National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC

Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in natio...

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Detalles Bibliográficos
Autores principales: van Doorn, Eva, Hak, Eelko, Wilffert, Bob
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2015
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4494354/
https://www.ncbi.nlm.nih.gov/pubmed/26343188
http://dx.doi.org/10.3390/vaccines3020263

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4494354/
https://www.ncbi.nlm.nih.gov/pubmed/26343188
http://dx.doi.org/10.3390/vaccines3020263

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