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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

15-16 Dec 2021

& 29-30 Jun 2022 , 14-15 Dec 2022

Book 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 now

15-16 Dec 2021
Live webinar
15-16 Dec 2021
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 10 Nov*
Enrol now
to attend
Live webinar
29-30 Jun 2022
Live webinar
29-30 Jun 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 25 May 22*
Enrol now
to attend
Live webinar
14-15 Dec 2022
Live webinar
14-15 Dec 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 9 Nov 22*
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

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...

  • 3M Healthcare Ltd
  • Abiogen Pharma S.p.A.
  • Adamed Sp. z o.o.
  • Albayan Co
  • Aptar France SAS
  • Aspen Pharmacare
  • AstraZeneca UK Ltd
  • DENTSPLY Limited UK Export
  • DextReg
  • Ego Pharmaceuticals Pty Ltd
  • Farmaprojects S.A.
  • Ferring Pharmaceuticals A/S
  • Galderma International
  • Galen Ltd
  • Health Authority
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Laboratoires Bailleul
  • Leo Pharmaceutical Products Sarath Ltd
  • LFB S.A.
  • MEDINOVA LTD
  • Medochemie Limited
  • Merck Sharp & Dohme
  • Mid-Reg GmbH
  • MSD Cyprus Ltd
  • Pharmaton SA
  • Pharmex Advanced Laboratories S.L
  • Procter & Gamble Pharma UK Ltd
  • Reckitt Benckiser Pharmaceuticals - Slough, Berkshire
  • Stiefel Labs (UK) Limited
  • WORLD MARKETS RESEARCH CENTRE

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

Very interesting and helpful for my job.

Anne-Valerie Faucher, GALDERMA Recherche & Developpement, May 17

Very interesting seminar.

Audrey Yahiya, International Regulatory Affairs Pharmacist, Horus Pharma, May 16

I liked it very much.

ROSA URZAY, TECHNICIAN, FAES FARMA, S.A., May 16