Forum Institut für Management GmbH

      e-Learning: Introduction to EU Marketing Authorisation - Principles, Procedures, Application Types and Maintenance

      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 familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe. It addresses the EU marketing authorisation procedures for the various products. It will also introduce you to post-authorisation duties.


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      Upon completion, you will be conversant with the key principles of regulatory affairs and have a good starting basis to work in this field.


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      This e-Learning was developed in May 2018.

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

      Zu berücksichtigen

      · An wen richtet sich dieser Kurs?

      Do you need basic regulatory affairs expertise since you already work in the pharmaceutical industry or plan to start working in this field? Then this e-Learning programme is the fast track to becoming knowledgeable in this field. No prior regulatory experience is required.

      Fragen & Antworten

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      Was lernen Sie in diesem Kurs?

      Marketing
      e-Learning
      IT

      Themenkreis

      - Module 1: Overview of the law and EU regulatory network - Module 2: Principles (The European Economic Area + the scope of Directive 2001/83/EC) - Module 3: Procedures (MRP, DCP, CP, Referrals) - Module 4: Application types (legal basis, CTD requirements, Generics, Herbals) - Module 5: Post authorisation (Renewals, Sunset Clause, Variations)

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