CTD, CEP and Active Substance Master File

Published: 6-Jan-2012

17 - 18 April 2012
Course
Heidelberg, Germany

This training course is intended to provide guidance on the format, content and submission procedures for the pharmaceutical documentation of the quality of the drug substance for different types of dossiers, the CTD, the CEP and the European ASMF and the US-DMF. Furthermore, the impact of the new variations regulations will be discussed

Organiser: Concept Heidelberg

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