E T 4-3 Meta分析及其在药品开发中的应用 二层,201 D T 6-3 中美植物药监管展望 二层,201 B+C T 9-1 药物毒理:从动物试验到人体试验 二层,201 A T 10-1 科技进展对临床数据管理的影响 二层,203 C T 11-1 医疗器械的创新、监管及研发投资 (一) 10:00-10:30 一层,展厅 茶歇/ 壁报展抽奖活动 10:30-12:00 一层,5 C+F T 1-4 从质量保证的角度谈药物警戒 一层,5 A+B+G+H T2-4 & T3-4 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价 一层,5 D+E T 4-4 药物研发中的定量科学 二层,201 D T 6-4 全球生物制药法规的发展 – CMC视角 二层,201 B+C T 9-2 GLP法规;数据的质量和完整性 二层,201 A T 10-2 安全数据管理 – 数据管理者的职责 二层,203 C T 11-2 医疗器械的创新、监管及研发投资 (二) 12:00-13:30 二层,一号厅 午餐 / DIA学术沙龙交流活动 13:30-15:00 一层,5 C+F T 1-5 临床研究机构面临的机遇与挑战 一层,5 A+B+G+H T 2-5 在中国开发治疗用生物制品 – CMC视角 一层,5 D+E T 3-5 为患者的利益平衡效益和风险 二层,201 D T 12-1 如何建立双赢关系 二层,201 B+C T 9-3 药物研发的毒理评价和风险评估 二层,201 A T 10-3 数据标准在临床研究中的应用和成功案例 (一) 二层,203 C T 14 药物流行病学的最佳实践和药物安全 15:00-15:30 一层,展厅 茶歇 15:30-17:30 一层,5 C+F T 1-6 中国伦理委员会的职责和发展 一层,5 A+B+G+H T 2-6 创新的标签说明书中心体系在亚洲的应用及与国际体系的整合 一层,5 D+E T 3-6 制定风险管理计划有益于患者吗? 二层,201 D T 12-2 合同研究机构对确保药品安全所起的作用 二层,201 B+C T 13 上市后和实际环境中的药物研究 二层,201 A T 10-4 数据标准在临床研究中的应用和成功案例 (二) 15:30 - 16:15 二层,203 C T 15 药品追溯体系建设—药品电子监管 会议活动交流活动会场通知会议一览 32 会前专题研讨 (全天) 08:30-17:30 运用数据分析技术监控和评价临床研究质量和结果 08:30-17:30 原料药和制剂的稳定性要求与实践 08:30-17:30 肿瘤临床试验中的数据管理 08:30-17:30 从药物监管角度看MedDRA (ICH国际医学用语词典) 在临床试验药物安全和药物警戒方面的应用 08:30-17:30 全球性药物临床试验的原则和案例研究 08:30-17:30 药品安全和原料药: 全球对原料药的监管及法律的要求和实践 2013年5月12日 星期日 | 会前专题研讨 目标听众 以下临床研究领域的人员: ? 临床管理和运作 ? 临床信息技术与计算机处理技术 ? 临床试验数据监查(临床监查,医疗监控) ? 数据保障和数据质控 ? 临床信息学 ? 药品法规 ? 数据管理和设计 ? 电子临床服务商管理 ? 药物研发 议程 第一节 | 临床研究管理的生物信息工具 I ? 早期研究探索阶段的数据审核 第二节 | 临床研究管理的生物信息工具 II ? 数据质量审查过程 ? 受试者数据跟踪 ? CDISC标准数据结构及应用方法 第三节 | 应用先进的报告和分析方法提高临床研发的效能 ? 临床研发效率和质量的提高 ? 资源调配 ? 研究计划的制定和决策 第四节 | 对全球数据进行有效的数据管理和信息发掘 – WHO全球药品监测中 心(UMC)的视角 I ? 用于信息发掘的信号检测和方法 ? 数据转化为信息: 标准化词典和术语的重要性 第五节 | 对全球数据进行有效的数据管理和信息发掘 – WHO全球药品监测中 心(UMC)的视角 II ? 如何运用WHO药物词典对临床试验和安全性数据进行编码 (全天) 专题研讨 一08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 B 运用数据分析技术监控和评价临床研究质量和结果 讲授专家 刘川 博士 Medidata Solutions Worldwide 大中华地区发展总监 Eric S. Herbel 美国Integrated Clinical Systems公司总裁 Yutaka Sato 日本Medidata Solutions公司方案建设部顾问 Madeleine Krieg 注册药师 瑞典Uppsala监测中心产品经理 Maria Lindquist 博士 瑞典Uppsala监测中心总监兼首席执行官 专题研讨介绍 过去的十年中,临床试验的周期和复杂性在不断增加,但药物研发经费却呈现 缩减之态,开发方无法在更长期和更复杂的试验中投入更多的资金.因此,寻 求更高效和创新的方法来进行临床研究显得迫在眉睫.本研讨会将讨论临床研 究数据分析的典型方法和最佳实践范例.议题包括支持临床试验医疗监控运行 的数据分析技术类型,风险监控所用CDISC数据结构,以及临床试验阶段和上 市后临床研究的试验管理.本研讨会也将讨论基于数据积累的临床数据审核各 种方法、临床研究计划制定以及决策.此外,涵盖的话题还包括如何实现更好 的资源调配以提高临床研发的效能和质量、受试者数据审查的益处、异常数据 检测的方法以及如何进行信号检测. 目的 ? 了解应用生物信息工具进行临床数据评价的时机和方法. ? 了解的已出现的新方法,侧重于"病人鉴别/深度发掘"的报告、图解和数 据系统中受试者信息的交互作用. ? 了解如何进一步提高临床研发的效能和质量. ? 掌握数据信息转化以便更好调配资源并进行风险决策. ? 学会运用全球性词典对临床试验和安全性数据进行编码. 33 (全天) 专题研讨 二08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 C 原料药和制剂的稳定性要求与实践 讲授专家 阮忠士 博士 美国百时美施贵宝公司分析研发部副总监 卜欣 博士 美国百时美施贵宝公司分析和生物分析部高级研究员 专题研讨介绍 稳定性是医药产品的重要质量属性;因此,遵循当前药物规范的稳定性试验方 案对药物开发和新药注册至关重要.稳定性试验方案的成功实施要求对全球的 药品监管规定、稳定性方法与最佳实践范例有全面的了解.本研讨会将概述美 国食品药品监督管理局(FDA)、国际协调组织(ICH)和世界卫生组织(WHO)对药 品的稳定性要求,并从监管和技术层面上探讨如何设计高效、规范的全球化药 物稳定性试验方案. 目的 ? 了解稳定性试验方案在药物开发过程中的重要性 ? 遵循ICH/WHO与全球的药物规范设计稳定性研究方案 ? 高效地实施稳定性试验方案 ? 了解稳定性检测方法的重要性 ? 全球技术转移的管理 ? 解读稳定性试验数据 目标听众 ? 研发及管理人员 ? 法规监管人员 ? 质量保证和质量控制专业人员 ? 合同研究机构和生产企业 ? 学术研究机构 议程 第一节 | 药物稳定性的监管要求概述 ? 稳定性在药物开发过程中的重要性 ? cGMP药物稳定性要求概述 ? ICH药物稳定性指南 ? 全球化药物稳定性试验方案的要求 ? 药品保存期的确定 第二节 | 药品稳定性的技术方面实践 ? 稳定性检测方法的建立 ? 强制降解研究的设计 ? 试验方法的验证和技术转移 ? 稳定性数据的评估 第三节 | 案例讨论 (全天) 专题研讨 三08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 D 肿瘤临床试验中的数据管理 讲授专家 颜崇超 博士 辉瑞(中国)研究开发有限公司 数据管理部门技术运营负责人 徐莉 医学博士,工商管理硕士 美国辉瑞公司肿瘤业务部, 肿瘤中国策略规划、贯彻和全球运作部副总裁 陈丽娟 新加坡 InVentiv Health Clinical 亚太区临床研究执行总监 张薇 辉瑞(中国)研发有限公司数据管理部门治疗领域经理 吴沭陵 辉瑞(中国)研发有限公司临床数据管理部门经理 王娟 辉瑞(中国)研发有限公司临床数据(肿瘤组)管理员 伍晓华 默沙东研发(中国)临床数据管理副总监 专题研讨介绍 在中国临床研究中,肿瘤临床试验占相当大的比重.本研讨会由两部分组成, 将分别介绍肿瘤临床试验的基础知识以及肿瘤临床试验各阶段中数据管理的具 体操作. 目的 ? 介绍肿瘤临床试验的基础知识 ? 阐述肿瘤临床试验具有特征性的试验设计,疗效评价以及安全性评价 ? 帮助理解肿瘤试验中各个阶段的数据管理的工作,强调病例报告表的设 计、数据清理、实验室数据管理、实体肿瘤测量以及长期试验的管理 ? 讨论肿瘤试验中的最佳操作方法.例如,关键数据点的确定,SAE的处 理以及实验室数据的审查等 目标听众 本次研讨会是为希望了解肿瘤临床试验或者肿瘤临床试验数据管理的专业人员 设置及下列相关领域的人员: ? 临床研究专业人员 ? 临床项目管理人员 ? 临床监查员 ? 统计学人员 ? 试验程序人员 议程 第一节 | 肿瘤学临床研究基础知识 第一部分: 概述 ? 肿瘤药物开发 ? 肿瘤学治疗标准以及相关术语 第二部分: 肿瘤试验的设计和终点 ? 肿瘤临床试验的分期以及类型 ? 肿瘤评价终点(无进展生存期、客观缓解率、总生存期、肿瘤评价标准 1.1) 第三部分: 肿瘤试验进行期 ? 知情同意 ? 现场监查与方案偏离 34 第四部分: 安全监测 ? 不良事件和严重不良事件 ? 不良事件通用术语标准(CTCAE) 第五部分: 案例讨论 第二节 | 肿瘤学数据管理员基础知识 第一部分: 试验启动阶段 ? 肿瘤试验的病例报告表的设计以及数据库的建立 ? 肿瘤学试验的治疗周期 ? 肿瘤学试验中有效性数据的收集与测量 第二部分: 试验进行阶段 ? 试验数据的清理 ? 肿瘤学研究中本地实验室数据与正常范围的处理 ? 支持有关有效性与安全性数据的临床审查 ? 第三方数据的审查对数据管理员的挑战 ? 外部数据的处理和一致性检查 ? 第三部分: 试验结束期 ? 中期分析时数据库临时性的锁定 ? 长期试验的管理与跟踪 第四部分: 肿瘤试验的最佳实践 ? 肿瘤试验中的关键数据点 ? 了解必要数据和最佳数据 ? SAE 处理 ? 实验室数据审核 ? 肿瘤测量 (全天) 专题研讨 四08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,203 C 从药物监管角度看MedDRA(ICH国际医学用语词典)在临床试验药物 安全和药物警戒方面的应用 讲授专家 Anna ZHAO-WONG 医学博士 美国MedDRA Maintenance and Support Services Organization副总监 Sonja BRAJOVIC 医学博士 美国FDA药物审评和研究中心 监测和流行病学办公室 MedDRA协调员 专题研讨介绍 本次研讨会将重点放在MedDRA在临床试验安全性和药物警戒方面的应用, 包括监管方面的观点.内容含有如何按照ICH认可的《MedDRA编码:考虑 要点》和《MedDRA数据检索和显示:考虑要点》指南文件统一精确地使 用MedDRA术语编码、检索、显示临床药物安全信息数据的方法,如何使用 MedDRA标准分析查询工具(SMQs)帮助识别,检测药物安全信号.同时还将 介绍美国FDA不良事件报告系统(FAERS)的实施,描述标准术语在药品安全数 据编码和分析中使用.鼓励参加者带有关MedDRA编码、数据检索/分析的问 题参加交流和讨论. 目的 ? 描述如何使用MedDRA术语进行不良事件数据编码 ? 阐述检索和分析MedDRA编码数据的策略及其在临床药物安全性和药物 警戒中的应用 ? 了解美国FDA如何使用MedDRA对FDA不良事件报告系统(FAERS)数据 进行上市后药物警戒.并在新药审评中将其运用于对临床试验安全性数 据的分析 目标听众 本次研讨会是为以下有MedDRA基本知识并想探索其在临床药物安全和药物 警戒中应用的专业人士设计的: ? 药物警戒和临床研究的专业人员 ? 临床数据管理人员 ? 医学写作者 ? 法规及监管人员 议程 第一节 | MedDRA简介 第二节 | MedRA编码和ICH认可的《MedDRA编码: 考虑要点》 ? 《MedDRA编码: 考虑要点》简介 ? 从美国FDA视角通过编码示例分析数据质量问题 ? 编码练习 ? 问答与互动 第三节 | MedDRA数据分析和ICH认可的《MedDRA数据检索和显示: 考虑要 点》 ? 《MedDRA数据检索和显示: 考虑要点》简介 ? 编写MedDRA查询 ? MedDRA查询编码练习 ? MedDRA标准分析查询工具 ? 自定义搜索 ? 从美国FDA AERS数据库和新药安全审查的例子中看FDA如何使用 MedDRA进行信号检测 ? 问答与互动 第四节 | MedDRA版本更新 (全天) 专题研讨 五08:30 - 17:30 (12:00 - 13:00 午餐) | 二层,201 A 全球性药物临床试验的原则和案例研究 讲授专家 王武保 博士 默沙东研发(中国)有限公司 生物统计与研究决策科学部 – 亚太区执行总监 寿琼 博士 默沙东研发(中国)有限公司 生物统计与研究决策科学部 – 亚太区资深生物统计师 Hsien-Ming James HUNG 博士 美国FDA药品审评与研究中心生物统计处处长 Sue-Jane Wang 博士 美国FDA药品审评与研究中心生物统计处, 转化科学处副处长 安藤 友纪 日本药物医疗器械监督局生物统计组, 药物评价中心资深生物统计师 专题研讨介绍 近年来,全球性临床试验在药物研发中占有越来越大的比重.ICH指南以及区 域的临床监管指南已经明确阐述了全球性临床试验的基本科学原则.本研讨会 通过心血管、中心神经系统、抗感染、肿瘤和其他治疗领域的案例阐述药物监 管、统计学、临床和运作原则.每一个案例将介绍疾病的背景、临床试验的设 计、药物全球发展的战略、临床试验的结果以及药物监管部门审评的考量. 35 目的 ? 回顾全球性临床试验中药物监管、统计学、临床学和运作的原则 ? 通过实例了解在不同区域开展临床药物研发及注册的策略 ? 通过实例了解不同地区对注册的法规要求 目标听众 以下领域的人员: ? 定量科学 ? 法规监管 ? 制药行业(临床前、上市前、上市后的开发) ? 合同研究组织 ? 政府机关 ? 学术界/研究机构 议程 第一节 | 心血管和中心神经系统案例以及原则 ? 一致性和不一致性的概念 ? 全球和区域临床试验的优势以及挑战 第二节 | 全球和地区药物基因组学试验案例及原则 ? 药物基因组学试验的设计和分析的特点 ? 全球和区域药物基因组学试验的优势以及挑战 第三节 | 亚洲临床试验案例及原则 ? 全球,亚洲和地区临床试验设计的选择以及发展战略 ? 对全球临床试验中总体及区域结果的评估 第四节 | 问答与互动 (全天) 专题研讨 六08:30 - 17:30 (12:00 - 13:00 午餐) | 三层,307 药品安全和原料药: 全球对原料药的监管及法律的要求和实践 欢迎致辞 翁新愚 中国食品药品监督管理总局原药品安全监管司生产监督处处长 苏岭 博士 DIA全球理事会主席 盛德国际律师事务所生命科学战略顾问 Nicole Taylor SMITH 法学博士 美国食品药品监督管理局驻中国办公室副主任 议程 第一节 | 2012年中美原料药法规监管和合作会议回顾总结 Jeffrey GREN 美国商务部健康与消费产品司司长 第二节 | 美国及欧盟对原料药和化学品生产的定义和监管以及原料药在全球 药品安全中的作用 有关欧盟原料药认证新要求和国际合作机遇的讨论 Nicole Taylor SMITH 法学博士 美国食品药物监督管理局驻中国办公室副主任 Patrizia TOSETTI 博士 欧盟委员会健康局科学官 第三节 | 企业对原料药监管的思考 维力士吉 葡萄牙好利安制药科学股份有限公司行政总裁,RX-360 Consortium 机构代表 顾桂国 中国中化帝斯曼制药(淄博)有限公司总经理 第四节 | 中国原料药监管进展概述 翁新愚 中国食品药品监督管理总局原药品安全监管司生产监督处处长 第五节 | 对原料药生产企业的监督检查及针对未受监管的化学原料的执法合作 Piotr KRAUZE 欧洲药品管理局检查部科学行政官 王刚 博士 美国食品药品监督管理局驻中国办公室助理主任 第六节 | 中国、欧盟和美国药典原料药标准的作用 王平 国家药典委员会副秘书长 Susanne KEITEL 博士 欧洲理事会欧洲药品质量局(EDQM)局长 胡江滨 博士 美国药典委员会中华区副总裁 第七节 | 确保原料药质量以及防止销售或出口不受监管或伪造的原料药的法 律和政策 杨晨 盛德国际律师事务所北京办事处合伙人 盛德中国生命科学业务负责人 刘志伟 教授 北京师范大学法学院 刘科 副教授 法学博士 北京师范大学刑事法律科学研究院 何菁 法学博士 安杰律师事务所高级顾问 第八节 | 具体法律和政策建议 主持人 Jeffrey GREN 美国商务部健康与消费产品司司长 翁新愚 中国食品药品监督管理总局原药品安全监管司生产监督处处长 第九节 | 建议与合作措施 第十节 | 总结 36 2013年5月13日 星期一 | 会议日程 (第一天) 现场注册 07:30 - 16:00 开幕式及全体大会 13:30 - 17:15 (茶歇 15:30-16:00) 介绍来宾 蔡伊志 博士 DIA中国区总监 DIA主席致辞 苏岭 博士 DIA全球理事会主席 盛德国际律师事务所生命科学战略顾问 尹力 博士 国家食品药品监督管理总局副局长 DIA志愿者杰出贡献奖颁奖仪式 大会主席致辞 谭凌实 博士 辉瑞全球开发运营副总裁 辉瑞(中国)研究开发有限公司总经理 赵亚军 中国医药国际交流中心主任 主旨嘉宾演讲 促进药物创新,保障患者安全 桑国卫 中国药学会理事长 中国工程院院士 风险管理计划: 促进创新确保患者安全 Patrizia A. Cavazzoni 医学博士 辉瑞全球研发中心高级副总裁, 全球安全负责人及成熟产品药政事务部负责人 艾滋病病毒携带者治疗药物现状和期待 孟林 北京爱之方舟创办者及负责人 中国艾滋病病毒携带者联盟秘书处协调员 中国全球基金项目国家协调委员会非政府工作委席位代表 欢迎招待会 — 中国之夜: DIA中国五周年庆典 17:30 - 19:30 国家食品药品监督管理总局 (CFDA) 专场会 2013年5月14日 星期二 13:30 - 17:30 一层, 三号会议厅 中国药品上市前和上市后的安全监管 会议主持 薛斌 国家食品药品监督管理总局中国医药交流中心副主任 2012年度中国药品审评报告 陈震 博士 国家食品药品监督管理总局药品审评中心化药药学一部副部长 2013年5月14日 星期二 | 会议日程 (第二天) 董江萍 国家食品药品监督管理总局药品注册司化学药品处处长 程刚 国家食品药品监督管理总局药品评价中心,国家药品不良反应监测中心主任助 理37 专题 1 | 临床研究与运作 分会场 T 1-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 C+F 成功的全球临床试验 - 优化利益,降低风险 会议主持 顾薇 百时美施贵宝(中国)投资有限公司临床运营部高级总监 为确保临床试验的成功,患者的安全和风险管理是关键要素.FDA和EMA颁布 了基于风险的监查规范, 中国在参与更多的全球临床同步研发过程中,需将这 些国际原则和规范应用于中国和亚洲国家.本专场将深入讨论实施优良临床 试验的指导原则. 临床试验的成功要素 John Ran Kim 韩国ICON公司亚太区临床研究部副总裁 基于风险的监控 Elaine Hawkings 百时美施贵宝(中国)投资有限公司临床运营部亚太区执行总监 包括中国和亚洲参与的全球临床试验的风险与收益 宫崎 浩一 注册药师 日本第一三共制药公司临床运营副总监 专家讨论 分会场 T 1-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 C+F 临床试验中各方的协调与沟通 会议主持 吴䶮 第一三共(中国)投资有限公司医药开发总部总经理 专家讨论 纵观整个临床试验的关键路径,从研究方案的确定,IEC/IRB审查,研究合 同签署,病人/受试者招募,到安全监测及研究结束,责任各方,如申办者, 主要研究者/研究机构,IEC/IRB和CRO等的合作协调和有效沟通对保证高效 率、高质量的临床试验至关重要. 来自临床研究中心(基地)、伦理委员会、申办方及CRO的各方人员将介绍各 自工作重点领域,以及如何建立通畅的交流沟通机制及协调合作.协调一致 以确保以患者安全和权益为中心的临床研究的高效运作. 专家讨论组 徐仲鍈 教授 香港中文大学公共卫生学院临床研究中心生物统计处处长 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 顾薇 百时美施贵宝(中国)投资有限公司临床运营部高级总监 陈莉 医学博士 ICON中国项目管理部负责人 分会场 T 1-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 C+F GCP诊所 会议主持 陈华 杨森(中国)制药研发质量保证部临床质量监控/药物警戒组总监 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 专家讨论 本专场将讨论在临床试验过程中常见的GCP质量问题.参加讨论的人员包括 涉及临床试验不同领域的专家, 药监局官员,临床试验基地主任,制药公司临 床运营部门的主管及质量保证部门的代表.专家将根据临床研究及监管的经 验交流观点.目的是促进相互的理解,提高临床试验的质量. 专家讨论组 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 戴欣 北京诺华制药有限公司国际临床开发部大中国、亚太、中东及非洲区域高级总监 巫雪莹 辉瑞医疗(中国)临床发展及运营负责人 李庆红 辉瑞医疗(中国)质量保证部亚洲地区负责人 分会场 T 1-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 C+F 从质量保证的角度谈药物警戒 会议主持 李庆红 辉瑞医疗(中国)质量保证部亚洲地区负责人 为保证病人的安全,全球的医药监管部门竭力加强对新药的安全监督和管 理.本专场旨在解读欧盟新药安全监督和管理的最新法规,分享和学习来自 监管部门视察和申办者内部稽查的经验和教训,共同思考如何规划未来,如 何符合法规要求、提高工作有效性及改进药物警戒的流程. 本专场并将侧重介绍欧盟药物警戒法规最新发展、药物警戒视察中常见问 题、企业内部稽查的经验. 欧盟药物警戒法规的最新进展和视察中常见问题 Carrie Scott 英国药品医疗产品监管局GPvP运营经理,资深药物警戒监察员 企业内部药物警戒稽查 Deborah Driscoll 博士 美国辉瑞公司医疗质量保证部副总裁 2013年5月14日 星期二 | 会议日程 (第二天) 2013年5月15日 星期三 | 会议日程 (第三天) 38 分会场 T 1-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 C+F 临床研究机构面临的机遇与挑战 会议主持 李海燕 教授 北京大学第三医院药物临床试验机构主任 北京大学临床研究所副所长 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 近年来,临床研究数量在快速增长,国家药监局也更关注研究质量,不仅通 过对申报项目的现场核查进行监管,同时在机构复核检查中也将此作为重要 内容之一.研究者在承担大量临床研究的同时,还要确保研究质量.面对这 样的挑战,临床研究机构应如何加强管理,为临床试验提供一个高效、有序 的GCP平台.本会场将针对这些问题进行深入的讨论. 高效规范的管理程序对临床试验受试者安全性的保障作用 梁茂植 研究员 华西医院国家药品临床试验机构副主任兼I期临床试验研究室主任 临床药理研究室主任 华西医院国家药物临床试验机构/GCP中心负责人 2012 年临床研究机构的问卷调查及分析 李树婷 中国医学科学院肿瘤医院GCP中心办公室主任 在中国药物研发中临床试验机构的作用 李海燕 教授 北京大学第三医院药物临床试验机构主任 北京大学临床研究所副所长 分会场 T 1-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 C+F 中国伦理委员会的职责和发展 会议主持 刘海涛 国际公共卫生学硕士 葛兰素史克(中国)投资有限公司 全球质量合规部 亚太地区临床发展质量保证 部高级顾问 本专场将着重于中国目前的伦理审批和伦理委员会的建设: 优势和挑战. 内容 不仅将侧重于内部架构和系统的建设,并从保护患者安全角度讨论目前伦理 委员会的职责.本专场旨在促进发展高效、高质量伦理审查体系. 通过伦理委员会审查确保患者安全 Cristina E. Torres 博士 菲律宾亚太地区伦理审查委员会亚洲区协调员 伦理审查中的挑战与思考 汪秀琴 教授 博士 江苏省人民医院科技处副处长,伦理委员会副主任委员 台湾伦理委员会基础设施策略规划 — 临床研究之关键主动支持 陈恒德 医学博士 台湾生技整合育成中心医务长 专家讨论 专题 2 | 监管科学 分会场 T 2-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 A+B+G+H 固定剂量复方制剂(FDCs)在中国及全球的发展 会议主持 闫小军 工商管理硕士 拜耳医药保健有限公司全球注册战略发展特药负责人 开发固定剂量复方制剂(FDCs)从公众健康角度来说越来越重要.这类药品被 广泛的应用于治疗例如艾滋病(HIV)、高血压、和口服避孕等疾病,通过科学 合理的组合,复方制剂在临床上可起到增加疗效,减少不良反应的作用.此外,FDC制剂的成本可能要小于同时分别给药.由于减少了病人服用的药片/ 丸等,从而提高了用药依从性. 本专场来自制药企业和医院的讲者将分享全球FDC的发展及其对患者的益 处.药监局审评中心的讲者将分享对复方药物开发的主要考虑. 固定复方制剂: 在中国控制高血压的意义与研究进展 王文 教授 中国医学科学院阜外医院国家心血管病中心 跨国公司如何科学理性地开发FDCs Dan Paulson 博士 美国拜耳医药保健有限公司全球临床负责人 复方药物开发的主要考虑 康彩练 国家食品药品监督管理总局 药品审评中心 化药临床二部高级审评员 分会场 T 2-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 A+B+G+H 生物类似药新的监管: 挑战与机遇 会议主持 周雪娟 赛诺菲(中国)监管事务部总监 自美国2011年颁布了生物类似药指南后,如何进行符合该指南要求的临床研 究已引起各方的关注.本场将讨论生物类似药开发的法规要求和试验设计. 美国FDA生物类似药指南要求 龚兆龙 博士 美国FDA同仁会国际网络成员 前美国FDA新药审评员 百济神州(北京)生物科技有限公司副总裁 生物类似药开发的CMC要求 吴笃恭 博士 法玛特咨询咨询部部长 前美国FDA新药审评质量评估部副处长 前美国FDA ICH Q5E 专家工作组代表 如何管理生物类似药上市后的不良反应监控及相关问题 陈少羽 法学博士 美国FDA同仁会成员 美国科文顿.柏灵律师事务所驻北京合伙人 专家讨论 中国生物类似药监管现状与展望 以上讲者及 王凯玲 美国瑞格律师事务所 中国生命科学首席顾问 39 分会场 T 2-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 A+B+G+H 新药临床试验/IND阶段的风险与受益权衡 会议主持 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 风险与受益评估是监管决策的基础.尽管风险/受益评估在过去的十年中取 得了进展,这一领域在目前仍面临着巨大的挑战,尤其是在所开发药物的受 益还无法确定的新药临床试验(IND)阶段.本专场为风险/受益评估主题的第 一部分,将介绍美国FDA和中国CFDA/CDE的观点. 美国FDA在临床试验阶段对药品受益/风险的权衡 Mark J. Goldberger 医学博士,公共卫生硕士 前美国FDA药品审评与研究中心药品审评四部部长 美国FDA同仁会成员 美国雅培制药法规政策部副总裁 临床试验暂停(Clinical Hold)-美国FDA在新药临床试验阶段进行风险管理的 重要措施 Robert J. Meyer 医学博士 前美国FDA药品审评与研究中心药品审评二部部长 美国FDA同仁会成员 美国弗吉尼亚大学医学院公共卫生科学系副教授,弗吉尼亚州立监管科学中 心主任 美国FDA权衡药品受益/风险的统计学考量 李宁 医学博士 赛诺菲药学与医学政策亚洲区副总裁 中国药品审评中心对临床试验申请的审批 杨志敏 中国药品审评中心化药临床一部副部长 专家讨论 分会场 T 2-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 A+B+G+H 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价 会议主持 Mark J. Goldberger 医学博士,公共卫生硕士 前美国FDA药品审评与研究中心药品审评四部部长 美国FDA同仁会成员 美国雅培制药法规政策副总裁 风险与受益评估是监管决策的基础.不同的监管机构对同一类药品申请有不 同的审评结论和决策.本专场为风险/受益评估主题的第二部分,将介绍 NDA及上市后,如何考量风险和受益,并着重介绍美国专家顾问委员会的作 用. NDA及上市后风险及效益平衡观 Robert J. Meyer 医学博士 前美国FDA药品审评与研究中心药品审评二部部长 美国FDA同仁会成员 美国弗吉尼亚大学医学院公共卫生科学系副教授,弗吉尼亚州立监管科学中 心主任 美国FDA借助外部咨询委员会对新药/NDA进行风险/受益评估 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 风险效益观在上市申请审评中的体现 徐丽娟 台湾卫生署药品食品监督局药品审评中心临床科学处首席执行官 上市后的风险效益再评价 詹思延 教授, 医学博士 北京大学医学部流行病和生物统计系副主任 专家讨论 分会场 T 2-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 A+B+G+H 在中国开发治疗用生物制品 – CMC的视角 会议主持 刘秀凤 美国安进公司北京办事处注册事务和安全部总监 在解决未能满足的医疗需求方面,已知治疗用生物制品正扮演着日益重要的 作用.在中国及时引入新的、安全有效的治疗用生物制品是国内外制药企业 和监管机构的共同目标.在这个专题的演讲和讨论中,来自制药企业和监管 机构的代表将从CMC的视角来分享和讨论如何加速临床研究申请的批准,包 括申报资料准备,顺利启动和完成样品检验,总结和分析所遇到的挑战和机 遇,并提出可能的解决方案. 生物制品临床申请中申报资料的准备和样品检验 程慧旸 博士 嘉和生物药业有限公司医学注册部总监 蔺亚萌 罗氏(中国)制药有限公司政策事务经理 饶春明 中国食品药品检定研究院 生物制品检定所重组药物室主任 专家讨论组 以上讲者及 徐砺新 医学博士 美国FDA药品审评与研究中心 单克隆抗体处,生物科技产品办公室,生物药 品质量评审专家 Anthony Ridgway 博士 加拿大卫生部健康产品和食品局生物和基因疗法处首席监管科学家 分会场 T 2-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 A+B+G+H 创新的标签说明书中心体系在亚洲的应用及与国际体系的整合 会议主持 Rie Matsui 注册药师 日本辉瑞公司WSR国际和全球产品信息部区域标记组亚洲区总监 岸达生 日本药物医疗器械监督局药物安全二处风险管理主任 许多跨国公司使用集中统一的标签说明书模式.支持该模式的核心数据表 (CCDS)由公司总部管理,而本地药品文件和病人使用说明书由所在地的公 司管理.本专场将对CCDS、USPI、EU-SPC等全球标签说明书体系进行综 40 述,并通过亚洲区的实例,探讨发展的前景.本专场还将从确保病人信息安 全的视角,阐述制药产业对全球标签说明书体系的管理. 跨国制药企业的全球药物安全说明书体系 Matthias BOEDDING 教授,医学博士 拜耳(中国)医药保健有限公司, 全球研发北京中心全球药物警戒-风险管理部负责人 一个亚洲区管理药物说明书的创新模式 Rie Matsui 注册药师 日本辉瑞公司WSR国际和全球产品信息部区域标记组亚洲区总监 日本药物说明书的政策法规 岸达生 日本药物医疗器械监督局药物安全二处风险管理主任 美国和欧洲的全球药物说明书流程以及相关组织 Jeffery Ho 英国WCI咨询公司负责人 专题 3 | 药物安全和警戒 分会场 T 3-1 | 2013年5月14日 星期二 08:30 - 10:00 一层, 5 D+E 上市批准前的药物警戒 — 探索研究 会议主持 夏峰 医学博士 美国辉瑞全球研发有限公司 全球安全和法规部 安全评价组医疗总监 药物警戒活动已转向更为早期、主动的风险和潜在效益评估,并成为新药开 发及上市前评估过程中的重要内容.生物学、药理学等基础科学的进步和药 物研发过程中对信息技术的运用已经促成对以往难以获得的更为复杂药物的 开发,并能更早地在药物开发过程中进行全面深入的风险效益评估. 公众对新药安全的加倍关注以及科学新发展促进了创新药开发方、药监部门 和医务工作人员的紧密合作,以制订相关的指南,加强在药物早期开发阶段 的药物警戒和安全风险管理.同时,制药企业也在不断努力适应新的要求以 确保病人安全. 本专场将分享关于评估、决策、沟通和规划的思路和观点,以及一个需对病 人安全有特殊考量的肿瘤临床试验. 从首次人体使用到批准上市:中国创新药开发中的安全性关键要素(评估、决策和 沟通) 张丹 医学博士,公共卫生硕士 方恩医药发展有限公司总裁兼首席执行官 新药上市批准前的安全评估 — 主要考量及案例回顾 陈之键 医学博士,工商管理硕士 阿斯利康(中国)全球药物研发 中国区副总裁兼负责人 专家讨论 ? 药品上市申请的临床安全性审评 ? 上市批准前安全风险评估的实践 ? 个例和整合的药物安全报告 ? 上市批准前的药品安全性信息沟通 分会场 T 3-2 | 2013年5月14日 星期二 10:30 - 12:00 一层, 5 D+E 产品批准上市后的药物警戒 — 长期的任务 会议主持 程刚 国家食品药品监督管理总局药品评价中心,国家药品不良反应监测中心主任 助理 裘行敏 辉瑞(中国)研发中心全球安全和法规部总监 药品监管机构基于新药申请上市时提供的信息批准药品上市.随着药品在不 同患者群中的使用和患者数量的增多,对于该药品的安全性的了解也随之变 化.除了常规的各项上市后安全性监测工作,还需要对某些有特殊安全性考 虑的药品采用额外的药物警戒方法.究竟采用何种最佳方法,取决于药物、 患者群和安全信号.随着主动监测成为药物警戒的发展新领域,严格设计的 观察性研究在实践中已经被大量应用.本专场将深入讨论上市后药品药物警 戒的方法和实际应用. 主动监测 — 上市后药物安全性监测的新机遇 周晓枫 博士 美国辉瑞制药公司 全球安全和药政事务部总监 上市后药物安全性主动监测的5大理由 Andy Stergachis 博士 美国华盛顿大学流行病学及全球卫生学教授 华盛顿大学公共卫生学院全球医药专业主任 "祖父药"一定安全吗?— 苯丙醇胺(PPA)的个案分享 庄易 博士 美国FDA药品审评与研究中心 生物统计处副处长 专家讨论 ? 上市后的安全性研究 — 什么是最佳途径? ? 实际环境中的研究 分会场 T 3-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 A+B+G+H 新药临床试验/IND阶段的风险与受益权衡 (见分会场T2-3) 分会场 T 3-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 A+B+G+H 美国FDA新药注册申请/NDA和上市后的风险与受益评估及再评价 (见分会场T2-4) 41 分会场 T 3-5 | 2013年5月15日 星期三 13:30 - 15:00 一层, 5 D+E 为患者的利益平衡效益和风险 会议主持 Hugues Berard 医学博士,工商管理硕士 益普生(法国)研发公司副总裁及代理首席医务官 高杲 辉瑞(中国)研究开发有限公司,安全监测及风险管理部副总监 对药物效益风险的评估和权衡贯穿于药品的研发、审评、上市后监测的整个 生命周期.如何建立能被广泛认可的评估模式成为药监部门和制药行业关注 的问题.近年来,不少国家的药品监管部门、制药行业均相继开展药物效益 风险评估方法的研究项目,并取得进展.本专场的讨论旨在: ? 介绍药物效益风险评估方法研究的进展和实施 ? 从制药行业角度探讨当前业界和监管部门采用的评估方法及相应问题 ? 分享制药公司在进行药物研发中进行效益风险分析的方法和实例 ? 探讨如何使各方在科学的评估模式上达成共识,以及其在药物创新中的 作用 效益风险的一体化及代表性: 欧州 PROTECT项目 Juhaeri Juhaeri 博士 美国赛诺菲药物警戒和流行病学部门副总裁及药物流行病学负责人 药物效益风险评估的实施:制药公司合作模式案例分析 Hugues Berard 医学博士,工商管理硕士 益普生(法国)研发公司副总裁及代理首席医务官 以中国为先导的药物研发中的效益 一 风险评估和风险管理 牟骅 博士 和记黄埔医药(上海)有限公司执行副总裁及首席医务官 专家讨论 ? 如何就科学的评估方式达成共识 ? 效益风险评估模式在药物创新中的作用 分会场 T 3-6 | 2013年5月15日 星期三 15:30 - 17:30 一层, 5 D+E 制定风险管理计划有益于患者吗? 会议主持 周凌云 医学博士,公共卫生硕士 赛诺菲全球药物警戒及流行病部 国际药物警戒协调员 茅蕴 工商管理硕士 辉瑞(中国)研究开发有限公司 安全监测及风险管理部总监 有效的风险管理计划已在药物研发和上市阶段发挥重要的作用.然而对于其 可能给医疗系统增加负担并可能限制患者获得药品的争议仍旧存在.风险管 理计划正趋于全球性的协调和统一,但区域的差异需加以考虑,因为不同地 区的患者人群和医疗服务体系的模式会很大程度地影响风险鉴别和分类, 以及 对降低风险工具的选择.有效的风险计划应基于对患者的最佳保护.本专场 重点: ? 介绍侧重于亚洲的全球风险管理计划 ? 介绍CIOMS工作组在有效降低风险方面的进展 ? 分享如何有效应用流行病学研究评估风险最小化手段 ? 讨论风险管理协调统一及工具应用 风险管理计划的全球概况和亚洲特色 William Gregory 美国辉瑞公司安全策略部高级总监 亚洲风险管理:日本的经验 Stewart Geary 医学博士 卫材(日本)全球医学事务副总裁暨首席医学官 观察性试验在风险识别分类以及评估风险最小化工具中的应用实践 Juhaeri Juhaeri 博士 美国赛诺菲公司药物警戒和流行病学部门副总裁及药物流行病学负责人 专题 4 | 统计学 分会场 T 4-1 & T 4-2 | 2013年5月14日 星期二 08:30 - 12:00 二层, 201 A 安全性信号检测和效益/风险定量评估 会议主持 袁维颖 博士 强生药物研发 中国生物统计和统计程序部门总监 曲鹏 博士 辉瑞(中国)研究开发有限公司统计部总监 保护病人的安全在药品开发和医疗中至关重要.辨别潜在性安全信号和效益/ 风险定量评估是安全评价的一个组成部分,统计学在其中起到不可缺少的作 用.本专场从制药界和监管部门两个角度进行探讨. QTc临床试验中的统计考量 庄易 博士 美国FDA药品审评与研究中心 生物统计处副处长 安全性信号检测的序贯GLR检验方法 陈杰 博士 默沙东北京药物研发有限公司生物统计总监 效益和风险的统计考量 Marcia LEVENSTEIN 辉瑞全球研发统计副总裁 安全性信号检测的贝叶斯收缩估计 戴鲁燕 博士 上海勃林格殷格翰药业有限公司 生物统计副总监 药物基因组学的安全性 Sue-Jane WANG 博士 美国FDA药品审评与研究中心生物统计处,转化科学处副处长 专家讨论 分会场 T 4-3 | 2013年5月15日 星期三 08:30 - 10:00 一层, 5 D+E META分析及其在药品开发中的应用 会议主持 Hendrik SCHMIDT 博士 德国勃林格殷格翰药业有限公司 生物统计部 副总监 Meta分析是医学研究和药品开发中应用最广泛的方法之一,例如,产生假 设,判定非劣效性临床试验的界值,以及基于大规模临床试验的治疗效果的 整合分析.但是该方法如果使用不当,其价值就会因各种偏差而减弱.本会 场将推动Meta分析的规范应用并介绍其最新发展. 42 Meta分析在药品安全评估中的应用:统计学挑战与最佳实践范例 George Quartey 博士 美国Genentech公司主任 Meta分析与混合疗法比较数据 — 治疗网络中直接证据和间接证据的测量与 报告:方法、软件和示例 Hendrik Schmidt 博士 德国勃林格殷格翰药业有限公司生物统计部副总监 Meta-回归及其在临床试验中的应用 陈峰 教授, 博士 南京医科大学 公共卫生学院院长 分会场 T 4-4 | 2013年5月15日 星期三 10:30 - 12:00 一层, 5 D+E 药物研发中的定量科学 会议主持 王武保 博士 默沙东研发(中国)有限公司 生物统计和研究决策科学部 – 亚太区执行总监 宋杨 博士 默沙东研发(中国)有限公司 生物统计和研究决策科学部亚太分部 后期研发统 计组首席统计学家 药物研发中的定量科学涵盖了生物统计学、流行病学、卫生经济统计学、科 学应用编程和数据管理等多门学科.这些学科在药物研发领域共同发挥着越 来越大的作用.这些作用不仅体现在战略的制定和实施上,也体现于药监申 请递交和药监决策制定;它不仅反映了发达地区的药物研究现状,也反映了 新兴市场地区的情况.本专场将探讨定量科学专业人员面临的挑战和机遇. 药品研发中的定量科学的新议题 Hsien-Ming James HUNG 博士 美国FDA药品审评与研究中心生物统计处处长 专家讨论 ? 建模与模拟的作用 ? 受益风险定量评估 ? 复杂的临床试验设计 ? 生物标识的预示或预后性 ? 整合分析或Meta分析的效用与缺陷 ? 全球化 专家讨论组 Hsien-Ming James HUNG 博士 美国FDA药品审评与研究中心生物统计处处长 Sue-Jane WANG 博士 美国FDA药品审评与研究中心生物统计处,转化科学处副处长 安藤 友纪 日本药物医疗器械监督局生物统计组, 药物评价中心资深生物统计师 Joan Shen 医学博士 辉瑞(中国)临床发展部高级总监 姚晨 教授 北京大学临床研究所副所长、北京大学第一医院医学统计室主任 黄钦 博士 中国药品审评中心生物统计学部副部长 专题 5 | 疫苗和生物制品 分会场 T 5-1 | 2013年5月14日 星期二 08:30 - 10:00 二层, 201 B+C 确保细胞/基因疗法和血液制品的创新和安全 会议主持 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 本专场将综合介绍中国CFDA/CDE及美国FDA生物制品审评与研究中心对血 液供应、细胞、组织和基因疗法的质量、有效性以及病人安全的监管方法. FDA对细胞/基因疗法药物的安全性和有效性的要求 胡劲捷 博士 FDA同仁会会员 前美国FDA/CBER血液研究和评价办公室,高级审评官员 美国生物咨询公司高级顾问 中国关于细胞/基因疗法安全性及有效性法规方面进展的报告 沈琦 中国食品药品检定研究院生物制品检定所所长 FDA在血液制品安全性方面的职责 胡劲捷 博士 FDA同仁会会员 前美国FDA/CBER血液研究和评价办公室,高级审评官员 美国生物咨询公司高级顾问 专家讨论组 郭秀霞 国家食品药品监督管理总局原药品注册司生物制品处副调研员 常卫红 国家食品药品监督管理总局原药品注册司生物制品处副调研员 分会场 T 5-2 | 2013年5月14日 星期二 10:30 - 12:00 二层, 201 B+C 流感大流行的应急准备原则以及批准上市后疫苗生产的变更 会议主持 Florence Houn 医学博士,公共卫生硕士 美国FDA同仁会国际网络联席主席 前美国FDA药品审评及研究中心药品评价三处处长 美国塞尔基因公司法规政策与战略副总裁 确保疫苗的安全对于各国监管当局都是困难但又必须履行的职责,目的是为 了促进公众健康,督促生物制药企业承担责任.美国FDA和中国CFDA有多 年的经验.为确保疫苗的安全有效,监管部门不仅鼓励采用新技术以推进高 质量和高效率的生产,也需要通过合适的验证及临床或非临床的实验研究来 证明因此引起的变化没有给产品的安全性和有效性造成不良影响,这是一个 非常艰巨的挑战.本专场将介绍美国和中国关于流感疫苗生产、应急准备和 安全性方面所开展的工作. FDA和WHO流感大流行疫苗的应急准备工作 Sara E. Gagneten 博士 美国FDA生物制品审评与研究中心 病毒产品部 疫苗审评与研究处副处长 43 推进中国疫苗安全性和创新性 罗建辉 中国药品审评中心生物制品药学部副部长 FDA的疫苗申请:有关安全性和上市后变更的法规 Sara E. Gagneten 博士 美国FDA生物制品审评与研究中 心病毒产品部 疫苗审评与研究处副处长 分会场 T 5-3 | 2013年5月14日 星期二 13:30 - 15:00 二层, 201 B+C 细胞药物和生物类似药的研发 - 机遇及监管要求 会议主持 史力 博士 上海泽润生物科技有限公司首席执行官 生物类似药和细胞疗法已进入生物制品开发及临床应用的热点阶段.这些领 域对当前和未来以生物为基础的药品开发发挥着越来越重要的作用.随着新 技术的发展,新的疾病治疗方法包括细胞治疗,在逐渐进入实践,其治疗方 法也在面临技术和监管方面的双重挑战.另外生物类似药进入监管成熟的国 家仍需要做很多工作以满足法规要求.本专场将讨论细胞治疗和生物类似药 开发、质量、安全性和监管要求的现状和机遇. 细胞治疗及发展和现状及其在医学美容治疗中的应用 朱宁文 博士 江苏华亿细胞组织工程有限公司创办人兼首席科学家 按照国际GLP标准对中国新生物医药进行安全评价研究 徐景宏 博士 中国Innostar公司国家上海新药安全评价研究中心副总裁及首席安全官 从监管的角度来看将中国生物类似药引进欧盟的期望和机会 Hoss Dowlat 博士 德国PharmaBio咨询公司政府事务部欧洲-美国区副总裁 分会场 T 5-4 | 2013年5月14日 星期二 15:30 - 17:30 二层, 201 B+C 中国与全球的疫苗产品认证和肝炎新疫苗研发 会议主持 史力 博士 上海泽润生物科技有限公司首席执行官 提高疫苗产品质量及新型疫苗的开发正在中国得到更多的关注.向世界供应 中国制造的疫苗已提上中国疫苗行业的议事日程.世卫组织预认证(PQ)和新 版GMP的实施已经在中国实实在在地展开并取得了实际成果.肝炎疾病是亚 洲包括中国最普遍和严重的疾病之一.本次会议将探讨WHO的PQ实践和肝 炎疫苗的有效性及新发展.本次会议还将回顾开发创新生物医药产品与抗传 染病产品开发的国际合作的机会. 世卫组织对疫苗和生物制品的质量预认证 Nora Dellepiane 博士 世界卫生组织基本药物和医疗产品部疫苗质量和监管组组长,质量安全科学家 滴定法检测甲型肝炎减毒活疫苗 汪萱怡 博士,教授 上海复旦大学医学院 新二代乙型肝炎疫苗的开发:新型佐剂提高疫苗的有效性 Tyler J. martin 医学博士 美国Dynavax总裁和首席医疗官 细胞治疗和生物类似药的开发机会和法规管理上的考虑 Hoss Dowlat 博士 德国PharmaBio咨询公司政府事务部欧洲-美国区副总裁 专题 6 | CMC 分会场 T 6-1 & T 6-2 | 2013年5月14日 星期二 08:30 - 12:00 二层, 201 D 仿制药与参比制剂之比较与评价 — 仿制药质量一致性评价 会议主持 桂敏 博士 百时美施贵宝全球注册科学部 亚太区和中国CMC及运营部总监 陈琦琬 博士 辉瑞全球CMC执行总监 前美国FDA新药审评质量评估部副部长 美国FDA同仁会国际网络成员 国家食品药品监督管理总局(CFDA)2012年开始对2007年前批准的仿制药进 行再评价.该项工作旨在确保药品的安全、有效和质量.如何科学有效地进 行评价?监管部门和制药企业面临着哪些实际挑战?如何解决发现的问题? 本专场将讨论仿制药再评价、分享生物等效性评价和体外溶出度试验的经 验. 国家食品药品监督管理总局仿制药质量一致性评价工作程序 林兰 中国食品药品检定研究院化学药品检定所副所长 参比制剂的选择及溶出度对比试验指南 张启明 中国食品药品检定研究院研究员 体内体外相关性- 挑战与考量 Deepak Hegde 博士 无锡药明康德有限公司配方研发部副总裁 美国药企对仿制药生物等效性和体外溶出度的研究 魏晓雄 医学博士 美国Medpace临床药理部总监 美国FDA同仁会国际网络成员 专家讨论 分会场 T 6-3 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 D 中美植物药监管展望 会议主持 陈琦琬 博士 辉瑞全球CMC执行总监 前美国FDA新药审评质量评估部副部长 美国FDA同仁会国际网络成员 在美国,植物药依照其用途被划分为食品增强剂或药品来监管.美国FDA在2004年发布了关于植物药的指导意见,其涵盖了FDA对临床研究的不同阶段 与新药申请前的CMC方面的建议.该建议使制药业和学术界得以开始药用植 物制品的研究,并在2006年批准了第一例植物药品.本专场将简要回顾植物 药品监管的历史,探讨美国在开发此类药品时所面临的挑战,并与中国长期 以来在中药监管方面的经验做比较. 44 中药产业前景 周俊杰 博士 上海和记黄埔医药有限公司总经理 中药新药研发策略和研发实践 叶祖光 教授 中国中医科学院首席研究员 中药全球化所面临的机遇和挑战 张迅 博士 葛兰素史克(上海)医药研发有限公司副总裁, 全球天然产物事业部负责人 分会场 T 7-2 | 2013年5月14日 星期二 10:30 - 12:00 二层, 203 C 中药开发的案例分析与实践 会议主持 许俊才 上海医药临床研究中心高级副总裁 本专场将通过案例分析讨论中药开发的经验和监管要求,也将讨论"如何制定 中药临床评价的标准". 中药在中国的监管准则和进展 陈易新 国家食品药品监督管理总局 原药品注册司 中药处处长 中国中药临床研究新进展 许俊才 上海医药临床研究中心高级副总裁 专题 8 | 肿瘤靶向药物的研发 合作单位; 美中抗癌协会 分会场 T 8-1 | 2013年5月14日 星期二 13:30 - 15:00 二层, 201 D 肿瘤诊断和治疗模式的改变对药物研发的影响 会议主持 陈之键 医学博士,工商管理硕士 阿斯利康(中国)全球药物研发 中国区副总裁兼负责人 徐莉 医学博士,工商管理硕士 美国辉瑞公司肿瘤业务部, 肿瘤中国策略规划、贯彻和全球运作部副总裁 肿瘤靶向创新药物研发现状概述以及2个成功研发案例的回顾分析 概述和介绍 Maria Koehler 医学博士 美国辉瑞公司肿瘤业务部,临床研究和医学事务部副总裁 案例:基于标志物或靶点的抗肿瘤药物的研发-对合适的人群在合适的时间给 予合适的药物 ? 案例 1 - 克唑替尼:间变性淋巴瘤激酶(ALK)和非小细胞肺癌(NSCLC) Maria Koehler 医学博士 美国辉瑞公司肿瘤业务部,临床研究和医学事务部副总裁 ? 案例 2 - 针对BRAF V600e/k 基因突变的黑色素瘤的BRAF抑制剂治疗 郭军 教授, 医学博士 北京肿瘤医院、北京大学临床肿瘤学院副院长,北京市肿瘤防治研究所 副所长,肾癌黑色素瘤内科主任 国家食品药品监督管总局(CFDA)对中药的监管要求 周跃华 中国药品审评中心中药民族药药学部副部长 美国植物药的监管背景 吴笃恭 博士 PPD法规部总监/资深顾问 美国FDA同仁会国际网络成员 美国植物药品开发所面临的监管挑战 林则全 博士 生物医药咨询公司资深顾问 美国FDA同仁会国际网络成员 专家讨论 分会场 T 6-4 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 D 全球生物制药法规的发展 — CMC视角 会议主持 蔺亚萌 罗氏(中国)技术监管政策部经理 桂敏 博士 百时美施贵宝全球注册科学部 亚太区和中国CMC及运营部总监 过去的十几年中,新技术的发展与应用不断促进生物制药的研发变革.本专 场将介绍全球生物制药产品法规的沿革,以及影响美国和欧盟监管框架的新 监管理念,如贯穿生物制药产品生命周期的工艺验证以及CMC变更管理方案 等.此外还将讨论新ICH Q11指南在生物制药产品原料药研发中的应用,并 结合具体的案例讨论如何将平台工艺应用于生物制药的开发. 美国生物制药监管法规的沿革 徐砺新 医学博士 美国FDA药品审评与研究中心单克隆抗体处,生物科技产品办公室,生物药 品质量评审专家 ICHQ11指南在生物制药原料药研发中的应用 Anthony Ridgway 博士 加拿大卫生部健康产品和食品局 生物和基因疗法处资深监管科学家 模块化病毒验证方法在单克隆抗体平台纯化工艺中的应用 陈琪 博士 美国Genentech公司病毒清除室,蛋白纯化系副总监兼资深科学家 专题 7 | 传统中药 (TCM) 分会场 T 7-1 | 2013年5月14日 星期二 08:30 - 10:00 二层, 203 C 开发适用于中国及全球的创新性中药 会议主持 张迅 博士 葛兰素史克(上海)医药研发有限公司副总裁, 全球天然产物事业部负责人 本专场将介绍关于创新性中药产品开发的研发战略和方法,并将讨论制药企 业致力于借鉴国际临床药物研发技术和标准,研发高质量、受专利保护以及 临床证实的中药新药所面临的机遇和挑战. 45 分会场 T 8-2 | 2013年5月14日 星期二 15:30 - 17:30 二层, 201 D 肿瘤靶向创新药物研发策略 会议主持 陈之键 医学博士, 工商管理硕士 阿斯利康(中国)全球药物研发 中国区副总裁兼负责人 徐莉 医学博士,工商管理硕士 美国辉瑞公司肿瘤业务部, 肿瘤中国策略规划、贯彻和全球运作部副总裁 讨论如何制定高质量、快速、有价值的肿瘤靶向药物开发和注册策略及中国 从参与到主导研发的角色转变. 创新肿瘤靶点识别和验证 杨炜 博士 强生中国上海研发中心研发科学事务部总监 临床研发策略:确定适当目标人群,采用最佳终点指标和研究设计,充分利 用中国优势 牟骅 医学博士 和记黄埔医药(上海)有限公司执行副总裁及首席医务官 中国在参与和领导肿瘤创新药物的发现和研发过程中的角色 周彩存 教授, 博士 同济大学医学院肿瘤研究所所长,肿瘤学系主任 专题 9 | 药物毒理 分会场 T 9-1 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 B+C 药物毒理:从动物试验到人体试验 会议主持 龚兆龙 博士 美国FDA同仁会国际网络成员 前美国FDA新药审评员 百济神州(北京)生物科技有限公司副总裁 讨论新药开发中美国和中国FDA对临床前安全性评价的法规要求,临床前安 全性数据的分析和解释,以及如何用动物数据预测人体的潜在风险和支持法 规申报和决策. 美国FDA临床前安全评价要求 Paul A. Andrews 博士 卫材公司全球法规事务部执行总监 中国CFDA临床前安全评价要求 彭健 博士 赛诺菲(中国)亚太研发中心科学顾问 专家讨论 分会场 T 9-2 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 B+C GLP法规;数据的质量和完整性 会议主持 姚大林 医学博士 美国FDA同仁会国际网络成员 前美国FDA资深药审官,GLP督查官 昭衍新药研究中心有限公司资深副总裁兼首席科学家 从CRO和政府监管机构观点出发,全面阐释与GLP法规相关的临床数据的质 量和完整性,终极目标是保证达到临床项目的安全. 非临床研究管理规范(GLP)的遵循问题对临床前研究的数据质量与完整性的影 响—合同研究组织(CROs)的视角 Jane PEARSE 博士 英国亨廷顿生命科学公司国际市场部特殊项目总监 GLP法规和药物安全性评价对公众健康的重要意义 - FDA 的观念 姚大林 医学博士 美国FDA同仁会国际网络成员 前美国FDA资深药审官,GLP督查官 昭衍新药研究中心有限公司资深副总裁兼首席科学家 专家讨论 以上讲者及 付立杰 博士, 美国毒理科学院院士 SNBL中国事业总经理,中国毒理学会副理事长,亚洲毒理学会副会长 左从林 昭衍新药研究中心有限公司总裁兼CEO 分会场 T 9-3 | 2013年5月15日 星期三 13:30 - 15:00 二层, 201 B+C 药物研发的毒理评价和风险评估 会议主持 付立杰 博士, 美国毒理科学院院士 中国事业总经理,中国毒理学会副理事长,亚洲毒理学会副会长 王英 博士, 美国认证毒理学家 葛兰素史克中国研发中心药物安全评价总监 本专场讨论毒理学在药物研发中的安全评价和风险评估,着重于中国生物药 和中药临床前安全评价,以及技术转让过程中非临床的风险评估. 毒理学的基本概念,危害与风险 付立杰 博士, 美国毒理科学院院士 SNBL中国事业总经理,中国毒理学会副理事长,亚洲毒理学会副会长 干细胞治疗产品的安全性评价 马璟 医学博士 国家上海新药安全评价研究中心研究员 中药的安全性评价及案例研究 王全军 医学博士 国家北京药物安全评价研究中心主任助理 化合物技术转让过程中非临床安全性评估 王英 博士, 美国认证毒理学家 葛兰素史克中国研发中心药物安全评价总监 46 专题 10 | 数据管理和电子临床 分会场 T 10-1 | 2013年5月15日 星期三 08:30 - 10:00 二层, 201 A 科技进展对临床数据管理的影响 会议主持 刘川 博士 Medidata Solution大中华地区发展总监 高新技术的发展也使临床研究领域发生变化,如临床试验方案制定和数据获 得与交换方式方法的改变.临床研究在应用高新技术和信息的某些方面相对 落后.因此了解云技术等高科技发展趋势及应用对推动制药业的发展非常重 要.本专场将讨论高新技术给数据管理者带来的益处,及对今后数据管理领 域的影响. 大数据运算 — 理念与实践 Glen de Vries 美国Medidata Solutions公司总裁 生命科学领域的云技术应用 Abhishek BAGGA 印度Cognizant Technology Solutions生命科学研发部临床中心经理 生物信息工具在数据分析和管理中的应用 Eric S. HERBEL 美国Integrated Clinical Systems公司总裁 专家讨论 分会场 T 10-2 | 2013年5月15日 星期三 10:30 - 12:00 二层, 201 A 安全数据管理 – 数据管理者的职责 会议主持 刘宗范 默沙东研发(中国)有限公司 全球临床数据管理中心亚太区总监 本专场将介绍如何通过数据验证计划,数据审核过程和医学编码程序确保安 全性数据的质量.经验丰富的讲者与参会者分享管理安全数据的经验,共同 讨论如何应对安全数据管理的挑战. 安全数据的验证及严重不良事件的考虑 陈朝华 辉瑞中国研发中心全球临床数据服务部负责人 I期临床研究的安全性数据管理 徐刚 葛兰素史克(中国)研发数据管理部总监 安全数据管理-编码 Lobo Loo 默沙东数据管理部中国区副总监 专家讨论 分会场 T 10-3 & T 10-4 | 2013年5月15日 星期三 13:30 - 17:30 二层, 201 A 数据标准在临床研究中的应用和成功案例 会议主持 张子豹 博士 PPD生物统计与编程部副总监 邓亚中 工商管理硕士 科文斯(中国)临床数据分析与报告负责人 数据标准一直是药物研发中优化临床研究及提升数据和信息流通水平的热门 话题.本专场将集中研讨标准化带来的价值以及全球实施的不同方法.专 家们将分享成功经验、讨论临床试验中采用数据标准化所遇到的挑战、及CDISC标准化实施及监管要求的最新动态. 从电子健康档案到临床数据库 Demetris ZAMBAS 美国默沙东全球数据管理部执行总监 一个全球CRO实施CDISC标准的经验 李建荣 PPD生物统计和编程亚洲运营部总监 应用CDISC标准的实例:从CDASH 到SDTM 和ADAM 吴崇胜 博士 科文斯(中国)公司生物统计部资深经理 使用CDISC标准以提高临床研究的效率 Ivan Tjong-A-HUNG 医学博士,工商管理硕士 上海霖谷医药科技有限公司总经理 CDISC标准在中国的最新进展 王兰香 诺华制药(中国)有限公司综合信息科学部首席统计师 中国CDISC协调委员会委员 专家讨论 以上讲者及 黄钦 博士 中国药品审评中心生物统计学部副部长 专题 11 | 医疗器械、药械组合产品的创新 分会场 T 11-1 & T 11-2 | 2013年5月15日 星期三 08:30 - 12:00 二层, 203 C 医疗器械的创新、监管及研发投资 会议主持 王凯玲 美国瑞格律师事务所 中国生命科学首席顾问 王春燕 圣犹达医疗用品(香港)有限公司 亚太区临床研究总监 本专场将讨论医疗器械的创新、注册和资金支持.资深专家将介绍CFDA最新 颁布的医疗器械GCP草案,审视风险投资在医疗器械创新和开发中所起的作 用、并进行案例分析. 医疗器械创新 Kok-Hwee NG 博士 圣犹达医疗用品有限公司 创新和策略制作中心设备研发部总监 47 中国医疗器械的GCP草案 岳相辉 国家食品药品监督管理总局 原医疗器械监管司研究评价处 优化医疗器械临床试验 宓现强 教授 中国科学院上海高等研究院 医疗器械创新: 案例分析 王凯玲 美国瑞格律师事务所 中国生命科学首席顾问 风险投资在医疗器械领域的作用 邢菲 医学博士 中国德诚资本投资公司总监 专题 12 | 合同研究机构 分会场 T 12-1 | 2013年5月15日 星期三 13:30 - 15:00 二层, 201 D 如何建立双赢关系 会议主持 蒋皓媛 医学博士 江苏恒瑞制药有限公司执行医疗总监 在药品/器械开发的过程中,企业可能不需要自行承担全部的研发工作.本场 将重点讨论药企寻求外包合作伙伴的考评标准.除费用因素外,药企与CRO 的沟通还包括具体业务要求,科学/医疗方面的专长,特殊领域的技术,定向 职能的合作,甚至是外派专业人员,直至整个项目的外包合作. 案例介绍:如何利用中国收集的安全数据在美国成功地申报IND 李锡明 医学博士 绿叶制药集团全球临床研究和监管事务部副总裁 药物早期临床研究: CRO的选择及协作的机会 吴安凡 博士 罗氏中国早期开发部负责人 案例分析: 企业与CRO合作成功在美国申报IND 王在琪 医学博士 中国默沙东临床研究执行总监 合作中共赢共生 蒋皓媛 医学博士 江苏恒瑞制药有限公司执行医疗总监 分会场 T 12-2 | 2013年5月15日 星期三 15:30 - 17:30 二层, 201 D 合同研究机构对确保药品安全所起的作用 会议主持 宫岩华 中国医药市场协会副理事长,中国医药技术市场协会CRO联合体副主席兼秘 书长, 新药创新和专业化委员会常务副主任 刘佳 爱恩希(北京)医疗科技有限公司 北亚及中国区总经理 本专场将重点探讨合同研究机构如何通过创建合理优化的内部组织结构和发 展在中国的高质量团队来保证研究中病人安全. 在临床试验实施中支持患者安全管理的药物警戒战略同盟 Sheona Stevenson 博士 新加坡INC Research药物警戒部副总监,亚洲区负责人 中国的临床监查: CRO视角下的质量保证 陈丽娟 InVentiv Health Clinical 公司 临床研究中心亚太区执行总监 一个中国本土CRO公司在IPO上市后的业务发展 沙伟郡 杭州泰格医药 事业发展部总监兼项目总监 专家讨论组 以上讲者 专题 13 | 上市后和实际环境中的药物研究 分会场 T 13-1 | 2013年5月15日 星期三 15:30 - 17:30 二层, 201 B+C 上市后和实际环境中的药物研究 会议主持 汤铭 医学博士 上海华斯泰生命策略研究所高级研究员 一个药品批准上市后,科学和医学研究仍在继续.有许多方法和机制可用于 在实际环境中进一步研究和评价该药物的安全与有效性,并发现其潜在的新 用途.本专场将围绕这些方法在国内的应用趋势、实用性、问题和其可能的 解决办法进行讨论. 引言和概述 汤铭 医学博士 上海华斯泰生命策略研究所高级研究员 病人登记 萧燕 医学博士 罗氏(中国)药物研发亚太区中心高级流行病学家 临床研究者启动的试验 ? 案例 I 范帆 博士 赛诺菲(中国)资深医疗总监 ? 案例 II 王伊龙 博士 北京天坛医院神经内科,科研处副处长 48 专题 14 | 药物流行病学的最佳实践和药物安全 分会场 T 14-1 | 2013年5月15日 星期三 13:30 - 15:00 二层, 203 C 药物流行病学的最佳实践和药物安全 会议主持 周伟 医学博士 默沙东默克实验室 流行病学亚太区总监 本专场邀请来自学术界、政府监管部门、及药业著名的药物流行病学家分享 对药物流行病的研究现状、最新进展及比较效益分析的见解. 药物研发和风险控制中药物流行病学基本原理及方法介绍 詹思延 教授, 医学博士 北京大学医学部流行病和生物统计系副主任 药物流行病及药物安全监管法规的进展 颜敏 国家食品药品监督管理总局 药品安全监管司副司长 药物流行病研究的最新进展:电子医疗及保险数据库,及比较效益分析在评 价药物安全和有效性中的应用 陈建炜 博士 台湾大学医院 医学研究科副主任 专题 15 | 中国药品电子监管 分会场 T 15-1 | 2013年5月15日 星期三 15:30 - 16:15 二层, 203 C 药品追溯体系建设 – 药品电子监管 王迎利 国家食品药品监督管理总局 信息中心信息规划处副处长 DIA eLearning Easy Access to Instant Education ? Flexibility to Learn Anytime, Anywhere ? Reduce Travel Costs ? Self-Paced Programs Visit diahome.org/elearning. 49 COMPANY WHITE PAPER SHOWCASE This year, the White Paper Showcase organized by three companies will share their experience, expertise and practices on drug safety and techonology for innovation. Quintiles 13:30 - 15:00 (3rd Floor, 308) Tectonic Transformations: The Future of Biopharma- ceuticals in Asia Amar Kurershi, MD, FRCPC Chief Medical Officer and Head of Drug Development, Quintiles Asia, Singapore Ling Zhen Vice President and General Manager, Quintiles, Greater China Proswell Medical Company 15:30 - 17:30 (3rd Floor, 308) PATIENT SAFETY AND PROACTIVE RISK MANAGEMENT IN CLINICAL TRIAL Establish a Post Marketing Safety System and Standard Procedure to Ensure Product Safety and Proactively Manage Risk ? A comprehensive "End-to-End" safety surveillance system ? Highly specified safety operational and pharmacovigilance processes ? Special designed pharmacovigilance programs support in global post marketing risk benefit assessment Sean Zhao, MD, PhD Vice President, Global Safety, Amylin Pharmaceuticals, Inc. U.S. Head of Pharmacoepidemiology (PV-Epi) Amgen Global Safety Surveillance Process Owner Chairperson of Amgen Safety Policy Committee Subjects Safety in Phase I Clinical Trial ? Category of safety issues ? Unpredictable safety issues ? Case analysis about unpredictable safety issues Bei Hu, PhD Chief Physician, Clinical Pharmacology Research Center, Peking Union Medical College Hospital, China. C3i 13:30 - 15:00 (3rd Floor, 308) Advance Clinical Trials Technology: Best Practices in Deploying Global Word-Class Support for eClinical Applications Discover how site-centric service desk support can provide a comprehensive single point of contact for all technology needs of global clinical sites, ensure accurate data collection and reduce the time spent by the clinical staff on non- clinical activities. Jonathan Song Business Development Director, Asia Pacific Region, C3i, Inc, China Sara DiMinno Project Manager, C3i, Inc, USA 参展商研讨会 本次年会新增参展商研讨会.3家企业将围绕"药品安全,技术创新"分享经 验. 昆泰公司 13:30 - 15:00 (三层 308) 结构性变革:亚洲生物制药企业的未来 Amar Kurershi 博士 昆泰公司亚洲区首席医务官兼药物开发主管 甄岭 昆泰公司大中华区总经理 北京春天医药 15:30 - 17:30 (三层 308) 关注临床试验中受试者用药安全及风险的主动管控 上市后研究体系和产品安全标准程序的建立以及风险的主动管控 ? 安全监管体系对于优化用药安全的重要性 ? 高标准的安全操作和药物警戒体系 ? 国际多中心药物上市后研究的风险利益评估 赵子贤 博士 美国Amylin Pharmaceuticals, Inc. 全球药品安全副总裁 药物流行病学总监(药物警戒-流行病学) 安进公司全球药品安全监查部总监 安进公司药品安全决策委员会主席 从I期临床研究谈谈药物研发早期的安全性问题 ? 安全性的分类 ? 非预期的安全性 ? 非预期安全性的案例分析 胡蓓 博士 中国北京协和医院临床药理中心主任医师 C3i 13:30 - 15:00 (三层 308) 电子临床软件全球部署及支持的最佳实践 讨论客服中心如何为全球临床试验基地提供单点联系的综合技术支持服务, 并确保精确的数据收集,减少试验人员花费在技术及软件方面的时间,提高 临床试验效率. 宋康 科睿特客服科技(大连)有限公司亚太地区业务拓展总监 萨拉 ? 狄米诺 科睿特客服科技 (大连)有限公司项目经理 NEW EXPERIENCES TUESDAY, MAY 14 5月14日 星期二 wednesday, MAY 15 5月15日 星期三 50 SUNDAY, MAY 12, 2013 | Pre-Conference WORKSHOPS ONLY 07:30-16:00 1st Floor, Foyer Registration 08:30-17:30 2nd Floor, 201B Full-Day Workshop 1 Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies 2nd Floor, 201C Full-Day Workshop 2 Drug Substance and Drug Product Stability Requirements and Practices 2nd Floor, 201D Full-Day Workshop 3 Data Management for Oncology Trials 2nd Floor, 203C Full-Day Workshop 4 Applying MedDRA in Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective 2nd Floor, 201A Full-Day Workshop 5 Global Clinical Trials in Drug Development-Principles and Case Studies 3rd Floor, 307 Full-Day Workshop 6 National Drug Safety and Active Pharmaceutical Ingredients (APIs) in China: Development of Recommendations for the Regulation of APIs 10:00-10:30 1st Floor, Exhibition Hall Tea Break 12:00-13:00 2nd Floor, Conference Hall 2 Lunch 15:00-15:30 1st Floor, Exhibition Hall Tea Break MONDAY, MAY 13, 2013 | CONFERENCE Day 1 07:30-16:00 1st Floor, Foyer Registration 13:30-17:30 1st Floor, Exhibition Hall Exhibition and Poster Session Open 13:30-17:15 2nd Floor, Conference Hall 1 Opening Plenary Session ( 15:30-16:00, Tea Break, 1st Floor, Exhibition Hall) Keynote Speech: Encourage Drug Innovation and Ensure Patient Safety Professor Guowei SANG, MD President, Chinese Pharmaceutical Association (CPA) Academician, Chinese Academy of Engineering Risk Management Planning Spurs Innovation and Enables Patient Safety Patrizia A. CAVAZZONI, MD Senior Vice President, Worldwide Safety and Established Products Regulatory, Pfizer Inc. USA Status and Expectations about ARV Treatment for People Living with HIV Lin MENG Director, Ark of Love Information Center General Secretary of China Alliance of People Living with HIV/AIDS Representative of Country Coordinating Mechanism (CCM) of the Global Fund China Programs 17:30-19:30 1st Floor, Exhibition Hall/2nd Floor, Conference Hall 2 Welcome Reception - China Night: DIA China 5th Anniversary Celebration TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 07:30-16:00 1st Floor, Foyer Registration 08:30-17:30 1st Floor, Exhibition Hall Exhibition and Poster Session Open 08:30-10:00 1st Floor, 5 C+F T 1-1 Clinical Excellence When Involving China in Global Clinical Development: Maximize Benefits and Minimize Risks 1st Floor, 5 A+B+G+H T 2-1 Global Trends and China Development Status on Fixed-dose Combinations (FDCs) 1st Floor, 5 D+E T 3-1 Pharmacovigilance during Pre-approval – An Exciting Journey of Investigation 2nd Floor, 201 A T 4-1 Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio- Part I 2nd Floor, 201 B+C T 5-1 Ensuring Innovation and Safety for Cell/Gene Therapy and Blood Products 2nd Floor, 201 D T 6-1 Evaluation of Generic Products vs. Reference Products - The 2007 Conundrum - Part I 2nd Floor, 203 C T 7-1 Development of Novel TCM Products for China and Global Market 10:00-10:30 1st Floor, Exhibition Hall Tea Break 10:30-12:00 1st Floor, 5 C+F T 1-2 Coordination and Communication among Stakeholders of Clinical Trials 1st Floor, 5 A+B+G+H T 2-2 New Biosimilar Regulation: Challenges and Opportunities 1st Floor, 5 D+E T 3-2 Pharmacovigilance during Post-approval - Path to Success 2nd Floor, 201 A T 4-2 Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio- Part II 2nd Floor, 201 B+C T 5-2 Principles for Pandemic Influenza Preparedness and Post-marketing Vaccine Knowledge NetWorking Meeting Information Quick guide to the program 51 Knowledge NetWorking Meeting Information Manufacturing Changes 2nd Floor, 201 D T 6-2 Evaluation of Generic Products vs. Reference Products - The 2007 Conundrum - Part II 2nd Floor, 203 C T 7-2 Case Studies and Good Practices in TCM Development 12:00-13:30 2nd Floor, Conference Hall 1 Lunch TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 (Continued) 13:30-15:00 1st Floor, Conference Hall 3 CFDA Townhall: Pre-marketing and Post-marketing Drug Safety Supervision in China 2nd Floor, 201 B+C T 5-3 Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations 2nd Floor, 201 D T 8-1 Changing Paradigm in Cancer Diagnosis and Treatment - Impact on Drug Development 15:00-15:30 1st Floor, Exhibition Hall Tea Break 15:30-17:30 1st Floor, Conference Hall 3 CFDA Townhall (continued) : Pre-marketing and Post-marketing Drug Safety Supervision in China 2nd Floor, 201 B+C T 5-4 Vaccine Product Qualification and Novel Hepatitis Vaccine Development for China and the World 2nd Floor, 201 D T 8-2 Strategies for Discovery and Development of Target-based Novel Cancer Medicines 17:30-19:30 2nd Floor, Conference Hall 2 Speaker & VIP Reception Wednesday, MAY 15, 2013 | CONFERENCE Day 3 07:30-16:00 1st Floor, Foyer Registration 08:30-17:30 1st Floor, Exhibition Hall Exhibition and Poster Session Open 08:30-10:00 1st Floor, 5 C+F T 1-3 GCP Clinic 1st Floor, 5 A+B+G+H T 2-3 & T 3-3 Balancing Risk and Benefit during IND Period 1st Floor, 5 D+E T 4-3 Overview of Meta - Analysis and Its Application in Drug Development 2nd Floor, 201 D T 6-3 Regulatory Perspectives on Botanical Drug Products in China and the United States 2nd Floor, 201 B+C T 9-1 Pharm/Tox: From Animal to Human 2nd Floor, 201 A T 10-1 Technology Advancement in the Landscape of Clinical Data Management 2nd Floor, 203C T 11-1 Medical Devices: Innovation, Regulation and Investment - Part I 10:00-10:30 1st Floor, Exhibition Hall Tea Break/ Announcement of Poster Price Winners 10:30 - 12:00 1st Floor, 5 C+F T 1-4 Pharmacovigilance - QA Perspective 1st Floor, 5 A+B+G+H T 2-4 & T 3-4 Balancing Risk and Benefit during NDA and Post-marketing Periods 1st Floor, 5 D+E T 4-4 Quantitative Sciences in Pharmaceutical Development (QSPD) 2nd Floor, 201 D T 6-4 Evolution of Global Biotherapeutic Regulations – A CMC Perspective 2nd Floor, 201 B+C T 9-2 GLP Regulatory Compliance for Data Quality and Integrity 2nd Floor, 201 A T 10-2 Data Managers' Roles in Drug Safety 2nd Floor, 203C T 11-2 Medical Devices: Innovation, Regulation and Investment - Part II 12:00 - 13:30 2nd Floor, Conference Hall 1 Lunch / DIA Community Networking 13:30 - 15:00 1st Floor, 5 C+F T 1-5 Challenges and Opportunities at Clinical Trial Sites/Institutions 1st Floor, 5 A+B+G+H T 2-5 Therapeutic Biologic Development in China from CMC Perspective 1st Floor, 5 D+E T 3-5 Benefit-Risk: Getting It Right for Patients 2nd Floor, 201 D T 12-1 How to Build Win-Win Relationship 2nd Floor, 201 B+C T 9-3 Patient Safety: Toxicological Evaluation and Risk Assessment in Pharmaceutical R&D 2nd Floor, 201 A T 10-3 Data Standards in Real World Clinical Research - Part I 2nd Floor, 203C T 14 Pharmacoepidemiology - Drug Safety and Best Practices 15:30 - 17:30 1st Floor, 5 C+F T 1-6 Ethics Committee Roles and Development in China 1st Floor, 5 A+B+G+H T 2-6 Implementation of an Innovative Labeling Hub in Asia and Integration with Global Model 1st Floor, 5 D+E T 3-6 Does Risk Management Planning Benefit Patients? 2nd Floor, 201 D T 12-2 CRO: Value-added Taskforce to Ensure Patient Safety 2nd Floor, 201 B+C T 13 Post-approval and Real World Studies 2nd Floor, 201 A T 10-4 Data Standards in Real World Clinical Research - Part II 15:30 - 16:15 2nd Floor, 203C T 15 Introduction of Drug Electronic Administration Quick guide to the program 53 Full-day 08:30-17:30 Analysis of Data Patterns to Monitor and Assess Outcomes of Clinical Studies 08:30-17:30 Drug Substance and Drug Product Stability Requirements and Practices 08:30-17:30 Data Management for Oncology Trials 08:30-17:30 Applying MedDRA in Clinical Safety and Pharmacovigilance Practices: Regulatory Perspective 08:30-17:30 Global Clinical Trials in Drug Development - Principles and Case Studies 08:30-17:30 National Drug Safety and Active Pharmaceutical Ingredients (APIs) in China: Development of Recommendations for the Regulation of APIs the system. ? To learn approaches for enhancing clinical R&D efficiency and quality ? To master transforming data to knowledge for better resource allocation and risk-based decision making ? To learn the usage of the global dictionaries for coding of clinical trial and safety data Targeted audience Professionals in the following areas: ? Clinical management and operation ? Clinical IT and computing ? Clinical trial data monitoring (CRAs, medical monitoring) ? Data assurance and data quality control ? Clinical informatics ? Regulatory affairs ? Data management and programming ? E-clinical vendor management ? Drug research and development Agenda Session I | Bioinformatic Tools in the Management of Clinical Studies I ? Data review during the discovery phase Session II | Bioinformatic Tools in the Management of Clinical Studies II ? Quality review process ? Patient data tracking ? CDISC standard data structures and approaches Session III | Advanced Reporting and Analysis to Drive Clinical Development Efficiencies ? Clinical R&D efficiency and quality ? Allocation of resources ? Studies planning and decision making Session IV | Effective Data Management and Knowledge Discovery on Global Data – the UMC Perspective I ? Signal detection and other methods for knowledge discovery ? Transforming data to knowledge: the importance of consistent dictionaries and terminologies Session V | Effective Data Management and Knowledge Discovery on Global Data – the UMC Perspective II ? Use of the WHO Drug Dictionaries for coding of clinical trial and safety data Workshop 1 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 B ANALYSIS OF DATA PATTERNS TO MONITOR AND ASSESS OUTCOMES OF CLINICAL STUDIES INSTRUCTORS Daniel LIU, PhD Director, China Development, Medidata Solutions Worldwide, China Eric S. HERBEL President, Integrated Clinical Systems, Inc., USA Yutaka SATO Business Consultant, Solutions Architecture, Medidata Solutions, Japan Madeleine Krieg, RPh Product Manager, Uppsala Monitoring Centre, Sweden Maria Lindquist, PhD Director & CEO, Uppsala Monitoring Centre, Sweden DESCRIPTION Overthepast10years,thedurationandcomplexityofclinicaltrialshavesteadily increased, Pharmaceutical R&D budgets are tighten and less resources on longer and more complex clinical trials have been observed. It becomes more critical to conduct clinical trials with more effective and innovative approaches. This workshop will discuss typical use patterns and best practices for data analysis of clinical studies. Topics include use patterns in support of ongoing medical monitor of clinical trials, use of CDISC data structure for risk-based monitoring, trial management during a clinical trial and post-approval clinical activities. A variety of approaches for reviewing clinical data, study planning, and decision-making based on the data accumulation will be discussed. The workshop will also cover topics such as a better allocation of resources to enhance clinical R&D efficiency and quality, benefits for patient data review, methods for outlier detection, and how to conduct signal detection. Learning objectives ? To understand when and how to use bioinformatic tools in reviewing clinical data. ? To learn typical use patterns that have emerged focusing on the "patient identification/drill-down" reports, graphs, patient profile interactions of SUNDAY, MAY 12, 2013 | PRE-CONFERENCE WORKSHOPS ONLY 54 Workshop 2 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 C DRUG SUBSTANCE AND DRUG PRODUCT STABILITY REQUIREMENTS AND PRACTICES INSTRUCTORS Joan RUAN, PhD Associate Director, Analytical Development Bristol Myers Squibb Co, USA Xin (Amy) BU, PhD Principal Scientist, Analytical and Bioanalytical Development Bristol Myers Squibb Co, USA DESCRIPTION Stability is a crucial quality attribute of pharmaceutical products; therefore, a stability program in compliance with current regulations is critical to all the phases of the drug development process and the new pharmaceutical product registration. Successful execution of stability programs requires a good understanding of global regulatory requirements, stability methodologies, and best practices. This session presents a comprehensive overview of FDA, ICH and WHO stability requirements for pharmaceutical products including regulatory and technical aspects to design global stability programs, which are cost effective and in compliance. Learning objectives ? To understand stability role in the drug development process ? To design stability study based on ICH/WHO and global requirements ? To execute global stability program effectively ? To understand the importance of stability indicating methods ? To manage global technology transfer ? To interpret stability data Targeted audience ? Pharmaceutical R&D scientists and managers ? Regulatory affairs staff ? Quality assurance and quality control professionals ? Contract Research/Manufacturing Organization ? Government health authority ? Academic institution Agenda Session I | Overview of Critical Regulatory Requirements for Drug Stability Program ? Stability role in the drug development process ? Review of cGMP stability requirements ? Review of ICH guidelines for stability ? Requirements for global stability programs ? Assignment of drug product shelf-life Session II | Practice in Technical Aspects of Drug Stability ? Development of stability indicating methods ? Design of forced degradation studies ? Method validation and transfer ? Evaluation of stability data Session III | Discussion - Case Study Workshop 3 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 D DATA MANAGEMENT FOR ONCOLOGY TRIALS Instructors Charles Yan, PhD Technical Operations Lead, Clinical Data Services, Pfizer (China) R&D Center, China Li Xu, MD, MSD, MBA Vice President, Oncology Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer, USA Emily Tan Executive Director, Clinical Research Asia Pacific, InVentiv Health Clinical, Singapore Wei Zhang, MD TA Lead, CDS, Pfizer (China) R&D Center, China Shuling Wu Data Management TA Lead, Pfizer (China) R&D Center, China Juan WANG Data Manger, Oncology Group, CDS, Pfizer (China) R&D Center, China Kiki Wu Associate Director, Clinical Data Management, MSD R&D (China), China DESCRIPTION The full day workshop consists of two sessions: session I (basic) will introduce the fundamentals for professionals new to oncology clinical trials and session II (advanced) will focus on the data management activities at each phase of oncology trials. Learning objectives ? To introduce the basics in cancer definition, diagnosis/treatment, and the stages of oncology trials. ? To specify the characteristics for an oncology trial in design, efficacy endpoints, and safety monitoring. ? To understand data management activities at each phase of the oncology trials by focusing on CRF design, data cleaning, lab data handling, response data measurement, and long-term study management. ? To discuss the best practices in oncology trials regarding the key data points, SAE handling, and lab data review. Targeted audience This workshop is designed for clinical professionals who are new in oncology trials or new in oncology data management. It will also benefit the following professionals: ? Clinical researchers ? Trial project managers ? Trial monitors ? Biostatisticians ? Trial programmers Agenda Session I | Oncology Clinical Trial Basics Part I : Overview ? Drug Development ? Oncology Standards of Care and Related Terminology 55 Part II : Trial Design and Endpoints ? Phases and Types of Oncology Trials ? Endpoints (PFS, ORR, OS, RECIST 1.1) Part III : Trial Conduction ? Informed Consent ? Site Monitoring and Protocol Deviation Part IV : Safety Monitoring ? Adverse Events and Serious Adverse Events ? Common Terminology Criteria for Adverse Events (CTCAE) Part V : Case Study Session II | Basics for Oncology Data Manager Part I : Study Initiation ? Understanding CRF design and database building for oncology trials ? Understanding treatment cycle for oncology studies ? Understanding efficacy data collection and measurement Part II : Study Execution ? Cleaning response data from oncology studies ? Handling local lab data with normal ranges ? Understanding/supporting clinical review on response and toxicity data ? 3rd Party review, challenges to DM ? Handling external data with reconciliation Part III : Study Completion ? Database lock for interim analysis for ongoing oncology studies ? Managing long-term studies with follow-up Part IV : Best Practices for Oncology Trials ? Critical data points in oncology trials ? Data collection: needs vs. nice to have ? SAE handling ? Panic lab test data review ? Tumor response Workshop 4 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 203 C APPLYING MedDRA IN CLINICAL SAFETY AND PHARMACOVIGILANCE PRACTICES: REGULATORY PERSPECTIVE Instructors Anna ZHAO-WONG, MD, PhD, PMP Deputy Director, MedDRA Maintenance and Support Services Organization, USA Sonja BRAJOVIC, MD MedDRA Coordinator, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), FDA, USA DESCRIPTION This workshop will focus on the application of MedDRA in clinical safety and pharmacovigilance, including a regulatory perspective. It will provide in- depth coverage of how to consistently and accurately encode clinical data with MedDRA and options to retrieve and present MedDRA-coded data as outlined in the ICH-endorsed "MedDRA Term Selection: Points to Consider" and "MedDRA Data Retrieval and Presentation: Points to Consider" documents. The use of Standardised MedDRA Queries (SMQs) as tools to aid case identification and signal detection will be discussed. The implementation of MedDRA in US FDA Adverse Event Reporting System (FAERS) database will be described, including the current use of the terminology for coding and analysis of safety data. Attendees are encouraged to bring questions about MedDRA coding, data retrieval/analysis to share and discuss. Learning objectives ? To describe the use of MedDRA terminology in coding adverse event data. ? To demonstrate strategies for retrieval and subsequent analysis of MedDRA-coded data in clinical safety and pharmacovigilance. ? To understand how US FDA applies MedDRA in post-market pharmacovigilance utilizing the FDA Adverse Event Reporting System (FAERS) and in analysis of clinical trial safety data in new drug review. Targeted audience This workshop is designed for the following professionals who already have a basic knowledge of MedDRA and wish to explore the implications of its use in clinical safety and pharmacovigilance: ? Pharmacovigilance and clinical research professionals ? Clinical data managers ? Medical writers ? Regulatory affairs professionals Agenda Session I | MedDRA Introduction Session II | MedDRA Coding and the ICH-endorsed Coding Guide: "MedDRA Term Selection: Points to Consider " ? Overview of MedDRA coding and the "MedDRA Term Selection: Points to Consider" document ? Data quality issues from US FDA perspective with coding examples ? Coding exercises ? Question & Answer Session III | Analyzing MedDRA-Coded Data and the ICH-Endorsed Data Retrieval Guide: "MedDRA Data Retrieval and Presentation: Points to Consider" ? Overview of the "MedDRA Data Retrieval and Presentation: Points to Consider" document ? Developing queries using MedDRA ? Query development exercise ? Standardised MedDRA queries ? Customized searches ? FDA approach to MedDRA search strategies for signal detection: examples from FDA AERS database and new drug safety review ? Question & Answer Session IV | MedDRA Versioning Workshop 5 08:30 - 17:30 (12:00 - 13:00 Lunch) 2nd Floor, 201 A GLOBAL CLINICAL TRIALS IN DRUG DEVELOPMENT – PRINCIPLES AND CASE STUDIES Instructors William WANG, PhD Site Head and Executive Director, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP) Merck Research Laboratories / MSD R&D (China) Co. Ltd., China Qiong Shou, PhD Senior Scientist, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP) Merck Research Laboratories / MSD R&D (China) Co. Ltd., China 56 Hsien-Ming James HUNG, PhD Director, Division of Biometrics I, Office of Biostatistics OTS , Center for Drug Evaluation and Research (CDER), FDA, USA Sue-Jane Wang, PhD Associate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA Yuki Ando Senior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan DESCRIPTION In recent years, there was a significant increase of global clinical trials in pharmaceutical development. ICH guidance and/or local regulatory guidelines have set the basic scientific principles. The purpose of this workshop is to show the regulatory, statistical, clinical and operational principles through case studies in Cardiovascular (CV), Central Neurological System (CNS), anti- infective, oncology, and other therapeutic areas that may involve genomic factors. In each case study we will illustrate the disease, typical trial design, global development strategies, the global or regional clinical trial results, and regulatory review considerations. Learning objectives ? To review the regulatory, statistical, clinical and operational principles in global clinical trials. ? To learn various clinical development strategies for registration with different regulatory agencies through case studies. ? To review regulatory guidelines for regional registration through case studies. Targeted audience Professionals working in the following areas: ? Quantitative science ? Regulatory affairs ? Pharmaceutical industry (preclinical, pre-market, post-market development) ? Contract Research Organizations (CROs) ? Government organizations ? Academia and research institutes Agenda Session I | Principle and Case Examples in the CV/CNS Areas ? Concepts of consistency and inconsistency (e.g. PLATO – acute coronary syndrome trial, and schizophrenia trials) ? Challenges and advantages of global versus regional trial strategy Session II | Principles and Case Examples in Global/Regional Pharmacogenomics Trials ? Special features in design and analysis of pharmacogenomics trials (e.g. cancer, anti-viral, and other drug development influenced by genomic factors) ? Challengesversusadvantagesinglobalversusregionalpharmacogenomics Session III | Principles and Case Examples in Global/Asian Clinical Trials ? Development strategy and selection of trial design - Global/Asian/ Regional ? Evaluation of overall and regional results in global clinical trials Session IV | Panel Discussion Workshop 6 08:30 - 17:30 (12:00 - 13:00 Lunch) 3rd Floor, 307 National Drug Safety and Active Pharmaceutical Ingredients(APIs) in China: Development of Recommendations for the Regulation of APIs Welcome Remarks Xinyu WENG Division Head, Division of Drug Manufacturing Supervision, Department of Drug Safety & Inspection, CFDA, China Ling SU, PhD President, DIA Board of Directors Strategic Advisor, Life Sciences, Sidley Austin LLP, China Nicole Taylor SMITH, JD Assistant Country Director, U.S. FDA, China Office Session I | Summary of the 2012 Roundtable Discussion on the Regulation of APIs and Cooperation Jeffrey GREN Director, Office of Health and Consumer Goods, U.S. Department of Commerce, U.S. Co-chair of JCCT Pharmaceuticals Task Force, USA Session II | Definition and Regulation of APIs and Chemical Manufacturing in the US and EU and the Role of APIs in Global Drug Safety Discussion on the new EU API certification requirements and opportunities for international cooperation. Nicole Taylor SMITH, JD Assistant Country Director, U.S. FDA China Office Patrizia TOSETTI, PhD Policy Officer, DG Health and Consumers, European Commission, France Session III | Industry Perspectives on the Regulation of APIs Guy VILLAX Chief Executive, HOVIONE, Representative of Rx-360, Portugal Gary GU General Manager, DSM Sinochem Pharmaceutical(Zibo) Co., Ltd, China Session IV | Overview of Progress on API Regulation in China The session will discuss the regulation and oversight of APIs and bulk chemical manufacturers in China. Xinyu WENG Division Head, Division of Drug Manufacturing Supervision, Department of Drug Safety & Inspection, CFDA, China Session V | Inspection of API Manufacturing Facilities and Enforcement Cooperation to Address Unregulated Bulk Chemicals Piotr KRAUZE Scientific Administrator, Inspections at European Medicines Agency, United Kingdom Gang WANG, PhD Assistant Country Director, U.S. FDA China Office 57 Registration Open 07:30 - 16:00 Opening Plenary Session 13:30 - 17:15 2nd Floor, Conference Hall 1 (Tea Break 15:30 - 16:00) Introduction Jane CAI, PhD Director, DIA China OPENING REMARKS Ling SU, PhD President, DIA Board of Directors Strategic Advisor, Life Sciences, Sidley Austin LLP, China Li Yin, PhD Vice Minister, China Food and Drug Administration AWARDS CEREMONY WELCOME ADDRESSES Lingshi TAN, PhD Vice President, Pfizer Worldwide Development Operations General Manager, Pfizer (China) R&D Co. Ltd., China Yajun ZHAO Director-General, China Center for Pharmaceutical International Exchange (CCPIE), China KEYNOTE SPEECH Encourage Drug Innovation and Ensure Patient Safety Professor Guowei SANG, MD President, Chinese Pharmaceutical Association (CPA) Academician, Chinese Academy of Engineering Risk Management Planning Spurs Innovation and Enables Patient Safety Patrizia A. Cavazzoni, MD Senior Vice President, Worldwide Safety and Established Products Regulatory, Pfizer Inc. USA Status and Expectations about ARV Treatment for People Living with HIV Lin Meng Director, Ark of Love Information Center, General Secretary of China Alliance of People Living with HIV/AIDS Representative of Country Coordinating Mechanism (CCM) of the Global Fund China Programs welcome Reception-CHINA NIGHT: DIA China 5th Anniversary Celebration 17:30 - 19:30 Exhibition Hall & Conference Hall 2 Session VI | Role of Pharmacopeias Related to APIs in China, EU and US Ping WANG Deputy Secretary General, Chinese Pharmacopoeia Commission, CFDA, China Susanne KEITEL, PhD Director General, Council of Europe, Europe Directorate for Quality of Medicines (EDQM), France John Hu, PhD Vice President and General Manager, US Pharmacopeia, China Session VII | Legal and Policy Considerations to Ensure the Quality of APIs and Prevent the Sale or Export of Unregulated or Falsified APIs Discussion and recommendations to prohibit and deter the manufacture and sale of unregulated bulk chemicals for use in pharmaceutical products, including potential suggestions for revisions to China's Drug Administration Law, criminal code, and other statutes and regulations. Chen YANG, LLM Partner, Sidley Austin Law Office, China Zhiwei LIU Professor, Beijing Normal University, China Ke Liu, JD Associate Professor, Department law school, Beijing Normal University, China Jing HE, JD Senior Consultant, ANJIE Law Firm, China SessionVIII|Development of Specific Legal and Policy Recommend- ations To address the manufacturing, sale and distribution of unregulated or counterfeit/falsified APIs that are intended for use as an API in a finished drug product that either originates from or is consumed in China. Open Discussion: Moderators: Jeffrey GREN Director, Office of Health and Consumer Goods, US Department of Commerce, USA Xinyu WENG Division Head, Division of Drug Manufacturing Supervision, Department of Drug Safety & Inspection, CFDA, China Session IX | Future Cooperation on the Implementation of Recommendations Session X | Next Steps MONDAY, MAY 13, 2013 | CONFERENCE DAY 1 58 Session T 1-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 C+F Coordination and communication among stakeholders of clinical trials Session Chair Yan WU, MD General Manager, Division of Medical and Drug Development, Daiichi Sankyo (China) Holding Co. Ltd., China Round-Table discussion Throughout the whole clinical trial critical path, from protocol development, IEC/IRB review, site contract, patient/subject recruitment, to safety monitoring and site closeout, smooth coordination and effective communication among stakeholders such as sponsor, PI/study site, IEC/IRB and CRO, are essential to ensuring high efficiency and quality of clinical trials. In this session, speakers from clinical trial site, IEC/IRB, sponsor and CRO will share experiences on clinical trial preparation and management from each of their perspectives. All speakers/panelists will engage the audience in discussing how to build up smooth communication and coordination among all stakeholders to yield desired outcomes to all parties. The harmonization will lead to high efficiency in the clinical trial conduct with patient safety and rights in mind. Panelists Benny Chung-Ying Zee, Professor, PhD Director, Division of Biostatistics, School of Public Health and Primary Care, Center of Clinical Trial, The Chinese University of Hong Kong, China Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China Vivian GU Senior Director, Clinical Operations, Bristol-Myers Squibb, China Li CHEN, MD Head of Project Manager, ICON, China CFDA Townhall Tuesday, May 14, 2013 13:30 - 17:30 1st Floor, Conference Hall 3 Pre-marketing and Post-marketing Drug Safety Supervision in China Session Chair Bin XUE Deputy Director, CCPIE, CFDA, China 2012 Drug Review and Evaluation in China Zhen CHEN, PhD Deputy Office Director, Office of New Drug Pharmaceutical Science, CDE, CFDA, China TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 Jiangping DONG Division Head, Division of Pharmaceuticals, Department of Drug Registration, CFDA, China Gang CHENG Assistant Director, National Center for ADR Monitor, Center for Drug Reevaluation, CFDA, China Theme 1 | Clinical Research & Operations Session T 1-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 C+F Clinical Excellence When Involving China in Global Clinical Development: Maximize Benefits and Minimize Risks Session Chair Vivian GU Senior Director, Clinical Operations, Bristol-Myers Squibb, China To ensure the successful operations of clinical trials, we need to identify critical success factors and focus on patient safety and risk management. These are of great interests to pharma companies as well as authorities. After FDA and EMA issued the guidance of risk based monitoring, the principles need to be applied also in China and Asian countries that are more actively involving in global clinical development simultaneously. The in-depth presentations and discussions in this section will provide audience guidance to archive the clinical excellence. Critical Success Factors in Clinical Trials Jong Ran Kim Vice President, Clinical Research of Asia Pacific, ICON, South Korea Risk-Based Monitoring Elaine Hawkings Executive Director, Regional Clincal Operations of Asia Pacific, Bristol-Myers Squibb, China Risk and Benefit When Involving China and Asia in Global Clinical Trials Koichi Miyazaki, RPh Associate Director, Clinical Operation, Daiichi Sankyo, Japan Panel discussion TUESDAY, MAY 14, 2013 | CONFERENCE DAY 2 WEDNESDAY, MAY 15, 2013 | CONFERENCE DAY 3 59 Session T 1-5 | Wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 C+F Challenges and Opportunities at Clinical Trial Sites/ Institutions Session Co-Chairs Haiyan LI, Professor, MD Director, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China The amount of clinical trials have increased greatly in recent years, and CFDA has paid more attention to quality than before through inspecting both sites and registration trials. Investigators are facing great challenge to ensure high quality of study conduct while running too many trials. How to cope with the challenge will be discussed in this session. The Guaranteed Role of Efficient Management Program for Subjects Involved Clinical Research Maozhi Liang, Professor Director, GCP Center, West China Hospital of Sichuan University, China A Survey of Clinical Trial Sites and Analysis in 2012 Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China The Role of Clinical Trial Center in Drug Development in China Haiyan LI, Professor, MD Director, Drug Clinical Trial Center, Peking University 3rd Hospital; Vice Director, Peking University Clinical Research Institute, China Session T 1-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 C+F Ethics Committee Roles and Development in China Session Chair: Haitao LIU, MD, MS of International Public Health Senior Advisor, Clinical Development Quality Assurance Asia Pacific, Global Quality and Compliance, GSK R&D, China The session focuses on the current ethical review practice and IEC construction in China: the strengths and challenges. It not only highlights the key areas of IEC construction in terms of infrastructure and system but also examines the existing paradigm defining the roles of EC, in terms of ensuring the protection of patient safety. It aims to develop an efficient review system and promote review quality. Ensuring Patient Safety through Ethics Committee Oversight Cristina E. Torres, PhD Asian Regional Coordinator, Forum for Ethical Review Committees in Asia Pacific (FERCAP), Philippines Challenge and Consideration in Ethical Review Xiuqin Wang, Professor, PhD Deputy Director, Scientific Research Department Vice Chair, IRB, Jiangsu Province Hospital, China Strategic Planning of Ethics Committee Infrastructure in Taiwan – A Critical Proactive Support for Clinical Research Herng-Der Chern, MD, PhD Chief Medical Director, Supra Integration and Incubation Center, Taiwan Panel Discussion Session T 1-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 C+F GCP CLINIC Session Co-Chairs Hannah CHEN, MD Director, CQA/PV China, Jansen Pharm R&D QA, Johnson & Johnson, China Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China Round-Table discussion GCP/ Quality issues that are commonly seen in clinical research will be discussed in this section. Experts from all parties involved in clinical research will provide insights and opinions, aiming to get a better understanding among stakeholders involved in clinical research and to facilitate future quality improvement. Panelists Shuting LI, MD Director, GCP Center, The Cancer Hospital of Chinese Academy of Medical Sciences, China Paul DAI, MD Senior Director, Regional Head of ICRO, AMAC, Greater China Region, Beijing Novartis Pharma Co. Ltd., China Xueying WU Head of Clinical Development and Operations, Pfizer Medical, China Helen LI, MD Director, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China Session T 1-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 C+F Pharmacovigilance - QA perspective Session Chair Helen LI, MD Director, Emerging Market QA Asia Lead, Pfizer Medical Quality Assurance, China Regulators are enhancing their oversight of pharmacovigilance with the ultimate aim to achieve patient safety. What are some of the lessons we have learned and experience gained from pharmacovigilance inspections and sponsor internal audits? Can we plan for the future and build quality and compliance into our quality management system and pharmacovigilance processes? In this section, discussion will focus on recent developments in EU Pharmacovigilance Legislation and common findings from PV inspections, and share one sponsor's experience regarding how to build quality and compliance into the quality system and pharmacovigilance activities. Recent Development in Eu Pharmacovigilance Legislation and Common Findings from Pharmacovigilance Inspections Carrie Scott GPvP Operation Manager, Senior Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA), UK Sponsor Internal Pv Audits: Build Compliance and Effectiveness into Pv Process Deborah Driscoll, PhD Vice President, Medical Quality Assurance, Pfizer, USA 60 Theme 2 | Regulatory Science Session T 2-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H Global Trends and China Development Status on Fixed- Dose Combinations (FDCs) Session Chair Wendy Yan, MD Global Regulatory Strategist, Asia Global R&D Center, Bayer Healthcare Co. Ltd., China The development of fixed-dose combinations (FDCs) is becoming increasingly important from a public health perspective. They are being used in the treatment of a wide range of conditions e.g. HIV, hypertension and oral contraception, etc. There can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. In addition, the cost of an FDC finished pharmaceutical product may be less than that of separate products given concurrently. Improved medication compliance by reducing the pill burden of patients may be difficult to prove, but there could be additional benefit. In this session, speakers from industry and hospital will share the experience of FDC development globally and its benefit to patients, the CDE speaker will share the main consideration of combination drug development. Significance of the Fixed dose Combination (FDC) in Patients with Hypertension Wen WANG, Professor National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences, China How MNCs Develop FDCs with Scientific Rationale Daniel PAULSON, PhD Global Clinical Leader, Bayer, USA Main Consideration of Combination Drug Development Cailian Kang Senior Reviewer, Office of Clinical Evaluation II, CDE, CFDA, China Session T 2-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H New Biosimilar Regulation: Challenges and Opportunities Session Chair Kitty Zhou Director, Regulatory Affairs, Sanofi, China Since US FDA released its biosimilar guidance in 2011, the issue surrounding how to conduct a regulatory acceptable study following the guidance becomes very critical. This session will focus on regulatory requirement and trial design of biosimilar development. US FDA Biosimilar Guidance Considerations John Gong, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Vice President, BeiGene (Beijing) Co. Ltd., China CMC Requirements in Biosimilar Product Development Duu-gong WU, PhD Member of FDA Alumni Association International Network (FDAAA) Director, Global Regulatory Affairs, Pharmaceutical Product Development, USA How to Manage Biosimilar Post-market Adverse Event Monitoring and Related Issues Shaoyu CHEN, JD Member of FDA Alumni Association International Network (FDAAA) Partner, Covington & Burling Beijing Office, China Panelists: Biosimilar Regulatory Status and perspective in China Speakers and: Katherine WANG, LLM Chief China Life Sciences Advisor, Ropes & Gray, China Session T 2-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit During IND Period (joint Session) Sessions Chair Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA Risk and benefit assessment is the foundation of any regulatory decision- making. Despite significant progress made in the past decade in risk/benefit framework development, the challenge remains, especially in IND period where the benefit of a potential drug has not been adequately demonstrated. This is the Part I of Risk/Benefit at the FDA and beyond, focusing on FDA's and CFDA/ CDE's approach to manage benefits and risk during IND period. Balancing the Benefits and Risks During IND Period at US FDA Mark J. Goldberger, MD, MPH, FIDSA Former Director, Office of Drug Evaluation IV, US FDA/CDER, Member of FDA Alumni Association, Vice President, AbbVie Regulatory Intelligence and Policy, USA Clinical Hold – An Important Tool of Risk Management During IND at US FDA Robert J. Meyer, MD Former Director, Office of Drug Evaluation II, US FDA/CDER Member of FDA Alumni Association Associate Professor, Public Health Sciences, Director, The Virginia Center for Translational and Regulatory Sciences, School of Medicine, University of Virginia, USA Statistical Considerations for Balancing the Benefits and Risks at US FDA Ning Li, MD, PhD Vice President, Regulatory and Medical Policy, Asia Region, Sanofi, China Approving Clinical Trial Application - Benefits and Risks Considerations at CFDA/CDE Zhimin Yang Deputy Director, Office of Clinical Evaluation I, CDE, CFDA, China Session T 2-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit during NDA and Post-Marketing Periods (joint Session) Sessions Chair Mark J. Goldberger, MD, MPH, FIDSA Former Director, Office of Drug Evaluation IV, US FDA/CDER Member of FDA Alumni Association International Network (FDAAA) Vice President, AbbVie Regulatory Intelligence and Policy, USA 61 Risk and benefit assessment is the foundation of any regulatory decision- making. Despite of the progress made in the past decade, the significant challenge remains as we often witness the different opinions and decisions from regulatory agencies on same applications. This is PART II of Risk/Benefit at the FDA and beyond, focusing on how benefits and risks are weighed during the application review and in the postmarketing period. FDA's use of external experts through a public advisory committee will be highlighted. Overview of Benefit-Risk Assessment During the NDA Review and Post- Marketing Reassessment at US FDA Robert J. Meyer, MD Former Director, Office of Drug Evaluation II, US FDA/CDER Member of FDA Alumni Association Associate Professor, Public Health Sciences, Director, The Virginia Center for Translational and Regulatory Sciences, School of Medicine, University of Virginia, USA Use of Public Advisory Committee in Risk/Benefit Assessment During NDA Review at US FDA Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA Approving Marketing Application - Benefits and Risks Considerations at TFDA/ CDE Lih-Jiuan Hsu, MD Senior Executive Officer, Division of Clinical Science, CDE, TFDA, Taiwan Post-Marketing Reassessment in China Siyan Zhan, MD Professor, Department of Epidemiology, Beijing University Medical School, China Panel Discussion Session T 2-5 | Wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 A+B+G+H Therapeutic Biologic Development in China from CMC Perspective Session Chair Phoenix Liu Director, Regulatory Affairs and Safety, Amgen Inc. Beijing Rep. Office, China Therapeutic biologics play more and more important role to address unmet medical needs. To timely introduce new therapeutic biologics with great efficacy and safety profile to China is also a shared goal of domestic industry, MNCs as well as Health Authorities. The session will focus on the best practice sharing in expediting CTA from CMC perspective, including dossier preparation, testing as well as challenge and recommended solution. Dossier Preparation and Specification Validation during CTA Huiyang Cheng, PhD Director, Preclinical, Clinical and Registration, Genor BioPharm Co. Ltd., China Melly LIN Regulatory Manager, CMC Policy/CMC, Roche (China) Holding Ltd., China Chunming RAO Director, Division of Recombinant Biological Products, NIFDC, China Panel Discussion Panelists: Speakers and: Lixin XU, MD, PhD Product Quality Reviewer, Office of Biotechnology Products, Division of Monoclonal Antibody, CDER, FDA, USA Anthony Ridgway, PhD Senior Regulatory Scientist, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada Session T 2-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 A+B+G+H Implementation of an Innovative Labeling Hub in Asia and Integration with Global Model Session Co-Chairs Rie Matsui, RPh Director, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR International & Global Product Information, Pfizer, Japan Tatsuo Kishi Risk Management Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA) , Japan Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the Headquarters organization while local product documents and patient leaflets are handled by affiliates based in local offices. This session will provide an overview of the Global Labeling System covering the CCDS, USPI and EU-SPC, as well as a case study discussion on the implementation of an Asian regional hub model. Consideration of differences in practice across countries and companies, as well as the prospects for future initiatives around labeling will be discussed. The session will also offer a perspective on how the industry is managing the integration and alignment of global safety and labeling systems and governance to ensure end to end oversight and implementation of patient safety information. Global Safety Labeling in a Multinational Corporation Matthias BOEDDING, Professor, MD, PhD Global Safety Leader, Global Pharmacovigilance – Risk Management, Global R&D Center Beijing, Bayer Healthcare Co. Ltd., China An Innovative Model for Handling Labeling in the Asian Region Rie Matsui, RPh Director, Regional Labeling Head for Asia, Labeling Operations and Translations, WSR International & Global Product Information, Pfizer, Japan Japanese Labeling Regulations Tatsuo Kishi Risk Management Director, Office of Safety II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Global Safety Labeling Process and Organization in US and EU Countries Jeffrey Ho Principal Officer, WCI Consulting Ltd. UK 62 Theme 3 | Drug Safety and Pharmacovigilance Session T 3-1 | Tuesday, May 14, 2013 08:30 - 10:00 1st Floor, 5 D+E Pharmacovigilance during Pre-Approval – an Exciting Journey of Investigation Session Chair Feng (Richard) Xia, MD, MS Medical Director, Former Global Pharmacovigilance Lead, Safety Evaluation and Reporting, Worldwide Safety and Regulatory, Pfizer Worldwide R&D, USA Pharmacovigilance has shifted toward earlier, proactive consideration of risks and potential benefits of drugs and has become an important aspect in the development of novel medicinal products, all the way to their market introductions. Further advances in biology, pharmacology and improvements in computational applications to medicine have led to the development of more complex medicines previously unobtainable and have also allowed a more thorough assessment of risks and potential benefits even earlier in the development process. Elevated public concern with the safety of more sophisticated medicines, combined with new science, have led pharmaceutical innovators, regulators and healthcare professionals to collaborate to develop guidelines,whichdriveenhancedpharmacovigilanceandsafetyriskmanagement earlier in drug development. On the other hand, the pharmaceutical industry is evolving to actively respond to these new requirements and to ensure the upmost patient safety. This session aims to provide a holistic view of safety in pre-approval stage, introducing the current thinking around pre-approval safety risk assessment, decision making, communication, and planning. The session will also bring practical examples from oncology clinical trials where special considerations about patient safety need to be taken. From FIH to Marketing Authorization: Critical Aspects of Safety in Developing Innovative New Medicinal Products in China (Assessment, Decision Making, and Communication) Dan Zhang, MD, MPH Chairman and CEO, Fountain Medical Development Ltd., China Pre-approval Safety Review for New Drug Application -Key Considerations and Case Review George Chen, MD, MBA Vice President and Head of Global Medicine Development in China, AstraZeneca Global Medicine Development, China Panel Discussion Topics ? Clinical Safety Review for Marketing Applications ? Practical Aspects of Pre-Approval Risk Assessment ? Individual and Aggregate Safety Reports ? Safety Communication During Pre-Approval 63 Session T 3-2 | Tuesday, May 14, 2013 10:30 - 12:00 1st Floor, 5 D+E PharmacovigilanceduringPost-Approval-PathtoSuccess Session Co-Chairs Gang CHENG Assistant Director, National Center for ADR Monitor, Center for Drug Reevaluation, CFDA, China Xingmin Qiu, MD Director, World Safety and Regulatory, Pfizer China R&D Center, China The decision to approve a drug is based on the information available at the time of approval. The knowledge related to the safety profile of the product can change over time through expanded use in terms of patient characteristics and the number of patients exposed. In addition to routine post-approval safety monitoring activities, the appropriate pharmacovigilance methods employed for products with special safety concerns need to be applied. The best method chosen can vary with the product, the population, and the safety signal. Rigorously designed and conducted observational studies are recognized as important tools while active surveillance evolves in pharmacovigilance. In this session, the overview, initiatives and practices of these methods for post- approval products will be deeply discussed. Active Surveillance: A New Opportunity Monitoring Safety of Marketed Medical Products Xiaofeng Zhou, PhD, MS Director, Worldwide Safety & Regulatory, Pfizer Inc., USA Five Reasons for Active Surveillance Post-marketing Surveillance Andy Stergachis, PhD, RPh Professor, Epidemiology & Global Health Director, Global Medicines Program, University of Washington, USA Is Grandfather Product Necessarily Safe? – The Experience of Phenylpropanolamine (PPA) Yi Tsong, PhD Deputy Director, Division of Biometrics VI, Office of Biostatistics, CDER, FDA, USA Panel discussion Topics ? Post-Approval Safety Study – Which Way to Go ? "Real World" Study Session T 3-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit during IND Period (joint Session with T2-3) Session T 3-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 A+B+G+H Balancing Risk and Benefit during NDA and Post-Marketing Periods (joint Session with T2-4) Session T 3-5 | Wednesday, May 15, 2013 13:30 - 15:00 1st Floor, 5 D+E Benefit-Risk: getting it right for patients Session Co-Chairs Hugues Berard, MD, MBA Vice President, Deputy Chief Medical Officer, Ipsen R&D, France Gao Gao, MD Associate Director, Worldwide Safety & Regulatory, Pfizer China R&D Center, China Monitoring benefit-risk balance is critical at each stage across the life cycle of drug development, review and post-approval activities. A Benefit-Risk assessment framework is recognized as important from both an agency and a company perspective. It is a rapidly moving field involving a number of ongoing initiatives across regulatory agencies and companies. The session aims to: ? Present the progress made on defining and implementing a benefit-risk methodology framework ? Provide industry perspectives and address the issues within the benefit risk-framework adopted by industry and regulatory authorities ? Share real-life examples on how companies implement different methodologies and their learnings ? Discuss how to achieve a consensus on a scientifically accepted approach for making benefit risk decision and the role of benefit-risk framework in drug innovation Benefit – Risk Integration and Representation: EU PROTECT Juhaeri Juhaeri, PhD AssociateVicePresident, HeadofPharmacoepidemiology, GlobalPharmacoviglance & Epidemiology, Sanofi, USA Practical Considerations When Approaching Benefit-Risk: A Case Study Showing The Benefit of A MAHs Collaborative Approach Hugues Berard, MD, MBA Vice President, Deputy Chief Medical Officer, ISPen R&D, France Benefit-Risk Assessment and Risk Management in Drug Development Initiated from China Hua Mu, MD, PhD Executive Vice President & Chief Medical Officer, Hutchison Medi Pharma, China Panel discussion Topics ? How to achieve a consensus on a scientifically accepted approach for making benefit risk decisions ? The role of benefit-risk framework in drug innovation Session T 3-6 | Wednesday, May 15, 2013 15:30 - 17:30 1st Floor, 5 D+E Does Risk Management Planning benefit patients? Session Co-Chairs Lynn Zhou, MD, MPH International Pharmacovigilance Coordinator, PV Affiliate Relations, Global Pharmacovigilance & Epidemiology, Sanofi, China Yun(Jackie) Mao, MD, MBA Director, Worldwide Safety & Regulatory, Pfizer China R&D Center, China Effective risk management planning (RMP) has been playing a critical role in drug development and commercialization, while debates remain that RMP could be burdensome to the healthcare system and potentially limit the access of patients to medicines. On the other hand, global harmonization of RMP is underway but the value of adopting local perspectives is intensively discussed because risk identification/categorization and selection of tools to minimize or mitigate the risk can be largely affected by local patient population and the 64 delivery of the healthcare. The success of a risk management plan should be measured with consideration of value to the patients. This session aims to: ? Provide overview of rmp regulation worldwide with focus on Asia regulation ? Introduce cioms working group ix (effectiveness of risk minimization) ? Share real-life examples on how to use epidemiology study to evaluate effectiveness of risk minimization ? Discuss how to harmonize risk management & toolkit and maintenance as the science of risk management evolves The Global Risk Management Planning Landscape and a Few Asian Perspectives William Gregory Senior Director, Safety Strategy, Policy and Standards, Pfizer, USA Risk Management in Asia: Experience in Japan Stewart Geary, MD Chief Medical Officer, Vice President, Corporate Medical Affairs Headquarters, Eisai Co. Ltd., Japan Observational Study for Risk Characterization and Assessment of Risk Minimization Tools Juhaeri Juhaeri, PhD Associate Vice President, Head of Pharmacoepidemiology, Global Pharmacoviglance & Epidemiology, Sanofi, USA Theme 4 | Statistics Sessions T 4-1 & T 4-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 A Safety Signal Detection and Quantitative Assessment of Benefit/Risk Ratio Sessions Co-Chairs Weiying YUAN, PhD Site Head of Biostatistics and Programming, China Pharmaceutical Research and Development, Johnson and Johnson, China Roger Qu, PhD Head of Clinical Statistics, Pfizer R&D Center, China Protection of patient safety is paramount in the drug development and medical treatment. Statistics plays an essential role in the identification of potential safety signals and quantification of benefit/risk ratio which is integral part of safety assessment. This session will focus on statistical application in both areas, from both regulatory and sponsor perspective. Statistical Considerations in Thorough QTc Clinical Trials Yi TSONG, PhD Deputy Director, Division of Biometrics VI, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Sequential GLR Tests for Signal Detection Jie Chen, PhD Director, Global Biostatistics, Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd., China Statistical Considerations for Risk/Benefit Assessment Marcia LEVENSTEIN, ScD Vice President and Head of Global Statistics of Specialty Care Business Unit, Pfizer, China Bayesian Shrinkage Estimator for Safety Signal Detection Luyan DAI, PhD Associate Director, Biostatistics, Boehringer Ingelheim Shanghai Pharmaceuticals Co. Ltd., China Safety in Pharmacogenomics Sue-Jane WANG, PhD Associate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA Panel discussion Session T 4-3 | Wednesday, May 15, 2013 08:30 - 10:00 1st Floor, 5 D+E Overview of Meta-Analysis and its Application in Drug Development Session Chair Hendrik SCHMIDT, PhD Associate Director, Biostatistics, Boehringer Ingelheim, Germany One of the most commonly used statistical methodologies in medical research and drug development is Meta-analysis, such as hypothesis generating, determination of effect margin for non-inferiority clinical trials, integrated analysis treatment effect based on large number of clinical trials. If conducted inappropriately, its value would be diminished by various sources of biases. This session will promote the good practice of meta-analysis and introduce its recent development. Meta-Analysis in Drug Safety Evaluation: Statistical Challenges and Best Practices/Meta George Quartey, PhD Principal Statistical Scientist, Biostatistics, Genentech, USA Meta-analysis and Mixed Treatment Comparisons - Measuring and Reporting Direct and Indirect Evidence of Treatment Networks: Methodology, Software and Examples Hendrik Schmidt, PhD Associate Director, Biostatistics, Boehringer Ingelheim, Germany Meta-Regression and it's Application in Clinical Trials/Meta Feng Chen, Professor, PhD Dean of School of Public Health, Nanjing Medical University, China Session T 4-4 | Wednesday, May 15, 2013 10:30 - 12:00 1st Floor, 5 D+E Quantitative Sciences in Pharmaceutical Development (QSPD) Session Co-Chairs William WANG, PhD Site Head and Executive Director, Biostatistics and Research Decision Sciences - Asia Pacific (BARDS-AP), Merck Research Laboratories / MSD R&D (China) Co. Ltd., China Yang Song, PhD Senior Principal Scientist, Biostatistics, Late Development Statistics, Biostatistics and Research Decision Sciences - Asia Pacific, MSD R&D (China) Co. Ltd., China 65 Quantitative Sciences in the pharmaceutical development encapsulate many disciplines such as biostatistics, epidemiology, health economics statistics, scientific programming, and data management. Collectively these scientific disciplines are playing increasingly important roles in pharmaceutical development. These important roles are reflected not only in strategic design, execution, but also in regulatory submission and regulatory decision making; not only for pharmaceutical development in the developed regions but also in the emerging market regions. This session will examine the top challenges and opportunities facing the quantitative science professionals. Emerging Issues with Quantitative Sciences in Drug Development Hsien-Ming James HUNG, PhD Director, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Panel discussion Topics ? Roles of Modeling and Simulation ? Quantitative Benefit-Risk Assessment ? Complex Clinical Trial Designs ? Predictive or Prognostic Characteristics of Biomarkers ? Utilities and Pitfalls of Integrated or Meta Analyses ? Globalization Panelists: Hsien-Ming James HUNG, PhD Director, Division of Biometrics I, Office of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA Sue-Jane WANG, PhD Associate Director, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), FDA, USA Yuki Ando Senior Scientist, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Joan Shen, MD, PhD Senior Director, Clinical Development, Pfizer, China Chen Yao, Professor Vice Director, Peking University Clinical Research Institute Head of Department of Biostatistics, Peking University First Hospital, China Qin HUANG, PhD Deputy Office Director, Office of Biostatistics, CDE, CFDA, China Theme 5 | Vaccines and Biologics Session T 5-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 201 B+C Ensuring Innovation and Safety for Cell/Gene Therapy and Blood Products Session Chair Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network (FDAAA) Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA A comprehensive presentation of the approaches to quality, efficacy and patient safety for the blood supply, cell, tissue, and gene therapies at the US FDA's Center for Biologics Evaluation and Research (CBER) and in CFDA/ Center for Drug Evaluation (CDE). FDA's Requirements for Safety and Efficacy for Cell/Gene Therapies Jinjie Hu, PhD Member of FDA Alumni Association International Network (FDAAA) Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBER Senior Consultant, Biologics Consulting Group, INC., USA China Update: Safety and Efficacy Requirements for Cellular/Gene Therapies Qi SHEN Director, Institute for Biological Product Control, NIFDC, China FDA's Role in Blood Product Safety Jinjie Hu, PhD Member of FDA Alumni Association International Network (FDAAA) Former Senior Reviewer, Office of Blood Research and Review, US FDA/CBER Senior Consultant, Biologics Consulting Group, INC., USA Panelists: Xiuxia GUO Associate Researcher, Division of Biological Products, Department of Drug Registration, CFDA, China Weihong CHANG Associate Researcher, Division of Biological Products, Department of Drug Registration, CFDA, China Session T 5-2 | Tuesday, May 14, 2013 10:30 - 12:00 2nd Floor, 201 B+C Principles for Pandemic Influenza Preparedness and Post- Marketing Vaccine Manufacturing Changes Session Chair Florence Houn, MD, MPH, FACP Co-Chair of FDA Alumni Association International Network (FDAAA) Former Director, Office of Drug Evaluation III, US FDA/CDER Vice President, Celgene Regulatory Policy and Strategy, USA Ensuring safety for vaccines is a difficult but necessary duty of all regulatory agencies to promote public health and responsibilities of the biologics industry. US FDA and China FDA have had many years of experiences to share. Ensuring vaccine safety and effectiveness by balancing the need to encourage the adoption of new technologies to advance quality and efficient manufacturing of vaccines with the need to demonstrate, through appropriate validation and/ or clinical or non-clinical laboratory studies, the lack of adverse effect of the change on the safety and effectiveness of the product remains a challenge. An update on recent US and Chinese activities regarding influenza vaccine production and preparedness and safety will be presented. FDA and WHO Pandemic Influenza Vaccine Preparedness Activities Sara E. Gagneten, PhD Associate Director, Regulatory Policy, Office of Vaccines Research and Review, Division of Viral Products (DVP), CBER, FDA, USA Advancing Vaccine Safety and Innovation in China Jianhui LUO Deputy Office Director, Office of Biological Products, CDE, CFDA, China Vaccine Applications at FDA: Regulations for Safety and Post-Marketing Changes Sara E. Gagneten, PhD Associate Director, Regulatory Policy, Office of Vaccines Research and Review, Division of Viral Products (DVP), CBER, FDA, USA 66 Session T 5-3 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 B+C Cell therapy and biosimilar development, opportunities, and regulatory considerations Session Chair Li Shi, PhD CEO, Shanghai Zerun Biotechnology Co. Ltd., China The new stage of biological product development and usage in treating diseases has been on biosimilars and cell therapeutics. These two areas are playing increasingly important rules in the current and future growth of biological-based pharmacuticals. Cell therapy are facing not only technical but also regulatory challenges. For biosimilars, getting into regulated markets still needs great effort in meeting regulatory requirement. This session will review current status of cell therapy and biosimilar development, quality, safety and regulatory considerations. Cell Therapy Development and Current Status in Its Application for Cosmetic Treatment Ningwen Zhu, MD, PhD CEO, Cell & Tissue Eng, China Safety Evaluation and Research in China for New Biologics by Following the International GLP Standard Gene C. Hsu, PhD, DABT Vice President and CSO, Innostar and National Shanghai Center for New Drug Safety Evaluation and Research, China Expectation and Opportunities of Bringing Biosimilars from China to EU, from Regulatory Point of View Hoss Dowlat, PhD Vice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany Session T 5-4 | Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 B+C Vaccine product qualification and novel hepatitis vaccine development for the world and China Session Chair Li Shi, PhD CEO, Shanghai Zerun Biotechnology Co. Ltd., China Vaccine product qualification and novel vaccine development have both been under much more serious consideration in China. Supplying vaccine made in China to the world has been getting on the agenda of China vaccine industry. WHO PQ activities and new GMP implementation have been a practical task already in China. Hepatitis diseases are among the most awared diseases in Asia countries including China. This session will review WHO PQ practice and hepatitis vaccines from effectiveness and new development point of view. This session will also review opportunities for international collaborations in developing new products for infectious diseases. WHO Prequalification for Vaccines and Biologicals Nora DELLEPIANE, PhD Group Leader of Essential Medicines and Health Products, WHO, Switzerland Accuracy of Titration Method for Detecting Live Attenuated Hepatitis A Vaccine Xuanyi Wang, PhD Professor, Shanghai Medical College, Fudan University, China New Generation of Hepatitis Vaccine Development with Novel Adjuvant for Improving Vaccine Tyler J. martin, MD President and Chief Medical Officer, Dynavax, USA Cell Therapy and Biosimilar Development, Opportunities, and Regulatory Considerations Hoss Dowlat, PhD Vice President, Regulatory Affairs EU-USA, PharmaBio Consulting (Life Sciences), Germany Theme 6 | CMC Sessions T 6-1 & T 6-2 | Tuesday, May 14, 2013 08:30 - 12:00 2nd Floor, 201 D Evaluation of Generic Products vs. Reference products - the 2007 Conundrum Session Co-Chairs Min GUI, PhD Director, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China Chi-Wan CHEN, PhD Member of FDA Alumni Association International Network (FDAAA) Former Deputy Director, Office of New Drug Quality Assessment, US FDA/ CDER Executive Director, Global CMC, Pfizer, USA CFDA kicked off an initiative in 2012 for the reevaluation of generic products approved before 2007. This initiative aims to ensure safety, efficacy and quality of drug products for patients. How to make ensure a scientifically sound process is in place to achieve the goal? What are the practical challenges faced by the regulatory authority and industry? How to address the identified issues? This session is designed to discuss the generic products reevaluation, experiences in bioequivalence evaluation and in-vitro dissolution tests. CFDA Working Procedures for the Generic Product Reevaluation Initiative Lan Lin Deputy Director, Institute for Chemical Drug Control, NIFDC, China Rule for Reference Product Selection and Guidance on Comparative Dissolution Qiming ZHANG Researcher, NIFDC, China IVIVC-Challenges and Considerations Deepak Hegde, PhD Vice President, Formulation Development Services, WuXi AppTec Co. Ltd., China Bioequivalence and In Vitro Dissolution Studies – A US Industry Perspective Xiaoxiong (Jim) Wei, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Director, Clinical Pharmacology, Medpace, USA Panel discussion 67 Session T 6-3 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 D Regulatory Perspectives on Botanical Drug Products in China and the United States Session Chair Chi-Wan CHEN, PhD Member of FDA Alumni Association International Network (FDAAA) Former Deputy Director, Office of New Drug Quality Assessment, US FDA/ CDER Executive Director, Global CMC, Pfizer, USA A botanical product is regulated as a dietary supplement or drug, depending on its intended use, in the US FDA issued a guidance on Botanical Drug Products in 2004 to outline its recommendations on CMC information for different phases of clinical studies and for pre-NDA consideration. The guidance has enabled the industry and academia to begin studying botanical products for drug use, leading to the approval of the first botanical drug product in the US in 2006. This session will introduce the brief regulatory history of botanical drug products and discuss the challenges in developing such products in the US China's long history and experience in regulating Traditional Chinese Medicines (TCM) will be presented as a comparison. CFDA Requirements for Traditional Chinese Medicines (TCM) Yuehua Zhou Deputy Office Director, Office of Traditional Chinese Medicines, CDE, CFDA, China Botanical Drug Products in the United States – Regulatory Background Duu-gong WU, PhD Member of FDA Alumni Association International Network (FDAAA) Director, Global Regulatory Affairs, Pharmaceutical Product Development, USA Regulatory Challenges in Developing Botanical Drug Products in the United States David LIN, PhD Member of FDA Alumni Association International Network (FDAAA) Senior Consultant, Biologics Consulting Group, USA Panel discussion Session T 6-4 | Wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 D Evolution of Global Biotherapeutic Regulations – A CMC Perspective Session Co-Chairs Melly Lin Regulatory Manager, CMC Policy, Roche (China) Holding Ltd., China Min GUI, PhD Director, CMC Asia Pacific, China CMC & Operation of the Global Regulatory Science, Bristol-Myers Squibb, China Over the past decades, the development and application of new technologies have transformed the biotherapeutic product development, and drive the evolution of biotherapeutic regulatory framework. This session will introduce the evolution of global biotherapeutic regulations and the emerging regulatory concepts that will change the regulatory framework in the US & EU, such as life- cycle management approach for process validation, CMC change management protocol, etc. Application of the new ICH Q11 principles in biotherapeutic drug substance development will also be discussed. In addition, this session will cover the platform manufacturing for biotherapeutic development and use cases to demonstrate its application. Evolution of the Biotherapeutic Regulations in USA and Driving Force Behind Lixin XU, MD, PhD Product Quality Reviewer, Office of Biotechnology Products, Division of Monoclonal Antibody, Center for Drug Evaluation and Research (CDER), FDA, USA Application of ICHQ11 Principles in Biotherapeutic Drug Substance Development Anthony Ridgway, PhD Senior Regulatory Scientist, Biologics and Genetic Therapies Directorate, Health Products and Food Branch, Health Canada Modular Viral Validation for Platform mAb Purification Process Qi Chen, PhD Associate Director and Senior Scientist, Process Virology, Purification Development, Genentech Inc. USA Theme 7 | Traditional Chinese Medicines (TCM) Session T 7-1 | Tuesday, May 14, 2013 08:30 - 10:00 2nd Floor, 203 C Development of Novel TCM Products for China and Global Market Session Chair Xun Zhang, PhD Vice President, Head of Global Natural Product Business Unit, GSK R&D, China This session is to provide an overview of the R&D strategies and activities on the development of novel TCM products, as well as a forum for open discussion of the opportunities and challenges faced by the drug industry in its efforts to convert traditional herbal medicines into high quality, patent-protected, and clinically-proven products using global drug discovery and development technologies and standards. TCM Industry Landscape Junjie Zhou, PhD General Manager, Shanghai Hutchison Pharmaceuticals, China R&D Strategy and Activity for New TCMs Zuguang Ye, Professor Director, TCM Platforms, China National Academy of Sciences, China TCM Globalization Opportunity and Challenge Xun Zhang, PhD Vice President, Head of Global Natural Product Business Unit, GSK R&D, China Session T 7-2 | Tuesday, May 14, 2013 10:30 - 12:00 2nd Floor, 203 C Case Studies and Good Practices in TCM Development Session Chair Jack Xu, MD Senior Vice President, Shanghai Clinical Research Center, China The regulatory requirements, experience, and practices for TCM development will be discussed with case studies at this session. The session will also discuss what criteria should be used for TCM clinical evaluations. 68 Regulatory Guidelines and Updates Yixin CHEN Division Head, Division of TCMs & Ethno-Medicines, Department of Drug Registration, CFDA, China Clinical Research Update about TCMs in China Jack Xu, MD Senior Vice President, Shanghai Clinical Research Center, China Theme 8 | Target-Based Oncology Drug Development Co-Organized By: US Chinese Anti-Cancer Association (USCACA) Session T 8-1 | Tuesday, May 14, 2013 13:30 - 15:00 2nd Floor, 201 D Changing Paradigm in Cancer Diagnosis and Treatment - Impact on Drug Development Session Co-Chairs George Chen, MD, MBA Vice President and Head of Global Medicine Development of China, AstraZeneca Global Medicine Development, China Li XU, MD, MSD, MBA Vice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA This session will overview the current target-based novel cancer drug development and review two successful cases of target-based cancer drug development. Overview and Introduction Maria Koehler, MD, PhD Vice President, Integrated Development Leader and Strategic and Scientific Assessments, Clinical Development and Medical Affairs, Oncology Business Unit, Pfizer Inc., USA Case Study: Integrating Biomarkers into Clinical Trials of New Therapies in Cancer, Right Drug for the Right Patients at the Right Time ? Case 1 - Xalkori for ALK+ NSCLC Maria Koehler, MD, PhD Vice President, Integrated Development Leader and Strategic and Scientific Assessments, Clinical Development and Medical Affairs, Oncology Business Unit, Pfizer Inc., USA ? Case 2 - BRAF Inhibitor for BRAF V600e/k Mut Melanoma Jun GUO, Professor, MD, PhD Director, Department of Kidney & Melanoma Vice President, Peking University Cancer Hospital & Institute, China Session T 8-2 | Tuesday, May 14, 2013 15:30 - 17:30 2nd Floor, 201 D Strategies for Discovery and Development of Target- Based Novel Cancer Medicines Session Co-Chairs George Chen, MD, MBA Vice President and Head of Global Medicine Development of China, AstraZeneca Global Medicine Development, China Li XU, MD, MSD, MBA Vice President, Oncology China Strategy, Implementation, and Oncology Operations, Oncology Business Unit, Pfizer Inc., USA This session will discuss the strategies for discovering, developing and registering novel target-based cancer drugs with quality, speed and value. In addition, this session will also discuss what China needs to do to transit from participating to leading target-based cancer drug development. Novel Cancer Target Identification and Validation Jennifer Yang, PhD Director, Science Affairs, Johnson & Johnson Asia R&D Center, China Clinical Development Strategy: Identify Right Target Population, Utilize Optimal Endpoints and Study Designs, and Leverage China Opportunities Hua Mu, MD, PhD Executive Vice President and Chief Medical Officer, Hutchison Medi Pharma, China China's Role in Participating and Leading Discovery and Development of Novel Oncology Medicine Caicun Zhou, Professor, PhD Director, Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, China Theme 9 | Pharm/Tox Session T 9-1 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 B+C Pharm/Tox: From Animal to Human Session Chair John Gong, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Vice President, BeiGene (Beijing) Co. Ltd., China A comprehensive presentation of requirements for preclinical safety evaluations in the US FDA and China CFDA. Discussions will be focused on the following: preclinical safety data analysis and interpretation; extrapolation of animal toxicity findings to humans; and methods on how to use animal data to predict potential human risk and support regulatory decisions. FDA Requirements for Preclinical Safety Evaluations Paul A. Andrews, PhD Executive Director, Global Regulatory Affairs, Eisai Inc. USA CFDA Requirements for Preclinical Safety Evaluations Jian Peng, PhD Scientific Advisor, Asia Pacific R&D, Sanofi, China Panel discussion Session T 9-2 | Wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 B+C GLPRegulatoryComplianceforDataQualityandIntegrity Session Chair Dylan D. Yao, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Senior Vice President and CSO, Joinn Laboratories, Inc., China Comprehensive presentations regarding GLP compliance issues associated with preclinical data quality and integrity from the view point of both CRO and government regulatory agency to ensure subjects safety. 69 GLP Compliance Issues ImpActing Data Quality and Integrity in Preclinical Studies - A Cro's Point of View Jane Pearse, PhD Director, Special Projects, Huntingdon Life Sciences, UK Importance of GLP & Safety Testing to Public Health Mission - A Perspective of FDA Dylan D. YAO, MD, PhD Member of FDA Alumni Association International Network (FDAAA) Senior Vice President and CSO, Joinn Laboratories, Inc. China Panelists Speakers and Lijie FU, PhD, FELLOW ATS General Manager, China Business, Senior Advisor of Regulatory, SNBL Vice President, Chinese Society of Toxicology, China Conglin ZUO, MD President and CEO, Joinn Laboratories, Inc., China Session T 9-3 | Wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 201 B+C Patient safety: toxicological evaluation and risk assessment in pharmaceutical R&D Session Co-Chairs Lijie Fu, PhD, Fellow ATS General Manager, China Business/Senior Advisor of Regulatory, SNBL Vice-President of Chinese Society of Toxicology Charles Y. Wang, PhD, DABT Director, Safety Assessment, GSK R&D, China This session focuses on toxicology in pharmaceutical safety evaluation and risk assessment, specifically the importance of pharmaceutical products and safety evaluation in China, as well as non-clinical risk assessment in compound license-in, which is a primary strategy for Chinese pharmaceutical industry. Hazard vs. Risk - Toxicology Consideration Lijie Fu, PhD, Fellow ATS General Manager, China Business/Senior Advisor of Regulatory, SNBL Vice-President of Chinese Society of Toxicology Drug Safety Assessment for Stem Cell-based Medicinal Products Jing Ma, MD, PhD Director, National New Drug Safety Evaluation and Research Shanghai Center, China Safety Evaluation of Chinese Traditional Medicines: Rhubarb and Its Major Constituents Quanjun Wang, MD, PhD Assistant Director, National Beijing Center for Drug Safety Evaluation and Research, China Non-Clinical Safety Assessment during Compound License-In Charles Y Wang, PhD, DABT Director, Safety Assessment, GSK R&D, China Theme 10 | Clinical Data Management/eClinical Session T 10-1 | Wednesday, May 15, 2013 08:30 - 10:00 2nd Floor, 201 A Technology Advancement in the Landscape of Clinical Data Management Session Chair Daniel LIU, PhD Director, China Development, Medidata Solutions Worldwide, China Technology is changing the clinical research landscape from protocol development, data acquisition and data exchange. Clinical Research is behind other industries in taking advantage of the uses of technology and information so it is important to know the trend such as cloud technology and tools to move the industry forward. This session will discuss the benefit of technologies to data managers and will provide a picture into the future of how it may impact our field. Big Data Computing – Current Concept and Practice Glen de Vries President, Medidata Solutions, USA Suitable Cloud Implementation for Life Sciences Research Abhishek BAGGA Manager, Clinical Systems Center of Excellence, Life Sciences R&D Practice, Cognizant Technology Solutions, India Bioinformatic Tools in Data Analysis and Management Eric S. HERBEL President, Integrated Clinical Systems, USA Panel discussion Session T 10-2 | Wednesday, May 15, 2013 10:30 - 12:00 2nd Floor, 201 A Data Managers' Roles in Drug Safety Session Chair Joanne LIU Director, Global Clinical Data Management & Standard, MSD R&D (China) Center, China This session will provide practical ideas on how to ensure the safety data quality through data validation plan, data review process and medical coding process. Hear from experienced speakers who have been successful in managing safety data and learn more about how you might address key challenges when managing safety data. Considerations in Safety Data Validation and SAE Reconciliation Jessie Chen, MD Head of Clinical Data Services, Pfizer China R&D Center, China Safety Data Management in Phase I Study Gang Xu, MD Director, Data Management, GSK R&D, China Coding in Safety Data Management Lobo Loo Associate Director, China Data Management Center, MSD R&D, China Panel discussion 70 Session T 10-3 & T 10-4 | Wednesday, May 15, 2013 13:30 - 17:30 2nd Floor, 201 A Data Standards in Real World Clinical Research Session Co-Chairs Zibao Zhang, Phd Associate Director, Biostatistics and Programming, PPD, China Yazhong DENG, MBA Head of Clinical Data Analysis and Reporting Organization (CDARO), Covance, China Data Standard is a continued hot topic to streamline clinical research and modernize data and information flow in drug development. This session will focus on the added values of standardization and implementation approaches around the globe. The audience will hear from experts who have been successful in their endeavors and learn how one could address the key challenges of integrating standard into clinical trials. Updates of the CDISC standards implementation and regulatory considerations in China will be shared. From Electronic Health Record to Clinical Database Demetris ZAMBAS Executive Director, Global Data Management & Standards, MSD, USA CDISC Standards Implementation - Experiences from a Global CRO Jianrong LI Director, Biostatistics and Programming Asian Operation, PPD, China Case Studies with CDISC Standards: from CDASH to SDTM and AdaM Victor Wu, PhD Senior Manager, Biostatistics, Covance, China CDISC Standards to Enhance Clinical Trial Efficiency Ivan Tjong-A-Hung, MD, MBA General Manager, Athena Healthcare Consultancy, China Updates of CDISC Standards in China Linda WANG, Master in Health Statistics Principle Biometrician, Integrated Information Sciences Department, Novartis, China China CDISC Coordinating Committee (C3C) Panel discussion Qin HUANG, PhD Deputy Office Director, Office of Biostatistics, CDE, CFDA, China Theme 11 | Innovation on Medical Devices and Combinational Products Sessions T 11-1 & T 11-2 | Wednesday, May 15, 2013 08:30 - 12:00 2nd Floor, 203 C Medical Devices: Innovation, Regulation and Investment Session Co-Chairs Katherine WANG, LLM Chief China Life Sciences Advisor, Ropes & Gray, China Spring WANG, MD Regional Clinical Director, St. Jude Medical, Asia Pacific, Hong Kong, China The session will cover topics of medical device innovation, registration and financing. With participations of senior and experienced experts, speakers will provide comprehensive review of the newly released medical devices GCP guideline by CFDA, innovations, roles of venture capital and cases studies on medical devices. Innovation on Medical Devices Kok-Hwee NG, PhD Director, Instrumentation Development, Center for Innovation and Strategic Collaboration, St. Jude Medical, Inc. USA The Draft GCP on Devices in China Xianghui YUE Division of Research & Reevaluation, Department of Medical Device Supervision, CFDA, China Streamlining Medical Device Clinical Trial Xianqiang Mi, Professor, MD, PhD Shanghai Advanced Research Institute, Chinese Academy of Science, China Medical Device Innovation: A Case Study Katherine WANG, LLM Chief China Life Sciences Advisor, Ropes & Gray, China Role of Venture Capital in Medical Devices Fay Xing, MD Pricipal, Decheng Capital, China Theme 12 | Contract Research Organization Session T 12-1 | Wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 201 D How to build win-win relationship Session Chair Helen JIANG, MD, PhD Executive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China In the journey of drug/device development, companies are not necessary to have all the scientific and operational capability and capacity to undertake all tasks, especially when it is related to patient safety or to the resolution to help patient out of disease suffering. The session will be emphasizing that the outsourcing decision is based on multiple factors besides money, with the aim to outline the various business need for CRO companies, including contribution to science/medicine, special area of service, delegated function services partner, in-sourcing people, and full service outsourced project. How to Leverage Safety Data from Chinese Population to File IND in US Successfully? Simon Li, MD, PhD Vice President, Global Clinic Trials and Regulatory Affair, Luye Pharma, China Early Development: CRO Selection and Partnership Anfan Wu, PhD Head of Early Development, Roche R&D Center (China) Ltd., China Case Study: A Chinese Company Successfully Filed IND in US with CRO Support Zaiqi Wang, MD, PhD Executive Director, Clinical Research, MSD, China Collaboration to Win a Path to Success Helen JIANG, MD, PhD Executive Medical Director, Jiangsu Hengrui Medicine Co. Ltd., China 71 Session T 12-2 | Wednesday, May 15, 2013 15:30 - 17:30 2nd Floor, 201 D CRO: Value-added Taskforce to Ensure Patient Safety Session Co-Chairs Yanhua GONG, MD Vice President & Secretary General of CROU (CRO Union), China Association for Pharmaceutical and Medical Technology Exchange, China Jessica Liu, MD General Manager, China/North Asia, INC Research, China The session will discuss how Contract Research Organization (CRO) build infrastructure in China to develop high performance team. Strategic Alliance on Pharmacovigilance to Support Patient Safety Management in Clinical Trial Sheona Stevenson, PhD Associate Director of PVG, Head of Asia-Pacific Region, INC Research, Singapore Clinical Monitoring in China – Assuring Quality from the CRO Perspective Emily Tan Executive Director, Clinical Research Asia Pacific, InVentiv Health Clinical, Singapore The Business Development of a Domestic CRO after IPO Sally Sha, MD Director, Business Development, Project Director, Hangzhou Tigermed Consulting Co. Ltd., China Panel discussion Theme 13 | Post-approval and Real World Studies Session T 13-1 | Wednesday, May 15, 2013 15:30 - 17:30 2nd Floor, 201 B+C Post-approval and Real World Studies Session Chair Ming TANG, MD Principal Scientist, Vital Strategic Research Institute (VSRI), China & USA After a drug is approved for marketing, scientific and medical research continues. Numerous study methodologies and mechanisms are available to further study and evaluate its efficacy and safety in the real word setting as well as to identify its potential new uses. The session will examine the trend, practicality, issues, and possible solutions surrounding the application of these methods in China. Introduction and Overview Ming TANG, MD Principal Scientist, Vital Strategic Research Institute (VSRI), China & USA Patient Registry Yan XIAO, MD, PhD Senior Epidemiologist, Roche Pharma Development Center, Asia Pacific, China Investigator-Initiated Studies: 1. Case I : Frank Fan, PhD Senior Medical Director, Sanofi, China 2. Case II: Yilong Wang, PhD Vice Division Chief, Department of Internal Neurology, Beijing TianTan Hospital, China Theme 14 | Pharmacoepidemiology - Best Practices and Drug Safety Session T 14-1 | Wednesday, May 15, 2013 13:30 - 15:00 2nd Floor, 203 C Pharmacoepidemiology - Drug Safety and Best Practices Session Chair Wei Zhou, Md, PhD Director, Epidemiology Asia Pacific Unit, Merck Research Laboratories, China This session is to share the status and progress of pharmacoepidemiology in drug safety and risk management, as well as comparative-effectiveness research. Introduction of Basic Pharmacoepidemiology Principles and Methods in Drug Development and Risk Management Siyan Zhan, Professor, MD, PhD Professor, Department of Epidemiology, Beijing University Medical School, China Regulatory Perspective and Progress of Pharmacoepidemiology and Drug Safety Min YAN Deputy Director General, Department of Drug Safety and Inspection, CFDA, China Recent Progress of Pharmacoepidemiology Research - Using Large Emr and Claim Databases, and Comparative-Effectiveness Research on Drug Safety and Efficacy of Different Treatments and Drugs. Arnold K. CHAN, MD, ScD, FISPE Deputy Director, Medical Research Department, National Taiwan University Hospital, Taiwan Theme 15 | DRUG ELECTRONIC ADMINISTRATION IN CHINA Session T 15-1 | Wednesday, May 15, 2013 15:30 - 16:15 2nd Floor, 203 C Introduction of Drug Electronic Administration Yingli WANG Deputy Director, Division of Information Research & Planning, Information Center, CFDA, China DIA CHINA 7/F, Room 766, Metropolis Tower No.2 Haidian East Third Street, Zhongguancun Xi Zone Haidian District, Beijing, 100080, China Tel: +86.10.6260.2240 DIA@diachina.org DIA worldwide headquarters 800 Enterprise Road, Suite 200, Horsham, PA 19044 DIA regional offices Horsham, Pennsylvania | Washington, DC Basel, Switzerland | Tokyo, Japan | Mumbai, India | Beijing, China