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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 will provide an analysis of the evolving regulatory landscapes governing artificial intelligence in drug development in the United States and the European Union. Attendees will gain a clear understanding of how differing regulatory approaches foster innovation and compliance.
Learning Objective : Compare and contrast the regulatory frameworks for AI in drug development in the US and EU; Assess regulatory approaches to spur innovation while maintaining patient safety; Identify best practices for navigating regulatory challenges associated with AI technologies across medical product development and areas of potential EU-US convergence.
Speaker(s)
Panelist
Representative Invited
FDA, United States
Panelist
Representative Invited
European Medicines Agency, Netherlands
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