Pharmaceutical Products Registration in United Arab Emirates

Pharmaceutical Products Registration in United Arab Emirates

Details

  • Start date: 20 October 2022
  • Start time: 10:00 (Kyiv)
  • Finish date: 20 October 2022
  • Finish time: 14:00 (Kyiv)
  • Duration: 4 hours + Q&A session
  • Break: yes
  • Category: Registration of medicines
  • Format: Streaming
  • Online broadcast available: yes
  • Venue: Online
  • Language class: English
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    PROGRAM

    The Key Topic of Pharmaceutical Products Registration in United Arab Emirates.

    1. Introduction (Overview of the Process)

    2. Letter of Authorization (In this section we will start our registration process by preparing the LOA, how it looks like? how to prepare it? legalized or notarized? and its validity)

    3. eCTD (This section is the introduction towards the e-CTD the actual shift from the CTD to the e-CTD with the MOH of the UAE, with deep focus on M1)

    4. Module # 01 - M1 (In this section we will dive deeply in M1, review it's checklist, and how to prepare that list, how to build up the eCTD dossier tree using the XML backbone file type)

    5. MOHAP e-Transformation (In this section we will go deeper into the registration process, we will explore together the MOHAP e-Transformation system, the actual manual)

    6. MOHAP- Drug Registration (In this section we will start the drug registration process with the MOHAP e System)

    7. Attachments (In this section we will review together the actual attachments to the MOHAP e system)

    8. The Renewal (In this section, we will continue with the renewal through the MOHAP e System)

    9. Actual Applications (In this section we will practice the actual forms, renewal forms for the site and the medicinal product as well)

    10. Variations (In this section, we will continue with MOHAP e System with the variations)

     

    COST
    Until September 30 - 150 Euro + 25 Euro for each additional participant
    From October 1 - 200 Euro + 25 Euro per additional participant

Speakers