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The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, PMDA, and CDE
Session Chair(s)
Jingyu (Julia) Luan, PHD
Executive Regulatory Science Director
AstraZeneca, United States
Senior leaders from FDA, EMA, PMDA, and CDE share insights on AI’s evolving role in regulatory review & decision-making. Attendees will explore current practices, key challenges, and future opportunities for AI in shaping global regulatory frameworks.
Learning Objective : Discuss how AI is transforming regulatory review and decision-making at FDA, EMA, PMDA and CDE; Analyze key challenges and opportunities facing AI adoption in regulatory review and decision-making; Identify emerging trends and future directions for AI in shaping global regulatory practices.
Speaker(s)
Panelist
Representative Invited
FDA, United States
Panelist
Tomoharu Numanyu
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewe, Safety II
Panelist
Representative Invited
European Medicines Agency, Netherlands
Panelist
Representative Invited
National Medical Products Administration (NMPA), China
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