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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

A Regulatory Perspective of Biosimilars in Emerging Markets

Session Chair(s)

Linda  Bowen, MSC, RAC

Linda Bowen, MSC, RAC

Adjunct Professor

Temple University Pharmacy School, United States

Biosimilar Regulatory Environment in the Asia Pacific Region

Learning Objective : Identify the key regulatory instruments related to the development and approval of biosimilar products in key markets of the Latin America (Brazil, Argentina and Mexico) and Asia Pacific (India, China, Korea) regions; Recognize the similarities and differences in the regulatory requirements in these markets.

Speaker(s)

Sonica Sachdeva Batra, MD

Biosimilar Regulatory Environment in the Asia Pacific Region

Sonica Sachdeva Batra, MD

Indegene Ltd., India

Associate Vice President Enterprise Medical;Global Head- Regulatory Affairs

Oliver  Cox, MSC

Biosimilar Regulatory Environment in Latin America

Oliver Cox, MSC

PAREXEL International, United Kingdom

Consultant

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