Course No 20254
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Dossier Requirements for the Drug Substance – An Introduction
Requirements for the Certificate of Suitability to the European Pharmacopoeia
The European Active Substance Master File Procedure
Pharmaceutical Impurities: Residual Solvents, Synthesis-derived and Genotoxic and Elemental Impurities
How to Read and Use a CEP
API Regulatory Starting Materials: how to Defend their Choice in a Submission
Comparison of the CEP and DMF Procedure
Registration Procedures in the US and Japan – what are the Differences?
The EDQM Inspection Program
Three Case Studies
Stability Studies and Establishing the Retest Date
Cristian Jimenez Sala
Description of the Manufacturing Process
Dr Wilhelm Schlumbohm
Top ten Deficiencies in new Applications for Certificates of Suitability for Chemical Purity
Dr Alma Kiso
In order to prepare the lectures and the Case Studies in an optimal way, please send your questions to special topics prior to the Live Online Training to Ms Anne Günster, firstname.lastname@example.org
She will forward your questions to the responsible speaker. Thank you in advance for your co-operation.
Registration Requirements for APIs in Emerging Countries
Variations/Changes and Life Cycle Management: in the EU, US and Rest of the World
Regulatory Procedures in Brazil and China