Module 3 2019

Directives / Regulations for IMP (1)

EU : 2001/20/EC – the clinical trial directive. Implemented 2004 2005/28/EC – Good Clinical Practice GMP – 2003/94/EC (was the same for commercial) Eudralex volume 4 Especially Annex 13 Eudralex volume 10

US : 21 CFR parts 210 & 211, except Ph I Guidance for Industry documents

The Organisation for Professionals in Regulatory Affairs

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