Pharmaceutical Regulatory Affairs in the Middle East

Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and Yemen

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 and will cover the regulatory requirements and developments in the individual countries as well as discuss harmonisation in the region.

Benefits of attending:

  • 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

Book both

This meeting runs back-to-back with our Medical Device Regulations in the Middle East and North Africa 19-20 June 2019, and there is a further £200/€280 discount when booked together.

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Who should attend?

This seminar will be of particular interest to:

  • Personnel involved in pharmaceutical regulatory affairs in the Middle East
  • Anyone new to the region
  • All those interested in an update on 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 – with individual presentations on:

  • Bahrain
  • Egypt
  • Iran
  • Iraq
  • Israel
  • Jordan
  • Kuwait
  • Lebanon
  • Libya
  • Oman
  • Palestine
  • Qatar
  • Saudi Arabia
  • Sudan
  • Syria
  • UAE
  • Yemen

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.

You may also be interested in

Previous customers include...

  • Actelion Pharmaceuticals Ltd
  • Astellas Pharma JLT
  • Atrexfi
  • Biogen IDEC Ltd
  • BioMarin Pharmaceutical Inc
  • Britannia Pharmaceuticals Ltd
  • Casen Recordati SL
  • Espicom Business Intelligence
  • Farmaprojects S.A.
  • Guerbet
  • GW Pharmaceuticals Limited
  • Health Authority
  • Janssen Cilag Ltd
  • Kedrion SpA
  • Mentholatum Co Ltd
  • Merck Sante s.a.s.
  • Met P Pharma AG
  • Modern Quality Est.
  • Octapharma Pharmazeutika Prod.Ges.m.b.H.
  • Pharma Experts Limited
  • Pharmaniaga Berhad
  • Reckitt Benckiser
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Sandoz GmbH
  • Sandoz International GmbH
  • SANOFI PASTEUR INC
  • Sanofi Pasteur SA
  • Seven Seas Limited
  • Shire International GmbH
  • STADA Arzneimittel AG

Great speakers and happy to answer any questions. Very knowledgable.

Charlie Atherton, Regulatory Affairs Assistant, Gilead Sciences International

Good introduction

Mark Pellett, Associate Director, Biogen Idec Ltd

Really good course, gives a general overview of all countries

Carlota Coll, Regulatory Affairs Expert, GALENICUM HEALTH, S.L.

Great speakers - it was possible to ask every question. Great country specific knowledge regarding the guidelines (all up-to-date).

Sabrina Waitz, International Drug Regulatory Affairs Manager, Octapharma Pharmazeutika Prod.Ges.m.b.H.

It is a valuable training

Rouba Rahi, Medical Pharmacovigilance & Regulatory Officer, Modern Quality Est.

It is so obvious that the speakers are highly experienced and have a huge knowledge regarding the region, but some of the presentations were a bit complicated to follow. Simply one of the best courses I have ever attended!

Nermin Ipek, Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc

Very interesting and helpful for my job

Anne-Valerie Faucher, , GALDERMA Recherche & Developpement

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 good

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

Good and interesting

Niina Lantelankallio, Regulatory Affairs Specialist, Santen Oy

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.

I liked it very much

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