3AM Program Final · Executive Vice General Manager, Shenzhen Kangtai Biological Products Co. , China Workshop Agenda ETHICAL MEDICAL WRITING PRACTICES – EVERY DOCUMENT, ... «Have

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As a global neutral platform, DIA invites you to attend the 3rd DIA China

Annual Meeting, which will explore the latest developments within the China

pharmaceutical industry, explore ideas that will impact global health, and

feature open debate by senior professionals, top academics and high-level

obcials from pharma, R&D, and regulatory acairs.

As China unveils its 12th Five-Year Plan, the Chinese biopharmaceuti-

cal industry once again draws global attention as one of the investment

heavyweights. Billions of special funds are pouring in. Yet, new policies and

industry reorganization have placed China’s pharma industry at a critical

stage. Future elevation and sustainable development of the industry require

revisiting quality and standards.

China’s new medical reform has both rationalized the health care sys-

tem and spiked enthusiasm to engage in new drug research. With quality

throughout the whole manufacturing process, and world-class normative

clinical research, the future of China’s drug innovation is golden.

KEY SESSIONS And TOPICS

CMC/cGMP, Drug Standards and Quality

Clinical Research and Drug Safety

Regulations and Implementation

Data Management and Statistics

Medical and Scientific Acairs

Clinical Development and Capacity Building

QA/QC in Clinical Development

Translational Medicine

Simultaneous translation will be available on May 16-18.

WHO SHOULD ATTEND

This program will benefit those who work in relevant areas of drug devel-

opment and medical marketing and who are practicing physicians treating

patients and conducting clinical trials in health care institutions, including,

but not limited to:

Clinical trial investigators

Clinical research and development

Clinical research operations

Drug safety and pharmacovigilance

Regulatory acairs

Biostatistics and data management

Medical writing

Medical practicing

Conference A

genda

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8:30 – 17:30 WORKSHOP 1

Meeting Room 1+2 (2nd Floor)

PRE-CONFERENCE WORKSHOPS | SUNDAY, MAY 15

HOW TO PREPARE FOR SUCCESSFUL COMPLIANCE AUDIT AND INSPECTIONS

ABOUT THE WORKSHOP

This is a brief training workshop on how to prepare and implement a regulatory inspection per GCP perspectives. The experienced global inspection experts and FDA authority will give trainees the funda-mental knowledge and understanding of regulatory inspection prac-tices and expectations in a global GCP environment. The trainees will also learn how to plan and conduct a regulatory process and how to explain an FDA regulatory report. Moreover, the training workshop will illustrate strategic techniques of e-clinical validation from the standpoint of regulatory inspection views.

LEARNING OBJECTIVES

Know what is involved when conducting an ecective internal and external quality audit, and how to plan for its successful imple-mentation Understand the types of QA audits conducted, why they are nec-essary, and the value they provide Learn how to prepare for an audit, achieve closure, and get the best out of your quality audit system Prepare for a clinical data system inspection and assess risk areas that need prioritizationReview the system for regulatory vulnerabilities and to develop an action plan intended to close those gaps.

WHO SHOULD ATTEND

Clinical study professionalsClinical project managementAuditor and inspectorRegulatory acairsData managementClinical information professionals Clinical monitorsQuality assurance and quality control professionalsClinical researchers and study coordinators

INSTRUCTORS

Earl HULIHAN, Professor Senior Vice President, Regulatory Acairs Medidata Solutions, USA

Daniel LIU, PhDDirector, China Development, Medidata Solutions Worldwide, China

Byungja MARCIANTEInvestigator, US FDA Shanghai Obce, China

KIM NITAHARAPrincipal Consultant and CEO, META Solutions, Inc. USA

BIO-ANALYTICAL METHOD DEVELOPMENT AND VALIDATION CHALLENGES AND PRACTICAL SOLUTIONS

The bio-analytical workshop will review the significance of bio-ana-lytical analysis and regulatory requirements for bio-analytical method development and validation, discuss general practice in bio-analytical method development and validation, share perspective and provide solutions on overcoming challenging issues in bio-analytical method development including chemical stability, metric stability, specific and non-specific binding, etc.

The instructors are senior scientists and managers from major phar-maceutical companies and contract research bio-analytical organiza-tion.

LEARNING OBJECTIVES

Understand technical and regulatory compliance requirements in developing robust and sensitive bio-analytical methods

Validate bio-analytical methods that are sensitive, selective, re-producible, and cost ecective

Explain strategies and skills in problem solving to ensure data integrity

8:30 – 17:30 WORKSHOP 2

KM Function Hall A (2nd Floor)

WHO SHOULD ATTEND

Bio-analytical scientistsPK/TK scientistsLab managementBio-analytical QA

INSTRUCTORS

GU Zhe-ming, Ph.D.Deputy General Manager, XBL-China, Inc. China

ZHANG Fa, PhDSenior Research Fellow, Johnson & Johnson, USA

Workshop Agenda

7:30 – 8:30 Onsite Registration

DIA Registration Station (2nd Floor)

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VACCINE CLINICAL DEVELOPMENT AND REGULATION

Developing a vaccine with a high quality ebcacy and safety profile is essential to public health. China has developed nicely in vaccine production and took the lead to market N1H1 vaccine products in 2009, which indicates the region’s established capability and capac-ity to develop vaccines. However, vaccine development and regula-tion should be improved match ICH GMP and ICH GCP standards so that vaccine products developed and manufactured in China are accepted internationally.

Global vaccine companies are shifting their strategy to adapt to the local regulation in order to market their products in China as early as possible. Their ecorts include setting up their own manufacturing plants or acquiring a local company with manufacturing capacity. Because the investment burden on global vaccine companies is so large, companies would like to harmonize Chinese vaccine regula-tion with ICH GCH.

TOPICS

China vaccine development landscapeVaccine clinical development program under FDA regulation-best practice from real caseVaccine clinical development-statistical considerationDiscussion-operational considerationPanel discussion

LEARNING OBJECTIVES

8:30 – 12:00 WORKSHOP 3

KM Function Hall C (2nd Floor)

Understand the high standards involved in the vaccine develop-ment process, focusing on clinical program design and executionOverview China’s vaccine development capability and opportu-nityDescribe global best practices in vaccine development, includ-ing strategy development, clinical consideration and statistical considerationIdentify gaps in Chinese vaccine development

WHO SHOULD ATTEND

Vaccine development professionals in Chinese companiesRegulatory acairs professionalsClinical project management in global and Chinese companiesQC/QA professionalsClinical research coordinators and site monitors

INSTRUCTORS

Mike CORRADO, MDChief Science Obcer, INC ResearchFellow of Infectious Disease Society of America, USA

Jessica LIU, MDSenior Director, Clinical Operations, Head of Asia-Pacific, Global Clini-cal Operations, INC (Beijing) Medical Technology Co., Ltd. China

William WANG, PhDHead of Asia Pacific Hub, Biostatistics and Research Decision Sci-ences (BARDS), Merck Research Laboratory, Merck & Co., Inc, China

ZHENG HaifaDirector for Biological Products DivisionNew Drug Development Fund Management CommitteeChina Medical FoundationExecutive Vice General Manager, Shenzhen Kangtai BiologicalProducts Co. , China

Workshop Agenda

ETHICAL MEDICAL WRITING PRACTICES – EVERY DOCUMENT, EVERY TIME, EVERY COUNTRY!

Medical writers in China are making increasingly important contribu-tions to documents designed to reach international audiences. Writ-ers are being asked to prepare many types of documents, including publications in international peer-reviewed journals, presentation materials for international conferences, protocols for international clinical trials, and clinical study reports for international regulatory submissions. Although each document has specific requirements, EVERY document must be prepared in an ethical manner. Thus, medical writers in China (and throughout the world) must be aware of and adhere to ethical medical writing practices. Failure to do so could endanger patient care and damage the reputations of the writer, the sponsor, the institution, and the country involved.

TOPICSReal-life examples to reinforce why ethical practices are criticalImportant international guidelinesCritical ethical practices writers should follow when prepar-ing dicerent types of documents (e.g., protocols, clinical study reports, abstracts, slides, posters, manuscripts)Solving ethical medical writing challenges

13:30 – 17:30 WORKSHOP 4

Meeting Room 7+8 (2nd Floor)

LEARNING OBJECTIVES

At the conclusion of this workshop, you should be able to:Explain why medical writers should follow internationally recog-nized ethical medical writing practicesIdentify important international guidelines that describe ethical medical writing practicesOutline ethical medical writing practices when preparing dicer-ent types of documents

WHO SHOULD ATTEND

Medical writersInvestigatorsClinical researchersRegulatory acairs stac

INSTRUCTOR

Karen WOOLLEY, PhD

CEO, ProScribe Medical Communications, Australia

Professor, University of Queensland, Australia

Honorary Fellow, American Medical Writers Association

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EUROMEETINGCOPENHAGEN 2012

2 4 T H A N N U A L

26-28 March 2012Bella Center | Copenhagen, Denmark

CDISC: GLOBAL OVERVIEW

The Clinical Data Interchange Standards Consortium (CDISC) has collaborated with numerous other organizations on a global basis to analyze research regulations and processes; through these col-laborations and the work of thousands of volunteers worldwide over the past 14 years, a set of enablers that can accelerate the medical research process, from protocol through analysis and reporting, has emerged.

This course outlines these enablers (including but not limited to the CDISC standards) so that you can understand their benefits and show how you can improve your data quality and streamline work-flow at both investigative research sites and clinical research and development sponsor organizations. This course also delivers rel-evant business information that demonstrates the real world value of CDISC and reviews the standards that are being used at the US FDA and by regulators in Europe and Asia.

This is a seminar-style workshop that presents an overview of the CDISC purpose and organization and provides attendees with an un-derstanding of the benefits of building a medical research process on industry standards. Anyone who is involved in medical research in any capacity, and at any level, will benefit from taking this course.

LEARNING OBJECTIVESUnderstand the purpose and value of collaboratively using indus-try standards to improve the medical research process and qualityGain an overview of the CDISC organization in the world of

13:30 – 17:30 WORKSHOP 5

Meeting Room 3 (2nd Floor)

Workshop Agenda

medical researchLearn about the process of developing consensus-based indus-try standardsHave a brief introduction to all of the CDISC standards, how they work together and how they link to healthcare

WHO SHOULD ATTENDAnyone who works in medical research will benefit from this work-shop, including, but not limited to personnel in the following func-tions.

Clinical Trial Investigation at Clinical SitesClinical Research and Development and Academic ResearchClinical research operations and program/project managementDrug Safety and PharmacovigilanceRegulatory Acairs and Government Regulatory ActivitiesBiostatistics and Data ManagementMedical Writing

INSTRUCTORS

Rebecca D. KUSH, PhDFounder, President and CEO of the Clinical Data InterchangeStandards Consortium (CDISC), USA

LEE Yonghao, PhDFounder & CEO, Absolute Clinical Data System Co., Ltd., China

Claire TANSenior Director, Biostatistics, Quintiles Medical Development (Shang-hai) Co., Ltd. Beijing Branch, China

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CONFERENCE DAY 1 | MONDAY, MAY 16

13:30 - 14:30 OPENING CEREMONY (PLENARY SESSION) YN Grand Ballroom A+B+C (3rd Floor)

INTRODUCTION

Jane CAI, PhDDirector, DIA China

OPENING REMARKS

James CAI, MDPresident, Pangu Biopharma Ltd., China

XUE BinDeputy Director-General, China Center for Pharmaceutical Interna-tional Exchange, SFDA, China

WELCOME

Paul POMERANTZWorldwide Executive Director DIA, USA

Richard O. DAY, AM, MB, BS, MD, FRACPPresident, DIAProfessor of Clinical Pharmacology St. Vincent’s Hospital, Australia

Christopher J. HICKEY, PhDCountry Director, U.S. Food and Drug Administration, China

AWARD & RECOGNITION

14:30 - 15:00 SPECIAL PRESENTATIONS

MODERATOR

CHANG YonghengDeputy Director-General, China Center for Pharmaceutical Interna-tional Exchanged, China

KEYNOTE SPEECH

Review and Prospect of China’s Drug Supervision

SHAO MingliCommissioner, State Food and Drug Administration (SFDA), China

15:00 – 15:30 PRESENTATION 1

“Indigenous Innovation” and Life Science in China

Michael ZIELENZIGERConsultant, The Monitor GroupVisiting Scholar, University of California, Berkeley, USA

15:30 – 16:00 PRESENTATION 2

Evolution of China Drug Evaluation Process

LI GuoqingDirector-General, Center for Drug Evaluation, SFDA, China

16:00 – 16:15 REFRESHMENT BREAK

16:15 – 17:45 OPENING DEBATE

Forum: Positioning China - The Strengths and Challenges in In-novative Drug Development

MODERATOR

SU Ling, PhDSenior Vice President, Head of Development Greater China, Bei-jing Novartis Pharma Co., Ltd., China

PARTICIPANTS:

ZHANG WeiDirector-General, Department of Drug Registration, SFDA, China

YANG Zhe, MDDeputy Director General, Department of Science and Technology for Social Development, Ministry of Science and Technology, China

FENG YI Director, Obce of Management and Communication, Center for Drug Evaluation, SFDA, China

DONG Ruiping, MD, PhDSenior Vice President, Head of Emerging Markets R&D, Merck Research Laboratories, USA

LI Ning, PhDSenior Group Director, Medical Policy, sanofi-aventis, China

LU Xianping, PhDCo-Founder, Member of the Board of Directors, President, and Chief Scientific Obcer, Chipscreen Biosciences, Ltd., Shenzhen, China

18:00 – 19:30 WELCOME RECEPTION KM Function Hall (2nd Floor)

Conference Agenda

7:30 – 13:30 Onsite Registration

DIA Registration Station (2nd Floor)

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CONFERENCE DAY 2 | TUESDAY, MAY 17

SFDA GxP Guidelines UpdateYN Grand Ballroom A+B+C (3rd Floor)

MODERATOR


1. Newly Revised GMP in China

WANG Zhexiong

Inspector-General, Department of Drug Safety and Inspection,

SFDA, China

2. Transparency of Drug Evaluation and Information Development

DONG Jiangping

Director, Obce of Human Resources & Informationization, Cen-

ter for Drug Evaluation, SFDA, China

3. GCP for Drugs in China

Li Jianming

Division Director, Center for Drug Certification, SFDA, China

8:30 – 10:00 TOWN HALL MEETING


Conference Agenda

©2010 Brad Yeo c/o theispot.com

D I A 2 0 1 1 Convergence of Science, Medicine, and Health47th Annual Meeting | June 19-23, 2011 | McCormick Place West | Chicago, IL

ANNUAL MEETING SNAPSHOT

New!

New!

New!

New!

New! SM

New!

New!

New!

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TRACK 1Clinical Research and Drug Safety

Session T 1-1KM Function Hall B+C (2nd Floor)

How to Improve Source Documents to Meet GCP Requirements?

Session Co-Chairs:

Hannah CHEN, MDClinical QA Regional Manager, Asia Pa-cific, GlaxoSmithKline, China

GUO Xiaojun, MD

Senior Manager, Patient Safety AstraZeneca, China

Share of FDA inspection findings around source documentation in clinical trials. Panel discussion is joined by representatives from all parties involved in clinical trials, e.g. physi-

cians, CRA, QA.

Key Findings in Clinical Trial Inspections

Byungja MARCIANTEInvestigator, US FDA Shanghai OBce, China

CASE STUDY AND PANEL DISCUSSION:

Challenges We are Facing in Conduct Clinical Trials

DiBculties in obtaining source docu-ment for OPD patientsSource documents and data qualityVerification of subject eligibility ac-cording protocol requirements – what source document we must have

PANELISTS:

Lois HONG, MDGCP QA Auditor, R&D Beijing Hub, Merck Serono, China

ZHANG Wen, MDInternal Medicine, Cancer Hospital, CAMS & PUMC, China

WANG Yuhong, MDDrug Safety Manager, Safety Opera-tion, Roche Product Development in Asia Pacific, China

Michelle YANGProject Manager, Clinical Develop-ment, R&D Department, AstraZen-eca Pharmaceutical Co., Ltd., China

CHEN Rui, MDSenior Clinical Research Associate, Pfizer Pharmaceutical, China

TRACK 2Regulation, Development & Practices

Session T 2-1YN Grand Ballroom B (3rd Floor)The New Trends of Drug Develop-ment Surveillance in China

Session Chair:

PENG Jian, MDClinical Research Director, Asia Pacific Expan-sion/Life Cycle Management of Asia Pacific R&D, sanofi-aventis(Former Director, Division 9, CDE SFDA), China

The surveillance of the new drug devel-opment process is a unique government’s responsibility in China based on the Chi-na pharmaceutical industry characteris-tics. Specifically the on-site inspection of pre-clinical research and clinical research will play a key part in standardizing the China new and generic drug develop-ment. In this section, the speakers from SFDA, PFDA and CCD will share the cur-rent R&D surveillance status, major chal-lenges and major findings, as well as recommendations for what sponsor and PI shall improve to ensure the regulatory compliance in this area.

Clinical Site Inspections

LI Jianming

Division Director, Center for Drug Certifi-

cation, SFDA, China

A Comparison of Clinical Trial Safety Surveillance in China and the U.S

Jason MASpecial Counsel, Covington & Burling LLP, China

TRACK 3Data Management and Statistics

Session T 3 -1Meeting Room 1+2+3 (2nd Floor)

Regulatory Guidelines and International Data Standards with Regard to Comput-erized Systems

Session Chair:

Daniel LIU, PhDDirector, China Development, Medidata Solu-tions Worldwide, China

Catch up the global regulatory standards of data management in clinical studies? Join the experts to learn what new concepts and standards of data quality and integrity are in the clinical de-velopment and what strategy and practices of e-clinical validation should be set up when utilizing the electronic system. The depth and compre-hension of the combination of global standards and practice with China readiness will be in the extensions of the panel discussion followed.

Computerized Systems in Clinical Trials-Data Quality and Data Integrity - Best Practices from PEACH

Earl HULIHAN, ProfessorSenior Vice President, Regulatory Aaairs Medidata Solutions, Inc., USA

Computerized Systems Validation in the E-System’s Life-Cycle

Kim NITAHARAPrincipal Consultant and CEO, META Solu-tions, Inc., USA

Data Management in Clinical Studies – Regulatory Perspective

HUANG Qin, MD, MPH, PhDOBce of Biostatistics, Center for Drug Evaluation, SFDA, China

PANEL DISCUSSION:Regulatory standard and expectations of data management in clinical study world

Significances of good data manage-ment practices (GDMP) Challenges that China data manage-ment faces How to improve and enhance the data management capacities for e-clinical studies

PANELISTS:

Speakers and

Andrew TAYLOR

Head of Clinical Data Management Biometrics Department, Roche Product Development in Asia-Pacific, China

Conference Agenda


10:30 – 12:00 PARALLEL TRACKS

12:00 – 13:30 LUNCH

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10:30 – 12:00 PARALLEL TRACK

Conference Agenda


TRACK 6Medical and Scientific AZairs

Session T 6-1KM Function Hall A (2nd Floor)

What Is MA/SA, in a Changing Envi-ronment, Its Role & Responsibility in Biopharmaceutical Value Chains and Transferring Scientific Data into Patient Centric Medical Practices

Session Chair:

Min IRWIN, MD, PhDMedical Head of BSP China and Hong Kong, Bayer HealthCare Company Ltd., China

This session will cover latest trends in medi-cal and scientific aaairs (MSA), and provide insights into how to structure a MSA organi-zation to best eaect. The session will cover developments in medical information, MSA deployment and marketing promotion sup-port. Skills for a successful future in MSA will

also be discussed.

Do We Need Medical Aaairs?

Richard NIEMAN, MDHead of Global Medical Aaairs Asia, Bayer Healthcare Global R&D Center, China

Overview of Medical & Scientific Aaairs in Life Cycle Management & Medical Marketing

Avery Basil INCEMedical Director, MSD, China

Compliance of Pharmaceutical Promo-tion

Katherine WANGChina Strategic Advisor, Sidley Austin LLP, Global Life Sciences Practice in USA and China

Clinical Path Way

JIAO YahuiDirector, Medical Management Division, Ministry of Health, China

TRACK 5Capability & Capacity Building, Clinical

Development

Session T 5-1

YN Grand Ballroom A (3rd Floor)Phase I Capability, Crossing the Chasm - Reshape Your Clinical Development Strat-egy in China

Session Co-Chairs:

Frank JIANG, MD, PhDVice President, Global R&D and Head of Asia Pacific R&D, sanofi-aventis, China

CHEN Xun, PhDSenior Director and Head, Clinical Sciences and Operations, sanofi-aventis, China

The data burden and regulatory hurdle for first in human trial in China are relatively high com-pared with other countries. Experts and indus-try 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.

Phase I Units - Pfizer’s ExperienceChew-Lan CHONG, MDMedical Director, Pfizer Clinical Research Unit, Singapore

China Phase I Capability Reality/Gaps and Catch-Up Plan

Jack XU, PhDSenior Vice President, Shanghai Clinical Re-search Center (SCRC), China

FIH in China: Regulatory and Clinical Consideration

ZHANG Dan, MD, MPHChairman & CEO, Fountain Medical Devel-opment Ltd., China

PANEL DISCUSSIONS:

Speakers and:

Carol ZHU, MBACEO, START Shanghai Ltd., China

TRACK 4CMC/cGMP

Drug Standard and Quality

Session T 4-1YN Grand Ballroom C (3rd Floor)

Pharmacopeia Standards

Session Chair:

John HU, PhDVice President, General Manager, USP-China

This session will cover roles of Pharmaco-peia and how to strengthen the interaction between standard-setting organizations and

various stakeholders.

A Brief Introduction of Chinese Pharma-copoeia

WANG PingDeputy Secretary General, Chinese Pharma-copoeia Commission, SFDA, China

The European Pharmacopoeia in a Glob-al Context

Susanne KEITEL, PhDDirector, European Directorate for the Qual-ity of Medicines & Healthcare (EDQM), Council of Europe, France

Compendial Aaairs

Erin WANGAssociate Consultant, Quality - Compendial Aaairs, Eli Lilly and Company, USA

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Conference Agenda

CONFERENCE DAY 2 | TUESDAY, MAY 17 (continued)



Serious Adverse Event (SAE) Reporting in Clinical Trials

Session Co-Chairs:


GUO Xiaojun, MDSenior Manager, Patient SafetyAstraZeneca, China

This session is to involve parties in clinical trial to ensure quality SAE reporting. Panel dis-cussion is joined by the representatives from investigator, CRA, QA, safety physician to dis-cuss challenges and solutions in identifying, re-porting, managing, and evaluating SAE to en-

sure patient safety and integrity of safe data.

Serious Adverse Event (SAE) Reporting in Clinical Trials Great Expectations

ZHANG Lin, MD, PhDMedical Director, Safety Surveillance, Pa-tient Safety, AstraZeneca, USA

CASE STUDY AND PANEL DISCUSSION:

How do we improve SAE reporting to en-sure compliance and patient safety? The discussion will focus on clear definition of SAE (Death as outcome, disease progres-sion); clear instruction of SAE management; safety information reconciliation between clinical and safety database.

PANELISTS:

Speakers and

Lois HONG, MDGCP QA Auditor, R&D Beijing Hub, Merck Se-rono, China

ZHANG Wen, MDCancer Hospital, CAMS & PUMC, China

WANG Yuhong, MDDrug Safety Manager, Safety Operation, Roche Product Development in Asia Pacific, China

Michelle YANGProject Manager, Clinical Development, R&D Department, AstraZeneca Pharmaceutical Co., Ltd., China

CHEN Rui, MDSenior Clinical Research Associate, Pfizer Pharmaceutical, China


Session T 2-2YN Grand Ballroom B (3rd Floor)

New Drug Development and Drug Regis-tration Management

Session Chair:

Janet LUHead of Regulatory in Asia Pacific, Prod-uct Development in Asia Pacific, Shanghai Roche Pharmaceuticals Ltd. , China

Technical guidelines are one of the most im-portant tools to guide China new drug devel-opment and evaluation. In the last few years, China SFDA already issued more than 80 tech-nical guidelines and some more guidelines are under call-for-comments. SFDA committed to develop and implement systematic guide-lines that enable pharmaceutical industry and the R&D society to increase the eaectiveness and reduce the risk in new drug development. In this section, speakers from SFDA, CDE will update the current technical guideline devel-opment plan and objective, speaker from in-dustry will share the feedback on the imple-mentation and some general common issues

and recommendation.

The New Drug R&D Technical Guidelines Development in China – Perception of RD-PAC Member Companies

Maggie CHANGDirector, Drug Regulatory & Medical Aaairs, China Association of Enterprises with For-eign Investment, R&D-based Pharmaceuti-cal Association Committee (RDPAC), China

Opinions On Trends In The Management Of Drug Registration

WU Zhiang, ProfessorShenyang Pharmaceutical University, China



Implementing Data Quality Measures That Integrate People, Process and Technology

Session Chair:Joanne LIURegional Director, Asia Pacific Data Man-agement Center, Global Data Management & Standards, Merck & Co. Inc, China

This session will provide an overview of build-ing quality to patient data in clinical trials from data management perspective, discuss eaec-tive oversight of data management process and quality using key performance indicators, and the win-win strategies for CRO with spon-

sor in data quality improvement.

A Winning Strategy on Data Quality - Putting the Right Pieces Together

Jessie CHEN, MDHead of Global Clinical Data Services, Pfizer (China) Research & Development Co., Ltd., China

Data Manager’s Role in Data Quality and KPI for Data Management Process

Joyce LAIManager, Global Data Operations Asia Pacific, Merck Sharp & Dohme (Shanghai) Pharma-ceutical Consulting Co., Ltd., China

Enhancing the CRO-Sponsor Collaboration to Ensure High Quality of Clinical Data

Charles YAN, MD, PhDSenior Director, Clinical Data Management, Shanghai Clinical Research Center (SCRC), China

PANEL DISCUSSION and Q&A

Speakers and

Michele ZHANGVice President, Real Data Medical Research Inc,

USA.

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Conference Agenda




Medical and Scientific Aaairs Value in Life Cycle Management, Outcome Research and Its Contribution to Public Health a Real World Example

Session Chair:

GU Zheng, MDSenior Medical Director, sanofi-aventis, China

This session provides a real world example on how life cycle management can be success-fully planned and carried out after first regu-latory approval to evaluate the eBcacy and safety of the product in new disease area or patient population to advance the knowledge, expand the clinical use and benefit the pa-tients. It will also show how outcome research led by external scientific community and sup-ported by unrestricted grant from industry can be developed in China to identify the gap between treatment guideline and practice and find solutions to close the gap for public

health impact.

Plavix® LCM: Looking Back, Moving Ahead

Dominique ROOME, MDAssociate Vice President, Strategic Mature Products, Global Operations, sanofi-aventis, France

Closing the Gap between Clinical Practice and Guideline Learning from the Clinical Pathways for Acute Coronary Syndrome in China (CPACS)

WU Yangfeng, ProfessorDirector, The George Institute for Global Health, China

TRACK 4CMC/cGMP


Session T 4-2

YN Grand Ballroom C (3rd Floor)Quality and CMC Vendor Qualification

Session Chair:

John HU, PhDVice President, General Manager, USP-China

This session covers the significance of the standard reference material in controlling the quality of pharmaceutical products and how multinational company identifies its service contractors from the quality and technical

perspectives.

Pharmaceutical Reference Standards: Overview and Role in Global Harmoniza-tion

Matthew BORER, PhDSenior Technical Advisor, Eli Lilly and Com-pany, USA

Evaluation and Qualification of Contract Analytical Laboratories (CALs)

Joan RUAN, PhDAssociate Director, Analytical Development, Bristol-Myers Squibb, USA

Building a Quality Mindset with Your Part-ner to Manufacture Safe Clinical Materials

Hung Chih CHANG, PhDDirector, Pharmaceutical Science R&D, Lilly Research Laboratories, Eli Lilly and Com-pany, USA


Development

Session T 5-2

YN Grand Ballroom A (3rd Floor)Traditional Chinese Medicines (TCM) De-velopment – What We Can Learn From

Session Chair:

PENG Jian, MDClinical Research Director, Asia Pacific Expan-sion/Life Cycle Management of Asia Pacific R&D, sanofi-aventis(Former Director, Division 9, CDE SFDA), China

People are paying more and more attention to TCM, and technology has been improved to in-tegrate TCM into modern Drug Development. This session will review the theory of TCM, discuss the trend, strategies and challenges in

TCM development.

New Drug Discovery Based on Traditional Chinese Medicine

LU Aiping, MD, PhD

Standing Deputy Director, Chinese Medical Academy Of Medical Research Institute of TCM Clinical Basis, China Academy of Chi-nese Medical Sciences (CACMS), China

The Challenges, New Trend and Strategy of Modern Drug Development

Bradley MARCHANT, MD FRCPSenior Director, Asia Pacific Research & De-velopment, sanofi-aventis, China Discovery of Novel Compounds for the Heart and Brain: A View of SCM (Scientific Chinese Medicine)

ZHU Yizhun, MD, PhDProfessor, Department of Pharmacology, School of Pharmacy, Fudan University, China

PANEL DISCUSSION

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Conference Agenda



Session T 2-3

YN Grand Ballroom B (3rd Floor)Variation Management During Drug Development

Session Chair:

Li JieDirector, Regulatory Aaairs, Pfizer, China

As the drug development is an evolving pro-cess many new information will be available during clinical trial. Some of them may result in protocol amendment, formulation change or more strict safety monitoring. This session will give you an overview on how to report and approve those variations during IND/CTA in USA and the current practice in CDE; what the responsibility of sponsor, IRB and HA should be respectively. This session would also like to introduce industry view how to build regula-tory framework in China to meet the new drug

development needs.

The Dilemma and Digculties in China on Both Clinical Protocol Variation and CMC Variation During the Review in CDE and after the SFDA Approval

Janet LUHead of Regulatory in Asia Pacific, Prod-uct Development in Asia Pacific, Shanghai Roche Pharmaceuticals Ltd., China

The Regulations and Regulatory Practices on Amendments - US & EU Perspectives

Alberto GRIGNOLO, PhDCorporate Vice President, Global Strategy and Services of PAREXEL International, USA

The Voluntary Harmonization Procedure (VHP) – A Novel Approach in Gaining Regulatory Approval for Multinational Clinical Trials and Substantial Amend-ments in the EU

Otmar PFAFF, PhDSenior Director Global Regulatory Oncol-ogy , Merck Serono, Germany



Data Monitoring and Adaptive Designs: Is China Ready?

Session Co-Chairs:

Roger QU, PhDSenior Director, Clinical Statistics, Pfizer (China) Research and Development Center, China

LUO Zhen, PhDAssociate Director, Clinical Statistics, Pfizer (China) Research and Develop-ment Center, China

This session will focus on the need and role of DMC (Data Monitoring Committee), and de-sign changes during clinical trials. The presen-

tations will be followed by a panel discussion.

Independent Data Monitoring Committee (iDMC) and Role of A Biostatistician

Irving HWANG, PhDPresident, Irving Consulting Group (ICG), USA

DMC in China

YAO Chen, ProfessorVice Director, Peking University Clinical Research Institute, Head of Department of Biostatistics, Peking University First Hospi-tal, China

Data Monitoring Models and Adaptive De-signs: Some Regulatory Experiences

Sue-Jane WANG, PhD [Call-In]Associate Director, OBce of Biostatistics, Center for Drug Evaluation and Research, FDA, USA

PANEL DISCUSSION

Speakers and



William WANG, PhDHead of Asia Pacific Hub, Biostatistics and Research Decision Sciences (BARDS), Merck Research Laboratories, Merck & Co., Inc, China



Evolutions and Implementation of the Varia-tions of Safety Regulations – How to Meet Appropriateness and Manage Varied Needs

Session Co-Chairs:

Conny MO, MDHead of US Drug Safety Unit Shanghai, Safety Evaluation and Reporting, Worldwide Safety and Regulatory Operations, Pfizer (China) Re-search & Development, Co., Ltd., China

Catherine XIE, MDDirector, Safety Evaluation and Reporting, Worldwide Safety & Regulatory Operations, Pfizer (China), Research & Development Co., Ltd. China

This theme will address the regulation evolutions, and discuss the appropriateness and needs of current level of safety regulations. The rationale and decision making process will be presented. Important initiatives are underway to facilitate safety data collection and interpretation includ-ing new technologies, legislative changes and scientific developments that aim at improving

the benefit/risk balance of drugs.

EMA Safety Regulations Updates and Evolv-ing Administrative Model

Jan PETRACEK, MD MSc DICCEO, Director of European PharmInvent Ser-vices, Czech Republic

The Diversity of Safety Reporting Require-ments and Systems in Asia

Jean-Christophe DELUMEAU, MD, PhDHead of Pharmacovigilance Asia-Pacific, Bay-er Healthcare, China

New Approaches to Safety and Risk Manage-ment

Ayman AYOUB, MDSenior Director, Safety Surveillance & Risk Management, Worldwide Safety Strategy, Pfizer, UK

Post-marketing Safety Surveillance and Pharmacovigilance Practice in CDER, FDA

CHEN Min, M.S, R.Ph. [Call-In]Associate Director, Division of Pharmacovigi-lance, OBce of Surveillance and Epidemiology, CDER, FDA, USA

Q&A, Quiz and Awards

43


Conference Agenda




Establish Medical / Scientific AZairs Function in China- A Practical Approach

Session Co-Chairs:

GU Zheng, MDSenior Medical Director, sanofi-aventis, China

Min IRWIN, MD, PhDMedical Head of BSP China and Hong Kong, Bayer HealthCare Company Ltd., China

This session will provide practical solutions in terms of how to establish medical/scientific af-

fairs function in China.

Getting the Right Evidence to the Right Stake-holder - Medical Information & Communication

LI HuafeiSenior Manager, Medical Aaairs, AstraZeneca, China

Impact of Outcomes Research in Medical Prac-tice - Today and Tomorrow

ZHANG Danyi, MDFounder and the Chief Medical OBcer, Vital Strategic Research Institute (VSRI), China & USA

Publication and DA: From Concept, Strategy, Resource Planning, Execution and Communi-cation

Joyce LIVice President, Medical, NovaMed Pharma, China

Building Diversified Medical Deliverable

Wilbur LIU, MD, PhDAssistant Director, Medical Aaairs, Head of Med-ical Excellence Function, sanofi-aventis, China

MOU Bo, MD, PhDSr. Medical Manager/Medical Liaison Head, MedicalAaairs, sanofi-aventis, China

Building A Competent Medical Aaairs Team to Support Business Needs: A Personal Per-spectiveJane LIN, MDVP, Regulatory Aaairs and Clinical Develop-ment, WuXi AppTec Co., Ltd., ChinaPANEL DISCUSSIONOperational Excellence-Debate and Group Dis-cussion of Specific Cases

FACILITATORS:

GU Zheng, MD and Min IRWIN, MD, PhD

SPEAKERS and:

ZENG Li, MDProfessor, College of Phamarceuticals and Bio-technolgy, Tianjin University, China

TRACK 4CMC/cGMP


Session T 4-3

YN Grand Ballroom C (3rd Floor)Application of QbD in Drug Development and Real Time Release Testing

Session Co-Chairs:

GUI Min, PhD Director, CMC Asia Pacific and China CMC & Operation, Global Regulatory Science, Bris-tol-Myers Squibb, China

Cheng (Charles) TONG, PhDDirector, Global CMC, Pharma Therapeutics Pharmaceutical Sciences, Worldwide Re-search and Development, Pfizer Inc., China

This session will introduce the QbD principles from ICHQ8, and discuss QbD application in drug development with case studies. The real time release testing (RTRt) opportunities achieved through the application of QbD will be demonstrated. Industry experience with the most recent movement of joint inspection by FDA and EMA, and application of continu-ous verification approach recommended in the newly published FDA Guidance for Indus-try: Process Validation: General Principles and

Practices will be shared.

Major Regulators’ Perspectives on QbD Implementation

Chi-Wan CHEN, PhDExecutive Director, Global CMC, PfizerMember of FDA Alumni Association, USA

Drug Development Utilizing QbD

GUI Min, PhD Director, CMC Asia Pacific and China CMC & Operation, Global Regulatory Science, Bris-tol-Myers Squibb, China

Practical Considerations for Implementa-tion of Real Time Release Testing (RTRt)

Cheng (Charles) TONG, PhDDirector, Global CMC, Pharma Therapeutics Pharmaceutical Sciences, Worldwide Re-search and Development, Pfizer Inc., China

Learnings from Pre-approval Joint Inspec-tion of a GSK QbD Product with US-FDA & EMA and the Application of Continuous Verification

LI ChiTechnical Manager, GSK (Tianjin) Co., Ltd., China


Development

Session T 5-3

YN Grand Ballroom A (3rd Floor)Modernize Clinical Development Through New Technology

Session Chair:

Michael IBARA, MDSenior Director, Operational Excellence, Worldwide Safety and Regulatory Opera-tions, Pfizer Inc., USA

As China ramps up to become a rapidly ex-panding center for conducting clinical re-search, there is the opportunity to reconsider the process of technology-enabled clinical development without being burdened with the legacy of old habits that are so firmly en-trenched in the West. This presentation will look at a number of potential innovative ap-

proaches for clinical development including:

Leveraging electronic healthcare re-cord systems to accelerate protocol development and improve safety signal detection and evaluation. Innovative methods for collecting and utilizing clinical research study data.Managing and utilizing research data as a long term information asset.

Rethinking Clinical Research with a Clean Slate

Wayne KUBICKSenior Director, Product Strategy, Oracle Health Sciences Global Business Unit, CDISC Board of Director, USA

Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety

Michael IBARA, MDSenior Director, Operational Excellence, Worldwide Safety and Regulatory Opera-tions, Pfizer Inc., USA

How to Use Social Software to Acceler-ate Clinical DevelopmentDING LIDirector and Head, Asian Pacific Trial Operation,

sanofi-aventis, China

Modeling & Simulation in Drug Develop-ment: Tools, Technoiogy and Challenges

Vikram SINHA, PhDSenior Research Advisor, Global Pharmaco-kinetics/Pharmacodynamics and Pharma-cometrics, Eli Lilly and Company, USA

44

44

CONFERENCE DAY 3 | WEDNESDAY, MAY 18

Conference Agenda





IRB/IEC Practices and Issues in China

Session Co-Chairs:

Paul DAI, MDSenior Director, Regional Head of ICRO AMAC & Greater China Region, Beijing Novartis Pharma Co., Ltd., China

MAO Yimin, ProfessorDept. of Gastroenterology, Renji Hospital Shanghai Jiao Tong University; School of Medicine, Shanghai Institute of Digestive Disease, China

PANEL DISCUSSIONS:

Ethics Review Processes in China

The new guideline of IEC/IRB review has been rolled out in China, which is one of the land-scapes in clinical research to improve the ethi-cal protections to the study patients as well as streamline the local review processes. The panel is going to share the interpretations of the new guideline and discuss how to optimize

the process from various perspectives.

PANELISTS:

LIU Haitao, MDClinical Research Institute, Peking Univer-sity, China

XIONG Ningning, MD, ProfessorDirector, Jiangsu Provincial Hospital of Tra-ditional Chinese Medicine, China

Eva YANG, MDHead of Monitoring and Site Management Asia Pacific, Bayer Healthcare, China


Session T 2-4

YN Grand Ballroom B (3rd Floor)The Regulatory Requirement and Practice of ANDA in the USA

Session Chair:

Cathleen CHANDirector, Regulatory Aaairs, sanofi-aventis, China

Abbreviated New Drug Application (ANDA) is the application for the generic drug approval in USA for an existing licensed medication or approved drug. With the rapidly growing pharmaceutical market in China, more and more domestic pharmaceutical companies are not only developing its products in China but also seeking the opportunities to enter global market. As ANDA is generally not required to include pre-clinical and clinical research to demonstrate safety and eaectiveness, it be-comes one of the fast and cost-eaective ways to launch products in USA. In this section, FDA speaker will give an overview on how to apply for ANDA and speakers from domestic com-panies will also share the real cases and their

experiences on ANDA application in USA.

Development & The US FDA Approval of Generic Drugs

Jack ZHENG, PhDChief Executive OBcer & President, Jiangsu Hengrui Medicine, Co., Ltd, China

Legal and Regulatory Considerations When Pursuing an ANDA

CHEN ShaoyuManaging Director, China Food and Drug Law Practice, Covington & Burling LLP, China


Session T 3-4Meeting Room 1+2+3 (2nd Floor)

Adopting CDISC Standards and Improving Data Quality

Session Chair:

Rachel YANG, MD, PhDDirector, Product Strategy, Health Sciences Global Business Unit, Oracle Corporation

CDISC has been the primary driver for stan-dards development in Clinical Research for over a decade. CDISC standards are relatively new to many in the Asia-Pacific region. In this

session, the speakers will:

Examine the current state and future direction of relevant data standards from CDISC, HL7 and the Joint Initia-tive Council. Gain practical insights into which standards to use now, and which ones to monitor as they become increas-ingly important in the near future.Describe the practical use of CDCIS in protocol representation, data collec-tion and integration, safety surveil-lance and regulatory submission.

Practical Use of CDISC Standards: Today and Tomorrow

Wayne KUBICKSenior Director, Product Strategy, Oracle Health Sciences, Global Business Unit, CDISC Board of Director, USA

Getting the Most out of CDASH and SDTM: Automating the Specification and Verifica-tion Process

Peter VAN REUSELBusiness Unit Director CRO Services, Busi-ness & Decision Life Sciences, Belgium

CDISC e-Protocol Representation

Rebecca D. KUSH, PhDFounder, President and CEO of the Clini-cal Data InterchangeStandards Consortium (CDISC), USA

CDISC in China

Simon WANG, MBASenior Manager, Biostatistics,PAREXEL China Co. Ltd, China

45

Conference Agenda

CONFERENCE DAY 3 | WEDNESDAY, MAY 18

TRACK 7QA/QC in Clinical Development, Regula-

tory Requirements and Practices

Session T 7-1

YN Grand Ballroom A (3rd Floor)

Regulatory Agency’s Eaorts to Ensure Qual-ity Execution of Clinical Research Globally

Session Chair:Karen J. ATKIN, MDVice President, Research and Development As-traZeneca, China

The session is joined by agency representa-tives from SFDA, FDA, MHRA to discuss vari-ous inspection programs implemented by the

agencies to safe guard the clinical research.

SFDA Inspection & Certification Program

LI Jinju, PhDDivision Director, Division of Drug Re-search Supervision, Department of Drug Registration, SFDA, China

US FDA Inspection Program and Common Findings in Asia

Byungja MARCIANTEInvestigator, US FDA Shanghai OBce, China

TRACK 4CMC/cGMP


Session T 4-4

YN Grand Ballroom C (3rd Floor)US FDA CMC/GMP New Guidance and Hot Topics

Session Chair:Chi-Wan CHEN, PhDExecutive Director, Global CMC, PfizerMember of FDA Alumni Association, USA

This session will focus on a new U.S. FDA GMP guidance and other CMC or GMP-related top-ics that are of interest to the regulator and industry in China. These include two U.S. FDA guidelines on CMC for Phase 1 and Phase 2/3 INDs, which have recently been translated into Chinese for possible adoption. The explanation of thinking and principles behind the guide-lines with examples will be discussed. The FDA Question-based Review initiative for ANDA, a life cycle management approach through pro-cess validation, and experience sharing with case study on how to prepare for an FDA pre-

approval inspection will be presented.

Guidance on CMC for Phase 1 and Phase 2/3 Investigational New Drug Applica-tions (INDs)

Chuck HOIBERG, PhDExecutive Director, Pfizer, USAMember of FDA Alumni Association

Guidance for Industry - Process Validation: General Principles and Practices

Mark TUCKER, PhDSenior Technical Advisor, Roche/Genetech, USA; Member of FDA Alumni Association


STAND ALONE /HOT TOPICS WHO Special Session

Session SH-1KM Function Hall A (2nd Floor)

WHO Prequalification of Medicines Pro-gramme and Other Activities Assuring Qual-ity Medicines

Session Chair:Milan SMID, PhD Technical OBcer, Prequalification of Medicines Program, WHO, Switzerland

WHO Pre-qualification Program applies to final medical products and APIs. The WHO Quality assurance procedure and principal requirements have been adapted by major international organizations. Opportunities for the Chinese manufacturers to participate in in-

ternational procurement will be discussed

WHO Prequalification Program for essen-tial medicines and standard setting func-tions.

Milan SMID, PhDTechnical OBcer, Prequalification of Medicines Program, WHO, Switzerland

Quality Assurance Policies Applied by Ma-jor International Organizations in Purchase of Medicines for Treatment Projects in China

HUANG Baobin

National Professional OBcer, Health Sys-tems Development, WHO, China

WHO Projects Organized in Cooperation with SFDA in China

Christina FOERG-WIMMER, PhDPharmaceutical Advisor, Health Systems Development, WHO, China

Experience from WHO Organized Assis-tance to Chinese Manufacturers

SUN Yueping External Expert to WHO, China

46

46

CONFERENCE DAY 3 | WEDNESDAY, MAY 18 (continued)

Conference Agenda

12:00 – 13:30 LUNCH




Egcient and High Quality Site Management

Session Co-Chairs:

Paul DAI, MDSenior Director, Regional Head of ICRO AMAC & Greater China Region, Beijing Novartis Pharma Co., Ltd., China

MAO Yimin, ProfessorDept. of Gastroenterology, Renji Hospital Shanghai Jiao Tong University; School of Medicine, Shanghai Institute of Digestive Disease, China

PANEL DISCUSSION:

Egcient and High-quality Site Manage-ment

The panel would share the expertise on how to establish a highly eaective and eBcient clini-cal trial centers in China to support high qual-

ity executions of clinical trials.

PANELISTS:

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


Grace WUHead of Clinical Operations, Pfizer (China) Research & Development Co., Ltd., China


Session T 2-5

YN Grand Ballroom B (3rd Floor)

Asian Regional Development and Collabo-ration

Session Chair:

SU Ling, PhDSenior Vice President, Head of Develop-ment Greater China, Beijing Novartis Pharma Co., Ltd., China

The Consideration of Regional Clinical Trials in China, Japan and Korea

YANG ZhiminDirector, OBce of Clinical Evaluation I, Cen-ter for Drug Evaluation, SFDA, China

Tripartite Collaboration and MRCT

Shinobu UZUInternational Planning Director (Pharmaceu-tical Aaairs), Ministry of Health, Labour and Welfare (MHLW), Japan

Update on Korea-China-Japan Tripartite Clinical Trial Collaboration

Gyuhan CHAEDeputy Director, Division of Pharmaceutical Safety, KFDA, Korea

STAND ALONE /HOT TOPIC Ethnicity and Drug Development In China

Session SH-2Meeting Room 1+2+3 (2nd Floor)

Ethnic Diaerence and Global Drug Development

Session Chair:

Bob POWELL, PharmDScientific Advisor, Clinical Pharmacology, Roche Pharmaceuticals China Ltd., China

Essential Considerations in Planning a Multi-Regional Clinical Trial

H.M. James HUNG, PhD [Call-In]Director, Division of Biometrics I, OBce of Biostatistics, Center for Drug Evaluation and Research (CDER), FDA, USA

Design Consideration for Simultane-ous Global Drug Development Program (SGDDP)

CHEN Gang, PhDDirector, Biostatistics and Programming, Johnson & Johnson, USA

Regulatory Convergence for Ethnicity Con-sideration in Simultaneous Global Drug Development - Chinese Taipei Regulatory Approach and Experience

Herng-Der CHERN, MD, PhDDistinguished Research Fellow, Center for Drug Evaluation(CDE), Chinese Taipei

How China Handles Ethnicity Concern

HU Pei, PhDProfessor and Director, Clinical Pharma-cology Research Center, Peking Union Medical College Hospital, China

47


Conference Agenda




Session T 7-1 (continued)

YN Grand Ballroom A (3rd Floor)

Regulatory Agency’s Eaorts to Ensure Qual-ity Execution of Clinical Research Globally

Session Chair:Karen J. ATKIN, MDVice President, Research and Development, AstraZeneca, China

The session is joined by agency representa-tives from SFDA, FDA, MHRA to discuss vari-ous inspection programs implemented by the

agencies to safe guard the clinical research.

Assuring Quality From Development to Pa-tient - Managing the Risk

Gerald HEDDELLDirector of Inspection, Enforcement and Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

PANEL DISCUSSION

TRACK 4CMC/cGMP


Session T 4-4 (Continued)

YN Grand Ballroom C (3rd Floor)

US FDA CMC/GMP New Guidance and Hot Topics

Session Chair:Chi-Wan CHEN, PhDExecutive Director, Global CMC, PfizerMember of FDA Alumni Association, USA

Question-based Review for ANDAs

Chi-Wan CHEN, PhDExecutive Director, Global CMC, PfizerMember of FDA Alumni Association, USA

Preparing For GMP Inspection: It Is Much More Than Audit!

Mark TUCKER, PhDSenior Technical Advisor, Roche/Genetech, USA; Member of FDA Alumni Association

PANEL DISCUSSION

STAND ALONE /HOT TOPICS Translational Medicine

Session SH -3KM Function Hall A (2nd Floor)

Translational Medicine - An Emerging View of Medical Practice in 21st Century

Session Chair:

Frank JIANG, MD, PhDVice President, Global R&D and Head ofAsia Pacific R&D, sanofi-aventis, China

More than often, the promising approaches to disease characterization or treatment estab-lished in vitro or animal models prove ineaec-tual in patients. This “gap” between Discovery and Clinical benefit illustrates the complex of human biology. Creative experimental ap-proaches, state-of-art technologies and new ways of conducting scientific explorations at the interfaces of various disciplines are the keys to make real progress. This Track is to dis-cuss what it takes for the rapid translation of new discoveries into clinical practice and drug

discovery.

The Significance of Biomarkers in Transla-tional Medicine

WANG Xiangdong, MD, PhDProfessor of Respiratory Medicine, Profes-sor of Molecular Bioscience, NCSU, USADirector of Biomedical Research Center, Fudan University

From Intellectual Property (IP), Concept Approval to Clinic: An Example of Transla-tional Medicine - What Chinese Physicians Should Learn From The Case?

WANG Jie, MD, PhDExecutive Vice President, Academy of Clini-cal Research and Translational Medicine, Ji-angsu Province Hospital

The Framework of Translational Medicine Research for New Drug Development

GENG, Meiyu, MDDivision of Anti-tumor Pharmacology and Glycobiology,State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica,Chinese Academy of Sciences

48

48



Conference Agenda


Session T 2-6

YN Grand Ballroom B (3rd Floor)Standardization and Internationalization of Traditional Chinese Medicines (TCM) R&D

Session Chair:

Henry SUN, PhDGroup Vice-President, Tasly Pharmaceu-ticals, Inc., China

New TCM R&D has been encouraged by China central government for many years, but the current situation is far from satisfaction. One of the biggest issues is the standardization on the matrix to evaluate the TCM development, and consequently its recognition by the major western authorities. In this session, speakers from SFDA, CDE will discuss the standardiza-tion and internationalization of TCM and the further support from government. Speaker from industry will share the real case and the

learning on introducing TCM into USA market.

WANG HaiNanDeputy Consultant, Traditional Chinese Medicine, Department of Drug Registra-tion, SFDA, China

System Biology for Traditional Chinese Medicines

LUO GuoAn, ProfessorDirector, Modern Research Center of Tra-ditional Chinese Medicines, Tsinghua Uni-versity, China

Clinical Proven for Drugs Made from Nature Sources

Henry SUN, PhDGroup Vice-President, Tasly Pharmaceu-ticals, Inc., China




Process of Product Benefit and Risk As-sessment – a Collaborative Approach among Regulators, Industry, Healthcare Professional and Patient

Session Co-Chairs:

Conny MO, MDHead of US Drug Safety Unit Shanghai, Safety Evaluation and Reporting, World-wide Safety and Regulatory Operations, Pfizer (China) Research & Development, Co., Ltd., China

Catherine XIE, MDDirector, Safety Evaluation and Report-ing, Worldwide Safety & Regulatory Op-erations, Pfizer (China), Research & De-velopment Co., Ltd. China

Pharmacovigilance is a set of joined and col-laborative activities among all stakeholders not only regulators, but also healthcare profes-sionals, industry, patient and community. This session will discuss how industry applies for the new approaches of safety assessment and risk minimization and make timely and proper deliverable; how healthcare professional grasp

and present safety information with patient.

The Impact of Global Drug Safety Informa-tion on the Drug Safety Management in China

XU JiaqiCounsel, Department of Policy & Regula-tions, SFDA, China

Drug Safety Labeling Issues in China

WANG DayouDirector, Shanghai Huashan HospitalProfessor, Fudan University, China

PANEL DISCUSSION

Safety regulations and administrative responsibilities Identification of safety signal and risk assessmentCommunication of benefit-risk assess-ment information

PANELISTS:

Speakers and

Lynn ZHOUAssistant Director, International PV Coor-dinator, Sanofi-Aventis

STAND ALONE /HOT TOPIC Ethnicity and Drug Development In China

Session SH-2 (Continued)Meeting Room 1+2+3 (2nd Floor)

Ethnic Diaerence and Global Drug Devel-opment

Session Chair:

William WANG, PhDHead of Asia Pacific Hub, Biostatistics and Research Decision Sciences (BARDS), Mer-ck Research Laboratories, Merck & Co., Inc, China

Asia Ethnicity and Drug Development-Regulatory Risk


PANEL DISCUSSION

Global drug development provides opportuni-ties and challenges, such as the opportunity and challenge to evaluate the ethnic factor in dis-ease and intervention. This panel will oaer dis-cussion and debates on how to leverage these opportunities and address these challenges.

PANELISTS:

Speakers and :

James CAI, MDPresident, Pangu Biopharma Ltd., China

CHEN Gang, PhDDirector, Biostatistics and Programming, Johnson & Johnson, USA


Herng-Der CHERN, MD, PhDDistinguished Research Fellow, Center for Drug Evaluation(CDE), Chinese Taipei.

HU Pei, MD, PhDProfessor and Director, Clinical Pharmacol-ogy Research Center, Peking Union Medical College Hospital, China

49



Conference Agenda



Session T 7-2

YN Grand Ballroom A (3rd Floor)Regulatory Agency, Industry and Institu-tion’s Eaorts to Ensure Quality Execu-tion of Clinical Research in China, Japan and KoreaSession Co-Chairs:

Spring WANG, MDSenior Medical Director, Asia Pacific, Cepha-lon, Hong Kong, China

Helen LIEmerging Market QA Asia Lead, Pfizer Med-ical Quality Assurance, China

The session is joined by agency representa-tives from Japan and Korea to discuss the current inspection programs in their countries, and representatives from the area of quality control and assurance at both institutions and industry to discuss quality systems/key steps to drive good quality study and develop-ment of QA professional. There will be plenty of opportunities for extensive discussion and interaction for anyone interested in clinical re-

search and quality assurance.

KFDA Inspection Program for Quality and Compliance Eaorts

Young-Ok KIM, PhDDirector, Clinical Trials Management Divi-sion, Risk Prevention Policy Bureau, Korea Food & Drug Administration, Korea

PMDA GCP Inspection Program for Quality and Compliance Eaorts

Mitsune YAMAGUCHI, PhDDeputy Director for GCP InspectionOBce of Conformity Audit, PMDA, Japan

Strengthen Clinical Trial System, Improve Clinical Study Quality

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

TRACK 4CMC/cGMP


Session T 4-5

YN Grand Ballroom C (3rd Floor)Comparability of Biotechnological/Biological Products: Manufacturing Changes and Biosimilars

Session Co-Chairs:

Duu-Gong WU, PhDExecutive Director, Consulting Division, PharmaNet Inc., USAMember of FDA Alumni Association

David LIN, PhDSenior Consultant, Biologics Consulting Group Inc., USAMember of FDA Alumni Association

This session will focus on the current topics of comparability for biotechnology / biological products related to manufacturing changes and development of biosimilars from the regu-latory and scientific perspectives. The com-parability concept was originally developed for assessing the quality, safety and eBcacy of the biotechnology / biological products following manufacturing changes within the same manufacturer as described in the ICH Q5E guidance. However, similar, although not identical, approaches have been widely used in recent years for the comparative testing of a biosimlar product developed by a diaerent company to establish the comparability to a reference product for its marketing approval.

The presentations will cover :

of biosimilar legislation and scientific is-sues.

-ments

Key considerations of comparability test-ing for manufacturing changes at diaerent stages

Regulatory and Scientific Issues of Biosimi-lars

Duu-Gong WU, PhDExecutive Director, PharmaNet Inc., USAMember of FDA Alumni Association

What You Should Know When Making Manufacturing Changes to Biotechnology Products

Mark ROSOLOWSKY, PhDVice President, Global Regulatory Science-CMC, Bristol-Myers Squibb, USA

50

50



Conference Agenda

17:30 CONFERENCE ADJOURNED



Operational Excellence in Clinical Trial

Session Chair:

Jessica LIU, MDSenior Director, Clinical Operations, Head of Asia-Pacific, Global Clinical Opera-tions, INC (Beijing) Medical Technology Co., Ltd., China

Operational excellence is important to im-prove trial conduction eBciency. This session will share and discuss the best practices in the fundamental elements of clinical safety op-erational excellence; a good safety system (in-cluding database and workflow management, etc.); eBcient collaboration among sponsors,

CROs and investigators/sites

Strive for Centre of Excellence - A High Performing Clinical Operations Team

CAI Yan, MD, PhDSenior Director,Head of Global Clinical Op-erations, Janssen Johnson & Johnson, China

Clinical Safety Information Reporting and Management in Real World

Conny MO, MDHead of US Drug Safety Unit Shanghai, Safety Evaluation and Reporting, World-wide Safety and Regulatory Operations, Pfizer (China) Research & Development, Co., Ltd., China

DEBATE:CROs Roles in Clinical Research

DEBATE FACILITATOR: XU Ning, MD, MBAExecutive Director, Head of Clinical Devel-opment Service, Covance, China

TEAM 1 LEADER (CRO): Jessica LIU, MD INC (Beijing) Medical Technology Co., Ltd., China

TEAM 2 LEADER (Sponsor): CAI Yan, MD, PhDJanssen Johnson & Johnson, China


Session T 3-5Meeting Room 1+2+3 (2nd Floor)

Joint Panel Discussion: How to Ensure End-To-End Quality - A Quantitative Evaluation

Session Co-Chairs:

William WANG, PhDHead of Asia Pacific Hub, Biostatistics and Research Decision Sciences (BARDS), Merck Research Laboratories, Merck & Co., Inc, China

ZHANG Lixin, PhDBiometrician, Biostatistics and Research De-cision Sciences (BARDS), Merck Research Laboratories, Merck & Co., Inc, China

This joint panel session will invite experts from multiple quantitative professions to discuss how these professionals can work together to ensure end-to-end quality.

Topics Include:The life of a data pointMessy/Missing data in the view of dif-ferent beholdersBiostatisticians, clinical programmers, database managers, epidemiologists, health economists and pharmacome-tricians: what they have in common

PANELISTS:


Claire TANSenior Director, Biostatistics, Quintiles Medical Development (Shanghai) Co., Ltd. Beijing Branch, China

Andrew TAYLORHead of Clinical Data Management Bio-metrics Department, Roche Product De-velopment in Asia-Pacific, China

Peter VAN REUSELBusiness Unit Director CRO Services, Busi-ness & Decision Life Sciences, Belgium

YAO Chen, ProfessorVice Director, Peking University Clinical Re-search Institute, Head of Department of Biosta-tistics, Peking University First Hospital, China

ZHAO Lueping, ProfessorDirector, Peking University Medical Infor-matics Center and Principal Investigator.Fred Hutchinson Cancer Research CenterUniversity of Washington

51



Conference Agenda




YN Grand Ballroom A (3rd Floor)Regulatory Agency, Industry and Institu-tion’s Eaorts to Ensure Quality Execu-tion of Clinical Research in China, Japan and Korea

Session Co-Chairs:

Spring WANG, MDSenior Medical Director, Asia Pacific, Ceph-alon, China


Quality Risk Management

Karen J. ATKIN, MDVice President, Research and Development, AstraZeneca, China

A Road to Quality Assurance


PANEL DISCUSSION

TRACK 4CMC/cGMP



YN Grand Ballroom C (3rd Floor)Biologics Regulations and Change Management

Session Co-Chairs:

Duu-Gong WU, PhDExecutive Director, Consulting Division, PharmaNet Inc., USAMember FDA Alumni Association

David LIN, PhDSenior Consultant, Biologics ConsultingGroup, Inc., USAMember FDA Alumni Association

Thinking About Comparability for Bio- similar Proteins

David LIN, PhDSenior Consultant, Biologics ConsultingGroup, Inc., USAMember FDA Alumni Association

PANEL DISCUSSION

12

DIA

DIA

5 16-18

Conference A

genda

13

8:30 – 17:30 11+2

|

GCP

GCP

FDA

Earl HULIHAN

Byungia MARCIANTEFDA

Kim NITAHARA

8:30 – 17:30 2A

PK/TK

7:30 – 8:30

22

22

15:30 – 18:00

CONFERENCE DAY 2 | 2011 5 17 ( )

T 1-3 B+C

EMA

Jan PETRACEK

Jean-Christophe DELUMEAU

Ayman AYOUB

FDA CDER

[ ]

T 2-3 B

CDE SFDA

Alberto GRIGNOLO

VHP

Otmar PFAFF

T 3 -31+2+3

SUE-JANE WANG [ ]

23

15:30 – 18:00


T 6-3A

T 4-3C

QbD

QbD

RTRt)

T 5-3A

Michael IBARA

Wayne Kubick

Michael IBARA

Vikram SINHA

24

24

CONFERENCE DAY 3 | 2011 5 18

10:00 – 10:30

8:30 – 10:00

T 1-4B+C

IRB/IEC

T 2-4B

ANDA

ANDA

T 3-41+2+3

CDISC

CDISC

Wayne KUBICK

Peter VAN REUSELBusiness & Decision Life Sciences,

CDISC

Rebecca D. KUSH

CDISC

25


T 4-4C

FDA CMC/GMP

Chuck HOIBERG

Mark TUCKER Genetech

8:30 – 10:00

T 7-1A

Karen J. ATKIN

Byungja MARCIANTEFDA

SH-1A

Milan SMID

Milan SMID

Christina FOERG-WIMMER

26

26


12:00 – 13:30

10:30 – 12:00

T 1-5B+C

T 2-5B

Gyuhan CHAE

SH-21+2+3

Bob POWELL, PharmD

H.M. James HUNG [ ]

27

10:30 – 12:00


T 4-4 ( )

FDA CMC/GMP

CMC

CMC

GMP

Mark TUCKER /Genetech

SH-3A

T 7-1 ( )A

Karen J. ATKIN

Gerald HEDDELL(MHRA)

28

28

13:30 – 15:00


15:00 – 15:30

T 1-6B+C

ICSR

SH-2 1+2+3

Bob POWELL, PharmD

T 2-6B

29


T 4-5C

Mark ROSOLOWSKY -CMC

T 7-2A

Young-Ok KIM

30

30

15:30 – 17:30


T 1-7B+C

17:30 CONFERENCE ADJOURNED

T 3-51+2+3

Bob POWELL, PharmD

Andrew Taylor

Peter VAN REUSELBusiness & Decision Life Sciences,

Fred Hutchinson

31

15:30 – 17:30

T 7-2 ( )A

Karen J. ATKIN, MD

-5 ( )C


Receive Deep Discounts on ALL DIA Educational O0erings!

For RMB 880 you can take advantage of all the benefits of membership.

Drug Information Journal, DIA’s peer-reviewed, scholarly journal

Global Forum

Contract Service Organization Directory

Area Communities (SIACs)

For more information, visit www.diahome.org and click on Membership.

The 3rd DIA China Annual Meeting: Quality & Standards - Elevating China Pharmaceutical DevelopmentMeeting I.D. # 11975

May 15-18, 2011 Crowne Plaza Sun Palace Beijing, China

TRAVEL AND HOTELAirport: Beijing Capital International AirportHotel: Crowne Plaza Sun Palace Yunnan Dasha, Northeast Corner of Taiyanggong Bridge, Xibahe, North-East 3rd Ring Road, Chaoyang District, Beijing, P.R. China. +86 10 6429 8888-6649

Attendees must make their own airline reservations and hotel reservations as early as possible to ensure availability.

Room Rate for DIA: Single/Double RMB945 (for self-paid attendees) NET

CANCELLATION POLICY: ON OR BEFORE APRIL 30, 2011

Cancellations must be made in writing and received by April 30, 2011, in order to receive a full refund minus the administrative fee of Member = RMB 500 Nonmember = RMB 500, before the cancellation date. Registrants who do not cancel in writing by the deadline date and do not attend the event will be responsible for paying the full registration fee. Registrants are also responsible for cancelling their own hotel and airline reservations. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

I agree with the terms of the cancellation policy.

Signature Participant ________________________________________________

REGISTRATION FEES FOR CONFERENCE (May 16-18, 2011)Registration fee includes refreshment breaks, luncheons, and will be accepted by mail, fax, or E-mail. NONMEMBER MEMBERIndustry Early-bird* (Jan 17-April 15) RMB 4380 q RMB 3500 qIndustry Standard (April 16-May 9) RMB 4880 q RMB 4000 qIndustry Onsite (May 10-May 18) RMB 5380 q RMB 4500 q* Early Bird Closes April 15, 2011

Join DIA now to qualify for the member discount (click here)! MEMBERSHIPTo qualify for the member discount, please submit both the Registration Form and RMB 880 qMembership Application accompanied by proof of payment. Student (Full-time) Membership Discount RMB 230 q

Discount Fees NONMEMBER MEMBERNonprofit/Academia/Government (Full-time) RMB 3480 q RMB 2600 qStudent (Full-time, One-day Pass) RMB 430 q RMB 200 q

• AFTER MAY 9 2011, ONLY ONSITE REGISTRATION WILL BE ACCEPTED.

PRE-CONFERENCE WORKSHOPS (May 15, 2011)Workshop #1 How To Prepare for Successful Compliance Audit RMB 2000 q and Inspections

Workshop #2 Bio-Analytical Method Development and Validation – RMB 2000 q Challenges and Practical Solutions

Workshop #3 Vaccine Clinical Development and Regulation RMB 1300 qWorkshop #4 Ethical Medical Writing – Quality and Best Practices RMB 1300 qWorkshop #5 New CDISC Global Approach RMB 2000 qWorkshop #3 + Workshop #4 RMB 2200 qWorkshop #3 + Workshop #5 RMB 2200 q

q REQUEST FOR CHINESE OFFICIAL INVOICE (FA PIAO)Please send the completed invoice request form to Mr. Tan by [email protected] or

fax +86-10 59231090. After the payment is received, the invoice will be mailed.

* Payment in other currencies will be subject to the financial institution’s exchange rate.

PAYMENT OPTIONS Please indicate payment method.

q BANK TRANSFER

Payment in the amount of RMB___________

Bank Account: 325956011898

Bank Name: Bank of China Beijing Jianguomenwai Sub-branch

Bank Address: No. 24 Jianguomenwai Street, Chaoyang District

Beijing, 100004, China.

Payee: KELLEN MANAGEMENT AND CONSULTING (BEIJING) CO., LTD.

SWIFT Code: BKCH CN BJ 110

Bank commission fee should be paid by the registrant.

q CREDIT CARD PAYMENTS BY:

Cardholder Name _____________________________________________

Card Issue Bank________________________ Exp. Date (mm/yyyy)______

Card #_____________________________________ Security Code____________

q Visa q Master Card q Other

Signature_____________________________

* Only following cards are accepted:Foreign Credit Card: VISA & MasterCard.Domestic Credit Card: Bank of China, China Construction Bank, Industrial and Commercial Bank of China, Guangdong Development Bank, China Industrial Bank, Huaxia Bank & China Merchants Bank Tele-banking.For more details, please contact DIA China office.

CONTACT INFORMATIONFor general inquiries and registration, Mr. Fei XIE [email protected].

Online Registration Opens Jan 17 - May 9 2011 on www.diachina.org Click here to register online.

Please check the applicable category: q Industry q Government q University q CRO/CSO q Hospital /Medical Practice q Indipandent Consultant q Other

PLEASE PRINT ALL INFORMATION CLEARLY

Last Name First Name M.I. Full Name in Chinese (If applicable) Gender q Mr. q Ms.

Job Title Affiliation (Company) q Business Address q 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

E-mail (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. a service provider for DIA China

https://kellen-china.ungerboeck.com/reg/reg_p1_form.aspx?oc=30&ct=DIAMEETING&eventid=5011

药物信息协会（DIA）第三届中国年会质量与规范——中国制药业的升级路径

会议编码：#11975

2011年5月15 -18日北京新云南皇冠假日酒店

会议地点：

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

电话：+86-10-64298888 传真：+86-10-64521889高级间/豪华间房费净价 RMB 945 (自付)

联系方式：

会议咨询：一般咨询与注册及学生报名，请与谢飞先生联系E-mail：[email protected]展览咨询：请与陈润珊女士联系E-mail：[email protected]

DIA 中国办公室

电话：+86-10-59231109 传真：+86-10-59231090

取消注册：须在2011年4月30日前（含4月30日）

• 取消注册必须进行书面确认（E-mail或传真）；

• 凡已注册并付款者，在2011年4月30日之前取消注册，须按注册规定扣除手续费RMB500元；

• 凡已注册并付款者，若逾期未确认取消或未参加者，其缴纳的注册全额将不予退还；

• 凡已注册但未付款者，在2011年4月30日之前取消注册，须按注册规定缴纳手续费RMB500元；

• 凡已注册但未付款者，若逾期未确认取消或未参加者，仍须按注册规定全额缴纳注册费；

• 参会注册者应自行取消住宿预订及差旅订票等

同意取消注册条款，请在下方横线处签名

参会代表签名____________________

会议注册费（5月16-18日）含茶歇、午餐及会议资料

非会员价会员价

提前注册（1月17日-4月15日） RMB 4380 q RMB 3500 q标准价格（4月16日-5月9日） RMB 4880 q RMB 4000q现场注册（5月10日-5月18日） RMB 5380 q RMB 4500q*提前注册优惠截止至4月15日

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。会员费

普通会员 RMB 880 q

学生会员 RMB 230 q

其他优惠非会员价会员价

政府机构/非营利组织/学术机构(全职人员) RMB 3480 q RMB 2600 q全日制学生（当天注册） RMB 430 q RMB 200 q

* 2011年5月9日后只接受现场注册

会前研习班注册费 (5月15日)研习班一 (全天，含茶歇、午餐及资料) RMB 2000 q研习班二 (全天，含茶歇、午餐及资料) RMB 2000 q研习班三 (上午，含茶歇及资料) RMB 1300 q研习班四 (下午，含茶歇及资料) RMB 1300 q研习班五 (下午，含茶歇及资料) RMB 1300 q研习班三 + 研习班四 (全天，含茶歇、午餐及资料) RMB 2200 q研习班三 + 研习班五 (全天，含茶歇、午餐及资料) RMB 2200 q

联系方式会议事宜：谢飞先生, [email protected]展览事宜：陈润珊女士, [email protected]

q 索取发票

请发送电子邮件至[email protected]或传真至 +86 10 5923 1090 收件人：谭祺先生发票将于全部款项到帐后寄出。

* 汇率以中国人民银行当日外汇牌价为准.

付款方式

q 银行汇款：

请即付人民币_________________________

银行帐号： 325956011898

开户行：中国银行北京建国门外支行

银行地址: 北京市朝阳区建国门外大街24号

收款人：科伦管理咨询（北京）有限公司

SWIFT : BKCH CN BJ 110

*请确保全额注册费到帐

q 信用卡支付：

持卡人姓名________________________________________________________

发卡行__________________________ 信用卡到期日___________________

卡号___________________________ 安全码 _________________________

p 维萨卡 p 万事达卡 p 其它卡

持卡人签名______________________

* 请注意目前只接受下列信用卡：

境外信用卡：维萨卡和万事达卡

境内信用卡：中国银行，中国建设银行，中国工商银行，广东发展银行，兴业银行，华夏银行，招商银行电话银行

更多注意事项，请联络DIA中国办公室

在线注册截止至2011年5月9日可登录www.diachina.org, 或点击此处

请核对单位类别 p 药厂 p 政府部门 p 科研院校 p 实验室/CRO/CSO p 医疗机构-医院/诊所 p 咨询公司 p 其它

请填写下表并保持字迹清晰

姓 _________________ 名 ___________________ 职位 ___________________________________________ 性别: p 先生 p 女士

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 ______________________________________________________________________________________________ p 公司地址 p 家庭地址

省份及城市____________________________________________ 国家 __________________________________________ 邮政编码_________________________

电话 _________________________________________________ 传真 __________________________________________ 手机 _____________________________

电子邮件（以便通过电子邮件发送确认） _______________________________________________________________________________________________________

若您传真或邮寄报名表，请提供名片或名片复印件。

科伦管理咨询（北京）有限公司为DIA中国提供会议服务

https://kellen-china.ungerboeck.com/reg/reg_p1_form.aspx?oc=30&ct=DIAMEETING&eventid=5011

DIA Membership Application Form

1. MEMBER INFORMATION

Last Name

Mobile Gender: □ Male □ Female

First Name

Degree

Organization

Job Function/Department

Job Position

Professional Title

Mailing Address

□ Business Address □ Home Address

Zip

Country Province City

E-mail

Phone Fax

2. PAYMENT METHODS ANNUAL MEMBERSHIP FEE: RMB 880

□ Credit Card

Card type: □ Domestic Credit Card* □ International Visa □ International Master * Bank of China, China Construction Bank, Industrial and Commercial Bank of China, Guangdong Development Bank, China Industrial Bank, Huaxia Bank, China Merchants Tele-Banking

Cardholder Name _____________________ Card # _____________________ Security Code _____________________ Expiry Date _____________________ Signature _____________________

□ Bank Transfer

Payee: Kellen Management and Consulting (Beijing) LTD. Bank Account: 325956011898 Bank Name: Bank of China, Beijing Jianguomenwai Sub-branch Bank Address: 24Jianguomenwai Street Beijing, 10004, China

□ Request Invoice Email or fax the request to [email protected]; fax: +86 10 5923 1090 Once payment is received, the invoice and the membership information will be mailed to the member.

3. YEARS OF WORKING EXPERIENCE ( Please select one)

□ <2 years □ 2-5 years □ 6-10 years □ 11-15 years

□ 16-20 years □ > 20 years

4. ORGANIZATION TYPE

□ Industry □ Government □ University □ CRO/CSO

□ Hospital/Medical Practice

□ Independent Consultant

□ Other

5. DIA CHINA CONTACT INFORMATION

□ Address: Room 1155, Block A, Gateway Plaza, No. 18 XiaGuangLi, North Road East 3rd Ring, ChaoYang District, Beijing, 100027, China

□ E-mail: [email protected] □ Fax: + 86 10 5923 1090 □ Telephone: + 86 10 5923 1109

DIA Website: www.diahome.org Notes:

1）Kellen Management and Consulting (Beijing) Co., Ltd., a Service Provider for DIA China。

2） Membership is not refundable or transferable.

DIA 会员申请表会员申请表会员申请表会员申请表

1. 会员信息会员信息会员信息会员信息姓手机性别: □男 □女名学位单位名称部门职位职称邮寄地址

□ 工作地址

□ 家庭地址邮编国家省城市电子邮件电话传真

2. 付款方式付款方式付款方式付款方式会员年费会员年费会员年费会员年费: 人民币人民币人民币人民币 880 元元元元

□ 信用卡支付

信用卡类型：

□ 境内信用卡*

□ 境外Visa 维萨卡

□ 境外Master 万事达

* 中国银行，建设银行，工商银行，广发银行，兴业银行，华夏银行，招行电话银行

持卡人姓名 _____________________

卡号 _____________________

安全码 _____________________

有效期 _____________________

签名 _____________________

□ 银行电汇

收款人：科伦管理咨询（北京）有限公司账号： 325956011898 开户行名称：中国银行北京建国门外支行开户行地址：中国北京建国门外大街24号

□ 发票若需发票，请电邮： [email protected] 或传真至： +86 10 5923 1090 发票和会员信息将在付款收到后邮寄给会员。

3. 从事从事从事从事本本本本行业行业行业行业时间时间时间时间（（（（请选择一项请选择一项请选择一项请选择一项））））

□ 2 年以下 □ 2-5 年 □ 6-10 年 □ 11-15 年

□ 16-20 年 □ 20 年以上

4.4.4.4.工作工作工作工作单位单位单位单位类别类别类别类别 □ 药厂 □ 政府部门 □ 科研院校 □ 实验室/CRO/CSO

□ 医疗机构 - 医院/诊所 □ 咨询公司 □ 其它

5. DIA 中国中国中国中国办事处办事处办事处办事处联系方式联系方式联系方式联系方式：：：：

□ 地址：中国北京市朝阳区东三环北路霞光里 18 号佳程广场 A 座 11 层 1155 室，邮编 100027

□ 邮箱：[email protected]

□ 传真：+ 86 10 5923 1090

□ 电话：+ 86 10 5923 1109

DIA 主页：www.diahome.org 备注：

1）科伦管理咨询（北京）有限公司代理 DIA 中国区会员服务。

2）会员费一旦支付将不予退还。

DIA Student Membership Application Form

1. MEMBER INFORMATION

Last Name

First Name

Mobile

Gender: □ Male □ Female

University/School Affiliation

Degree

Degree Program/Discipline

Mailing Address

Country

Province

City

Zip

Email

Phone

Fax

2. PAYMENT METHODS Annual Fee: RMB 230

□ Credit Card

Card type: □ Domestic Credit Card* □ International Visa □ International Master * Bank of China, China Construction Bank, Industrial and Commercial Bank of China, Guangdong Development Bank, China Industrial Bank, Huaxia Bank, China Merchants Tele-Banking

Cardholder Name _____________________ Card # _____________________ Security Code _____________________ Exp. Date _____________________ Signature _____________________

□ Bank Transfer

Payment in the amount of RMB 230 Payee: KELLEN MANAGEMENT AND CONSULTING (BEIJING) LTD. Bank Account: 325956011898 Bank Name: Bank of China, Beijing Jianguomenwai Sub-branch Bank Address: 24Jianguomenwai Street Beijing, 10004, China

□ Request Invoice Email or fax the request to [email protected]; fax: +86 10 5923 1090 Once payment is received, the invoice and the membership information will be mailed to the member.

□ I guarantee above information is correct and accurate, and will provide documentation of studentship if necessary.

Signature _____________________ Date_____________________

DIA Website: www.diahome.org Notes:

1）Kellen Management and Consulting (Beijing) Co., Ltd., a Service Provider for DIA China。

2） Membership is not refundable or transferable.

3. DIA CHINA CONTACT INFORMATION

□ Address: Room 1155, Block A, Gateway Plaza, No. 18 XiaGuangLi, North Road East 3rd Ring, ChaoYang District, Beijing, 100027, China

□ E-mail: [email protected] □ Fax: + 86 10 5923 1090 □ Telephone: + 86 10 5923 1109

DIA 学生学生学生学生会员申请表会员申请表会员申请表会员申请表

1. 会员信息会员信息会员信息会员信息姓

名

手机

性别: □男 □女学校

学位

院系项目邮寄地址

国家省城市邮编电子邮件电话传真

2. 付款方式付款方式付款方式付款方式会员年费会员年费会员年费会员年费: 人民币人民币人民币人民币 230 元元元元

□ 信用卡支付

信用卡类型：

□ 境内信用卡*

□ 境外Visa 维萨卡

□ 境外Master 万事达

* 中国银行，建设银行，工商银行，广发银行，兴业银行，华夏银行，招行电话银行

持卡人姓名 _____________________

卡号 _____________________

安全码 _____________________

有效期 _____________________

签名 _____________________

□ 银行电汇

付款金额： 230元人民币收款人：科伦管理咨询（北京）有限公司账号： 325956011898 开户行名称：中国银行北京建国门外支行开户行地址：中国北京建国门外大街24号

□ 发票若需发票，请电邮： [email protected] 或传真至： +86 10 5923 1090 发票和会员信息将在付款收到后邮寄给会员。

□ 我保证以上所有信息是准确的，并可提供学生身份相关证明。

签名 _____________________ 日期_____________________

DIA主页：www.diahome.org 备注：

1）科伦管理咨询（北京）有限公司代理 DIA中国区会员服务。

2）会员费一旦支付将不予退还。

3. DIA中国办事处联系方式中国办事处联系方式中国办事处联系方式中国办事处联系方式：：：：

□ 地址：中国北京市朝阳区东三环北路霞光里 18号佳程广场 A座 11层 1155室，邮编 100027

□ 邮箱：[email protected]

□ 传真：+ 86 10 5923 1090

□ 电话：+ 86 10 5923 1109

3rd

DIA China Annual Meeting

Block Code: X11

May 15 - 18, 2011 Beijing, China

May 15: Pre-Conference Workshops

Reservation/Confirmation ��

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!"#/Company: _____________________________________________ $%/Date: ___________________

&'(/Booker: _____________________ )*/Fax: _____________________ +,/Tel: _____________________

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"2 Audi A6 (RMB480.00 per one way) " Mercedes Benz (RMB900.00 per one way)

" Buick GL8 (RMB600.00 per one way)

§¨�� Special Request:

LM Notices:

- Bookings will be released after 6pm on arrival day if not guaranteed. The AMEX, Visa, Master, Diners Club and JCB card can be accepted for guarantee.

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Please kindly fill out the form and send it back to the hotel. We will confirm the room according to the availability of the hotel.

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Crowne Plaza Sun Palace Beijing Reservation Center !"#$%&'()*+,-./ / /

[email protected]/

Tel342(86 10) 6429 8888 Fax 562(86 10) 6452 1889

No. 12 Qisheng Middle Street North-East 3rd Ring Road, Chaoyang District, Beijing

7 89:;-< 12=>?@, ! 100028

http://www.ichotelsgroup.com/h/d/cp/1/en/cwshome/DPRD-8CCAJD/PEGSP