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 to assist with registration in the region. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.
Countries to be covered include: Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE and 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
Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
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:
- Saudi Arabia
Each regional presentation will cover:
Markets and culture
Regulatory environment and characteristics
General regulatory requirements
Company and product registration
Variations and renewals
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
Ms Heba Hashem,
Middle East and Africa Associate Director ,
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.
Ms Ilona Putz,
Ilona Putz founded PULONA Emerging Markets based in the UAE which is dedicated to creating and developing tailor-made business concepts for clients in the healthcare sector across the Middle East.
She has worked in the pharmaceutical industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard and HEXAL where she has held the position of Regulatory Affairs Regional Manager, responsible for regulatory affairs and later on in commercial operations for countries in the Middle East and Africa. Between 2005 and August 2008 she was Regional Head, Middle East, for Sandoz International, Germany, responsible for all commercial and business development activities.
She consults also for RegAff for the Middle East which is the only Global Specialist Regulatory Affairs company with a broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices. She spoke also for DIA (Drug Information Association) Switzerland on “Clinical Trials in the Middle East”, DIA Europe Meeting, Geneva 2011.
Sheikh Rashid Road
United Arab Emirates
Raffles Dubai occupies a pre-eminent position right on Sheikh Rashid Road, the premium business and shopping district located in the heart of Dubai.
- 15 minutes from Dubai International Airport
- 5 minutes from Dubai business district and Dubai International Financial Centre
- Minutes from Dubai’s tourist attractions and renowned Burj Khalifa
- Connected to WAFI
- Easy access to the Dubai Metro station
The easiest way to get to the hotel from the airport is by taxi. There are plenty of taxis available and the hotel is only 15 minutes away. You can also ask us to arrange transfers to and from the hotel at an extra cost. Alternatively you can jump on the Dubai Metro – although there are luggage restrictions - from Dubai International Airport and get off at the Dubai Healthcare City station, a short 2 minute walk to the hotel.