Forum Institut für Management GmbH

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

      Forum Institut für Management GmbH

      Preis auf Anfrage
      Möchten Sie den Bildungsanbieter lieber direkt anrufen?
      06221... Mehr ansehen

      Wichtige informationen

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

      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.

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

      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

      Teilen Sie Ihre Fragen und andere User können Ihnen antworten

      Was lernen Sie in diesem Kurs?



      - 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

      Vergleichen Sie und treffen Sie die beste Wahl:
      Mehr ansehen