This seminar will provide you with an essential overview of the key areas of pharmaceutical regulatory affairs in the Middle East.
Countries to be covered include: Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan Syria, UAE, Yemen
BENEFITS OF ATTENDING THIS MEETING
This seminar will provide you with an essential overview of the key areas of regulatory affairs in the Middle East. This two day course will focus on practical aspects to assist with regulatory affairs in the region. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.
This seminar will be of particular interest to:
This course will cover regulatory activities in- Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, UAE, Yemen
Each country presentation will cover the following topics:-
*The Pharmaceutical Regulatory Environment
Economic Overview of the Middle East
Following the country presentations, there will be presentations updating on developments in the Middle East as a region
Harmonisation and Recent Developments in the Region
Discussion will take place throughout the 2 days
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.
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.
| 17-18 Jun 2019 | |||
| 17-18 Jun 2019 | Cavendish Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
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“Good introduction ”
Mark Pellett, Associate Director, Biogen Idec Ltd
“It is a valuable training ”
Rouba Rahi, Medical Pharmacovigilance & Regulatory Officer, Modern Quality Est.
“Really good course, gives a general overview of all countries ”
Carlota Coll, Regulatory Affairs Expert, GALENICUM HEALTH, S.L.
“It is so obvious that the speakers are highly experienced and have a huge knowledge regarding the region, but some of the presentations were a bit complicated to follow. Simply one of the best courses I have ever attended! ”
Nermin Ipek, Global Regulatory Affairs Manager, Ferring Pharmaceuticals Inc
“Great speakers - it was possible to ask every question. Great country specific knowledge regarding the guidelines (all up-to-date). ”
Sabrina Waitz, International Drug Regulatory Affairs Manager, Octapharma Pharmazeutika Prod.Ges.m.b.H.
“Great speakers and happy to answer any questions. Very knowledgable. ”
Charlie Atherton, Regulatory Affairs Assistant, Gilead Sciences International
“Very good”
Marie Bailey, Regulatory Affairs Manager, Wockhardt (UK) Ltd
“Good and interesting ”
Niina Lantelankallio, Regulatory Affairs Specialist, Santen Oy
“The course was very good and gave a comprehensive overview of the regulatory requirements within the Middle East region. This coupled with the experience and knowledge of the two presenters who were able to give their advice on specific enquiries..”
Shane Freeth, Regulatory Associate, RB
“Very interesting and helpful for my job”
Anne-Valerie Faucher, , GALDERMA Recherche & Developpement
“I liked it very much”
ROSA URZAY, TECHNICIAN, FAES FARMA, S.A.
“Very interesting seminar”
Audrey Yahiya, International Regulatory Affairs Pharmacist, Horus Pharma
“It has been the best course I attended, focused on the topics, effective and clear. It will be very useful for the ongoing working activities. ”
Francesca Porchia, Regulatory Affairs Specialist , Abiogen Pharma S.p.A.
“Excellent, thorough and comprehensive.”
Emily-Jane Bowles, Regulatory Liaison, EEMEA, MSD Europe Inc.