ECA - CTD, CEP and Active Substance Master File / Quality of Drug Substance

Art-No.: A-458
Date: 01/02 March 2016

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6728Dossier Requirements for the Drug Substance - An Introduction035
6729How to compile an ASMF (Active Substance Master File) using the CTD format046
6730Requirements for the Certificate of Suitability062
6732Handling Variations/Changes in the EU and the US034
6733Stability Data032
6734Impurities and Residual Solvents044
6735Description of the Manufacturing Process and Process Controls041
6740Comparison of the CEP and DMF Procedure029
8804Registration requirements for APIs in emerging countries031
9339Workshop: Stability studies and establishing the restest-date014
9340Workshop: Description of the Manufacturing Process037
9341Workshop: How to compile Data for Impurities and Residual Solvents015
9342Workshop: Questions and Answers of the CEP Procedure062

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