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

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

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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    publication by

    Delphine Decker thumbnail
    Delphine Decker
    Director
    Florence Philippoz thumbnail
    Florence Philippoz
    Senior Director Regulatory CMC
    Jilla K. Boulas thumbnail
    Jilla K. Boulas
    Director CMC

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