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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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Detalles Bibliográficos
Autores principales: Breithaupt-Grögler, Kerstin, Hardman, Tim, de Hoon, Jan, Donazzolo, Yves, Rottey, Sylvie, Sourgens, Hildegard, Stringer, Steffan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6491518/
https://www.ncbi.nlm.nih.gov/pubmed/31068811
http://dx.doi.org/10.3389/fphar.2019.00398