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CMC Regulatory Pathways in the Emerging Markets: Focus on Asia Pacific
Session Chair(s)
Nirdosh Jagota, PHD
Managing Partner, GRQ Biotech Advisors LLC, United States
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 : Discuss the CMC regulatory challenges involved with the drug approval process in the Asia Pacific region.
Speaker(s)
Freddie Foo, MSC
Senior Regulatory Specialist, Therapeutic Products Branch, Health Sciences Authority (HSA), Singapore
Regulatory Challenges for CMC Submissions in Singapore
Gau Churn-Shiouh, DRSC
Office Director, Project Office of Sustainable Platform For Big Data In Health by MOHW, Ching-Kan, Taiwan
Perspective from Taiwan
Nirdosh Jagota, PHD
Managing Partner, GRQ Biotech Advisors LLC, United States
CMC Regulatory Landscape in China
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