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Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?
Hans-Georg Eichler1, Nicola Bedlington2, Mathieu Boudes3
1European Medines Agency (EMA), London, UK.
Abstract:
Medicines Adaptive Pathways to Patients (MAPPs) seeks to foster access to novel beneficial treatments for the right patient groups at the earliest appropriate time in the product life-span, in a sustainable fashion. We summarize the MAPPs engagement process and critical questions to be asked at each milestone of the product life-span. These considerations are of relevance for regulatory and access pathways that strive to address the "evidence vs. access" conundrum.
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