Hangzhou Economic & Technological Development Area

(Wenhui Hotel, Hangzhou Dianzi University)

Sept. 24^th (Thursday)

All day

Registration

14:00—15:00

Press Conference

15:00—17:00

Seminars between honored guests and HEDA enterprises

18:00—20:00

Reception dinner hosted by HEDA in honor of specially invited

Sept. 25^th (Friday)

8:40—9:00

Opening Ceremony

9:00—12:30

Keynote Presentations (1)

12:30—13:30

Lunch

13:30—18:00

Panel Discussions (1)

19:00—21:30

Reception Dinner---“Welcome to Hangzhou”

Sept. 26^th (Saturday)

8:30—12:00

Keynote Presentations (2)

12:00—13:30

Lunch

13:30—18:00

Panel Discussions (2)

18:00—18:30

Director Conference of National CRO Alliance

19:00—21:00

West Lake Night

Sept. 27^th (Sunday)

9:30—12:00

Visiting Bio-pharmaceutical enterprises in HEDA

Sept. 24^th (Thursday)   14:00——20:00                                            

All day

Representative registration

14:00—15:00

Conference Press

15:00—17:00

Seminars between honored guests and HEDA enterprises

18:00—20:00

Reception dinner hosted by HEDA in honor of specially invited

Sept. 25^th (Friday)    8:40——12:30                                            

8:40—9:00

Organizers’ Welcome Speech

Speeches by specially invited leaders

Keynote Presentations (1)

9:00—9:40

Sang Guowei

Academician of Chinese Academy of Engineering; Chairman of China Pharmaceutical Association

Innovative strategy plan of significant new drugs researches in China

9:40—10:20

Paul Casey

Vice President, Strategic Sourcing of Quintiles

Developments and trends of CRO under the global economic crisis

10:20—10:30

Tea Break

10:30—11:00

Yu Mingde

Administrative Director of China Pharmaceutical Enterprises Management Association;

Former director of Pharmacy Department of National Economic and Trade Committee;

The urgent priorities towards the development of pharmaceutical industry

11:00—11:25

Bill Harrison

President and Chief Operating Officer of MPI Research

Global Pre-clinical CRO’s Markets and Their Relationship to China

11:25—11:50

Yang Jing

Director of Health Bureau of Zhejiang Province

Development advantages of Biomedical in Zhejiang

11:50—12:15

Yan Hao

Chairman of EPS Group;

President of Chinese Chamber of Commerce in Japan

The current situation and the future of Japanese biomedicine contract service (thinking mode of biopharmaceuticals such as CRO, SMO, CSO etc)

12:15—12:30

Zhang Xuening

Vice-director of management committee of Hangzhou Economic & Development Area(HEDA)

An introduction to bio-pharmaceutical industry in Hangzhou Economic & Development Area(HEDA)

Sept. 25^th (Friday)    13:30——18:00                                            

Panel Discussions (1)

13:30—14:30

Quality certification system of international multi-center clinic trials

Moderator

Zhang Dan

Chairman & CEO of Fountain Medical Development Ltd.

Speakers

Zheng Shusen

Dean of the first affiliated hospital of College of Medicine, Zhejiang University; Academician of Chinese Academy of Engineering

Xie Yanbin

President of Beijing KendleWits  Inc.

Xu Ping

Chairman of EPS International (China) Co., Ltd.

Jiang Shixin

GM of Rundo-Cronova International Pharmaceutical Research & Development Co., Ltd.

Zhao Jun

Vice dean of Jiangsu Province Hospital

Chen Wen

VP of Tigermed Consulting Ltd.

Zhou Kan

Quality assurance auditor of PRA International, USA

Main topics

Advantages and disadvantages for China to involve in international multi-centre clinic trials

The main problems to influence the quality of international multi-centre clinic trials and hence the solutions

Factor analysis and the suggestions upon policies and regulations of  international multi-centre clinic trials

Expectations and worries from contractees about the implements in China of the international multi-centre clinic trials

14:30—15:30

Discussion upon the mode of China’s SMO construction

Moderator

Gong Yanhua

Secretary-general of China Association for Pharmaceuticals and Medical Technology Exchange Contract Research Organization Union;

Former director of the division of drug research supervision of SFDA

Speakers

Benny.c.y.ZEE

Director of center for drug clinic research of Hong Kong Chinese University

Ye Guowei

President of Singapore Gleneagles Clinical Research Center

Mao Yimin

Director of the agency for drug clinic trials, Renji Hospital

Masaharu SHIGA

General manager of Tokyo Branch 2 EP-Mint Co., Ltd.

Li Haiyan

Director of the agency for clinic researches of Peking University Third Clinical Hospital

Main topics

The action of SMO in clinic experiments

The current situation and development of Chinese CRC

Introduction of SMO in Singapore and Malaysia

Growth model of Japanese SMO

15:30—15:40

Tea Break

15:40—16:50

Focus issues await to resolve towards the sustainable development of Chinese CRO industry

Moderator

Jin Kewen

Director of the work councils of Shanghai Putong bio-medicine R&D contract service;

General manager of Shanghai Charles River Bio-technology Co., Ltd.

Speakers

Darren Ji

CEO & Partner of PharmaLegacy Laboratories (Shanghai) Co., Ltd.

Zhai Yifan

Current President of Chinese Biopharmaceutical Association, USA

Tan Yong

Director of GlaxoSmithKline (China) R&D Co., Ltd.

Yang Guang

Associate Director, Bio-reagents and Compound Management, GlaxoSmithKline (China) R&D Co., Ltd.

Li Bo

Investigator & Director of the Center for Drug Safety Evaluation, SFDA

Zhang Hancheng

Former chairman of SAPA, VP of Shanghai ChemPartner Co., Ltd.

Yang Qicheng

Chairman of MicroConstants (Beijing), Inc.

Main topics

To view from global horizon upon the current situation and problems of Chinese CRO industry development

The extension and all-in-one-integration of CRO industry

Optimization both competition and the flow of talents to promote sound  development of industry

16:50—18:00

The certification management system of drug research

Moderator

Gong Zhaolong

CTO of JOINN Laboratories; chairman of American filial; former FDA reviewer

Speakers

Ron Connolly

VP of Frontage Laboratories Inc.

Wang Tianxun

QA inspector-general of Rundo-Cronova International Pharmaceuticals Research & Development Co., Ltd.

Xiong Ningning

Director of the agency for clinic trials of Jiangsu Province Hospital of TCM

Wang Jie

Director of the Center for Drug Safety Evaluation of Shenyang University of Chemical Technology

Song Yuewei

Management representative of CQM Certification Group

Dr. Simmons

Former FDA director of CMC Department

Main topics

Qualification of IEC/IRB clinic trials

CRO-ISO9001 certification of clinic trials/17025 certification of  experimental laboratory

The AAALAC certification of experimental animals and the building of IACUC

Sept. 26^th, 2009（Saturday）   8:30——12:00                                             

Keynote Presentations (2)

8:30—8:55

Zhang Wei

Director of registration department of SFDA

The drug registration regulations

8:55—9:20

Xiao Shiying

Department chief of 21 century biology center of the ministry of Science and Technology of the People's Republic of China

Initiative of significant new drug researches—platform buildings of national clinic drug research

9:20—9:45

John Duan

U.S. FDA clinical pharmacology reviewer for generic drugs

9:45—10:10

Chen Ling

VP of GlaxoSmithKline (China) R&D Co., Ltd.

10:10—10:20

Tea Break

10:20—10:45

Hong Hao

CEO of Asymchem Life Science (Tianjin) Co., Ltd.

10:45—11:10

Li Bo

Investigator & director of the Center for National Drug Safety Evaluation

Key technologies for the safety evaluation of biotechnology-derived pharmaceuticals

11:10—11:35

Li Xiang

Chairman of Hangzhou Chinese Peptide Co., Ltd.

How to Build a World Class CRO in China

11:35—12:00

R.Stephen

Chief Scientific Officer of Medicilon/MPI Preclinical Research Co., Ltd., Pharm.D.MRCP,FCP

Survey of China preclinical CRO’s: progress and hurdles to success

12:00—12:25

Sun Hui

Assistant director of management committee of Hangzhou Economic & Development Area(HEDA)

Current situation  of the construction for high-tech industrial base of National Biomedical Industrial Base

Sept. 26^th, 2009 (Saturday)   13:30——18:30                                             

Panel Discussions (2)

13:30—15:00

The significance of technology platform-buildings for new drug clinic researches towads the quality elevation of national clinic drugs

Moderator

Zeng Mingde

Professor of Renji Hospital

Speakers

Gong Yanhua

Secretary-general of China Association for Pharmaceuticals and Medical Technology Exchange Contract Research Organization Union;

Former director of the division for drug research supervision of SFDA

Wang Jian’an

Dean of the second affiliated hospital of College of Medicine, Zhejiang University;

Li Ning

Dean of Beijing Youan Hospital, Capital Medical University

Mao Yimin

Director of the agency for drug clinic trials, Renji Hospital

Li Haiyan

Director of the agency for clinic trials, Peking University Third Clinical Hospital

Jiang Ji

Chief of Peking Union Medical College Hospital

Xiong Ningning

Director of the agency for clinic trials, Jiangsu Province Hospital of TCM

Main topics

The clinic significance of the construction of technology platforms such as new drug clinic researches upon liver disease, cardiovascular disease, tumor, pharmacokinetics and Chinese medicine etc.

Creation and key points of the technology platform-building for new drug clinic research

15:00—16:20

The key points of development for contract service of biological agents R&D

Moderator

Yu Guoliang

Initiator and president of Bayhelix and Chinese Biopharmaceutical Association, USA; Chairman of Epit Mics Co., Ltd

Speakers

Hu Jingshan

Chief of Commerce Department of Merck Sharp & Dohme (China) Ltd.

Wang Deqian

Chief of Formulation Department, Bayer (German)

Yang Naibo

President of Chinese-American Biopharmaceutical Society（CABS）; Vice-chairman of BioChain (USA) Inc.

Ni Jian

Chairman of Suzhou Industrial Park Chenjian Antibody Group Drug R&D Co., Ltd.;

Chief of public service platform of Suzhou BioBAY Antibody and Nano-drug

Qiu Jiwan

Chairman of Taikang Inc.

Mark Engel

Chairman of Excel (Beijing) PharmaStudies Co., Ltd.

Sietsema

Senior VP of Kendle International supranational business management

Main topics

R& D and quality control of biological agents

Demands and expectations from contractees to contract service of  biological agents R&D

The discussion of international cooperation upon significant public health diseases

Application and development of antibody-group drug and antibody public service platform

Taizhou CMC builds biopharmaceutical CMO service platform to promote new drug creation

16:20—16:30

Tea Break

16:30—18:00

The environment of CRO investment

Moderator

Yang Zhi

Founder & Chairman of BioVeda China Fund

Speakers

Ling Zhen

JD & MBA, General Manager of Quintiles China

Leon Chen

Partner of Fidelity Investment

Vicky Chen

General Manager of Martin Currie China Healthcare Fund

Dr. Wu

FDA pre-clinical safety reviewer

Lilly Huang

Inspector-general of Chinese offices in Los Angeles U.S.A.

Main topics

The promoter action of the equipment-building by Economic & Development Area towards the CRO service

Investment demand and payoff expectation through CRO service

Success case of CRO service investment and its enlightment

The effect of global financial crisis towards the CRO investment and their future trend

Establish world-class CRO industry through strategic partnering

Full Company Name： 

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Tel. of Secretary

Email of Contact Person

Fax

Fax of Secretary

Postal Add

Name(s) of participant(s)               Sum of expenses: RMB__   ___

Name 1

Title

Name 2

Title

Name 3

Title

Name 4

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Visiting Bio-pharmaceutical enterprises in HEDA:   cYES    cNO

accommodation

cYES   cNO

picking-up

cYES   cNO

Expectations or Suggestions：

Registration Fee

fair

Total cost

2000 RMB/person

 5000RMB

Registration fee includes the representative card, program, proceedings, dinner and tea on Sept.24^th-27^th, “Reception Dinner” on Sept. 25^th, and “Night at the West Lake” on Sept. 26^th, excludes accommodation fee.