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Recent CMC Changes in Emerging Regulatory Agencies
Session Chair(s)
Nirdosh Jagota, PhD
Managing Partner
GRQ Biotech Advisors LLC, United States
The international regulatory landscape is changing rapidly as more regulatory agencies are maturing their regulatory systems, defining their regulatory expectations, and aligning with other regulators through organizations such as ICH and PIC/S. This session will focus on recent developments in Chemistry, Manufacturing and Controls (CMC) and inspections for emerging health authorities. Invited regulatory speakers are from China’s NMPA, South Korea’s MFDS, and Russia’s Ministry of Industry and Trade. Speakers will address current regulatory changes and harmonization efforts related to dossier content, inspections, and pharmacopeia alignment.
Learning Objective : Discuss recent changes in regulations by emerging regulatory agencies; Identify efforts to harmonize regulatory systems for oversight of pharmaceutical quality.
Speaker(s)
Perspective from Korea
Younglim Kim, PhD
National Institute of Food & Drug Safety (NIFDS), Korea, Republic of
Director General
Russian Regulatory System in the Field of Medicines and its Potential Harmonization with International Requirements
Tatiana Nikolko
State Institute of Drugs and Good Practices, Russian Federation
Deputy Head of Inspections Department
Industry Perspective on China
Chi-Wan Chen, PhD
Pfizer, Inc., United States
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