Presented by
Management Forum

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

15-16 Dec 2021 + 2 more dates

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  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Pharmaceutical Regulatory Affairs in the Middle East course will cover:

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

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Ilona Putz

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.

More details

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.

More details

Book Pharmaceutical Regulatory Affairs in the Middle East Live online training

15-16 Dec 2021

Live online

09:00-16:45 UK (London) (UTC+00)
10:00-17:45 Paris (UTC+01)
04:00-11:45 New York (UTC-05)
Course code 11940

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 10 Nov

In your basket 

29-30 Jun 2022

Live online

09:00-17:15 UK (London) (UTC+01)
10:00-18:15 Paris (UTC+02)
04:00-12:15 New York (UTC-04)
Course code 11671

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 25 May

In your basket 

14-15 Dec 2022

Live online

09:00-17:15 UK (London) (UTC+00)
10:00-18:15 Paris (UTC+01)
04:00-12:15 New York (UTC-05)
Course code 11958

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 09 Nov

In your basket 

Reviews of IPI's Pharmaceutical Regulatory Affairs in the Middle East training course


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.

Jun 28 2021

Hafsa Khan
Regulatory Associate, Gilead Sciences International Ltd

Jun 28 2021

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

Tarak Patel
Regulatory Affairs Manager, Syri Limited

Jun 17 2019

Speakers of a very high quality. EXCELLENT.

Marianne Serritzlev
Senior Regulatory Affairs Specialist, PHARMANOVIA A/S

Jun 17 2019

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 18 2018

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 2018

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

Charlie Atherton
Regulatory Affairs Assistant, Gilead Sciences International

Jun 18 2018

Really good course, gives a general overview of all countries

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

Jun 18 2018

Valuable training.

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

Jun 18 2018

Good introduction.

Mark Pellett
Associate Director, Biogen Idec Ltd

Jun 18 2018

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.

May 23 2017

Very good!

Marie Bailey
Regulatory Affairs Manager, Wockhardt (UK) Ltd

May 23 2017

Very interesting and helpful for my job.

Anne-Valerie Faucher
GALDERMA Recherche & Developpement

May 23 2017

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 23 2016

Excellent, thorough and comprehensive.

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

May 23 2016

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 23 2016

I liked it very much.

ROSA URZAY
TECHNICIAN, FAES FARMA, S.A.

May 23 2016

Very interesting seminar.

Audrey Yahiya
International Regulatory Affairs Pharmacist, Horus Pharma

UK

  • 3M Healthcare Ltd
  • Actavis UK Ltd
  • Allergan UK Limited
  • Alliance Pharmaceuticals Ltd
  • Amdipharm Mercury Company Limited
  • AMGEN LTD
  • Archimedes Pharma Ltd
  • AstraZeneca UK Ltd
  • Atnahs
  • Atnahs Pharma UK Limited
  • BAUSCH & LOMB INC
  • Biogen IDEC Ltd
  • Bristol Myers Squibb
  • Britannia Pharmaceuticals Ltd
  • Business Monitor International Ltd
  • Cambridge Healthcare Supplies Ltd.
  • ClinTec International Ltd
  • Colorcon Limited
  • CRANFIELD UNIVERSITY
  • Cyton Biosciences Ltd
  • DDD LTD
  • DENTSPLY Limited UK Export
  • Eisai
  • Eisai Ltd (EGC)
  • ELAN PHARMA LTD
  • Espicom Business Intelligence
  • Forest Laboratories UK Ltd
  • Galen Ltd
  • GE Healthcare Ltd
  • Genus Pharmaceuticals Ltd
  • Gilead Sciences
  • Gilead Sciences International
  • Gilead Sciences International Ltd
  • GlaxoSmithKline
  • GW Pharmaceuticals Limited
  • GW PHARMACEUTICALS PLC
  • IHS Global Insight
  • Janssen-Cilag Ltd
  • Leadiant Biosciences
  • Liquent
  • Macarthys Laboratories Ltd
  • Management Forum Ltd
  • Martindale Pharma
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mentholatum Co Ltd
  • Mercury Pharmaceuticals Ltd
  • Ministry of Defence
  • Molnlycke Healthcare
  • MSD
  • Mundipharma Research Ltd
  • Mylan
  • Niche Generics Limited
  • NMC Regulatory Ltd
  • Norgine Ltd
  • Novo Nordisk A/S
  • Nutricia Ltd
  • Owen Mumford Ltd
  • Pharma Experts Limited
  • PHARMACEUTICAL BUSINESS NEWS
  • Pharmalink Consulting Ltd
  • Pharmareg Consulting Ltd
  • Procter & Gamble Pharma UK Ltd
  • Prostrakan Group Ltd
  • RB
  • Reckitt Benckiser
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Reckitt Benckiser Pharmaceuticals - Slough, Berkshire
  • Seven Seas Limited
  • Shire Pharmaceutical Development Ltd
  • Shire Pharmaceutical Ltd
  • SRG LTD
  • Stiefel Labs (Maidenhead) Ltd
  • Stiefel Labs (UK) Limited
  • Subiaco Associates Ltd
  • Syri Limited
  • Takeda Development Centre Europe Ltd
  • Thornton & Ross Ltd
  • Wockhardt (UK) Ltd
  • Wockhardt UK Ltd
  • WORLD MARKETS RESEARCH CENTRE

France

  • Aptar France SAS
  • BEAUFOUR IPSEN INTERNATIONAL
  • DextReg
  • Galderma International
  • GALDERMA Recherche & Developpement
  • Guerbet
  • Horus Pharma
  • Ipsen Pharma SAS
  • Laboratoires EXPANSCIENCE
  • LFB S.A.
  • MACOPHARMA
  • Merck Sante s.a.s.
  • Sanofi Pasteur SA
  • Sanofi Winthrop Industrie
  • Sanofi-Aventis
  • Sanofi-Aventis Groupe
  • Sanofi-Aventis R&D
  • Sanofi-Aventis Recherche & Development
  • Sanofi-Aventis Recherche & Developpement
  • Science Union SA
  • Septodont
  • Teva Sante

Germany

  • Abbott Products GmbH
  • Alfred E Tiefenbacher GmbH & Co KG
  • ASTELLAS PHARMA GMBH
  • Bayer Pharma AG
  • Bionorica GmbH
  • Cesra Arzneimittel GmbH & Co. KG
  • Dr Willmar Schwabe GmbH & Co
  • Dr. Willmar Schwabe GmbH & Co. KG
  • Engelhard Arzneimittel GmbH KG
  • FUJISAWA DEUTSCHLAND GmbH
  • Grunenthal GmbH
  • Helm AG
  • Intendis GmbH
  • medac GmbH
  • Merck KGaA
  • Merck Selbstmedikation GmbH
  • Pharmalex GmbH
  • Riemser Arzneimittel AG
  • Sandoz International GmbH
  • SCHERING AG BERLIN
  • STADA Arzneimittel AG

United Arab Emirates

  • Abbott International S.A.
  • Abbvie
  • Accord Healthcare MENA DMCC
  • Actavis MEEA FZE
  • Aspen Healthcare FZ LLC
  • Astellas Pharma JLT
  • BOEHRINGER INGELHEIM GULF STATES
  • Boehringer Ingelheim Middle East Regional Office
  • BOOTS HEALTHCARE INTERNATIONAL
  • CERTIFIED OILFIELD RENTALS
  • GlaxoSmithKline Consumer Healthcare
  • Gulf Pharmaceutical Industries Julphar
  • Health Authority
  • Hospira (ME & NA)
  • Johnson & Johnson
  • Merck Serono Middle East FZ LLC
  • Pfizer Gulf FZ LLC
  • Pharma World
  • Sandoz
  • SANOFI-AVENTIS GULF
  • United Trademark & Patent Services

Switzerland

  • Abbott Products Operations AG
  • AbbVie AG
  • Acino Pharma AG
  • Actelion Pharmaceutical Ltd
  • Actelion Pharmaceuticals Ltd
  • CSL Behring AG
  • F. Hoffmann-La Roche Ltd
  • Ginsana SA
  • Hadicon AG
  • Laboratoires Bailleul
  • MEDINOVA LTD
  • Merck Serono SA
  • Met P Pharma AG
  • Mid-Reg GmbH
  • Mundipharma Laboratories GmbH
  • Novartis Consumer Health SA
  • Shire
  • Shire International GmbH
  • Tillotts Pharma AG
  • Valeant Pharma Switzerland GmbH

Netherlands

  • Astellas BV
  • Astellas Learning Center
  • Astellas Pharma International
  • Astellas Pharma International BV
  • Centocor BV
  • CHIRON BV
  • DADA Consultancy B.V.
  • Genzyme Europe BV
  • HOSPIRA
  • Janssen Biologics BV
  • MEDRAD Europe BV
  • Merck Sharp & Dohme
  • N.V. Organon

Spain

  • Almirall S.A.
  • Casen Recordati SL
  • FAES FARMA, S.A.
  • FAES Pharma SA
  • Farmaprojects S.A.
  • GALENICUM HEALTH, S.L.
  • GRIFOLS S.A.
  • Grifols, S.A.
  • Laboratorios CINFA SA
  • Pharmex Advanced Laboratories S.L
  • Qualicaps

Denmark

  • Ferring
  • Ferring Pharmaceuticals A/S
  • Ferring Pharmaceuticals Inc
  • H. Lundbeck A/S
  • Leo Pharma A/S
  • Novo Nordisk A/S
  • Pharmanovia A/S
  • Statens Serum Institut
  • Takeda Pharma A/S
  • Tarius A/S

Belgium

  • Atrexfi
  • Glaxo Smithkline Biologicals
  • Janssen Infectious Diseases - Diagnostics BVBA
  • Janssen Pharmaceutica NV
  • Laboratoria Qualiphar NV/SA
  • Merck Sharpe & Dohme Europe Inc
  • MSD Europe Inc.
  • Nutriad International BV
  • UCB Pharma SA

Saudi Arabia

  • AstraZeneca
  • Galderma International
  • Janssen-Cilag
  • Modern Quality Est.
  • Novo Nordisk Gulf Health Care
  • Octapharma
  • Sandoz GmbH
  • Saudi Food and Drug Authority

United States of America

  • Bill & Melinda Gates Medical Research Institute
  • BioMarin Pharmaceutical Inc
  • C.B. FLEET COMPANY INC
  • Enturia Inc
  • GENZYME CORP
  • SANOFI PASTEUR INC
  • UNIGENE LABS

Italy

  • Abiogen Pharma S.p.A.
  • Acs Dobfar S.p.a
  • Chiesi Farmaceutici SPA
  • Kedrion SpA
  • Menarini Biotech Srl
  • PH&T SpA

Ireland

  • Amdipharm Limited
  • Bristol-Myers Squibb
  • IVAX PHARMACEUTICALS LTD
  • Labopharm Europe Ltd
  • Teva Pharmaceuticals Ireland

Lebanon

  • F. Hoffmann-La Roche Ltd
  • MEALIS
  • Mersaco Janssen-Cilag
  • Pharmamed
  • Pierre Fabre Medicaments

Austria

  • Baxter Innovations GmbH
  • GEROT Pharmazeutika GmbH
  • Octapharma Pharmazeutika Prod.Ges.m.b.H.
  • Octapharma Pharmazeutika Produktionsges.m.b.H.

Greece

  • CANA SA
  • Demo SA Pharmaceutical Industry
  • Merck Sharp & Dohme
  • Periohi Pigadi

Turkey

  • Biomarin
  • Biomarin Pharmaceutical Turkey
  • Novo Nordisk Saglik Urunleri Tic Ltd Sti
  • Sanovel Pharmaceutical INC

Cyprus

  • Delorbis Pharmaceuticals Ltd
  • Medochemie Limited
  • MSD Cyprus Ltd

Czech Republic

  • Edwards Lifesciences AG
  • Zentiva ks

Egypt

  • Janssen-Cilag Egypt
  • PPD

Finland

  • Borealis Polymers Oy
  • Santen Oy

Poland

  • Adamed Sp. z o.o.
  • Valeant SP Zoo SP7

Australia

  • Ego Pharmaceuticals Pty Ltd

Bosnia and Herzegovina

  • Bosnalijek d.d

Canada

  • APOTEX PHARMACHEM INC

Croatia

  • Pliva Croatia Ltd

Iceland

  • Actavis Group PTC ehf

India

  • Micro Labs Limited

Iran

  • Shafayab Gostar

Jordan

  • TABUK Pharmaceutical Manufacturing Company-Amman Regional

Kuwait

  • Yiaco Medical Co

Malaysia

  • Pharmaniaga Berhad

Malta

  • STUDENT

Pakistan

  • Janssen-Cilag

Slovak Republic

  • Janssen-Cilag

South Africa

  • Aspen Pharmacare

Sweden

  • Oasmia Pharmaceutical AB

Syria

  • Albayan Co

Thailand

  • Concept Foundation

Ukraine

  • Farmak JSC

Yemen

  • GlaxoSmithKline

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy