Course overview
This course will equip participants with practical understanding and essential insights into the latest regulatory requirements and developments specific to individual countries within the Middle East.
It will also explore regional initiatives aligned with global trends, including Common Technical Documents (CTD), and electronic Common Technical Documents (eCTD) submissions, and regional harmonisation efforts.
With a strong emphasis on real-world application, this course aims to provide valuable knowledge for navigating the evolving regulatory landscape in one of the world's most dynamic pharmaceutical markets.
CPD Hours: 12
Course Content
- Day 1
- Introduction to Regulatory Affairs in the Middle East
- Economic overview of the Middle East
- Harmonisation and recent developments
- The pharmaceutical regulatory environment in the Middle East and North Africa - with individual presentations on:
- 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
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 and 2022. Moreover, Ilona published articles in the Journal of Medical Device Regulations on the regulatory overview for Medical Devices in Egypt, Kuwait and the UAE.
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.
