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Clinical Trial Events
BIO-Europe 2026

Fireside chat Regulatory Strategy track

Addressing Unmet Medical Needs in Europe’s Evolving Pharmaceutical Landscape

Tue, Nov 10, 2026 · 10:30–10:55 AM CET Regulatory Strategy Stage, Koelnmesse

About this session

Regulatory pathways and benefits available for unmet medical need targeted products, and how can they accelerate development and approval? How do you define unmet medical needs and that are the thresholds? Navigating the challenge of variable regulatory interpretations across diseases and therapeutic areas Case study insight into different conditions and how they qualify for Unmet Need Have the changes in the GPL really moved the needle when it comes to stimulating development for unmet medical needs?

Speakers

  • Sara Escola

    Regulatory Affairs Europe Head · PTC Therapeutics

    Speaker

  • Stefano Romanelli

    Government Affairs Associate Director · EUCOPE

    Speaker