Pharma & Healthcare / Regulatory Affairs
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).


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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
  • Module 1: CTD basic structure
     Content: ICH and the origin of the CTD General aspects of the CTD EU legislation - Eudralex - Notice to applicants CTD Modules 1-5 electronic CTD = eCTD Learning objectives: ...
  • Module 2: Organisation and content of the CTD Modules
    Content: Information "flow" in the CTD triangle Module 1 - Regional and Administrative documents (EU focus) Module 2 - Overviews and Summaries Module 3 - Quality (headings only) Module 4 ...
  • Module 3: Dossier considerations for Generics and other "un-complete" application types
    Content: Application Types Data Exclusivity Article 8(3) Full Application Article 10: Generic, Hybrid or Similar Biological Applications 10a Well Established Use Applications 10b (New) Fi...
  • Module 4: Details on CTD Module 3 & considerations for ASMF and CEP filings
    Content: Module 4a: Introduction CTD Module 3 structure Guidelines applicable Module 4b: Drug Substance CTD Module 3 drug substance data requirements Module 4c: ASMP &am...
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