#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.

Registered attendees

AH
Aaron Holliday
Vice President, Clinical OperationsKowa Research Institute
AS
Aaron Smith
Senior Manager, Regulatory OperationsImmunocore LLC
AY
Abigail Yu
Regulatory AffairsAbbVie