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Management Forum

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

★★★★★ "Very well. I enjoy all the course."

9-10 December 2024
+ 25-26 February 2025, 23-24 June 2025, 21-22 October 2025 »
from £1099

Need help? Enrol or reserve

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

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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

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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

Enrol or reserve

This course will cover:

Day 1
Day 2

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

Bahrain

Qatar

Oman

Kuwait

Yemen

UAE

Egypt

Sudan

Libya

Syria

Lebanon

Jordan

Iran

Iraq

Palestine

Israel

Local trade associations

MERC

Enrol or reserve

Ilona Putz
PULONA Emerging Markets

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 and 2022. Moreover, Ilona published articles in the Journal of Medical Device Regulations on the regulatory overview for Medical Devices in Egypt, Kuwait and the UAE.

More details

Heba Hashem
PPD

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

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

9-10 December 2024

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 14090

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 04 Nov

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

25-26 February 2025

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 14630

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 21 Jan

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

23-24 June 2025

Live online

09:00-16:45 UK (London) (UTC+01)
10:00-17:45 Paris (UTC+02)
04:00-11:45 New York (UTC-04)
Course code 14778

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 19 May

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

21-22 October 2025

Live online

Course code 15136

GBP 1,099 1,299
EUR 1,589 1,869
USD 1,817 2,129

Until 16 Sep

2 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

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

Comprehensive coverage, expert presenters, and high-quality organization.

Jun 26 2024

Rima Baqain Jordan
Regulatory Affairs Executive, The Mentholatum

Jun 26 2024

Thumbs up. Very information and detailed. Would recommend to colleagues and friends working in the area.

Rukhsana Sofia United Arab Emirates
Pharmaceutical Affairs Manager, Aspen Healthcare FZ LLC

Jun 26 2024

Very comprehensive.

Cláudia Medeiros Portugal
International Head of Regulatory Affairs, Pharma Bavaria Internacional (PBI)

Jul 19 2023

I found it excellent and very useful. It did exactly what I hoped it would - provide a good overview of the Middle east.

Georgina Wells United Kingdom
Regulatory Affairs Manager, Jazz Pharmaceuticals

Dec 14 2022

Very well. I enjoy all the course.

Indrani Elisabet Zambrana Navarro Spain
Grifols,S.A.

Dec 14 2022

Content : very good Presentation : very good Speakers : excellent

Zohra Smili France
Regulatory Affairs Officer, Septodont

Dec 14 2022

the content was excellent.

Maria Cecilia Diaz Germany
Regulatory affairs senior manager, farco pharma

Dec 14 2022

Excellent speakers! Very much experienced, providing the most up-to-date information about the countries, and also some tips from their own experience on how to deal with different kinds of submission within each regulatory authority. Very good insightful content, well prepared presentations, excellent speakers!! Perfect webinar!

Paulette Girgis Germany
Regulatory Project Manager, Grünenthal R&D

Dec 14 2022

It was very useful for me. The content was understandable. Thank you for organising this webinar.

Ayse Gulden Oztekin Turkey
International Markets Regulatory Affairs Coordinator, Recordati Ilac Sanayi ve Ticaret Anonim Sirketi

Jun 29 2022

Content 9/10, presentation 8/10 (live would be better). speaker 9/10

Caroline Sell Germany
Merz Therapeutics GmbH

Jun 29 2022

Both [speakers] are very nice and supportive.

Caroline Sell Germany
Merz Therapeutics GmbH

Jun 29 2022

Very useful explanation of Egypt, great implication of the lecturers and fantastic interaction of the whole group

Marina Vaquerizo Spain
Regulatory Affairs Officer , Faes Farma, S.A

Jun 28 2021

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 United Kingdom
Regulatory Associate, Gilead Sciences International Ltd

Jun 28 2021

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

Tarak Patel United Kingdom
Regulatory Affairs Manager, Syri Limited

Jun 17 2019

Speakers of a very high quality. EXCELLENT.

Marianne Serritzlev Denmark
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.

Zulfikar Mamon United Kingdom
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 Denmark
Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc

Jun 18 2018

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

Charlie Atherton United Kingdom
Regulatory Affairs Assistant, Gilead Sciences International

Jun 18 2018

Really good course, gives a general overview of all countries

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

Jun 18 2018

Valuable training.

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

Jun 18 2018

Good introduction.

Mark Pellett United Kingdom
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 Austria
International Drug Regulatory Affairs Manager, Octapharma Pharmazeutika Prod.Ges.m.b.H.

May 23 2017

Very good!

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

May 23 2017

Very interesting and helpful for my job.

Anne-Valerie Faucher France
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 United Kingdom
Regulatory Associate, RB

May 23 2016

Excellent, thorough and comprehensive.

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