A brave new Europe with the introduction of the EU Clinical Trials Directive: Impact upon the pharma industry and academic research with special emphasis on pharmacovigilance

Issue  JCB, Volume 11, Number 1, 2004  Article 

Graeme Ladds

DOI:https://doi.org/10.5912/jcb100


Abstract:

1st May, 2004, saw the national implementation of the EU Clinical Trials Directive (2001/20 EEC). Additionally, Europe changed from 15 to 25 member states, all implementing the Directive nationally at the same time and all being affected by the many and varied aspects covered in the Directive. The paper looks at the new changes to European clinical trials and what this will mean for the pharmaceutical industry and research academia alike, especially in relation to safety reporting and risk/benefit assessments.

Keywords:clinical trials ,Directive ,pharmacovigilance ,electronic submissions ,SUSARs ,en ,

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