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Drug Assessment for Regulatory and HTA Purposes: Similarities and Differences, the Way Forward
Session Chair(s)
Mira Pavlovic, DrMed, MD, MS
HTA Expert /Director/HTA Professor
NDA Advisory Services, Medicines Development and Training (MDT) Services, France
This session will explain similarities & differences about regulatory and HTA requirements to support product authorization and access to market, as well as the concept of added therapeutic benefit both from regulatory and HTA points of view.
Learning Objective : Learn about similarities & differences in regulatory & HT assessment process, relative to patient population, intervention, comparators & outcomes (endpoints); learn how to best design a trial especially with regards to the choice of endpoints & comparators; learn about different types of consultations in EU & how to choose the most appropriate one to support product development & access to market
Speaker(s)
Panelist
Marie Manley
Sidley Austin LLP, United Kingdom
Partner, Head of EU and UK Life Sciences (UK)
Panelist
Jean-Hugues Trouvin
Afssaps, France
Director
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