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AI in Medicines Regulation: Beyond our Imagination
Session Chair(s)
Peter Richard Arlett, MD, FFPM, FRCP
Head Data Analytics and Methods Task Force
European Medicines Agency, Netherlands
In December 2023 the European Medicines Regulatory Network (EMRN) adopted a bold vision for AI in medicines regulation, for “a regulatory system harnessing the capabilities of AI for personal productivity, process automation and systems efficiency, increased insights into data and strengthened decision-support for the benefit of public and animal health”. The vision is being implemented through an ambitious workplan to 2028 organised into workstreams on Guidance, policy and product support, AI tools and technology, Collaboration and training, and experimentation. This session will explore the vision by asking the panellists and audience to imagine medicines regulation completely transformed by AI. The session will then challenge the current planning to test views on whether the actions, the organisation, the safeguards and the pace of transformation are on target.
Speaker(s)
Opportunities for AI enabled regulation – Thinking the Unthinkable
Julian Isla, MS
Foundation 29, Spain
Director
Panelist
Julian Isla, MS
Foundation 29, Spain
Director
Panelist
Karl Broich, DrMed
Federal Institute for Drugs and Medical Devices (BfArM), Germany
President
Panelist
Margi Sheth
Astrazeneca, United Kingdom
Director, Data & AI Policy, Responsible AI Champion
Panelist
Gerard van Westen, PhD, MS
Leiden Academic Centre for Drug Research, Leiden University, Netherlands
Professor Artificial Intelligence & Medicinal Chemistry
Panelist
Simon Piatek
London School of Hygiene and Tropical Medicine U. of London, United Kingdom
Digital Analytics Lead
Panelist
Gabriel Westman, DrMed, MSc
Swedish Medical Products Agency, Sweden
Head of Artificial Intelligence
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