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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

★★★★★ "I wanted to learn more about regulations in the middle east and the content was definitely very info... more"

29-30 Jun 2022 + 1 more date

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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

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:

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

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.

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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.

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Book Pharmaceutical Regulatory Affairs in the Middle East Live online training

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*

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

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

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

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

* 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.

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 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.

Zul 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.