Pharmaceutical Regulatory Affairs in the Middle East

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.

17-18 Jun 2019

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Course overview

Countries to be covered include: Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan Syria, UAE, Yemen

BENEFITS OF ATTENDING THIS MEETING

  • Gain an Overview of the Regulatory Environment in the Middle East
  • Understand the Economic and Cultural Background to the Markets
  • Clarify Procedures for Company and Product Registration
  • Discuss Harmonisation and Recent Developments in the Region
    • Centralised Registration in the Gulf (GCC-DR)
    • Middle East Regulatory Conference (MERC)
    • MERC Follow-up Activities
    • Industry Regulatory Groups and Activities

Why you should attend

This seminar will provide you with an essential overview of the key areas of regulatory affairs in the Middle East. This two day course will focus on practical aspects to assist with regulatory affairs in the region. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.

Who should attend

This seminar will be of particular interest to:

  • Anyone involved in pharmaceutical regulatory affairs in the Middle East
  • Anyone new to the region
  • Anyone interested in an update of recent developments

Programme

This course will cover regulatory activities in- Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE, Yemen

Each country presentation will cover the following topics:-

*The Pharmaceutical Regulatory Environment

  • Markets and Culture
  • Healthcare
  • Business Culture
  • Regulatory Environment and Characteristics
  • General Regulatory Requirements
  • Company and Product Registration
  • Variations and Renewals
  • Drug Classification
  • Regulatory Summary

Economic Overview of the Middle East

  • Population and GDP per capita
  • Unemployment rate
    GDP Real Growth Rate
    • Inflation Rate
    • Healthcare spend per capita

Following the country presentations, there will be presentations updating on developments in the Middle East as a region

Harmonisation and Recent Developments in the Region

  • Centralised Registration in the Gulf (GCC-DR)
  • Middle East Regulatory Conference (MERC)
  • MERC Follow Up Activities
  • Industry Regulatory Groups and Activities

Discussion will take place throughout the 2 days

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17-18 Jun 2019
17-18 Jun 2019 Venue not yet confirmed
+ VAT @ 20.00%
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Previous customers include...

  • 3M Healthcare Ltd
  • Abbvie
  • Actavis Group PTC ehf
  • Actelion Pharmaceuticals Ltd
  • Aegis Ltd
  • Alfred E Tiefenbacher GmbH & Co KG
  • Almirall S.A.
  • Aspen Healthcare FZ LLC
  • Astellas Learning Center
  • Baxter Innovations GmbH
  • Biogen IDEC Ltd
  • Biomarin Pharmaceutical Turkey
  • Bristol-Myers Squibb
  • Business Monitor International Ltd
  • C.B. FLEET COMPANY INC
  • Centocor BV
  • CERTIFIED OILFIELD RENTALS
  • Chiesi Farmaceutici SPA
  • CRANFIELD UNIVERSITY
  • Janssen-Cilag Egypt
  • Laboratoires Bailleul
  • Leadiant Biosciences
  • Macarthys Laboratories Ltd
  • Mundipharma Research Ltd
  • Novo Nordisk Saglik Urunleri Tic Ltd Sti
  • Prostrakan Group Ltd
  • Riemser Arzneimittel AG
  • Shafayab Gostar
  • Shire International GmbH
  • Valeant Pharma Switzerland GmbH

The course was very good and gave a comprehensive overview of the regulatory requirements within the Middle East region. This coupled with the experience and knowledge of the two presenters who were able to give their advice on specific enquiries..

Shane Freeth, Regulatory Associate, RB

Very interesting and helpful for my job

Anne-Valerie Faucher, , GALDERMA Recherche & Developpement

Very good

Marie Bailey, Regulatory Affairs Manager, Wockhardt (UK) Ltd

Good and interesting

Niina Lantelankallio, Regulatory Affairs Specialist, Santen Oy

I liked it very much

ROSA URZAY, TECHNICIAN, FAES FARMA, S.A.

It has been the best course I attended, focused on the topics, effective and clear. It will be very useful for the ongoing working activities.

Francesca Porchia, Regulatory Affairs Specialist , Abiogen Pharma S.p.A.

Very interesting seminar

Audrey Yahiya, International Regulatory Affairs Pharmacist, Horus Pharma

Excellent, thorough and comprehensive.

Emily-Jane Bowles, Regulatory Liaison, EEMEA, MSD Europe Inc.