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

Track:
Pharmaceutical Quality

Day & Time:
June 24, 11:00AM - 12:30PM

Session Number:
116

Room Number:
153C

Level:
Intermediate

Type:
Session

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

Chair(s):
Thirunellai G Venkateshwaran, PhD
Director Pharma Technical Regulatory
Genentech, A Member of the Roche Group, United States

Description:
This session will discuss the challenges observed due to the changing regulations in emerging markets.

Learning Objective(s):
Discuss the CMC regulatory challenges involved with the drug approval process in emerging markets.

Presentation(s) & Speaker(s):
Regulatory Landscape in China– Challenges and Opportunities
Chi-Wan Chen, PhD
Executive Director, Global CMC
Pfizer Inc, United States

An Industry Perspective of the Approval Process in Russia
Rebecca E. Komas, MS
Director, CMC Advocacy
GlaxoSmithKline, United States

Latin America: Emerging Regulations - Are They a Challenge or an Opportunity?
Sampat Singhvi, PhD,MBA
Senior Director, International Regulatory Affairs
Millennium Pharmaceuticals, Inc., United States