e-Learning: Common Technical Document and eCTD - including CMC requirements for marketing authorisation applications

Die Themen

- 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 submissions

Ziele

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 completely revised in August 2025.

Wer sollte teilnehmen?

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.