Application challenges of the new EU Clinical Trials Regulation.

Purpose: The purpose of this paper is to discuss the challenges of the upcoming policy change in the field of clinical drug trials due to the shift from the Clinical Trials Directive 2001/20/EC to the new Clinical Trials Regulation 536/2014, adopted in 2014. Although it is expected that the new EU C...

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Publicado en:European Journal of Clinical Pharmacology Vol. 73; no. 7; pp. 795 - 799
Autores principales: Gefenas, Eugenijus, Cekanauskaite, Asta, Lekstutiene, Jurate, Lukaseviciene, Vilma
Formato: Journal Article
Publicado: Springer Nature Jul2017
Acceso en línea:Ver este registro en EBSCOhost