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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
Details
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
Programme
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
Presenters
Ilona Putz (More...)
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 (More...)
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
Book now
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29-30 Jun 2022 Live webinar |
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29-30 Jun 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 25 May 22* |
Enrol now
to attend Live webinar |
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|
14-15 Dec 2022 Live webinar |
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14-15 Dec 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 9 Nov 22* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code