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
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
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
Bahrain
Qatar
Oman
Kuwait
Yemen
UAE
Day 2
- Egypt
- Sudan
- Libya
- Syria
- Lebanon
- Jordan
- Iran
- Iraq
- Palestine
- Israel
- Local trade associations
- MERC
Speakers
Ms Heba Hashem,
Middle East and Africa Associate Director ,
PPDHeba 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,
Founder ,
PULONAIlona 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.
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
