Malina Müller: Rethinking Accelerated Approvals in Europe
In this episode of the Vital Health Podcast, host Duane Schulthess speaks with Dr. Malina Müller, Head of Health Economics at WifOR Institute, to explore the heated debate around accelerated and conditional approvals in Europe, how demographic and budget pressures shape HTA decisions, the tradeoffs between surrogate endpoints and overall survival, the challenges of using real world evidence under GDPR, and the broader pricing and competitiveness threats facing Europe’s life science ecosystem.
Key Topics:
Accelerated Approvals: Uncertainty versus early access, conditional pathways…
The skinny
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