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Clinical Trial Events
BIO-Europe 2026

Panel Regulatory Strategy track

Unlocking Clinical Trial Systems

Tue, Nov 10, 2026 · 4:00–4:45 PM CET Regulatory Strategy Stage, Koelnmesse

About this session

Examining the current state of EU CTR and upcoming changes under the EU Biotech ActAssessing practical impacts on regulatory approval processes and timelines for clinical trialsNavigating divergent regulatory feedback: understanding similarities and differences in how key global regulators engage with sponsors throughout the regulatory journeyCan Europe move faster without compromising confidence? How can we embrace global data, streamline approvals and maintain patient safety?

Speakers

  • Raun Kupiec

    Founder & Principal · R Kupiec Consulting

    Moderator

  • Claire Browne

    Head of Regulatory Strategy and Submissions · Parexel

    Panelist

  • Christine Mayer-Nicolai

    VP, Global Regulatory and Scientific Policy · Merck KGaA

    Panelist

  • Hannie Munnik

    Executive Director EUCAN Regulatory Affairs · AstraZeneca

    Panelist