Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

BACKGROUND: In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe. METHODS: We conducted a survey in order to identify th...

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Detalhes bibliográficos
Main Authors: Gluud, Christian, Kubiak, Christine, Whitfield, Kate, Byrne, Jane, Huemer, Karl-Heinz, Thirstrup, Steffen, Libersa, Christian, Barraud, Béatrice, Grählert, Xina, Dreier, Gabriele, Geismann, Sebastian, Kuchinke, Wolfgang, Temesvari, Zsuza, Blasko, Gyorgy, Kardos, Gabriella, O'Brien, Timothy, Cooney, Margaret, Gaynor, Siobhan, Schieppati, Arrigo, de Andres, Fernando, Sanz, Nuria, Kreis, German, Asker-Hagelberg, Charlotte, Johansson, Hanna, Bourne, Sue, Asghar, Adeeba, Husson, Jean-Marc, Demotes-Mainard, Jacques
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2012
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC3338370/
https://ncbi.nlm.nih.gov/pubmed/22452964
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/1745-6215-13-27
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