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Square Brussels Convention Centre

Mar 12, 2024 9:00 AM - Mar 14, 2024 4:00 PM

Glass Entrance, Mont des Arts/Kunstberg, 1000 Brussels, Belgium

DIA Europe 2024

AI in Medicines Regulation: Beyond our Imagination

Session Chair(s)

Peter Richard Arlett, MD, FFPM, FRCP

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.


Julian  Isla, MS

Opportunities for AI enabled regulation – Thinking the Unthinkable

Julian Isla, MS

Foundation 29, Spain


Julian  Isla, MS


Julian Isla, MS

Foundation 29, Spain


Karl  Broich, DrMed


Karl Broich, DrMed

Federal Institute for Drugs and Medical Devices (BfArM), Germany


Margi  Sheth


Margi Sheth

Astrazeneca, United Kingdom

Director, Data & AI Policy, Responsible AI Champion

Gerard  van Westen, PhD, MS


Gerard van Westen, PhD, MS

Leiden Academic Centre for Drug Research, Leiden University, Netherlands

Professor Artificial Intelligence & Medicinal Chemistry

Simon  Piatek


Simon Piatek

London School of Hygiene and Tropical Medicine U. of London, United Kingdom

Digital Analytics Lead

Gabriel  Westman, DrMed, MSc


Gabriel Westman, DrMed, MSc

Swedish Medical Products Agency, Sweden

Head of Artificial Intelligence

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