Presented by
Management Forum

Pharmaceutical Regulatory Affairs in the Middle East, Dubai

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

Find out more

  • Format: Bespoke training
  • CPD: 12 hours for your records (depending on your requirements)
  • Certificate of completion

Course Overview

This two-day seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East to help you navigate the challenges and demands of this fast-growing market. The programme will focus on practical aspects and will cover the regulatory requirements and developments in individual countries as well as harmonisation across the region. Interactive discussion sessions will allow you to exchange experiences with our experienced trainers and other delegates.

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

Why you should attend

  • 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
  • Opportunities to meet, network and share experiences with other industry colleagues

Who should attend

  • Anyone involved in pharmaceutical regulatory affairs in the Middle East
  • Anyone new to the region
  • Anyone 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 – individual presentations will be given on the following regions:

  • Bahrain
  • Egypt
  • Iran
  • Iraq
  • Kuwait
  • Lebanon
  • Libya
  • Oman
  • Palestine
  • Qatar
  • Saudi Arabia
  • Sudan
  • UAE
  • Yemen
  • Syria
  • Jordan

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

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

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

We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

See below or contact us to discuss yor requirements.

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


Good overview and easy to understand

Oct 25 2017

Benedicte Brask
Senior Regulatory Country Coordinator, Novo Nordisk A/S

Oct 25 2017

So helpful and useful

Badr Mohammed Arafah
Manager, Eli Lilly SA

Oct 25 2017

It was an interesting [and] helpful experience.

Raghad Mousa
RA Officer, MS Pharma Jordan

Oct 25 2017

The course and everything was very good, enjoyable and helpful

Raghad Mousa
RA Officer, MS Pharma Jordan

Oct 25 2017

So helpful and useful

Badr Mohammed Arafah
Manager, Eli Lilly SA

Oct 25 2017

It was very good.

Lizzie Bejstrup Nielsen
Senior Regulatory Country Coordinator, Novo Nordisk A/S

Oct 25 2017

Everything was excellent

Majed Almajed
RA Associate, Aspen

Oct 25 2017

Everything was excellent.

Majed Almajed
RA Associate, Aspen

Oct 25 2017

Very informative, good discussions, details etc

Lizzie Bejstrup Nielsen
Senior Regulatory Country Coordinator, Novo Nordisk A/S

Saudi Arabia

  • Aspen
  • Eli Lilly SA

Denmark

  • Novo Nordisk A/S

Jordan

  • MS Pharma Jordan

Sudan (the)

  • Minamas Company

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