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):
Clinical Trial Application in China
Chi-Wan Chen, PhD
Executive Director, Global CMC, Global Research & Development
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?
Nirdosh K. Jagota, PhD
Vice President and Global Head - Small Molecules
Genentech, A Member of the Roche Group, United States