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Pharmaceutical Regulatory Affairs in the Middle East Training Course

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

14-15 Dec 2022

& 24-25 Apr 2023 , 19-20 Jul 2023 , 11-14 Dec 2023

Book or reserve now

Details

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

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

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

Programme

Introduction to Regulatory Affairs in the Middle East

General overview on the following topics:

  • Markets and culture
  • Healthcare
  • Business culture
  • Regulatory environment and characteristics
  • General regulatory requirements
  • Company and product registration
  • Variations and renewals
  • Pharmacovigilance
  • 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

Saudi Arabia

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

Bahrain

Qatar

Oman

Kuwait

Yemen

UAE

Egypt

Sudan

Libya

Syria

Lebanon

Jordan

Iran

Iraq

Palestine

Israel

Local trade associations

MERC

Presenters

Ilona Putz (More...)

Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including regulatory consultancy for international manufacturers in the healthcare sector across the Middle East. Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, HEXAL and Sandoz where she was the Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities. She also consults for RegAff, Emergo and Dr. Regenold GmbH for the Middle East. Ilona spoke during the DIA Europe Meeting on “Clinical Trials in the Middle East” and at the Global Pharmaceutical Regulatory Affairs Summit 2021.

Heba Hashem (More...)

Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk.

Heba is now the Middle East and Africa Associate Director at PPD where she is providing regulatory consulting services and training to Health Care companies.

Book now

Book or reserve now

NEW higher discounts for booking multiple places - bring your colleagues to make your training budget go further:
30% off the 2nd delegate; 40% off the 3rd delegate; 50% off the 4th delegate

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
14-15 Dec 2022
Live webinar
09:00-16:45
UK (London)
14-15 Dec 2022
Live webinar
09:00-16:45
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 9 Nov*
Enrol now
to attend Live webinar
24-25 Apr 2023
Live webinar
09:00-16:45
UK (London)
24-25 Apr 2023
Live webinar
09:00-16:45
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 20 Mar 23*
Enrol now
to attend Live webinar
19-20 Jul 2023
Face-to-face, Rembrandt Hotel London
09:00-17:15
UK (London)
19-20 Jul 2023
Face-to-face
Rembrandt Hotel London
09:00-17:15
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 14 Jun 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
11-14 Dec 2023
Live webinar
13:00-16:45
UK (London)
11-14 Dec 2023
Live webinar
13:00-16:45
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 6 Nov 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbvie
  • Amdipharm Mercury Company Limited
  • Aspen Healthcare FZ LLC
  • Astellas Learning Center
  • Astellas Pharma JLT
  • Boehringer Ingelheim Middle East Regional Office
  • CHIRON BV
  • CRANFIELD UNIVERSITY
  • Edwards Lifesciences AG
  • Genus Pharmaceuticals Ltd
  • GEROT Pharmazeutika GmbH
  • GRIFOLS S.A.
  • Gulf Pharmaceutical Industries Julphar
  • H Lundbeck AS
  • Health Authority
  • Laboratoires EXPANSCIENCE
  • Leo Pharma A/S
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Molnlycke Healthcare
  • N.V. Organon
  • Niche Generics Limited
  • Novo Nordisk Saglik Urunleri Tic Ltd Sti
  • Nutriad International BV
  • Nutricia Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Sandoz GmbH
  • Septodont
  • Statens Serum Institut
  • Wockhardt UK Limited
  • Zentiva ks

Very useful explanation of Egypt, great implication of the lecturers and fantastic interaction of the whole group

Marina Vaquerizo, Regulatory Affairs Officer , Faes Farma, S.A, Jun 22

Both [speakers] are very nice and supportive.

Caroline Sell, Merz Therapeutics GmbH, Jun 22

Content 9/10, presentation 8/10 (live would be better). speaker 9/10

Caroline Sell, Merz Therapeutics GmbH, Jun 22

I wanted to learn more about regulations in the middle east and the content was definitely very informative. The speakers had a lot of knowledge, there were a few technical issues however these were quickly resolved.

Hafsa Khan, Regulatory Associate, Gilead Sciences International Ltd, Jun 21

Overall it was a good informative webinar. Content was detailed.

Tarak Patel, Regulatory Affairs Manager, Syri Limited, Jun 21

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, Jun 19

Speakers of a very high quality. EXCELLENT.

Marianne Serritzlev, Senior Regulatory Affairs Specialist, PHARMANOVIA A/S, Jun 19

Simply one of the best courses I have ever attended! It is so obvious that the speakers are highly experienced and have a huge knowledge regarding the region.

Nermin Ipek, Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc, Jun 18

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., Jun 18

Good introduction.

Mark Pellett, Associate Director, Biogen Idec Ltd, Jun 18

Valuable training.

Rouba Rahi, Medical Pharmacovigilance & Regulatory Officer, Modern Quality Est., Jun 18

Really good course, gives a general overview of all countries

Carlota Coll, Regulatory Affairs Expert, GALENICUM HEALTH, S.L., Jun 18

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

Charlie Atherton, Regulatory Affairs Assistant, Gilead Sciences International, Jun 18

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

Shane Freeth, Regulatory Associate, RB, May 17

Very good!

Marie Bailey, Regulatory Affairs Manager, Wockhardt (UK) Ltd, May 17