The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum

The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum

The European Federation for Exploratory Medicines Development (EUFEMED) organized a meeting in Leuven, Belgium entitled ‘The new FIH EMA guideline: Disruptive or constructive?’ to provide a forum for stakeholders to discuss the guideline’s operational impact. The revised EMA Guideline on strategies...

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Bibliographic Details
Main Authors: Kerstin Breithaupt-Grögler, Tim Hardman, Jan de Hoon, Yves Donazzolo, Sylvie Rottey, Hildegard Sourgens, Steffan Stringer
Format: Article
Language:English
Published: Frontiers Media S.A. 2019-04-01
Series:Frontiers in Pharmacology
Subjects:
early phase clinical drug development
revised first-in-human guideline
conference report
EMA (European Medicines Agency)
guidelines
EUFEMED
Online Access:https://www.frontiersin.org/article/10.3389/fphar.2019.00398/full

Internet

https://www.frontiersin.org/article/10.3389/fphar.2019.00398/full

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