Pharma & Healthcare / Regulatory Affairs

Common Technical Document and 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).


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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...
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Kursinhalt

  • Important information
    You will find all the important information you need to complete the e-Learning programme here.
    • First steps
    • Information on tests