Global Registration and Life Cycle Management of APIs

Art-No.: A-1169
Date: 10-12 March 2020

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
14210Dossier Requirements for the Drug Substance033
14211Requirements for the certificate of Suitability045
14212Pharmaceutical Impurities: REsidual solvents, synthesis-derived and genotoxis impurities025
14213Stability data032
14214Workshop: Stability studies and estabilishing the restest-date014
14215Workshop: Description of the manufacturing process030
14216Workshop: Top Ten deficiences in new applications for certificates of Suitability for chemical purity055
14218APIs Regulatory staring materials033
14219Comparison od the CEP and DMF Procedure029
14220Variations/Changes and life cycle management in the EU, US and rest of the world042
14221Registration requirements for APIs in emerging countries033
14652How to read and use a CEP055
14653Pharmaceutical Impurities041
14654Registration procedures in the US and Japan042
14655The EDQM inspection program026
14656ICH Q3D - how to do in practice for APIs040
14805The European Active Substance Master File Procedures046

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