Pharmaceutical Regulatory Affairs in the Middle East

This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.

17-18 Jun 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

Countries to be covered include: Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan Syria, UAE, Yemen

BENEFITS OF ATTENDING THIS MEETING

  • 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

Why you should attend

This seminar will provide you with an essential overview of the key areas of regulatory affairs in the Middle East. This two day course will focus on practical aspects to assist with regulatory affairs in the region. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.

Who should attend

This seminar will be of particular interest to:

  • Anyone involved in pharmaceutical regulatory affairs in the Middle East
  • Anyone new to the region
  • Anyone interested in an update of recent developments

Programme

This course will cover regulatory activities in- Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE, Yemen

Each country presentation will cover the following topics:-

*The Pharmaceutical Regulatory Environment

  • Markets and Culture
  • Healthcare
  • Business Culture
  • Regulatory Environment and Characteristics
  • General Regulatory Requirements
  • Company and Product Registration
  • Variations and Renewals
  • Drug Classification
  • 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

Following the country presentations, there will be presentations updating on developments in the Middle East as a region

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

Discussion will take place throughout the 2 days

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%
Enrol now

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Previous customers include...

  • Acino Pharma AG
  • Actavis MEEA FZE
  • Actelion Pharmaceutical Ltd
  • Aegis Ltd
  • BAUSCH & LOMB INC
  • Baxter Innovations GmbH
  • Bayer Pharma AG
  • BioMarin Pharmaceutical Inc
  • Borealis Polymers Oy
  • C.B. FLEET COMPANY INC
  • Casen Recordati SL
  • Cesra Arzneimittel GmbH & Co. KG
  • DextReg
  • Dr Willmar Schwabe GmbH & Co
  • Glaxo Smithkline Biologicals
  • Grunenthal GmbH
  • Labopharm Europe Ltd
  • Leo Pharma A/S
  • MEALIS
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • MSD Europe Inc.
  • NMC Regulatory Ltd
  • Pharma World
  • PHARMACEUTICAL BUSINESS NEWS
  • Pharmalink Consulting Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Saudi Food and Drug Authority
  • United Trademark & Patent Services
  • Valeant Pharma Switzerland GmbH
  • Yiaco Medical Co

Good introduction

Mark Pellett, Associate Director, Biogen Idec Ltd

It is a valuable training

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

Really good course, gives a general overview of all countries

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

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 - 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.

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

Charlie Atherton, Regulatory Affairs Assistant, Gilead Sciences International

Very good

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

Good and interesting

Niina Lantelankallio, Regulatory Affairs Specialist, Santen Oy

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

I liked it very much

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

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.