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Favourable Regulatory Procedures in The Netherlands Phase I-IIa

Published 24 September 2014 | By PRA Health Sciences

The EU Clinical Trials Directive (CTD) has been fully implemented in The Netherlands. Prior to beginning to a clinical trial, an identical Clinical Trial Application (CTA) dossier must be submitted to an accredited Ethics Committee (EC) and to the Central Commision on Research in Humans (the Competent Authority [CA] in The Nettherlands).

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Favourable Regulatory Procedures in The Netherlands Phase I-IIa