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. - 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.