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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

28-29 Jun 2021

& 5-6 Jul 2021

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

- Centralised registration in the Gulf (GCC-DR)
- Middle East Regulatory Conference (MERC)
- MERC follow-up activities
- Industry regulatory groups and activities

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

Presenters

Ilona Putz (More...)

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.

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

28-29 Jun 2021
Live webinar
28-29 Jun 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 17 May 21*
Enrol now
to attend
Live webinar
5-6 Jul 2021
Face-to-face, (venue not yet confirmed)
5-6 Jul 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 24 May 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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

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

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

You may also be interested in

Previous customers include...

  • Abbott Products GmbH
  • Aspen Healthcare FZ LLC
  • Astellas BV
  • Astellas Learning Center
  • Astellas Pharma International
  • BAUSCH & LOMB INC
  • Baxter Innovations GmbH
  • Demo SA Pharmaceutical Industry
  • DENTSPLY Limited UK Export
  • Enturia Inc
  • Grifols, S.A
  • Grunenthal GmbH
  • Gulf Pharmaceutical Industries Julphar
  • Ipsen Pharma SAS
  • IVAX PHARMACEUTICALS LTD
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Janssen Pharmaceutica NV
  • Laboratoires EXPANSCIENCE
  • MEALIS
  • Mentholatum Co Ltd
  • Mercury Pharmaceuticals Ltd
  • Ministry of Defence
  • N.V. Organon
  • Pharmaton SA
  • Procter & Gamble Pharma UK Ltd
  • Reckitt Benckiser
  • Sanofi-Aventis Groupe
  • Sanofi-Aventis Recherche & Developpement
  • Science Union SA
  • UNIGENE LABS

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

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., May 16

Excellent, thorough and comprehensive.

Emily-Jane Bowles, Regulatory Liaison, EEMEA, MSD Europe Inc. , May 16