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CMC Regulatory Pathways in the Emerging Markets: Focus on Asia Pacific

Track:
Pharmaceutical Quality

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
394

Room Number:
10

Level:
Intermediate

Type:
Session

Title:
CMC Regulatory Pathways in the Emerging Markets: Focus on Asia Pacific

Chair(s):
Nirdosh Jagota, PhD
Vice President Regulatory - Small Molecules
Genentech, A Member of the Roche Group, United States

Description:
This session will cover some of the CMC challenges observed during clinical trial authorization (CTA) and market application submission in Asia Pacific countries, provide the regulatory agency perspective on some of the reasons for the complexities, and provide an industry perspective from multinational corporations on ways to tackle some of the challenges observed in the process.

Learning Objective(s):
Discuss the CMC regulatory challenges involved with the drug approval process in the Asia Pacific region.

Presentation(s) & Speaker(s):
Regulatory Challenges for CMC Submissions in Singapore
Freddie Foo, MSc
Senior Regulatory Specialist, Therapeutic Products Branch
Health Sciences Authority (HSA), Singapore

Perspective from Taiwan
Churn-Shiouh Gau, PhD, MS
Executive Director
Center for Drug Evaluation, Taiwan

CMC Regulatory Landscape in China
Nirdosh Jagota, PhD
Vice President Regulatory - Small Molecules
Genentech, A Member of the Roche Group, United States