彻底犯懒
我说我最近心悸，苏岭说我是彻底犯懒。原来犯懒也会让人生病。
在20多位顾问成员的努力下，DIA第三届中国年会雏形已现。
我似乎感受到一项宏大工程的细节之美。
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The 3rd DIA China Annual Meeting 药物信息协会（DIA）第三届中国年会 Quality & Standards—— Elevating China Pharmaceutical Development 质量与规范——中国制药业的升级路径 |
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| Pre-conference Workshops: May 15, 2011
会前研习班：2011年5月15日 Conference & Exhibition: May 16-18, 2011 大会及展览：2010年5月16-18日 |
Crowne Plaza Sun Palace Beijing
No.12 Qisheng Middle Street, North-East 3rd Ring Road, Yunnan Dasha ,Chaoyang District, Beijing, P.R. China 北京新云南皇冠假日酒店 北京市朝阳区东北三环七圣中街12号云南大厦 |
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Program Co-Chairpersons联席主席 |
Co-sponsored by
1. 希望简短些并能总结前两次会议并展望本次会议的结果 2. 名单上人员的支撑及单位需更正，那些不积极参加的人 员建议删除。 China Center for Pharmaceutical International Exchange of the SFDA 合办单位：中国医药国际交流中心
China’s drug innovation and development are moving ahead rapidly. A local, as well as global, perspective will help all players involved to exchange critical information for research and strategic positioning in an increasingly complex regulatory landscape. 中国药物的创新和发展日新月异。本次大会将从地区乃至全球的视角帮助参会人员对日愈复杂的监管环境中的研究和策略定位进行探索和交流。 This third DIA China Annual Meeting will serve as an international, neutral forum for attendees to collectively discuss how China can play a leadership role in drug development. Speakers from major regulatory agencies, industry, and academia will present and lead the panels and sessions. 药物信息协会（DIA）第三届中国年会作为一个国际性的中立论坛，参会人员将对中国如何在药物发展中扮演领导角色进行探讨。来自管理机构、企业界和学术界的演讲人将出席并主持会议的讨论。 This multidisciplinary meeting will benefit all professionals from regulatory agencies and institutions, the biopharmaceutical industry, investigational sites, contract research organizations, and academia. Together we can better understand how to reach the next stage for our profession as well as deliver benefits for human health and well-being globally. 本次大会涉及众多领域及学科，将有益于来自监管机构，科研院所、生物制药、临床研究基地、合同研究机构和学术界的专业人士就提升本专业的水平，在中国乃至全球新药研发中发挥更重要的作用互相交流、切磋和探讨。 KEY SESSIONS AND TOPICS主要分会与议题
– CMC/cGMP 化学、生产、质控／cGMP – Clinical Research, Drug Safety & Pharmacovigilance药物临床开发与安全警戒 – Regulation, Development & Practices 药政法规及实践 – Clinical Data Management and Statistics临床数据管理与统计 – Medical and Scientific Affairs医学事务 – Capability & Capacity Building, Clinical Development/Regulatory Strategy临床开发与建设 – QA/QC in Clinical Development, Regulatory Requirements/Practices临床开发中的质量保证与质量控制
WHO SHOULD ATTEND 参会人员 This program will benefit individuals involved in: 本会议将有益于从事以下领域的工作人员： – Regulatory affairs法规监管事务 – Clinical research临床研究 – Drug R&D strategies药物研发战略 – Quality assurance and quality control质量保证和质量控制 – Drug safety and pharmacovigilance药物安全与药物警戒 – Strategic sourcing/planning战略资源与规划 – Bioinformatics生物信息学 – Biostatistics生物统计学
Simultaneous translation will be available on May 16-18. 5月16-18日将提供同传服务
CONTACT INFORMATION： 联系方式： Conference: For general inquiries and registration, contact Mr. Fei XIE at fei.xie@diachina.org 会议咨询：一般咨询与注册，请与谢飞先生联系，Email：fei.xie@diachina.org Exhibits: Ms. RunShan CHEN at: ting.chen@diachina.org 展览咨询：请与陈润珊女士联系，email：ting.chen@diachina.org |
| James CAI, MD
President, Pangu Biopharma Ltd. Vice President, Clinical Development aTyr Pharma Inc 蔡学钧, 医学博士 盘古生物制药有限公司总裁 aTyr Pharma Inc. 临床开发副总裁
ZHAO Yajun Director-General, China Center for Pharmaceutical International Exchange, SFDA, China 赵亚军 中国医药国际交流中心主任
Program Vise Chairperson组委会副主席 John J. HU, PhD Vice President, International General Manager, USP-China 胡江滨, 博士 美国药典委员会国际部副总裁兼中华区总经理 |
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Program Committee 会议组委会 |
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| Paul DAI, MD, Director, Clinical Development, Beijing Novartis Pharma Co., Ltd., China
戴欣 医学博士 北京诺华制药有限公司临床开发总监 |
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| 杜文民 | |
| GUI Min
Bristol-Myers Squibb (BMS) Director of CMC AP, China CMC & Operation of the Global Regulatory Science 桂敏 百时美施贵宝全球注册科学部亚太区CMC，中国CMC和运营部的总监 |
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| GUO Xiaojun
Safety Manager-Patient Safety AstraZeneca China 郭晓军 阿斯利康中国研发部高级经理-患者安全 |
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| Laurence HUANG
Executive Director, Regulatory Affairs AstraZeneca Pharmaceutical Co., Ltd. 黄彬 药政事务执行总监 阿斯利康制药有限公司 |
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| JIAO Qingan, MD
Director, Clinical Research Unit, R&D China, sanofi-aventis, China 焦庆安 医学博士 赛诺菲-安万特中国研发中心中国临床研究中心总监 |
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| LI Haiyan, MD
Vice Director, Peking University Clinical Research Institute; Director, Drug Clinical Trial Center, Peking University Third Hospital, China 李海燕 医学博士 教授 北京大学临床研究所副所长，北京大学第三医院药物临床试验机构主任 |
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| LI Ning, MD, PhD
Senior Group Regulatory and Medical Policy Director, Sanofi-Aventis, China 李宁 医学博士 赛诺菲-安万特中国区集团注册和医学政策高级总监 |
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| LI Shuting, MD
Cancer Institute & Hospital Chinese Academy of Medical Sciences 李树婷 医学博士 中国医学科学院肿瘤医院伦理委员会秘书 |
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| Daniel LIU, PhD
刘川 |
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| Jessica LIU, MD
Senior Director of Clinical Operations Head of Asia-Pacific, Global Clinical Operations, INC Research 刘佳 医学博士 |
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| Joanne LIU, MS
Regional Director, Asia Pacific Data management Center Global Data Management & Standards Merck. & Co. Inc,China 刘宗范 硕士 默克全球临床数据管理中心亚太区总监 |
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| MENG Yuan
Head of Country Pharmacovigilance, Greater China Bristol-Myers Squibb Company 孟渊 百时美施贵宝公司大中华区药物警戒经理 |
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| Roger QU, PhD
Senior Director, Department of Statistics Pfizer China R&D Center 曲鹏 辉瑞（中国）研究开发有限公司统计部总监 |
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| Frank SHEN, PhD
Head of Biometrics and Clinical Study Management, Roche Product Development Center in Asia Pacific 沈志华 博士 罗氏药品临床研发亚太中心生物统计与临床研究管理总监 |
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| Lily SUN, MD, Director of Medical,
Pfizer Pharmaceutical Ltd., China 孙丽梅 博士 |
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| Claire TAN
谭朝瑜 |
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| 童成 | |
| WANG Peng, PhD
Chief Scientific Officer, Simcere Pharmaceutical Group, China 王鹏 博士 先声药业首席科学官 |
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| William WANG, PhD
Head of Asia Pacific Hub, Department of Biostatistics and Research Decision Sciences, Merck Research Laboratories, Merck & Co., Inc, China 王武保 博士 默克研究所生物统计与研究决策科学部亚太区运营总监 |
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| Jenny WU
Site head and Chief Medical Officer, Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. 吴健宇 默克雪兰诺(北京)医药研发有限公司研发中心负责人、首席医学执行官 |
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| Catherine XIE
Safety Evaluation & Reporting Site Planner Pfizer（China) Research and Development Co., Ltd 谢珺 辉瑞（中国）研究开发有限公司安全评估和报告总监 |
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| XU Ning, MD, MBA
Executive Director, Head of Clinical Development Service, Covance, China 徐宁 医学博士 科文斯公司执行总监，中国临床研究事业部负责人 |
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| Wendy YAN
Global Regulatory Strategist, Global R&D Center, Bayer Healthcare Co. Ltd. |
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| Rachel YANG, MD, PhD
Director, Product Strategy, Health Sciences Global Business Unit, Oracle Corporation, China 杨佩蓉 医学博士 甲骨文（中国）软件系统有限公司生命科学全球事业部产品策略总监 |
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| ZHANG Dan
Chairman & CEO, Fountain Medical Development Ltd. 张丹 方恩医药发展有限公司董事长兼首席执行官 |
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| Tony ZHANG, PhD
Managing Director, and Site Head, Eli Lily Global R&D, China 张彦涛 博士 礼来制药中国研发董事总经理 |
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| ZHEN Ling
甄岭 |
3rd DIA CHINA ANNUAL MEETING ADVISORS
第三届药物信息协会中国年会顾问委员会
| Karen J. ATKIN, MD
Vice President, R& D Center, AstraZeneca China Karen J. ATKIN 博士，阿斯利康中国药物研发部副总裁 |
| BI Honggang,PhD
Vice President and General Manager, Covance China 毕红钢 博士 科文斯中国公司副总裁及中国区总经理 |
| Wen CHANG, PhD
Head of Regulatory Intelligence and Advocacy, Asia Pacific Region, Global Drug Regulatory Affairs, Beijing Novartis Pharma Ltd 张薰文 博士 诺华全球药事法规亚太地区战略发展研究部主任 |
| JIN Kewen, PhD, General Manager,
Charles River Preclinical Services, China 金克文 博士 上海查士睿华生物医药科技有限公司总经理 |
| Frank JIANG, MD, PhD
Vice President, Global R&D and Head Asia Pacific R&D, sanofi-aventis, China 江宁军 博士 赛诺菲-安万特全球研发副总裁 亚太区研发总裁 |
| LI Jinju, PhD
Director of Drug Research Supervision Division, Department of Drug Registraion of SFDA, China 李金菊 博士 国家食品药品监督管理局药品注册司药品研究监督处处长 |
| SU Ling, PhD
Vice President, Asia Pacific Research Organization, Pfizer, China 苏岭 博士 辉瑞(原惠氏公司）亚太区临床研究组织副总裁 |
| TAN Lingshi, PhD
General Manager，Pfizer(China)R&D Co., Ltd. China 谭凌实 博士 辉瑞（中国）研究开发有限公司总经理 |
| YAO Chen
Vice Director, Peking University Clinical Research Institute, Head of Department of Biostatistics Peking University First Hospital,China 姚晨 教授 北京大学临床研究所副所长 北京大学第一医院药学统计室主任 |
| ZHANG Beibei
张蓓蓓 |
Sunday, May 15, 2011 Pre-conference Workshops
- 学习班的目的及讲者的题目需明确。
- 可移2个学习班至16日上午。
8:30 – 17:30 Workshop 研习班 1
如何遵循GCP规范准备和应对药政稽查的最佳实践
About the workshop 研习班介绍
Who should attend 参加者
Learning Objectives学习目标
Speakers: 讲师：Earl Hulihan, Kim Nitahara, Byungia Marciante (FDA) (Confirmed)
Lead: Daniel Liu
8:30 – 17:30 Workshop 2 研习班2
生化分析方法的开发和验证
About the Workshop 研习班介绍
Who Should Attend 参加者
Learning Objectives学习目标
Speakers 讲师: Fa Zhang, PhD (J&J), Shaolian Zhou (Novartis), Yun He (BioDuro )
8:30 – 12:30: Workshop 3 研习班3
疫苗临床研发及法规
Lead: 刘佳、Bill Wang
About the Workshop 研习班介绍
Who Should Attend 参与者
Learning Objectives学习目标
Speakers 讲师:
13:30 – 17:30: Workshop 4 研习班4
Ethical medical writing practices – every document, every time, every country
伦理医学报告写作
About the Workshop 研习班介绍
Who Should Attend 参与者
Learning Objectives学习目标
Speakers 讲师: Karen Woolley (confirmed)
8:30 – 17:30: Workshop 5 研习班5
New CDISC Global Approach course
Lead: 谭朝瑜
About the Workshop 研习班介绍
Who Should Attend 参与者
Learning Objectives学习目标
Speakers 讲师:
Monday, May 16, 2011
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PLENARY SESSION 全体大会
13:30-14.15 (45′) 年会开幕大会 （三层 云南厅）Opening Ceremony (3F YunNan Grand Ballroom A+B+C)： JANE CAI主持并介绍来宾。 会议主席（JAMES CAI,赵亚军）致辞。 James CAI, MD President, Pangu Biopharma Ltd. Vice President, Clinical Development aTyr Pharma Inc 蔡学钧, 博士 盘古生物制药有限公司总裁
ZHAO Yajun Director-General, China Center for Pharmaceutical International Exchange, SFDA, China 赵亚军, 中国医药国际交流中心主任
致辞并发奖。 Richard O. Day, AM, MB, BS, MD, FRACP President, Drug Information Association 药物信息协会候任主席 Professor of Clinical Pharmacology, St. Vincent’s Hospital, Australia 澳大利亚，圣文森（St. Vincent’s）医院，临床药理学教授
Paul Pomerantz Worldwide Executive Director Drug Information Association 药物信息协会全球执行总监
14:15-15:00 (45′) 特邀贵宾演讲 邵明立 先生国家食品药品监督管理局局长 keynote speaker: Mr. Shao Mingli Commissioner of SFDA, China 15:00-15:15 (15′) 茶歇 Tea Break 15:15 -15:45 (30′) 演讲一：Speech 1China Drives to “Indigenous Innovation”. 演讲人：Speaker Mr. James McGregor/ Michael Zielenziger 15:45-16:15 (30′) 演讲二：中国新版GMP 综述 演讲人：Speaker SFDA（孙咸泽） 16:15-17:30 (75′) 辩论会：迈向医药强国的中国式跨越 Opening Debate 参与者：Participants 苏岭（主持）、董瑞平、李自力、李宁、张伟(SFDA)、冯毅(CDE)、施一功教授
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| 18:00-19:30 (90′) 联谊招待酒会Networking Reception 特邀嘉宾演讲常昊？ |
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Monday, May 17, 2010 |
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| 8:30 – 10:00 SFDA Town Hall Meeting: 十一五主要成绩及十二五规划及展望
Speaker: 局办主任/副主任主持，注册司，安监司，器械司？，稽查局，评审中心 CDE， CDR， CDC， CMD 各派人介绍十一五主要成绩和近期计划 （需交流中心协调国合司局办） – 临床核查的回顾总结李金菊 – 指导原则/CTD – 政府在鼓励创新方面的举措－回顾 杨建虹、冯毅 – 信息管理、数据库等董江萍 – 国家局政策法规总体规划 – 中国在APIC中的角色 丁建华
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| 10:30 – 12:00 PARALLEL TRACKS – SESSION 1 平行会议 – 第一场 | ||||||||||
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Track 1 |
Track 2 |
Track 3A |
Track 3B |
Track 3C |
Track 4 |
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药物临床开发与安全警戒 Clinical Research, Drug Safety & Pharmacovigilance 1.是否将质量有关内容移到QC/QA部分
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药政法规及实践 Regulation, Development & Practices 1. 能否增加一些国外的讲者e.g. WHO西太平洋地区负责伦理的人员？ 2. 白皮书解读部分能否加一位学者给予解读或评论 3. 一位学者给予解读或评论 4. eCTD部分能否加入国外经验分享
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数据管理与统计 Data Management and Statistics
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医学事务 Medical and Scientific Affairs
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临床开发与建设 Capability & Capacity Building, Clinical Development /Regulatory Strategy |
药品标准与质量 Drug Standard and Quality
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Session 0101 |
Session 0102 |
Session 0103A |
Session 0103B |
Session 0103C |
Session 0104 |
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Quality in clinical research, drug safety & pharmacovigilance
Chairpersons会议主持 Hannah Chen Guo Xiaojun, 郭晓军
1. What are the key inspection findings? Challenges we are facing in conduct clinical trials (20 min) Byungja Marciante (FDA) FDA Officer (Hannah to further confirm)
2. Panel discussion ¨ Insufficient source documents – main challenge due to medical system in China? ¨ Missing data (AE and SAE) ¨ Safety information reconciliation between clinical database and safety database due to inconsistency of source document reporting Helen Li (Pfizer) Chen Yuling (307 Hospital) Zhou Aiping (CAMS, Tumor Hospital) Wang Yuhong (Roche) A Sr. CRA (TBD)
3．Case study: How do we improve source documents to meet GCP requirements? 1 case oncology and 1 case non-oncology protocols and 1 case of SAE case to be distributed to audiences in advance; some of them will be invited to the panel to join the discussion ¨ Verification of subject eligibility according protocol requirements – what source document we must have ¨ Clear Definition of SAE (Death as outcome, disease progression) ¨ Clear instruction of SAE management Above panelists + some audiences
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Session 1： AD (Adaptive Design)
Chairpersons会议主持 Roger QU（Pifzer）曲鹏 Robert LUO (Pifzer)罗震
Panel or Debate
Topics: Part 1 – an oncology case (or other applicable disease) . Imbed the “guidance comparison” session in this: – Is China ready for adaptive design (e.g., DMC ready)? – Discuss different options: fixed sample, GSD, SSR – Why we need adaptive design and How can the adaptive design increase quality (speed, resource, result) – How the ICH，FDA guidance, and SFDA guidance differs (focusing on why, what, how) Format: – A panel discussion for DMC in China (The panel could consist of the speakers in the first part plus all of the lead and maybe more )
其他讲者: 1 speaker from the regulatory perspective on the practice of DMC and adaptive design in its broad sense (Sue-Jane Wang) – 1 speaker from the perspective of DMC members (Irving K. Hwang) – 1 speaker from China, topic could be the current practice of DMC in China or comparison of sFDA guidance and ICH and FDA guidance (we are seeking a speaker familiar with the current practice in China, not necessarily a statistician)
Part 2 – 1 or 2 cases for adaptive designs (The format of the second part could be further refined.) Roger QU 曲鹏（Pifzer） Robert LUO 罗震 (Pifzer) |
Chairpersons会议主持 James CAI Zheng GU(顾峥) Irving Wang (王敏) Session 1: What is MA/SA, its role & responsibility in biopharmaceutical value chains and transferring scientific data into patient centric medical practices (Half of a day) Topics: • Overview of Medical & Scientific Affairs definition, position, role, responsibility, competency requirement in professional medical information communication, patient safety, regulatory compliance and product life cycle management Speaker: Dr. Rick Sax, VP Global R&D of AstraZeneca (TBC)
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Reshape your clinical development strategy in China? Join the experts to learn if China clinical development has delivered its promises, find out what are the gaps, and how to reshape your strategy in the next 3-5 years.
Chairpersons会议主持 Frank JIANG Lingshi TAN Tony ZHANG
Session 1: Phase Capability, Crossing the chasm -The data burden and regulatory hurdle for first in man trial in China are relatively high compared with other countries. Experts and industry observers will delineate root causes for this phenomenon and contemplate solutions to bridge the gap in the drug development value chain. Capabilities (readiness) will be a focus of the discussion. Potential speakers: -HU Bei 胡蓓 -ZHANG Dan (Fountain Med)张丹 -GAN Rongxing (Covance)甘荣新 -Roisin Armstrong/Chew Lan Chong
Session 2: Has China delivered its promises for global pivotal studies? Strategy, Gap analysis and Recommendation Topic: • Growing market potential and abundance in patients needing medical breakthroughs in China have driven the number of international muliticentered trials in China to triple in 2009 over 2008. Numbers aside, what has kept the country from becoming a dominant player for first in kind pivotal trails? Where are the limiting factors and how are the problems addressed? Potential speakers: -Rae Yuan -Wang Min -Karen Atkin (AstraZeneca)
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Chairpersons会议主持 John HU (USP) Min GUI Charles TONG
Session 1： 2010版中国药典-how to deal with different compendia How to Strengthen the Interactions between Standard-Setting Organizations and manufacturers (如何强化标准建立机构和企业间的互动) SFDA Perspective (new) FDA Perspective (new) WANG Ping or LI Huiyi (ChP 1 speaker) Susanne Keitel (EDQM) John HU胡江滨(USP) Erin Wang (Lily)
Panel Presentation + Case studies, Q&A
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12:00 – 13:30 Lunch 午餐 |
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| 13:30 – 17:30 (Break 15:00 – 15:30) PARALLEL TRACKS – SESSION 2 13:30 – 17:30 (茶歇15:00 – 15:30) 平行会议–第二场 | ||||||||||
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Track 1 |
Track 2 |
Track 3A |
Track 3B |
Track 3C |
Track 4 |
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药物临床开发与安全警戒 Clinical Research, Drug Safety & Pharmacovigilance |
药政法规及实践 Regulation, Development & Practices |
数据管理与统计 Data Management and Statistics |
医学事务 Medical and Scientific Affairs |
临床开发与建设 Capability & Capacity Building, Clinical Development /Regulatory Strategy |
药品标准与质量 Drug Standard and Quality
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| Session 0201 | Session 0202 | Session 0203A | Session 0203B | Session 0203C | Session 0204 | |||||
| IRB/IEC practices and issues in China
Chairpersons会议主持 Paul Dai 戴欣 Mao Yimin 茅益民
Panel discussion- #1 What are the impacts of new issued IRB/IEC guideline? Liu Haitao刘海涛 (Institute of Clinical Research, Beijing University) Xiong Ningning (Jiangsu Provincial Hospital of Traditional Chinese Medicine) Eva Yang (Bayer)
Panel discussion- #2 Efficient and high quality site management Study site management ¨ Investigator’s responsibilities ¨ Site resource management ¨ Management of clinical research center ¨ Clinical research coordinator
Li Haiyan (No. 3 Hospital of Beijing University) 李海燕（北医三院） Hannah Chen (GSK) Grace Wu (Pfizer)
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Topic 中国新药研发?监管的新?趋势 （1.5 h） LI Jinju, 李金菊（SFDA） PFDA代表, CAO Cai/LI Jianming 曹彩／李见明（CDC） (每位讲者25分钟，Q&A最短15分钟）
Topic 4 中国新药研发指导原则体系的完善（1.5 h）
HOU Renping 候仁萍（SFDA注册司) WEN Baoshu 温宝书 (CDE) Industry代表 (每位讲者25分钟，Q&A最短15分钟）
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Session 2： Adopting International Standards and Improving Data Quality
Chairpersons会议主持 Joanne LIU (Merck)刘宗范 Daniel Liu (Medidata)刘川 Rachel Yang (Oracle)杨佩蓉
Panel Discussion, Q&A
Topics: Regulatory Guidelines and international data standards with regards to computerized systems • A newly published GCP guideline: computerized systems in clinical research – current data quality and data integrity concepts • CDISC application and trends: e-Protocol frameworks and EDC scope with CDISC elements • Foundation and strategy of e-clinical practice: computerized systems validation for the e-system’s lifecycle 刘川邀请到3-4位讲者 杨佩蓉正在联系CDISC的讲者，刘宗范正在寻找有关DM role和data quality的讲者
Session 2 续 (Panel Discussion)
Adopting International Standards and Improving Data Quality
Topics: Implementing data quality measures that integrate people, process and technology • A winning strategy on data quality — putting the right pieces together (culture, infrastructure, information technology and SOPs). • EDC implementation in China: historical defects, current environments and challenges of data management • Data Manager’s Role in data quality and KPI for data management process • Improving data quality with partnerships and collaborations (Sponsor, CROs, Investigators, Clinical Data Manager, CRAs, and Biostatisticians.)
Joanne LIU (Merck)刘宗范 Daniel Liu (Medidata)刘川 Rachel Yang (Oracle)杨佩蓉 |
Session 2: Establish practical and effective medical/scientific affairs strategy Topics: • Evidence based medicine in established markets and emerging markets: case study of LCM Speaker: Dr. Dominique Roome, VP Global Medical operations • China experience Speaker: Dr. Gao Runlin, People Hospital Beijing China • Working with Marketing and Clinicians on evidence based medical-marketing communication • Epidemiology study and outcome study • Post marketing study and data assembling Speaker: Li Huafei, Medical Liaison Manager AstraZeneca China • Publication and DA • From concept, strategy, resource planning, execution and communication Speaker: Joyce Li, VP Medical of NovaMed Pharma • Promotional material development and review Speaker: Dr. Gu Zheng, Medical Director of Sanofi-Aventis China • Establish an a-player team Speaker: Dr. Jane Lin, Medical Director of Baxter China
Session 3: Regulation update and trend Topics: • SOX • Legal and compliance perspective • MOH Clinical path initiative Speaker: Katherine Wang, Sidley Austin LLP
Session 4: Clinical outcome-research Topics: • Outcomes Research Impact in Medical Practice Speaker: Dr. Danyi Zhang, CMO of Vital Strategic Research Institute (VSRI)
Session 5: Operational excellence-Debate and Group discussion of specific cases (2 hours) Topics: • All, facilitated by Dr. GU Zheng (Roundtable discussion) |
Session 3: Modernize clinical development through New technology
Due to its highly regulated nature and long development timeline, medicines are not normally associated with the image of cutting edge technologies. Have we overlooked what technology can deliver for improving patient adherence, data integrity, quality of the studies, and overall probability of success? This panel will invites experts from several different fields and examine the possibilities of leveraging technological innovation to speed up medicine development. A must attend session. – Potential Speakers: -Michael AIbara, others?
Session 4: TCM development – What we can learn from? – Traditional Chinese medicine (TCM) personifies personalized care, tailored therapy, systems biology, and out-come based medicine. While the complexity of multi-components and multi targets mechanism have thwarted traditional Western clinical research approach, it will be rewarding to learn with an open mind on what’s the state of art on TCM clinical development. Potential speakers: -Bradley Marchant -SFDA -(Jockey club TCM institute, HK?) -Selwyn Fung
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Session 2: QbD-结合案例分析以及PAT新技术介绍
Chairpersons会议主持 GUI Min (BMS)桂敏 Charles TONG (BMS)童成
Topics: Implementation of QbD Principles in Drug Development and Real Time Release Testing (RTRT) Drug Product Development Utilizing QbD Speaker: GUI Min (BMS)桂敏
Practical Considerations for Implementation of Real Time Release Testing (RTRT) Speakers: Charles TONG (BMS)童成
Session 3: Supply Chains Management (SCM) Chairpersons会议主持 John HU (USP)
Topics:
1. Pharmaceutical Reference Standards: Overview and Role in Global Harmonization (Dr. Matthew Borer, Eli Lily)
2. Vendor qualification (Dr.Joan Ruan, BMS)
3. Building a Quality Mindset with Your Partner to Manufacture Safe Clinical Materials(Dr. HUNG CHIH CHANG. Eli Lily)
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Wednesday, May 18, 2010 |
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| 8:30 – 12:00 (Break 10:00 – 10:30) PARALLEL TRACKS – SESSION 3 8:30 – 12:00 (茶歇 10:00 – 10:30) 平行会议 – 第三场
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Track 1 |
Track 2 |
Track 3A |
Track 3B |
Track 5 |
Track 4 |
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药物临床开发与安全警戒 Clinical Research, Drug Safety & Pharmacovigilance |
药政法规及实践 Regulation, Development & Practices |
数据管理与统计 Data Management and Statistics |
医学事务 Medical Research and Medical Affairs |
临床开发中的质量保证与控制 QA/QC in Clinical Development, Regulatory Requirements/Practices 1.能否将QC有关内容从临床转到这部分 |
生物制药 Biologics
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Session 0301 |
Session 0302 |
Session 0303A |
Session 0303B |
Session 0305 |
Session 0304 |
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| From compliance to beyond compliance – how to manage the safety data throughout product life cycle
Chairperson会议主持 Conny Mo磨晓垚 Catherine Xie 谢珺
Presentation Quiz and awards + Panel discussion
¨ Overview in evolving regulatory requirements from global major HAs ¨ China safety regulation and implementation challenge ¨ Safety signal detection in professional assessment of ICSR ¨ Experience sharing of Signal management and Interpretation strategies in different phases of product life cycle
Presenters:
Panelists: Above speakers + some audiences |
Topic 5
中药研发的规范化与国际化 (1.5 h) CHEN Yixin/WANG Hainan 陈易新/王海南（SFDA） HU Jun胡军（CDE） SUN He孙鹤（天士力） (每位讲者25分钟，Q&A最短15分钟）
Topic 6 美国 aNDA 的要求与实践（2小时） 恒瑞代表 海正代表 (每位讲者25分钟，Q&A最短20分钟）
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Session 3:
Talent need in China (e.g. epidemiology, health economics, clinical sciences)
Chairperson会议主持 Tony ZHANG张彦涛 (Eli-lily)
看张彦涛的follow up，也可考虑将此session换成刘川说的内容（CDISC的内容）
Session 4: How to design and implement a meaningful and interpretable post-marketing studies Tony ZHANG张彦涛 (Eli-lily)
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Session 2:
Maximize Medical and Scientific Affairs contribution to drive evidence based medical communication to clinicians and medical marketing in China and/or emerging markets Speakers: Topics: • What are publication strategy and how to assemble the data • What are China regulations regarding issues PMS, Off-label communication, sharing scientific research paper, plus the practice best • International and Asian experience and practices of MA/SA • Ask expert @ a case Chinese MA/SA or • Roundtable and panel discussion, case study of • Promotional material development and review • What are clinical path (MOH initiative) • SOX/global compliance vs creative Medical marketing
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Chairpersons会议主持 Spring WANG Joanne LIU
Session 1: Focus on Quality Control in both early and late clinical Development Speakers: Topics: o What are the key QC steps to drive good quality study o What are the major findings of QC from agency perspectives o Experiences sharing QA/QC management at study site (LI Haiyan) o Case studies 4 presentations inc. Case studies Interactive panel discussion
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Session 4 – Biologics
Chairpersons会议主持 GUI Min桂敏
Topics:
Proposed speakers: CHANG Weihong (SFDA) industry speaker (桂敏邀请) David LIN (BCG Consulting) Duu-Gong WU (PharmaNet Consulting)
Round Table 圆桌讨论 |
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12:00 – 13:30 Lunch 午餐 |
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| 13:30 – 17:30 (Break 15:00 – 15:30) PARALLEL TRACKS – SESSION 4 13:30 – 17:30 (茶歇15:00 – 15:30) 平行会议–第四场 | ||||||||||
| Session 0401 | Session 0402 | Session 0403A | Session 0403B |
Session 0405 |
Session 0404 |
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Pharmacovigilance 1
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Clinical Data Management and Statistics 2
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1. Experiences and lessons sharing from oncology drug development
Chairperson: 会议主持 George Chen, one oncologist
Case Study ¨ Accelerating oncology portfolio in Asia ¨ Investigator perspectives: opportunities and challenges of running oncology trials in China
TBD (George to provide the list after Chinese New Year)
2. Operational excellence Chairperson: 会议主持 Jessica Liu Cai Yan
¨ Operational Excellence to improve trial conduction efficiency The fundamental elements of clinical safety operational excellence – a good safety system (including database and workflow management, etc.). Effective liaison management of sponsor, CRO and investigator/site
1. Presentation Cai Yan
2. Presentation Sun Yonghui (Novo Nordisk)
3. Debate Debate host: Xu Ning (Covance) Debate team 1-leader: Jessica Liu Debate team 2-leader: Cai Yan |
Topic 7
2010年药品注册白皮书解读 (1.5 h) ZHANG Wei 张伟（SFDA） FENG Yi 冯毅（CDE） Industry代表 (每位讲者25分钟，Q&A最短15分钟）
Topic 8 新药临床研究过程中的变更管理 (包括临床方案变更和药学毒理变更) (1.5 h) FDA代表 PI代表 Industry代表 (每位讲者25分钟，Q&A最短15分钟）
Two backup topics — Topic 9 • eCTD电子申报的进展 Topic 10 • Pharmaceutical IPR and data protection in China |
Session 5:
Ethnicity and Global Drug Development Panel Session
Chairperson: 会议主持 William WANG (Merck)王武保 Bob Powell (Roche)
Other Speakers: Bruce Binkowitz (Merck) James Hung (FDA)
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Session 2 续 |
Session 2: Focus on QA in both early and late clinical development, plan is to especially focus on PK and phase I study QA/QC Speakers: Topics: • Representatives from sponsor, investigator sites, CRO and agency to share: o QA findings o Case studies o QA/QC in PK and phase I study 4 or 5 presentations inc. Case studies Interactive panel discussion
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Session 5 (with FDAAA) U.S. FDA New CMC/GMP Guidance and Hot Topics ICH Q3 Round Table Discussion 圆桌讨论
Chairperson: 会议主持 Charles TONG (BMS)童成
Topics (tentative): ¨ IND Guidance Chuck Hoiberg ¨ Impurities and Polymorph in ANDA Chi-wan CHEN ¨ Process Validation Guidance Mark Tucker (Genetech) ¨ PAI program.
* Chuck Hoiberg, Chi-wan Chen, Mark Tucker (Genetech) (All proposed speakers are former managers in ONDC/ONDQA or former FDA field investigator)
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