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

29-30 Jun 2020

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 29 May

Book now

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

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


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


Ilona Putz

Ilona Putz founded PULONA Emerging Markets based in the UAE which is dedicated to creating and developing tailor-made business concepts for clients in the healthcare sector across the Middle East. She has worked in the pharmaceutical industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard and HEXAL where she has held the position of Regulatory Affairs Regional Manager, responsible for regulatory affairs and later on in commercial operations for countries in the Middle East and Africa. Between 2005 and August 2008 she was Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities.
She consults also for RegAff for the Middle East which is the only Global Specialist Regulatory Affairs company with a broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices. She spoke also for DIA (Drug Information Association) Switzerland on “Clinical Trials in the Middle East”, DIA Europe Meeting, Geneva 2011.

Book now

29-30 Jun 2020
29-30 Jun 2020 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 29 May*
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • 3M Healthcare Ltd
  • Abbott Products Operations AG
  • Abiogen Pharma S.p.A.
  • Actelion Pharmaceuticals Ltd
  • Archimedes Pharma Ltd
  • Baxter Innovations GmbH
  • Cambridge Healthcare Supplies Ltd.
  • Concept Foundation
  • GEROT Pharmazeutika GmbH
  • Gilead Sciences International
  • GlaxoSmithKline
  • Ipsen Pharma SAS
  • Janssen-Cilag
  • Kedrion SpA
  • Laboratoires EXPANSCIENCE
  • Laboratoria Qualiphar NV/SA
  • Merck Sharpe & Dohme Europe Inc
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Pharmalink Consulting Ltd
  • RB
  • Riemser Arzneimittel AG
  • Sanofi-Aventis Recherche & Developpement
  • Stiefel Labs (UK) Limited
  • UCB Pharma SA

Speakers of a very high quality. EXCELLENT.

Marianne Serritzlev, Senior Regulatory Affairs Specialist, PHARMANOVIA A/S

Speakers are definitely experts in their area and have a depth of knowledge. Well worth it if you need an update on product registration issues / processes in the region.

Zul Mamon, Senior Consultant, Responsible Person and Pharmacist, Pharma Experts Limited

Overall good

Ravi Shah, Senior RA Consultant, Atnahs

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

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

Charlie Atherton, Regulatory Affairs Assistant, Gilead Sciences International

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.

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.

Very interesting and helpful for my job

Anne-Valerie Faucher, GALDERMA Recherche & Developpement

Good and interesting

Niina Lantelankallio, Regulatory Affairs Specialist, Santen Oy

Very good

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

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

I liked it very much


Very interesting seminar

Audrey Yahiya, International Regulatory Affairs Pharmacist, Horus Pharma

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.

Excellent, thorough and comprehensive.

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