e-Learning: Common Technical Document and eCTD - including CMC requirements for marketing authorisation applications - E-Learning von FORUM Institut für Management GmbH

- CTD principles and structure - Format and content of Module 1 - 5 CTD - CMC data required for Module 3 (drug substance and drug product) - Dossier requirements for generics and further abridged procedures - Dossier requirements for ASMF and CEP submissionsDo you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.

This e-Learning programme will provide you with detailed knowledge on the structure and content of the (electronic) common technical document - the only valid dossier format for marketing authorisation applications for human pharmaceuticals in the ICH region.- It will address full as well as abridged dossier application formats, enabling participants to select the data necessary for each application type.Module 3 requirements will be addressed in depth (drug substance and drug product data requirements).- This e-Learning was developed in July 2018 and was completely revised in August 2022.

Do you need expertise in CTD and eCTD? Then this e-Learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required. It can be also used as a refresher course providing in depth knowledge with regards to CMC requirements.