In this episode of the Vital Health Podcast, host Duane Schulthess speaks with two experts in European regulation and evidence of new medicines:

• Steffen Thirstrup: Chief Medical Officer at European Medicines Agency.
• Richard Bergstrom: Head of Policy at IQVIA.

They compare regulatory benefit-risk decisions with HTA’s comparative effectiveness and economics, unpack the role of conditional versus accelerated approvals, debate surrogate endpoints versus overall survival, and explore how real-world evidence, patient experience data, and joint scientific advice can make adaptive approaches workable across Europe, including through the European Health Data Space and joint clinical assessments.

Key Topics

• Regulatory Versus HTA: Benefit-risk focus, added benefit comparisons, joint clinical assessments.
  
• Conditional Approvals: Surrogate endpoints, confirmatory commitments, withdrawal, or label narrowing.
  
• Endpoints & Outcomes: Overall survival pressure, validated biomarkers, patient experience relevance.
  
• Real-world Evidence: Registries and randomized rollout, data quality limits, outcomes-based contracting lessons.
  
• Adaptive Pathways & Data Space: Early joint advice, platform and sandbox tools, European Health Data Space.

Opinions expressed are those of the speakers.

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