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Evolving Artificial Intelligence Regulatory Landscape in Drug Development Across US and EU
Session Chair(s)
Junyang Wang, MSC
Global Regulatory and Scientific Policy
EMD Serono, United States
This session examines evolving US and EU regulatory approaches to AI in drug development and explores how policy expectations are translated into real world GxP implementation. Attendees will gain insight into regulatory convergence, operational challenges, and good practices for compliant AI adoption.
Learning Objective : Compare and contrast US and EU regulatory frameworks governing AI use across the drug development lifecycle; Assess how regulatory expectations and emerging convergence efforts translate into practical implementation challenges; Identify good practices for operationalizing AI within GxP quality systems while maintaining compliance and innovation.
Speaker(s)
Panelist
Martin Benedikt Heitmann, MS
International Society for Pharmaceutical Engineering (ISPE), Germany
Volunteer – ISPE GAMP Guide Artificial Intelligence Co-Lead, Secretary of the GA
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
European Medicines Agency, Netherlands
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