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Session 9 Track A: International CMC Topic
Session Chair(s)
Nagesh Bandi, PhD
Executive Director
Merck & Co., Inc, United States
In the rapidly growing emerging markets, multi-national companies (MNCs) face tremendous challenges in ensuring that they are following 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 most of the world (MOW) markets whose countries have extremely diverse regulatory histories, systems, and capacities. This session will provide a close examination of the regulatory CMC landscape across the key country/regions (China; LATAM; Asia Pacific) and an opportunity for regulatory CMC experts (industry and agency) to share their experiences with the audience.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand regulatory CMC challenges and opportunities in China market
- Understand regulatory CMC challenges and opportunities in LATAM region
- Understand regulatory CMC challenges and opportunities in Asia Pacific region
Speaker(s)
Improvements and Challenges of China’s Drug Regulatory Reform – Key CMC Issues
Zhengyu Wu
Novo Nordisk, China
Regulatory CMC Challenges and Opportunities in LATAM Region
Tatiana Gaban, MPharm
Merck & Co., Inc., United States
Executive Director, Regulatory Affairs - CMC
Regulatory CMC Challenges and Opportunities in the Asia Pacific (APAC) Region
Jennifer L. Brown
Pfizer Inc., United States
Director, Global CMC