The 3^rd 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

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

No.12 Qisheng Middle Street, North-East 3^rd 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

Program Co-Chairpersons联席主席 

 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

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

Program Committee
3^rd DIA China Annual Meeting

会议组委会

戴欣 医学博士

北京诺华制药有限公司临床开发总监

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

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

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

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

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

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

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

刘川

Senior Director of Clinical Operations

Head of Asia-Pacific,

Global Clinical Operations,

INC Research

刘佳 医学博士

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

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

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

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

Pfizer Pharmaceutical Ltd., China

孙丽梅 博士
辉瑞制药（中国）有限公司医学部总监

谭朝瑜

Chief Scientific Officer,

Simcere Pharmaceutical Group, China

王鹏 博士

先声药业首席科学官

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

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

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

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

Global Regulatory Strategist, Global R&D Center, Bayer Healthcare Co. Ltd.
闫小军

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

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

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

甄岭

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

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

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

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

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

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

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

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

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

张蓓蓓

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

Monday, May 17, 2010

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

Track 1

Track 2

Track 3A

Track 3B

Track 3C

Track 4

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

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

数据管理与统计

Data Management and Statistics

1. 1.    请确认演讲者
2. 2.    在十八日下午Bill Wang可否增加一内容：Drug Development Globalization vs. Regionalization

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

Session 0101

Session 0102

Session 0103A

Session 0103B

Session 0103C

Session 0104

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

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)

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)

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

12:00 – 13:30 Lunch 午餐

Track 1

Track 2

Track 3A

Track 3B

Track 3C

Track 4

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

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)

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）
 Guidelines for New Drug research & development are one of the important tools to guide China new drug development. In the last few years, SFDA already issued more than 70? technical guidelines and more than –guidelines are requesting comments or under drafting. In this section, SFDA will provide an overview on the systemically technical guideline development planning and will illustrate, describe and discuss these new guidelines from SFDA’s point of view

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）

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

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)

Wednesday, May 18, 2010

Track 1

Track 2

Track 3A

Track 3B

Track 5

Track 4

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

Session 0301

Session 0302

Session 0303A

Session 0303B

Session 0305

Session 0304

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:

1. 1.   EMEA Officer of Drug Safety
2. 2.   Xu Jiaqi, SFDA (Conny to confirm)
3. 3.   Sonja Brajovic, FDA, Medical Officer (Confirmed)
4. 4.   Craig Harford, VP, Safety Surveillance & RM (Pfizer)

Panelists:

Above speakers + some audiences

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）
FDA代表

恒瑞代表

海正代表
With the rapidly growing pharmaceutical market in China, more and more domestic pharmaceutical companies are seeking the opportunities to enter into global market. aNDA is  one of fast and cost-effective way to launch products into global market. In this section, US FDA will give an introduction on how to apply for aNDA in US. This section will also include the speakers from domestic companies to expose real cases and share their experiences about their aNDA application in US.

The analysis of the 2010 China Drug Registration Whitepaper (or the Annual Report)
In 2009, China SFDA issued its first drug registration whitepaper (annual report) in SFDA website and got very positive feedback from public. In this section, SFDA or sb else will present comprehensive information about drug registration status in 2010, analyze the drug development trends, and further goals etc.

   (每位讲者25分钟，Q&A最短20分钟）

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)

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

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

Session 4 – Biologics

Chairpersons会议主持

GUI Min桂敏

Topics:

• ICH Q5E biological process change
• Biotech Comparability
• Biosimilar

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

12:00 – 13:30 Lunch 午餐

Session 0405

Session 0404

    Pharmacovigilance 1

Clinical Data Management and Statistics 2

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

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

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)

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

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)