The 1St DIA China Annual Meeting Drug Development in a Flat World

Click Here to Register Online! The 1st DIA China Annual Meeting Drug Development in a Flat World:

Innovation, Regulation, and Globalization ,

Pre-conference Workshops: November 1, 2009 Beijing Capital Renaissance Hotel, Beijing, CHINA Conference & Exhibition: November 2-3, 2009 61 Dongsanhuan Middle Road, Chaoyang District

Co-sponsored by China Center for Pharmaceutical International Exchange of the SFDA

There is no doubt that drug discovery, development, and regulation is becoming more and more globalized and China is playing an increasingly important role in this new paradigm. This inaugural DIA China Annual Meeting will serve as an international and neutral forum to examine important issues in global drug development and their relevance to China. Speakers from major regulatory agencies, the industry, and academia will present and lead the discussions. This multidisciplinary meeting will benefit all professionals from regulatory agencies and institutions, the biopharmaceutical industry, investigational sites, contract research organizations, and academia, who must understand how drug development impacts China as the country takes an increasingly pre-eminent place in the global arena.

KEY SESSIONS AND TOPICS

Drug Development and Regulation in the 21st Century Simultaneous Global Development and Multiregional Trials PROGRAM CO-CHAIRPERSONS Evolving Innovation Ecology and Innovation Cluster in China Ling Su, PhD Transformational Bioinformatics Vice President, Clinical Research and Development Good Regulatory Practice Asia Pacific, Wyeth, China Biosimilars Xue Bin Developing High-quality Clinical Study Sites Deputy Director-General, China Center for Ethical Review of Clinical Trials Pharmaceutical International Exchange, State Implementation of Global GCP Standards Food and Drug Administration (SFDA), China Biometrics in China PROGRAM COMMITTEE Lili Cao WHO SHOULD ATTEND Division Director, China Center for Pharmaceutical This program will benefit individuals involved in: International Exchange, SFDA, China Regulatory affairs Mark Engel Clinical research Chairman, Excel PharmaStudies, China Drug R&D strategies Ronald Fitzmartin, PhD, MBA Quality assurance and quality control Vice President, Informatics and Knowledge Drug safety and pharmacovigilance Management, Daiichi Sankyo Pharma Development, USA Strategic sourcing/planning Bioinformatics Kewen Jin, PhD General Manager, Charles River Preclinical Biostatistics Services, China Daniel Liu, PhD Director, China Development, Medidata Solutions Preconference workshops will be presented in Chinese. LLC, China Simultaneous translation will be available on November 2 and 3. Lai-Lee Tan Former General Manager and Head of Clinical Operations, Quintiles Medical Development CONTACT INFORMATION (Shanghai) Co., Ltd., China Conference: For general inquiries and registration, contact Ms. Stephanie Liu at [email protected] Lingshi Tan, PhD Vice President and General Manager, Pfizer Exhibits: Ms. Ting Chen at: [email protected] (China) Research and Development Co., Ltd., China VISIT WWW.DIAHOME.ORG FOR A COMPLETE% SCHEDULE OF DIA EVENTS! Jack Xu, MD Senior Vice President, Shanghai Clinical Research DIA, 800 Enterprise Road, Suite 200, Horsham, PA 19044, USA tel: +1-215-442-6100 fax: +1-215-442-6199 email: [email protected] Center, China BASEL, SWITZERLAND TOKYO, JAPAN MUMBAI, INDIA BEIJING, CHINA Sunday, November 1, 2009 7:15-15:00 Registration AM Tea Break: 10:00-10:20 8:30-17:00 Concurrent Preconference Workshops PM Tea Break: 15:00-15:20

WORKSHOP #1 — R&F Ballroom 1 (Level 3) WORKSHOP #2 — R&F Ballroom 2 (Level 3) Translating the Principles of GCP to Practicalities of Pharmacovigilance Audit, Risk Management, and Effective Site Management: The Study Coordinators, Introduction to MedDRA®-Chinese The Lifeline ABOUT THE WORKSHOP Over the past few years, there has been an increasing public awareness of ABOUT THE WORKSHOP safety issues relating to medicinal products. As a result, both regulatory This workshop provides site staff with a fundamental understanding of agencies and pharmaceutical companies have devoted their attentions to the clinical processes involved in running a study. From the time a study is this important area in order to better safeguard public health. Regulations conceptualized to the time it gets closed, the site staff is faced with many surrounding pharmacovigilance (also known as drug safety) have been challenges and demands of the trial sponsor. This workshop is designed tightened up by the worldwide regulatory agencies, and accordingly, to help site staff understand the principles and processes involved in the inspections and audits have also been evolving along the way, with regards entire chain of a clinical trial – from feasibility to start-up and initiation, to not only the scope but also the methodology of the quality review. from monitoring to finally close-out of a study. Through a combination The workshop gives an introduction of how a global pharmaceutical com- of lectures, case studies, and Q&A, it aims to arm site staff with practical pany conducts internal pharmacovigilance audits, with a specific focus on tips and knowledge of the processes, and the critical role they play Adverse Drug Reaction (ADR) collection, processing, submission to the regu- throughout. latory agencies as well as dissemination to the health care professionals. The workshop also introduces an innovative quality risk management sys- WHO SHOULD ATTEND tem in order to closely monitor various risks emerging from the global This workshop will benefit site personnel involved in clinical management Drug Safety system and mitigate the risks as appropriate. In addition, as of a study at a site. the MedDRA-Chinese will be officially released in September, this workshop • Clinical Study Coordinators includes an introduction to the MedDRA coding rules, analysis guidance • Clinical Trial Investigators from ICH, and the translation rules that were followed by MedDRA-Chinese. • Clinical Research Unit Managers • Quality Control and Quality Assurance WHO SHOULD ATTEND This workshop will particularly benefit professionals who work in pharma- LEARNING OBJECTIVES covigilance and related quality functions, or quality assurance and compli- At the conclusion of the workshop, participants should be able to: ance professionals who desire further development in pharmacovigilance auditing. The attendants must have a basic understanding of pharmaco- • Identify the basic ICH-GCP principles, drug development process, and vigilance and be familiar with its terminology. clinical development parties • Discuss the purpose of and the role the site staff, in particular, the study • Drug Safety Operations coordinator, play in a site selection, initiation, monitoring, and close-out • Drug Safety Compliance visit • Quality Assurance • Gain practical, in-depth knowledge and finer points on managing effec- • Clinical Research Operations tively, processes associated with each visit type – ICF management, LEARNING OBJECTIVES source data, filing, ethics committee submission, and other important At the conclusion of the workshop, participants should be able to: aspects in a clinical trial • Describe basic concepts of how pharmacovigilance works in early devel- • Apply knowledge to practical management of clinical studies at a site opment and postauthorization phase of a medicinal product • Recognize the importance of implementing a sound pharmacovigilance SPEAKERS system within a pharmaceutical company Haiyan Li, MD • Discuss the benefit of introducing a quality risk management approach Vice Director, Peking University Clinical Research Institute in managing a pharmacovigilance system within a pharmaceutical Director, Drug Clinical Trial Center, Peking University Third Hospital, China company Laura Lin, MD • Summarize the basic auditing approach in conducting an internal Clinical Operations Manager, Quintiles Medical Development (Shanghai) pharmacovigilance audit Co., Ltd., China • Identify common pharmacovigilance audit findings and potential mitigating actions SPEAKERS Wenhong Li, MD, MSc Senior International Clinical Auditor, Roche Products Pty Ltd., Australia Anna Zhao-Wong, MD, PhD Deputy Director, MedDRA MSSO, USA Vera Liang Associate Director, Drug Safety Surveillance, Pfizer (China) Research and Development Co., Ltd., China

14:00-17:00 Forum for Young Professionals: Emerging Career Opportunities in the Emerging Market* Capital Ballroom 5 (Level 3) PM Tea Break: 15:00-15:20

*This career forum will be conducted in English and Chinese. SPEAKER This forum will provide the target audience of young professionals with Lai-Lee Tan the opportunity to hear from a panel of senior executives and managers Former General Manager and Head of Clinical Operations, Quintiles from the industry on how the evolving landscape in biopharmaceutical Medical Development (Shanghai) Co., Ltd., China research and development in China, an important emerging market, may PANELISTS: bring an impact to the career development for young professionals. The James Cai, MD workshop will also provide a forum for discussion on how one may Vice President, Clinical Development, aTyr Pharma, China become better prepared to respond to the changing dynamics and to Min Irwin, MD, PhD grasp the opportunity for career advancement. Medical Director, Bayer Schering Pharma, China

2 Frank Jiang, MD, PhD Prof. Yao Chen Vice President, Global R&D; Head, China R&D Vice Director, Peking University Clinical Research Institute sanofi-aventis, China Head, Department of Biostatistics Ning Xu, MD, MBA Peking University First Hospital, China Senior Director, Head of Clinical Development Services Carol Zhu, BSc, MBA Covance Pharmaceutical Research and Development (Beijing) Co., Ltd., China Director, Organization Development and Communication, GlaxoSmithKline China R&D, China

Monday, November 2, 2009 PLENARY SESSIONS — Capital Ballroom 1, 2, 3

7:00-15:00 CONFERENCE REGISTRATION DRUG REGULATIONS AND SUPERVISION IN CHINA Zhang Wei 8:00-19:00 EXHIBITION OPEN Director-General, Department of Drug Registration, State Food 3rd Floor, Renaissance Beijing Capital Hotel and Drug Administration (SFDA), China

8:30-9:40 WELCOME IMPLEMENTATION OF ICH GUIDELINES IN NON-ICH COUNTRIES: Jeffrey Sherman, MD, FACP THE WAY FORWARD President, Drug Information Association Kohei Wada Executive Vice President and Chief Medical Officer, Vice President/General Manager, Asia Development Department, Horizon Therapeutics, Inc., USA R&D Division, Daiichi Sankyo Co., Ltd., Japan William J. Brassington, MBA Acting Executive Director Drug Information Association 12:15-13:30 BUFFET LUNCH — CAPITAL BALLROOM 5, R&F BALLROOM 1, 2 (LEVEL 3) REMARKS FROM THE CHAIRPERSONS Ling Su, PhD Vice President, Clinical Research and Development 13:30-15:00 PLENARY SESSION 2 Asia Pacific, Wyeth, China Xue Bin SIMULTANEOUS GLOBAL DEVELOPMENT AND MULTIREGIONAL Deputy Director-General, China Center for TRIALS Pharmaceutical International Exchange, SFDA, China CO-CHAIRPERSONS OPENING ADDRESS Ling Su, PhD Shao Mingli Vice President, Clinical Research and Development Asia Pacific, Commissioner, State Food and Drug Administration, Wyeth, China China Ning Li, MD, PhD Senior Group Regulatory and Medical Policy Director KEYNOTE ADDRESS sanofi-aventis China THE PHARMACEUTICAL INDUSTRY AND INNOVATIVE DRUG R&D IN CHINA UNDER THE ENVIRONMENT OF VALUE AND CHALLENGES IN MULTIREGIONAL TRIALS FINANCIAL CRISIS H. M. James Hung, PhD Prof. Sang Guowei, MD Director, Division of Biometrics I, Office of Biostatistics, Office of Vice Chairman, Standing Committee of the National Translational Sciences, Center for Drug Evaluation and Research People’s Congress of PRC; Member, Chinese Academy (CDER), FDA, USA of Engineering, China MULTIREGIONAL TRIALS: OPERATIONAL ISSUES 9:40-10:00 BREAK Edmund S. Tsuei, PhD, MSc Regional Head, Pharma Development Operations, Asia-Pacific- 10:00-12:15 PLENARY SESSION 1 Africa, Roche Products Pty Ltd., Australia

DRUG DEVELOPMENT AND REGULATION IN THE 21ST CENTURY REGULATORY CONSIDERATION AND INITIATIVES TO FACILITATE CHAIRPERSON INNOVATIVE DRUG DEVELOPMENT Xue Bin Feng Yi Deputy Director-General, China Center for Pharmaceutical Director, Division of Review Management, Center for Drug International Exchange, SFDA, China Evaluation, State Food and Drug Administration (SFDA), China

GLOBALIZATION – DRUG DEVELOPMENT IN A GLOBAL SUPERMARKET Murray M. Lumpkin, MD, MSc 15:00-15:30 BREAK Deputy Commissioner for International Programs, Food and Drug Administration (FDA), USA 15:30-17:45 PLENARY SESSION 2 continued INNOVATION AND DRUG DEVELOPMENT SIMULTANEOUS GLOBAL DEVELOPMENT AND MULTIREGIONAL Thomas Lönngren, Pharm, MSc Executive Director, European Medicines Agency, European Union TRIALS

PMDA STRATEGY OF INTERNATIONAL REGULATORY COOPERATION PMDA INITIATIVES FOR CONDUCTING APPROPRIATE MULTI- TO PROVIDE USEFUL DRUGS TO THE PUBLIC REGIONAL TRIALS IN CONSIDERATION OF ETHNIC FACTORS Satoshi Toyoshima, PhD Yoshiaki Uyama, PhD Executive Director and Director, Center for Product Evaluation, Review Director, Office of New Drug III, PMDA, Japan Pharmaceuticals and Medical Devices Agency (PMDA), Japan

3 OVERVIEW OF CLINICAL TRIALS IN KOREA AND REGULATORY PANELISTS CHANGES FOR GLOBAL COMPETITIVENESS Kohei Wada Chang-Won Park, PhD Vice President/General Manager, Asia Development Department, Senior Scientific Officer (Deputy Director), Oncology and R&D Division, Daiichi Sankyo Co., Ltd., Japan Antibiotic Products Division, Drug Evaluation Department, Robert W. Makuch, PhD Korean Food and Drug Administration (KFDA), Republic of Professor of Biostatistics and Director, Regulatory Affairs Korea Program, Yale University School of Medicine, USA

SIMULTANEOUS GLOBAL DEVELOPMENT: FROM A PERSPECTIVE OF PROMOTION AND PROTECTION OF PUBLIC HEALTH 18:00-20:00 ANNUAL MEETING NETWORKING RECEPTION Chih-Hwa Wallace Lin, PhD Foyers (Level 3) Director, Division of Resource Development, Center for Drug Evaluation, Taiwan Tuesday, November 3, 2009

7:00-12:00 CONFERENCE REGISTRATION

8:00-16:30 EXHIBITION OPEN 3rd Floor, Renaissance Beijing Capital Hotel 8:30-11:30 PARALLEL TRACKS – SESSION 1 (Break 10:00-10:30) Track 1 – Capital Ballroom 5, Track 2 – Capital Ballroom 1, 2 Track 3 – R&F Ballroom 1, 2 (All on Level 3)

SESSION 1 – TRACK 1: INNOVATION SESSION 1 – TRACK 2: REGULATION SESSION 1 – TRACK 3: GLOBALIZATION

EMERGING INNOVATION CLUSTER PROCESS AND PRACTICE TO ENHANCE DEVELOPING HIGH STANDARD CLINICAL IN CHINA: DIFFERENT STRATEGIES REGULATORY OUTCOMES STUDY SITES AND CAPABILITIES AND MODELS Session Chair Session Chair Session Chair Alberto Grignolo, PhD Spring Wang, MD Li Chen, PhD Corporate Vice President, Global Strategy Director of Clinical Research & Development Chief Scientific Officer, Roche R&D and Services, PAREXEL Consulting, USA Xian-Janssen Pharmaceutical Ltd., China Center China, China

Speakers Speakers Speakers

TREND OF GLOBAL PHARMACEUTICAL R&D HARMONIZATION SETS THE STAGE FOR GOOD EXPERIENCE WITH FDA INSPECTIONS WORLDWIDE AND INNOVATION REVIEW PRACTICES David A. Lepay, MD, PhD Christopher P. Milne, DVM, JD, MPH Justina A. Molzon, JD, MPharm, CAPT. USPHS Senior Advisor for Clinical Science, Science and Associate Director, Tufts Center for the Study of Associate Director for International Programs, Health Coordination, Office of the Commissioner, Drug Development, Tufts University, USA Center for Drug Evaluation and Research (CDER), FDA, USA FDA, USA

NEW MEDICAL ENTITY DEVELOPMENT COST UPDATE ON SFDA’S CERTIFICATION PROGRAM AND R&D EFFICIENCIES DEVELOPMENT OF GOOD REGULATORY PRACTICE OF CLINICAL TRIALS SITES Tony Zhang, PhD IN CHINA Prof. Cao Cai Managing Director and Site Head, Chen Zhen, PhD Certification Center of Drugs, SFDA, China Eli Lilly Global R&D, China Deputy Director, Review Division V, Center for Drug Evaluation, SFDA, China INVESTIGATOR’S PERSPECTIVE CAN MULTINATIONAL COMPANIES FACILITATE Haiyan Li, MD GOOD REVIEW PRACTICE: INDUSTRY THE TRANSITION FROM “MADE IN CHINA” TO Vice Director, Peking University Clinical Research PERSPECTIVES “INNOVATED IN CHINA”? Institute; Director, Drug Clinical Trial Center, Ling Chen, PhD Zili Li, MD, MPH Peking University Third Hospital, China Vice President, Pharmaceutical R&D Operations, Medical Director, Merck Sharp & Dohme (China) GlaxoSmithKline China R&D, China Ltd., China RAISING SITE STANDARDS:EXPERIENCE FROM A Panelists EUROPEAN PERSPECTIVE AN EFFICIENT MODEL TO LEVERAGE THE BEST Yoshiaki Uyama, PhD Tony Owen OF EAST AND WEST IN BIOTECH Review Director, Office of New Drug III, PMDA, Vice President, Quality Assurance, Europe and James Cai, MD Japan Asia Pacific, Quintiles, UK Vice President, Clinical Development Liu Lu aTyr Pharma, China Panelist Center for Drug Evaluation, SFDA, China Paul Dai, MD Panelist Head, International Clinical Research Frank Jiang, MD, PhD Organization, Beijing Novartis Pharma Ltd., Vice President, Global R&D; Head, China R&D, China sanofi-aventis, China

11:30-12:30 BUFFET LUNCH – Capital Ballroom 3, R&F Ballroom 3, 5 (Level 3)

4 Tuesday, November 3, 2009 continued

12:30-15:00 PARALLEL TRACKS – SESSION 2

SESSION 2 – TRACK 1: INNOVATION SESSION 2 – TRACK 2: REGULATION SESSION 2 – TRACK 3: GLOBALIZATION

THE EVOLVING ECOLOGY OF REGULATION OF BIOSIMILARS INTEGRATION OF UPDATED GCP INNOVATION IN CHINA Session Chair IMPLEMENTATION IN CLINICAL TRIALS Session Chair Ning Xu, MD, MBA FOR GLOBAL REGULATORY CHORUS Kewen Jin, PhD Senior Director, Head of Clinical Development Session Chair General Manager, Charles River Preclinical Services, Covance Pharmaceutical Research Daniel Liu, PhD Services, China and Development (Beijing) Co., Ltd., China Director, China Development Medidata Solutions LLC, China

Speakers Speakers Speakers

EVOLVING MODELS FOR DISCOVERY RESEARCH OVERVIEW OF REQUIREMENTS FOR THE COMPUTERIZED SYSTEM IN CLINICAL RESEARCH: John Oyler DEVELOPMENT AND REGULATION OF CURRENT QUALITY AND DATA INTEGRITY President and Chief Executive Officer BIOSIMILARS CONCEPTS Bioduro, China Cecil Nick, BSc (Hons.), FTOPRA Earl W. Hulihan, MEd Vice President (Technical), PAREXEL Consulting, Chairperson of Peach Program; Corporate UK Compliance Officer, Senior Vice President, ENHANCED PARTNERSHIP MODELS BETWEEN Regulatory Compliance, Medidata Solutions CROS AND THEIR CLIENTS Worldwide, USA Nancy Gillett, DVM, PhD, DACVP BIOSIMILARS EXPERIENCE: INDUSTRY LESSONS Corporate Executive Vice President and LEARNED President, Global Preclinical Services Ingrid Schwarzenberger COMPLIANCE OF GLOBAL GCP STANDARDS IN Charles River Laboratories, USA Head, Regulatory Affairs, Biopharmaceuticals, CLINICAL TRIAL IMPLEMENTATION IN CHINA Sandoz GmbH, Austria Li Jinju Director, Division of Drug Research Supervision, THE ROLE OF CLINICAL CRO IN PROMOTING Department of Drug Registration, SFDA, China PHARMACEUTICAL AND BIOTECH INNOVATION BIOSIMILARS – LINKING QUALITY, NONCLINICAL Dan Zhang, MD, MPH AND CLINICAL CHARACTERISTICS Chairman and CEO Inger Mollerup, MSc EMBRACING GLOBAL STANDARDS: STARTING WITH Fountain Medical Development Ltd., China Vice President, Regulatory Affairs Future Insulin, THE END IN MIND NovoNordisk, Denmark Paul S. Chung Executive Vice President of Global Services, Image SECURING YOUR MARKET POSITION IN CHINA Solutions, Inc., China WITH A PROACTIVE PATENT STRATEGY Tony Chen Partner, Jones Day, China

INVESTMENT IN BIOMEDICAL INNOVATION Nisa Leung Partner, Qiming Ventures, China

15:00-15:30 BREAK

Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organization they represent, or that of the Drug Information Association. Speakers and agenda are subject to change without notice. Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.

5 Tuesday, November 3, 2009 continued

15:30-18:00 PARALLEL TRACKS – SESSION 3

SESSION 3 – TRACK 1: INNOVATION SESSION 3 – TRACK 2: REGULATION SESSION 3 – TRACK 3: GLOBALIZATION

THE OPPORTUNITIES AND CHALLENGES ETHICS PRINCIPLES AND ETHICAL BIOMETRICS IN CHINA: WHY THE OF TRANSFORMATIONAL TECHNOLOGIES REVIEW OF CLINICAL TRIALS WORLD IS TURNING TO CHINA? IN THE NEW GLOBAL PHARMA MODEL Session Chair Session Chair Session Chair Jack Xu, MD Mark Engel Ronald Fitzmartin, PhD, MBA Senior Vice President, Shanghai Clinical Chairman, Excel PharmaStudies, China Vice President, Informatics and Knowledge Research Center, China Management, Daiichi Sankyo Pharma Development, USA

Speakers Speakers Speakers

INFORMATICS STRATEGY TO SUPPORT ETHICS AND GOVERNANCE OF BIOMEDICAL THE NEEDS OF THE GLOBAL PHARMA REGULATORY MODERNIZATION IN A GLOBAL RESEARCH INVOLVING HUMAN SUBJECTS: Mark Engel ENVIRONMENT INTERNATIONAL GUIDELINES AND NATIVE Chairman, Excel PharmaStudies, China Theresa Mullin, PhD CULTURES Associate Director, Office of Planning and Prof. Qiu Renzong Informatics, Center for Drug Evaluation and Program in Bioethics, Institute of Philosophy, STATISTICAL PROGRAMMING – IS CHINA READY? Research (CDER), FDA, USA Chinese Academy of Social Sciences, China Xun Chen, PhD Biostatistics and Programming Site Head, China R&D Center, sanofi-aventis, China POTENTIAL OF LINKED SEMANTIC DATA IN CHALLENGES IN ETHICAL REVIEW OF CLINICAL DRUG DISCOVERY, DEVELOPMENT, AND DRUG TRIALS IN CHINA STATISTICS – LESSONS LEARNED IN DEVELOPING APPROVAL Zhai Xiaomei, PhD AN IN-HOUSE TEAM Eric Neumann, PhD Professor and Executive Director, Center for Roger Qu, PhD Director, Clinical Semantics, MIT Fellow, Bioethics, Chinese Academy of Medical Head of Statistics Department, Pfizer (China) Science Commons, USA Sciences/Peking Union Medical College; Research and Development Co., Ltd., China Director, Department of Social Sciences and the Humanities, Peking Union Medical College, China DATA MINING FOR TRANSFORMATIONAL PROMOTING BIOMETRICS PROFESSION BIOINFORMATICS: APPLICATIONS, CHALLENGES, IN CHINA AND OPPORTUNITIES BUILDING QUALITY INTO ETHICAL REVIEW William Wang, PhD Eric Brinsfield, MS Haitao (Heidi) Liu, MD, MIPH Site Head, Asia-Pacific Hub, Department of Director, Health and Life Sciences R&D, Shanghai Huashan Hospital, Fudan University, Biostatistics and Research Decision Sciences, SAS Institute, USA China Merck Research Laboratories, China

Panelist MORE WITH LESS IN DRUG DEVELOPMENT: THE 2008 REVISED DECLARATION OF HELSINKI CAN MODEL-BASED APPROACH HELP? AND ITS IMPACT: THE NEW CHALLENGES Prof. Yao Chen Shuying Yang, PhD Francis P. Crawley, MA, FFPM Vice Director, Peking University Clinical Research Principal Clinical Pharmacokineticist, Clinical Good Clinical Practice Alliance – Europe (GCPA) Institute; Head, Department of Biostatistics, Pharmacology/Modelling & Simulation, & Strategic Initiative for Developing Capacity in Peking University First Hospital, China GlaxoSmithKline, UK Ethical Review (SIDCER), Belgium

Panelist Haiyan Li, MD Vice Director, Peking University Clinical Research Institute; Director, Drug Clinical Trial Center, Peking University Third Hospital, China

18:00 END OF CONFERENCE

6 1st DIA China Annual Meeting

Block code : DIA

Oct 31 – Nov 03, 2009 Beijing, China

酒店住宿预订单

北京富力万丽酒店为本次会议提供并且预留住宿房间，参会人员可以将此住宿预订单直接发送至酒店，传真或者邮件均可，请参照下表酒店详细信息。

客人姓名客人姓名客人姓名姓姓姓名名名 (请选择性别) 先生( ) 女士 ( ) 公司名称公司名称公司名称:

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国籍国籍国籍: 护照号码护照号码护照号码: 出生日期出生日期出生日期:

电话号码: 传真号码:

到达日起航班 ETA 离开日起航班 ETD

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豪华间人民币 750 元净（0请于 1 月 16 日前预定） 1双人双床间 1大床间

行政豪华间人民币 900 元净（0请于 1 月 16 日前预定） 1双人双床间 1大床间

行政标准套间人民币 1250.00 元净（0请于 1 月 16 日前预定） 1双人双床间 1大床间

吸烟房型 (不确定) 吸烟 1 无烟 1

备注备注备注：备注：：： • 上述价格均包含 15%服务费 • 上述价格均包含 1 份或者 2 份自助早餐。如需额外早餐则需加收每份人民币 101,00 元净。 • 房间内高速上网费用为人民币 60.00 元净/小时，人民币 120.00 元净/天 • 上述房价只适用于本次活动内的时间

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The 1st DIA China Annual Meeting Drug Development in a Flat World: Innovation, Regulation and Globalization www.diachina.org Click here to Register Online Now! Meeting I.D. #09976 November 1-3, 2009 Renaissance Beijing Capital Hotel, Beijing, China

TRAVEL AND HOTEL MEETING CONTACT INFORMATION A group rate has been made available to registrants at the Renaissance Ms. Stephanie Liu, Drug Information Association, China Office: Beijing Capital Hotel: (Standard Room: RMB750/night incl. breakfast). 11F/1177, Block A, Gateway Plaza, No.18, XiaGuangLi, North Road When making your reservation please indicate that you are participating East 3rd Ring, Chaoyang District, Beijing 100027, P. R. China in the DIA China Event. Please note that registrants are kindly requested Tel: +86-10-59231109 Fax: +86-10-59231090 to make their own transportation and accommodation arrangements; www.diahome.org [email protected] DIA is not responsible for transportation, accommodation or other costs incurred by registrants. CANCELLATION POLICY: On or before October 16, 2009 Please download the Renaissance Beijing Capital Hotel Reservation Cancellations must be in writing and be received by October 16, 2009. Registrants who do Form from DIA Website (Click here for hotel registration form) not cancel by that date and do not attend will be responsible for the full registration fee Ms. Jasmin Yin Tel: +86 10 58638650 / Fax: +86 10 58638660 paid. Registrants are responsible for canceling their own hotel and airline reservations. 61 Dongsanhuan Middle Road, Chaoyang District, Beijing, 100022, If the event is cancelled, the organizers are not responsible for any airfare, hotel or other People’s Republic of China costs incurred by registrants. Email: [email protected] Upon cancellation, the administrative fee that will be withheld from refund amount is: Web: www.renaissancehotels.com Member/Nonmember = RMB500 DIA reserves the right to alter the venue, if necessary. If an event is cancelled, Government/Academia/Nonprofit Member/Nonmember = RMB250 DIA is not responsible for any airfare, hotel or other costs incurred by registrants. For Visa information and invitation letters, please contact the DIA China Ofﬁce.

Payment in other currencies will be subject to the financial institution’s exchange rate. Pre-Conference Registration Deadline: on or before October 16, 2009 * Registration Fees After October 16, 2009 Only On-site Registration Will Be Accepted. Please Indicate Payment Method Registration Fee includes refreshment breaks, luncheons, networking reception Bank Transfer and will be accepted by mail, fax or eMail. Payment in the amount of RMB ______Meeting I.D. #09976 NONMEMBER MEMBER Bank Account: 803020296408091001 Conference Only (November 2-3, 2009) RMB 4080 RMB 3200 Bank Name: Bank of China Beijing Jianguomenwai Sub-branch Join DIA now to qualify for the member discount (click here)! MEMBERSHIP RMB 880 Payee: KELLEN MANAGEMENT AND CONSULTING (BEIJING) LTD. To qualify for the member discount, please submit both the Registration Form and Membership Application accompanied Credit card payments by: by proof of payment. Card Issue Bank ______Exp. Date (mm/yyyy) ______

Discount Fees MEMBER NONMEMBER Card #______Signature ______

Government (Full-time) RMB 1400 RMB 2280 AMEX Visa Master JCB Charitable Nonprofit/Academia (Full-time) RMB 2600 RMB 3480 Non-China credit card payment will be subject to the currency conversion rate at the time of charge. Workshop* (November 1, 2009 No member/non-member rate.) Corporate Checks in RMB (Beijing Only) Note: Space for Workshops is limited Payable to: KELLEN MANAGEMENT AND CONSULTING (BEIJING) CO., LTD. REQUEST CHINESE OFFICIAL INVOICE (FA PIAO) Workshop 1 Workshop 2 Workshop 3 Please eMail your information to the attention of RMB 1750 RMB 1750 RMB 300 (Standard Price) Ms. Stephanie Liu to [email protected] or fax to +86-10 59231090 RMB 0 (In combination with Conference) After receipt of payment, the invoice will be mailed to you.

*Workshop 1 (Full Day) Translating the Principles of GCP to Practicalities of Effective Site Management: The Study Coordinators, The Lifeline

*Workshop 2 (Full Day) Pharmacovigilance Audit, Risk Management, and Introduction to MedDRA-Chinese

*Workshop 3 (Half Day) Forum for Young Professionals: Emerging Career Opportunities in the Emerging Market

Please check the applicable category: Academia Government Industry CRO

PLEASE PRINT ALL INFORMATION CLEARLY

Last Name First Name M.I. Full Name in Chinese (If Applicable) Please check one: Mr. Ms.

Job Title Affiliation (Company) Business Address Home Address

Address (Please write your address in the format required for delivery to your country.) City Postal Country

Address in Chinese (If Applicable)

Telephone Number Fax Number Mobile Number

eMail (Required for confirmation) IF FAXING OR MAILING THIS FORM, PLEASE PROVIDE A COPY OF REGISTRANT’S BUSINESS CARD. Kellen Management And Consulting (Beijing) Co., Ltd. represents DIA in China and provides services. DIA 第一届中国年会在线注册，请点击此处：从“平坦世界”的视角看药物研发：创新、法规和全球化 www.diachina.org 会议编码 #09976 2009年11月1-3日中国•北京富力万丽酒店

旅行与酒店会议咨询：会前培训及年会期间有住房需求的代表可在北京富力万丽酒店预订房间。刘丹女士，DIA中国地区联络处从www.diachina.org网站上下载酒店住宿预订表(点击此处可立即下载)。享受团体优惠价：RMB750元/晚/间，双标间，含早餐。本住宿价格是酒店北京市朝阳区东三环北路霞光里18号佳程广场A座11层1177室为会议提供的优惠价格，组委会不负责为代表办理酒店预订手续及费用。电话：+86 10 5923 1109；传真：+86 10 5923 1090 请自行办理。如需预定酒店房间，请尽早联系。 www.diahome.org [email protected] 酒店联系方式：北京富力万丽酒店取消注册：须在2009年10月16日前（含10月16日）电话： +86 10 5863 8650/传真：+86 10 5863 8660 取消注册必须进行书面确认，并且确保DIA中国联络处于2009年10 地址：北京市朝阳区东三环中路61号邮编：100022 月16日之前收到该确认。参会注册者如果逾期未能取消或未能参加电子邮件：[email protected] 培训，则注册费不能退还，并应自行取消住宿预定及差旅订票等。网址： www.renaissancehotels.com 如需取消注册，则将扣除手续费如下： ▲ 必要时，DIA保留更改培训地点的权利。如果本次培训项目取消，DIA不负责参会注会员/非会员：RMB500 册者的往来旅费、住宿费用及其它任何费用。政府机构/学术机构/非营利组织会员/非会员：RMB250 ▲ 签证（非代办）与邀请函事宜，可联系DIA China

会议注册费预注册及在线注册截止至2009年10月16日，之后只接受现场报名。汇率以中国人民银行当日外汇牌价为准含茶歇、午餐和会议资料请注明您的付款方式。 □ 银行汇款非会员价会员价请即付金额为人民币RMB ______会议编码 #09976 年会注册费(11月2-3日） RMB 4080 □ RMB 3200 □ 银行账号: 803020296408091001 开户行: 中国银行北京建国门外支行现在就加入DIA只需880元，即享有会员优惠会员费收款人: 科伦管理咨询（北京）有限公司立即加入DIA吧！ RMB 880 □

□ 信用卡支付同时提交会议注册表及会员申请表并付款，即可享受会员优惠。发卡行______信用卡到期日(月/年)______其他优惠会员价非会员价卡号______持卡人签名______政府机构(全职人员) RMB 1400 □ RMB 2280 □ □ 美国运通卡 □ 维萨卡 □ 万事达卡 □ JCB 非营利组织/学术机构(全职人员) RMB 2600 □ RMB 3480 □ * 境外信用卡将发生汇率折算费用。会前研习班注册费(11月1日） □ 公司支票（仅限北京地区）研习班注册费无任何优惠，额满为止。支票抬头：科伦管理咨询（北京）有限公司

研习班一研习班二研习班三 □ 索取发票 RMB 1750 □ RMB 1750 □ RMB 300 □（标准价）请发送电子邮件至[email protected]或发送传真至+86 10 5923 1090 收件人：刘丹女士 RMB 0 □（与年会一起报名）在收到您的全部款项后，我们会将发票邮寄给您。 ▲ 研习班1 8:30-17:00 ▲ 研习班3 14:00-17:00 临床研究的管理和GCP的实际应用- 青年论坛：新兴市场中的新兴职业机会临床研究协调员的关键作用 ▲ 研习班2 8:30-17:00 药物警戒的稽查、风险管理 +MedDRA中文版简介

请核对适用类型 □ 学术机构 □ 政府机构 □ 制药企业 □ CRO 请填写下表并保持字迹清晰

姓 ______名 ______职位 ______性别 □ 男 □ 女

单位（公司）名称 ______

中文地址（请注明地址以便今后能正确邮寄）______

英文地址 ______□ 公司地址 □ 家庭地址

省份及城市 ______国家 ______邮编 ______

电话 ______传真 ______手机 ______

电子邮件（以便通过电子邮件发送确认）______

如果您传真或邮寄报名表，请提供您的名片或者名片复印件。科伦管理咨询（北京）有限公司在中国境内代表DIA，并在中国境内为DIA会员提供服务。 1st DIA China Annual Meeting

Block code : DIA

Oct 31 – Nov 03, 2009 Beijing, China

HOTEL RESERVATION FORM

Accommodation at special rates has been reserved at the Renaissance Beijing Capital Hotel for the above event. Delegates should send reservation directly to the Hotel. Please fax or mail this booking form to the fax number stated below to secure your rooms.

Guest’s Name details: First Name Surname/ Family name (Please indicate gender) Mr. ( ) Ms. ( ) Company name:

Designation/Position/Title:

Street Address OR P.O.Box Number:

City/ State:

Nationality: Passport number: Date of birth:

Telephone number: Fax number:

Arrival Date Flight number ETA Departure Date Flight number ETD

Please indicate by marking ( X ) Room Type Room Rates Please select your preferred category # of rooms

Deluxe Room RMB 750.00 nett （book before October 16） 1Double Double Room 1King Room

Executive Club Room RMB 900.00 nett （book before October 16） 1Double Double Room 1King Room

Club Studio RMB1250.00 nett （book before October 16） 1Double Double Room 1King Room

Smoking (Non guaranteed) Yes 1 No 1

TERMS & CONDITIONS • The above room rates are including 15% surcharge fee • The above room rates are including 1 or 2 buffet breakfasts. Additional Buffet breakfast is RMB101.00 nett per person. • High speed internet access is RMB 60.00 nett / hour, RMB 120.00 nett / day. • The above rates are only applicable for the duration of the event.

AIRPORT TRANSFERS Arrival transfer @ RMB 588.00 nett per car Yes ( ) No ( ) Departure transfer @ RMB 588.00 nett per car Yes ( ) No ( )

Credit Card Type: 111Visa 111Master 111Amex 111JCB 111Diners

Credit card number Expiry date

3 digit security pin (on the reverse of the card) Or 4 digit for AMEX (on the front of the card) Cardholder’s name Signature

TERMS AND CONDITIONS No bookings will be accepted without credit card details or one-night deposit. In the event of no-show or cancellation within 7 days from arrival for a guaranteed booking, one night’s deposit will be forfeited. Check-in time is after 1400 hours and check out is before 1200 hours. Half-day room charge will apply for late check out till 1800 hours. Rooms occupied beyond 1800 hours will be charged a full-day rate.

Please return the completed forms to the address as stated below. Confirmations of reservation are subject to availability.

Reservation Center Renaissance Beijing Capital Hotel Telephone No (86 10) 5863 8888 61 Dongsanhuan Middle Road Facsimile No (86 10) 5863 6569 Chaoyang District, Beijing, 100022 E-mail [email protected]

Hotel Sales Contact Jasmin Yin Telephone No. (86 10) 58638650 Mobile No. (86) 13911038665 E-mail [email protected] ______FOR HOTEL USE ONLY Reservation status Confirmed Yes No Confirmation number Waitlisted Yes No Remarks Handled by Date