This site is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

18 - 22 October 2021
Virtual EventDelivered in CEST time zone

Training Course: Medical Devices in the MENA Region

Break through the market access hurdles in the Middle East and North Africa with expert guidance and regulatory know-how

LIVE Online Training Course | 11-12 October 2021 | 10am - 6pm CEST

Course Overview

Navigate the ins and outs of company registration, product registration, labelling, fees and contact information in Saudi Arabia, UAE, Kuwait, Oman, Bahrain, Yemen, Egypt, Sudan, Iran, Iraq, Syria, Lebanon, Jordan and Palestine

As healthcare spending continues to rise in the Middle East and North Africa (MENA), this region is becoming a key growth target for medical device manufacturers. One of the main challenges companies face in the region is navigating the non-harmonised regulatory landscape which contains different systems, requirements and procedures. Having a solid regulatory strategy in the region will require an in-depth knowledge of the regulations and can open up a growing market.

This 7 module, 2-day online course will provide you with a complete overview of the regulatory landscape in the region before focusing in on specific countries such as those in the Gulf Cooperation Council (GCC), Egypt, Iran, Lebanon and Jordan. For each country, you will examine company registration, product registration, labelling, fees and contact information.

What will you learn?

Dossier requirements

Guidance on dossier requirements and structure to avoid rejections and gain faster approval of devices in MENA

Regulatory developments

Learn about future regulatory developments in the MENA region

Regional and national systems

Understand regional and national systems of standards for medical devices

Trends

Learn about the medical device trends in the MENA region

Key differences between countries

Compare regulatory submission requirements and highlight differences in key countries.

Who is this course for?

This course would be useful for people within regulatory affairs departments who have local representations in these markets and want to know more about the region. It will provide them with an overview and would allow them to monitor local representatives more thoroughly.

This course would also be good for local representatives wanting to learn more about other countries registrations.

People who work  in the following areas will benefit:

  • Global Regulatory Affairs
  • International Regulatory Affairs
  • MENA Regulatory Affairs
  • Regulatory Affairs Manager
  • Priority Departments
  • Registration
  • Medical Affairs

Meet The Trainer

Ilona Putz, Consultant, PULONA Emerging Markets FZE 

Ilona Putz 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.

Ilona consults for Regulatory Affairs for the Middle East which is the only Global Specialist Regulatory Affairs company with broad geographical coverage, and for Emergo Group, which is a global consultancy company for Medical Devices.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. MedTech Series online training courses are live courses developed by our expert faculty providing learning on a range of technical topic areas.

Students will learn through:

  • Direct interaction with the trainer
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact jessica.purnell@informa.com