Marketing Authorisation Documents in the EU - Dossier compilation and electronic submission

- Module 1 and 2 of the Marketing authorisation dossier - The SmPC and package leaflet - Chemistry, manufacturing and controls (CMC) - Module 3 - Compilation of non-clinical and clinical data in Modules 4 and 5 - eCTD and electronic submission requirementsThis seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and Modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.LernzieleThis seminar aims to provide participants with a comprehensive understanding of the marketing authorisation dossier and its components.- By focusing on the Common Technical Document (CTD) structure and the electronic submission process, participants will gain essential insights into compiling and submitting drug approval documents in the EU.- The seminar also addresses common errors and authority findings to ensure successful applications.ZielgruppenThis seminar is ideal for professionals involved in the drug approval process needing in-depth knowledge of marketing authorisation documents and submission. Basic knowledge of European marketing authorisation procedures is recommended.