#442: The State of Artificial Intelligence in Regulatory Review and Decision-Making: Perspectives from FDA, EMA, MHRA, and PMDA
Monday, June 15, 2026 2:30 PM to 3:30 PM · 1 hr. (America/New_York)
204AB
03: Data-Tech-AI08: RegPolicy-Strategy-GlobalCollaboration
Information
Senior leaders from FDA, EMA, MHRA and PMDA 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.
CE
ACPECMERN
Session Level
Intermediate
Featured Topics
Artificial Intelligence
Learning Objectives
Discuss how AI is transforming regulatory review and decision-making at FDA, EMA, MHRA, and PMDA; 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.
Speakers
Jingyu (Julia) Luan
Executive Regulatory Science DirectorAstraZenecaJBJ
Joaquim Berenguer Jornet
AI Implementation lead, Digital Business Transformation Task ForceEuropean Medicines AgencyJL
Jin-Zhong Liu
Deputy Office Director, Office of Drug Evaluation Sciences, OND, CDERU.S. Food and Drug AdministrationTN
Tomoharu Numanyu
Senior Reviewer, Office of New Drug IPharmaceuticals and Medical Devices Agency (PMDA)