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

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 nati...

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Bibliographic Details
Main Authors: Eva van Doorn, Eelko Hak, Bob Wilffert
Format: Article
Language:English
Published: MDPI AG 2015-04-01
Series:Vaccines
Subjects:
clinical trial
vaccine
directive 2001/20/EC
approval documentation
Online Access:http://www.mdpi.com/2076-393X/3/2/263

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