CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe

Die Themen

- Regulatory requirements in the EU and the ICH region - Update on the new (Draft) ICH M4Q(R2) - 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

Ziele

This training will provide you with practical information on CMC requirements for marketing authorisation in the ICH region. Including an update on the new (Draft) ICH M4Q(R2), plus an overview on the Draft Revision of the Classification Guideline. 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.

Wer sollte teilnehmen?

This seminar will particularly benefit CMC managers, regulatory affairs managers and quality assurance specialists dealing with the
- the compilation and the maintenance of CTD Module 3 and/or
- the classification of quality-related changes.