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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

CMC Review: Challenges and Opportunities - Singapore HSA Perspective

Dinesh Khokal, PhD, MSc

Health Sciences Authority, Singapore

Regulatory Consultant, Generics & Biosimilars Branch

Zhen Chen, PhD

Changes in CMC Submission and Review

Zhen Chen, PhD

Center for Drug Evaluation of CFDA , China

Deputy Office Director, Office of New Drug Pharmaceutical Science

Chi-Wan Chen, PhD

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

Chi-Wan Chen, PhD

Pfizer, Inc., United States

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