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Clinical Trial Events
BIO-Europe 2026

Fireside chat Regulatory Strategy track

AI Regulations: Driving Innovation While Navigating Compliance

Wed, Nov 11, 2026 · 10:00–10:45 AM CET Regulatory Strategy Stage, Koelnmesse

About this session

How can regulators and industry create sufficient regulatory certainty to enable AI innovation?What specific regulatory obligations do companies need to meet under the current regulatory framework? How do they impact innovation in drug development?Regulatory convergence: EMA and FDA common principles for AI in medicine developmentRegulators as AI usersWhat would an innovation-enabling regulatory ecosystem look like?

Speakers

  • Mariam Jamali

    Head of Regulatory Affairs Iberia & Regulatory Policy Manager · Bayer

    Moderator

  • Frank Petavy

    Methodology and Digitalisation senior specialist · European Medicines Agency (EMA)

    Speaker

  • Marc Vandemeulebroecke

    VP, Head of Statistical Innovation · Bayer

    Speaker