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Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 3C: Post-Approval Regulatory Landscape in Asia-Pacific: Challenges to Multinational Companies

Session Chair(s)

Chi-Wan  Chen, PhD

Chi-Wan Chen, PhD

Pfizer, Inc., United States

In the rapidly growing emerging market, multi-national companies (MNCs) face tremendous challenges in ensuring that they are in compliance with regional and country-specific regulations and policies while maintaining the drug supply to patients throughout the product life cycle. Nowhere are these challenges as pronounced as the Asia Pacific region whose 15 countries/autonomies have extremely diverse regulatory histories, systems, and capacities. This session will provide a close examination of the post-approval landscape across the region and an opportunity for MNC regulatory CMC experts to share their experiences with the audience.

Speaker(s)

Chi-Wan  Chen, PhD

What is New in China?

Chi-Wan Chen, PhD

Pfizer, Inc., United States

Susan  Stolz

ASEAN Region – Is it Harmonized?

Susan Stolz

Eli Lilly and Company, United States

Sr. Research Scientist, CMC Regulatory Affairs

Nirdosh  Jagota, PhD

Experiences in Other Asian Countries – Japan, South Korea, Taiwan, and Hong Kong

Nirdosh Jagota, PhD

GRQ Biotech Advisors LLC, United States

Managing Partner

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