Forum Institut für Management GmbH

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

      Forum Institut für Management GmbH
      Online

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      Wichtige informationen

      Tipologie Seminar
      Methodologie Online
      Dauer 1 Tag
      Beginn 31.12.2019
      • Seminar
      • Online
      • Dauer:
        1 Tag
      • Beginn:
        31.12.2019
      Beschreibung

      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 was developed in July 2018.

      Einrichtungen (1)
      Wo und wann
      Beginn Lage
      31.Dez 2019
      Online
      Beginn 31.Dez 2019
      Lage
      Online

      Zu berücksichtigen

      · Verstanden. Auf geht's!

      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.

      Fragen & Antworten

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      Was lernen Sie in diesem Kurs?

      Marketing
      e-Learning

      Themenkreis

      - 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

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