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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Detalhes bibliográficos
Publicado no:Front Pharmacol
Main Authors: Breithaupt-Grögler, Kerstin, Hardman, Tim, de Hoon, Jan, Donazzolo, Yves, Rottey, Sylvie, Sourgens, Hildegard, Stringer, Steffan
Formato: Artigo
Idioma:Inglês
Publicado em: Frontiers Media S.A. 2019
Assuntos:
Pharmacology
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6491518/
https://ncbi.nlm.nih.gov/pubmed/31068811
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fphar.2019.00398
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