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.See omnystudio.com/listener for privacy information.

Ask this episode

“What did the council decide on item 42?” — answered with the speaker and the moment.

Transcript

Related