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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)
Yiannos Tolias
Legal Lead AI and AI liability in healthcare & European Health Data Space (EHDS), Team, DG SANTE, European Commission, Belgium
European Strategy on AI in health care
Tala Fakhouri, PHD, MPH
Vice President, AI & Digital Policy, Real-World Research, Parexel International, United States
Reflecting on the Use of AI in Clinical Trials – the FDA Perspective
Gabriel Westman, MD, PHD, MSC
Head of Artificial Intelligence, Swedish Medical Products Agency, Sweden
Reflecting on the Use of AI in Clinical Trials from an EU Regulatory Perspective