Global Registration and Life Cycle Management of APIs

Art-No.: A-1169
Date: 12-14 March 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
14210Dossier Requirements for the Drug Substance038
14211Requirements for the certificate of Suitability044
14212Pharmaceutical Impurities: REsidual solvents, synthesis-derived and genotoxis impurities026
14213Stability data032
14214Workshop: Stability studies and estabilishing the restest-date014
14215Workshop: Description of the manufacturing process030
14216Workshop: The CEP prodecure - do´s and dont´s061
14218APIs Regulatory staring materials035
14219Comparison od the CEP and DMF Procedure029
14220Variations/Changes and life cycle management in the EU, US and rest of the world041
14221Registration requirements for APIs in emerging countries033
14652How to read and use a CEP053
14653Pharmaceutical Impurities041
14654Registration procedures in the US and Japan042
14655The EDQM inspection program025
14656ICH Q3D - how to do in practice for APIs040

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