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14 November 2022

Anders Gorst-Rasmussen, Anne Willemsen, Anja Schiel, Dima Samaha, Mihai Rotaru, Lara Wolfson.
Starting in 2025, a system for HTA, not entirely unlike that of EMA for regulatory assessments, will apply to new medicinal products submitted for EMA regulatory review. The system will require manufacturers to submit an HTA evidence dossier broad enough to support each member state’s evaluation of relative effectiveness within the context of their specific healthcare system.   Is this a ripple that will matter mostly for statisticians specializing in HTA – or is it a splash that should be on all pharmaceutical statisticians radar?

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