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Session 3C: Post-Approval Regulatory Landscape in Asia-Pacific: Challenges to Multinational Companies
Session Chair(s)
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)
What is New in China?
Chi-Wan Chen, PhD
Pfizer, Inc., United States
ASEAN Region – Is it Harmonized?
Susan Stolz
Eli Lilly and Company, United States
Sr. Research Scientist, CMC Regulatory Affairs
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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