Presented by
Management Forum
Pharmaceutical Regulatory Affairs in the Middle East and North Africa Training Course
Covering Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE, Yemen, Tunisia, Morocco and Algeria.
21-23 October 2025 »
from £1599
- Format: Live online
- CPD: 18 hours for your records
- Certificate of completion
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Course overview
The course will equip participants with practical understanding and essential insights into the latest regulatory requirements and developments specific to individual countries within the Middle East and North Africa.
Additionally, this course will explore regional initiatives aligned with global trends, including Common Technical Documents (CTD), and electronic Common Technical Documents (eCTD) submissions, and regional harmonisation efforts. With a strong emphasis on real-world application, this seminar aims to provide valuable knowledge for navigating the evolving regulatory landscape in one of the world's most dynamic pharmaceutical markets.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Benefits of attending
- Gain an overview of the regulatory environment in the Middle East and North Africa
- Understand the economic and cultural background to the markets
- Obtain insights regarding procedures for company and product registration
- Receive information about Dossier format in each country (CTD, eCTD or other)
- Examine 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 and North Africa
- Anyone new to the region e.g. Regulatory Affairs, Pharmacovigilance, Market Access and Business Development leads
- All those interested in an update on recent developments
This course will cover:
Introduction to Regulatory Affairs in the Middle East and North Africa
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 and North Africa
- 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
Real case examples
UAE
Yemen
Sudan
Egypt
Libya
Lebanon
Jordan
Syria
Iraq
Algeria
Morocco
Tunisia
Palestine
Israel
Iran
Local trade associations
MENA Regulatory Conference
Case studies for practical application
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.
Heba Hashem
MERAS
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.
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
21-23 October 2025
Live online
09:00-17:30 UK (London) (UTC+01)
10:00-18:30 Paris (UTC+02)
04:00-12:30 New York (UTC-04)
Course code 16636
- GBP 1,599 1,899
- EUR 2,239 2,659
- USD 2,571 3,039
Until 16 Sep
- 3 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
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.
Denmark
- Novo Nordisk
Run Pharmaceutical Regulatory Affairs in the Middle East and North Africa Live online for your team
Pricing from:
- GBP 1,350
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
