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Harmonizing Regulatory Science Through the International Council for Harmonization (ICH)
Session Chair(s)
Camille Jackson
Director, Regulatory Policy; Legal and Regulatory
Flatiron Health , United States
This session will provide an overview of the ICH Association and offer insight into strategic, long-term views on advancing global convergence of regulatory science through ICH.
Learning Objective : Identify the value and benefits of global regulatory harmonization and the ICH; Discuss opportunities to advance regulatory science through ICH; Describe the current harmonization initiatives that are currently underway and the impact on global drug development.
Speaker(s)
FDA Update
Theresa Mullin, PHD
FDA, United States
Associate Center Director - CDER
EMA Update
Agnès Saint-Raymond, DrMed
European Medicines Agency, Netherlands
Head of Division International Affairs
MHLW Update
Naoyuki Yasuda, MSC
Pharmaceuticals and Medical Devices Agency, Japan