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Boston Convention and Exhibition Center

2013年6月23日 (日) 午前 8:30 - 2013年6月27日 (木) 午後 12:45

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Chemistry, Manufacturing and Controls (CMC) Regulatory Landscape in Emerging Markets

Session Chair(s)

T.  Venkateshwaran, PHD

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)

Chi-Wan  Chen, PHD

Regulatory Landscape in China– Challenges and Opportunities

Chi-Wan Chen, PHD

Pfizer, Inc., United States

Rebecca E. Thomas, MS

An Industry Perspective of the Approval Process in Russia

Rebecca E. Thomas, MS

Bekki Thomas Consulting, LLC, United States

Owner

Sampat  Singhvi

Latin America: Emerging Regulations - Are They a Challenge or an Opportunity?

Sampat Singhvi

Takeda Pharmaceutical International, United States

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