Clinical Trials in the EU/EEA: focus on CMC aspects

Published on: Sept 30, 2013

Clinical Trials in the EU/EEA- Focus on CMC Aspects

Clinical trials testing the Benefit/Risk ratio of Investigational Medicinal Products (IMPs) in the European Union/European Economic Area (EU/EEA) are governed currently by Directive 2001/20/EC. This has led to different requirements amongst the Competent Authorities (CAs) and Ethics Committees (ECs) of each concerned MS.

Jilla Boulas, Delphine Decker, Valerie Pimpaneau, Florence Philippoz

2013 – Pharmaceutical Outsourcing

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Clinical Trials in the EU/EEA: focus on CMC aspects

Published on: Sept 30, 2013

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