CMC Management in
Regulatory Affairs

• Regulatory requirements in the EU and the ICH region
• Essential quality data for marketing authorisation
• CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary
• Management of post-approval changes
• Classification of quality related variations

Who should attend

• the compilation and the maintenance of CTD Module 3 and/or
• the classification of quality-related changes.

This training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region.
Our experts will pass on their in-depth knowledge of challenges with essential quality data, CMC writing and global lifecycle management.

The content focus is on small molecules, biologics will be addressed during another event, see seminar recommendation.

Your learning outcomes after having participated:

• Knowledge of regulatory framework in Europe and the ICH region
• Ability to choose the essential quality data for drug substance and drug product section of Module 3
• CMC writing skills
• Background knowledge in interdisciplinary field: non-clinical, GMP and clinical meets CMC
• Familiarity with life cycle management in a global environment
• The ability to classify quality-related changes

• "I liked in partictular the insights about the CMC submissions."
• "The seminar was very enlighting, lot of information that has to sit a bit, in overall the materialis about the guidlines were very helpful."
• "Very useful, complex but well structured."
• "I was aware of a few topics but still received so many new information, which was good. BPA manufacturing/specificatioin in particular was very interesting."