CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe - Webinar von FORUM Institut für Management GmbH

- 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 variationsThis online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.

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.

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