Key Requirements affecting Clinical Trials In Europe 5th Edition

This publication combines the key requirements and guidelines with a unique subject index that allows the user to search for the appropriate sections using key words. It brings together the globally accepted ICH GCP E6(R2) guidelines, the three major EU Directives affecting clinical trials – Directive 2001/20/EC (including amendments since 2001), Directive 2005/28/EC, Directive 2003/94/EC – Annex 13 (July 2010) relating to investigational medicinal products and both the 1996 and 2013 versions of the Declaration of Helsinki.

 

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