Pharmaceutical Products Registration in United Arab Emirates
October 20, 2022

Speaker: Waqas Ali Khan

Duration: 4 hours + Q&A
WAQAS ALI KHAN
(Head / Senior Manager Regulatory Affairs)
B.Sc, MBA, Double Masters, Medical Transcription.
Current Place of Work: Qatar Pharmaceutical Industries Co. (QPI)
Country of Origin: Pakistan
Key Expertise: Regulatory Affairs & Quality Operations

  • Accomplished regulatory professional with more than 14 years of in-depth experience in the Development, Registration and Licensing of innovative and follow-on medicinal products.
  • Freelance Regulatory Consultant to the Pharmaceutical (Drugs, Medical Devices, Cosmetics, Food & Supplement) Industry as of 2020.
  • Leading Regulatory Affairs / Quality Operations Professional from Medical Transcriptionist to Head of RA, having Drug Development experience, Registration of Products within global regulatory affairs platform across the various therapeutic areas.
  • Proven scientific, regulatory and managerial expertise in driving both early development teams and full development.
  • Prove ability to lead and manage quality teams through complex global regulatory submissions and interactions with numerous global health authorities.
  • Achieved Safety, Environmental & Manufacturing licence approval for New Established Company in Asian & GCC Regions.
  • Implementation of Regulatory Affairs Management System in respect of strategic & operational activities. Standardized Effective Pre & Post Market Regulatory Activities.
  • Launched the inspection programs in the industry with the systematic collection and use of data throughout the inspection process
  • Improved product approval decisions by incorporating targets with expertise.
  • Supporting the safe use of new drugs in children through industry incentives and critical clinical data
    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)
    Registration and Cost
    Until September 30 - 150 Euro + 25 Euro for each additional participant
    From October 1 - 200 Euro + 25 Euro per additional participant
    Number of participants
    +
    Comments (promo code)