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

- 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 variationsThis online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Including an update on the new (Draft) ICH M4Q(R2) and the Draft of the Revision of the Classification Guideline. Take the chance to participate in our virtual seminar and get qualified.LernzieleThis 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 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.ZielgruppenThis 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.