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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information