e-Learning: Common Technical Document & eCTD

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.
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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).
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This e-Learning was developed in July 2018 and completely updated in August 2022.

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