Medical Device Regulations in the Middle East and North Africa Training Course
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa.
Covering Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
Details
Course overview
The size of the medical device market in the Middle East has expanded over recent years and this trend is forecast to continue. The growth is due in part to innovations in technology as the majority of Middle Eastern countries are early adopters of technological advancement, which provides opportunities for medical device companies. The regulatory environment in the region is also developing and this annual seminar will provide an essential overview of the key requirements for product approvals for medical devices in the Middle East and North Africa.
The programme will focus on the regulatory requirements and developments in individual countries and include interactive discussion sessions to allow you to exchange experiences with our expert faculty and other delegates.
Benefits of attending:- Gain a valuable introduction to the medical device markets: countries, numbers, economical facts and trends, regulatory environment
- Familiarise yourself with medical device regulations in the countries of the Middle East and North Africa
- Understand medical devices and their classification
- Clarify procedures for company and product registration
- Discuss recent developments in the region
- Meet, network and share experiences with other industry colleagues
Who should attend
The event will be of particular interest to:
- Anyone involved in regulatory affairs for medical devices in the Middle East and North Africa
- Anyone new to the region
- Anyone interested in an update of recent developments
Programme
The medical device markets in the Middle East and North Africa (MENA)
- Markets and culture
- Healthcare
- Business culture
- Economic overview
- Regulatory environment and characteristics
- General regulatory requirements
- Company and product registration
- Key documents needed
- Basic structure of a dossier
- Regulatory summary
- What is a medical device
- Different classes of products
Individual Country Presentations:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE and Yemen
Recent Developments in the Region
- Harmonisation activities
- Countries with new regulatory requirements for medical devices
- Countries in the process of establishing regulatory guidance for obtaining marketing authorisations
Discussion sessions will take place throughout the two days
Programme
Economic Overview
Saudi Arabia
GCC Prequalification GPP
Kuwait
Bahrain
Oman
Yemen
UAE
Iran
Eygpt
Algeria
Morocco
Tunisia
Israel
Palestine
Syria
Jordan
Lebanon
Iraq
Sudan
Medical Device Network
Presenters
Heba Hashem (More...)
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.
Ilona Putz (More...)
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.
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8-9 Dec 2021 Live webinar |
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8-9 Dec 2021 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 3 Nov* |
Enrol now
to attend Live webinar |
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15-16 Jun 2022 Live webinar |
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15-16 Jun 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 11 May 22* |
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to attend Live webinar |
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20-21 Sep 2022 Face-to-face, (venue not yet confirmed) |
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20-21 Sep 2022 Face-to-face (venue not yet confirmed) |
GBP 1,499 1,299 EUR 2,099 1,819 USD 2,338 2,026 Until 16 Aug 22* |
Enrol now
to attend Face-to-face (venue not yet confirmed) |
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7-8 Dec 2022 Live webinar |
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7-8 Dec 2022 Live webinar |
GBP 1,299 1,099 EUR 1,859 1,579 USD 2,098 1,786 Until 2 Nov 22* |
Enrol now
to attend Live webinar |
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Learn more about our face-to-face and webinar training formats.
* Note the early booking discount cannot be combined with any other offers or promotional code