Talk Data Science, RWE & Artificial Intelligence track
S0301 - AI in Medicines Development: Making it Happen - Part 1: A European Viewpoint
Tue, Mar 18, 2025 · 1:30–2:40 PM CET San Francisco Room, Congress Center Basel
About this session
This session will follow on from two sessions at DIA Europe 2024 which focused on the regulatory framework for AI in the medicines development lifecycle. Speakers will, dive more deeply into specific AI applications being utilised by the industry and regulatory authorities . Industry speakers will cover AI applications within the clinical trials and Pharmacovigilance settings (as two of the more prominent areas of medicines development where AI is being explored, and a focus of upcoming EMA guidance on AI), and the EMA/EMRN will discuss how they are also using AI methods and approaches in their work as regulators.
The speakers will then discuss their experiences across the development and implementation of these applications in terms of lessons being learnt, what challenges are being faced, and what considerations they have for further development of EU guidance and policy which could help facilitate responsible, safe and ethical use of AI in this specific area of medicines development.
Programme:
- Panel Discussion — Milana Trucl, Nadia Terranova, Luis Pinheiro, Nicolas Loeffler-Perez
- 3. EMA AI Policy Current State of Play — Luis Pinheiro
- 2. Patient Perspectives on AI — Milana Trucl
- 4. AI Sandboxes at Swissmedic — Nicolas Loeffler-Perez
- 5. Industry Use Cases in Model-Informed Precision Medicine — Nadia Terranova
- 1. Introduction — Susan Sandler
Speakers
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Director, EMEA Policy Lead, Global regulatory Policy & Intelligence · Johnson & Johnson
Chair
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Head of Advanced Data Science, Data Sciences · Merck KGaA, Darmstadt, Germany (EMD Serono, US)
Speaker
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Senior Epidemiology Expert, RWE, Data Analytics and Methods Taskforce · European Medicines Agency
Speaker
