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Raffles City Convention Centre

Jan 28, 2013 7:00 AM - Jan 30, 2013 5:00 PM

252 , North Bridge Road, Singapore 179103, Singapore

Asia Regulatory Conference 2013

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Breakout Session 1 A: Global CMC Reviews: Challenges and Opportunities

Session Chair(s)

Lucky Surjadi Slamet, MSC

Lucky Surjadi Slamet, MSC

Deputy,Therapeutic Prod, Narcotics, Psychotropic and Addictive Substance Control, NADFC, The Republic of Indonesia, Indonesia

Chi-Wan Chen, PHD

Chi-Wan Chen, PHD

, Pfizer, Inc., United States

This session will discuss CMC challenges that are faced by the industry in obtaining a right first time approaches to securing successful filing and regulatory approval of pharmaceuticals, biological and vaccines in Asia. The session will cover not only the challenges encountered by industry but also the available opportunities for ensuring a smooth filing and approval from a regulator perspective.

Speaker(s)

Dinesh Khokal, PHD, MSC

Dinesh Khokal, PHD, MSC

Regulatory Consultant, Generics & Biosimilars Branch, Health Sciences Authority, Singapore

CMC Review: Challenges and Opportunities - Singapore HSA Perspective

Zhen Chen, PHD

Zhen Chen, PHD

Deputy Office Director, Office of New Drug Pharmaceutical Science , Center for Drug Evaluation of CFDA , China

Changes in CMC Submission and Review

Chi-Wan Chen, PHD

Chi-Wan Chen, PHD

, Pfizer, Inc., United States

Challenges to Multi-National Companies in a Global Regulatory Environment – with Case Studies

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