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Virtual

Nov 15, 2023 1:00 PM - Nov 16, 2023 6:40 PM

DIA Innovating Clinical Trials in Europe

This year's must-attend virtual live conference for pharmaceutical innovators and clinical researchers alike!

Session 6: Leveraging Artificial Intelligence (AI) In Clinical Trials - Regulatory Perspectives

Session Chair(s)

Florian  Lasch

Florian Lasch

Biostatistics Specialist, Data Analytics and Methods Task Force

European Medicines Agency, Netherlands

Gunilla  Andrew-Nielsen

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

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)

Tala  Fakhouri, PhD, MPH

Reflecting on the Use of AI in Clinical Trials – the FDA Perspective

Tala Fakhouri, PhD, MPH

FDA, United States

Associate Director for Data Science and Artificial Intelligence, CDER

Gabriel  Westman, DrMed, MSc

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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