Pharmaceutical Regulatory Affairs in the Middle East, Dubai

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

Course Overview

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

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

Why you should attend

  • 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
  • Opportunities to meet, network and share experiences with other industry colleagues

Who should attend

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

Programme

Economic overview of the Middle East

  • Population and GDP per capita
  • Unemployment rate
  • GDP real growth rate
  • Inflation rate
  • Healthcare spend per capita

The pharmaceutical regulatory environment in the Middle East – individual presentations will be given on the following
regions:

  • Bahrain
  • Egypt
  • Iran
  • Iraq
  • Kuwait
  • Lebanon
  • Libya
  • Oman
  • Palestine
  • Qatar
  • Saudi Arabia
  • Sudan
  • UAE
  • Yemen
  • Syria
  • Jordan
Each regional presentation will cover:
  • Markets and culture
  • Healthcare
  • Business culture
  • Regulatory environment and characteristics
  • General regulatory requirements
  • Company and product registration
  • Variations and renewals
  • Regulatory summary
  • Practical advice on registration in each region
Harmonisation and Recent Developments
  • Centralised registration in the Gulf
    • Gulf Central Committee for Drug Registration (GCC-DR)
    • SGH Tender
  • Middle East Regulatory Conference (MERC)
  • MERC follow up activities
  • Industry regulatory groups and activities
  • Local trade associations

Final Discussion and Objectives Review

Book now

We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.

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Previous customers include...

  • Aspen
  • Cesra Arzneimittel GmbH & Co. KG
  • Eli Lilly SA
  • Minamas Company
  • MS Pharma Jordan
  • Novo Nordisk A/S

Very informative, good discussions, details etc

Lizzie Bejstrup Nielsen, Senior Regulatory Country Coordinator, Novo Nordisk A/S

Everything was excellent.

Majed Almajed, RA Associate, Aspen

So helpful and useful

Badr Mohammed Arafah, Manager, Eli Lilly SA

Good overview and easy to understand

Benedicte Brask, Senior Regulatory Country Coordinator, Novo Nordisk A/S

So helpful and useful

Badr Mohammed Arafah, Manager, Eli Lilly SA

It was very good.

Lizzie Bejstrup Nielsen, Senior Regulatory Country Coordinator, Novo Nordisk A/S

It was an interesting [and] helpful experience.

Raghad Mousa, RA Officer, MS Pharma Jordan

Everything was excellent

Majed Almajed, RA Associate, Aspen

The course and everything was very good, enjoyable and helpful

Raghad Mousa, RA Officer, MS Pharma Jordan