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

17-18 Jun 2019

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 10 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 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

Presenters

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.

Heba Hashem

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

17-18 Jun 2019
17-18 Jun 2019 Cavendish 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 10 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...

  • Abbvie
  • Acino Pharma AG
  • Aegis Ltd
  • Archimedes Pharma Ltd
  • BAUSCH & LOMB INC
  • Bionorica GmbH
  • Boehringer Ingelheim Middle East Regional Office
  • Celgene Europe Ltd
  • Colorcon Limited
  • Edwards Lifesciences AG
  • ELAN PHARMA LTD
  • FUJISAWA DEUTSCHLAND GmbH
  • Galen Ltd
  • Gulf Pharmaceutical Industries Julphar
  • Kedrion SpA
  • MEALIS
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MEDINOVA LTD
  • Mentholatum Co Ltd
  • Micro Labs Limited
  • Novo Nordisk Saglik Urunleri Tic Ltd Sti
  • Oasmia Pharmaceutical AB
  • Pharmaniaga Berhad
  • Pharmaton SA
  • Procter & Gamble Pharma UK Ltd
  • RB
  • Sanofi Winthrop Industrie
  • Sanofi-Aventis R&D
  • Shafayab Gostar
  • Zentiva ks

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

Good introduction

Mark Pellett, Associate Director, Biogen Idec Ltd

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

Charlie Atherton, Regulatory Affairs Assistant, Gilead Sciences International

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 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

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.

I liked it very much

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