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January, 2013 Introduction of Early Drug Development Dr. Sean Zhang , MD, FCP

SAPA-GP Webinar Program A Professional Training Tool for SAPA Members Non-members are Welcome to Participate. January, 2013 Introduction of Early Drug Development Dr. Sean Zhang , MD, FCP Medical Director, Bristol-Myers Squibb (BMS) February, 2013

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January, 2013 Introduction of Early Drug Development Dr. Sean Zhang , MD, FCP

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  1. SAPA-GP Webinar ProgramA Professional Training Tool for SAPA MembersNon-members are Welcome to Participate January, 2013 Introduction of Early Drug Development Dr. Sean Zhang , MD, FCP Medical Director, Bristol-Myers Squibb (BMS) February, 2013 Late Stage of Clinical Drug Development, e.g., Ph 2b/3 Studies/Strategies Dr. Joan Shen, MD. PhD. Senior Medical Director, China Clinical Lead, PCBU Pfizer Inc. April, 2013 Regulatory Requirements for the CTA of Multinational Clinical Trials in China Dr. Cathleen CHAN/陈明 Regulatory Director, Sanofi R&D China

  2. SAPA-GP Webinar Program Regulatory Requirements for the CTA of Multinational Clinical Trials in China April. 16th, 2013 Cathleen CHAN, MD. Regulatory Director, Regulatory R&D China, GRA Sanofi R&D

  3. Background • Dr. Chan is a physician. She starts her career in the sales and marketing in the pharmaceutical and medical device industry in China • Dr. Chan has worked as the regional head in the sales and marketing for the North of China, director in regulatory and government affairs for China and Asia • Dr. Chan gained her broad regulatory experience in Servier and Sanofi, where she is the head in regulatory, responsible for IND, NDA and LCM for Asia and China • Dr. Chan has been very devoted to Multinational Clinical Trial Applications for global and regional clinical trials with the CFDA in the last 10 years • Dr. Chan leads Asian regional and China R&D regulatory team in regulatory strategy and operation for Sanofi, success in shorting the CTA review timeline by improving internal practice and collaborating with academy, associations in China

  4. Presentation Outlines: • General Regulatory Requirements for the Multinational Clinical Trials • Hurdles of CTA for the Multinational Clinical Trials for IND in China • Description of China CTA Package contents – CFDA requirement • How to Prepare an China CTA Package Based on EU/IMPD (Investigational Medical Product Document) or US/IND package

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