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Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets
Session Chair(s)
T. Venkateshwaran, PhD
Vice President and Global Head CMC Biologics, Medical Devices and Comb
Merck & Co., Inc., United States
This session will discuss the challenges observed due to the changing regulations in emerging markets.
Learning Objective : Discuss the CMC regulatory challenges involved with the drug approval process in emerging markets.
Speaker(s)
Regulatory Landscape in China– Challenges and Opportunities
Chi-Wan Chen, PhD
Pfizer, Inc., United States
An Industry Perspective of the Approval Process in Russia
Rebecca E. Thomas, MS
Bekki Thomas Consulting, LLC, United States
Owner
Latin America: Emerging Regulations - Are They a Challenge or an Opportunity?
Sampat Singhvi
Takeda Pharmaceutical International, United States
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