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Day 4
06 December 2024
The International Council for Harmonisation (ICH) day
07:30 - 08:30 CET
ICH: Driving global harmonization to advance global health
Speakers
Moderator
Kum Cheun Wong
Head Asia Pacific Regulatory & Development Policy, Novartis Asia Pacific Pharmaceuticals Pte Ltd
Speakers
Su Jin Kong
Representative to ICH and international regulatory affairs, Ministry of Food and Drug Safety (MFDS), Republic of Korea
Angelika Joos
Executive Director, MSD
08:30 - 09:30 CET
eCTD Harmonization in Asia: Unlocking benefits of standardized submissions
Speakers
Moderator
Wei Chuen Tan-Koi
Lead of Regulatory Systems Strengthening, Centre of Regulatory Excellence, Duke-NUS Medical School
09:30 - 10:30 CET
Advancing clinical trials: The impact of E6(R3) guideline
Speakers
Moderator
Sally (Ping) Zhang
Executive Director, Head of R&D Quality Assurance APAC, AstraZeneca
Panelists
Dr Bo Fu
Head, Biostatics and Programming, Astellas China, Astellas
Dr Hideyuki Kondo
Head of Immunology, Regulatory Affairs Japan, Novartis Pharma K.K.