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Session 6: Leveraging Artificial Intelligence (AI) In Clinical Trials - Regulatory Perspectives
Session Chair(s)
Florian Lasch
Biostatistics Specialist, Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
Gunilla Andrew-Nielsen
Head of Clinical Trials
Swedish Medical Products Agency (läkemedelsverket), Sweden
Building on the previous session on opportunities and ethical considerations related to AI in medicines development, this session will put the spotlight on the regulatory perspectives. It will bring together an outlook on the EU strategy for AI with reflections on the use of AI in clinical trials from different regulatory perspectives.
Speaker(s)
European Strategy on AI in health care
Yiannos Tolias
Team, DG SANTE, European Commission, Belgium
Legal Lead AI and AI liability in healthcare & European Health Data Space (EHDS)
Reflecting on the Use of AI in Clinical Trials – the FDA Perspective
Tala Fakhouri, PhD, MPH
FDA, United States
Associate Director for Policy Analysis, Office of Medical Policy, CDER
Reflecting on the Use of AI in Clinical Trials from an EU Regulatory Perspective
Gabriel Westman, DrMed, MSc
Swedish Medical Products Agency, Sweden
Head of Artificial Intelligence
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