Medical Device Regulations in the Middle East and North Africa

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.

19-20 Jun 2019

GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 3 May

Book now

Course overview

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. The programme will cover the regulatory requirements and developments in the individual countries. The course will include interactive discussion sessions to allow you to exchange experiences with other delegates.

Countries to be covered include:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, Tunisia, UAE, Yemen

Please note we are also running a seminar on Pharmaceutical Regulatory Affairs in the Middle East 18-19 June 2018. Please visit www.management-forum.co.uk for further information.

Who should attend

This seminar 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

Benefits of attending

  • Gain an introduction to the medical device markets: countries, numbers, economical facts and trends, regulatory environment
  • Understand medical device regulations in the countries of the Middle East and North Africa
  • Understand What is a medical device and their classification
  • Clarify procedures for company and product registration
  • Discuss recent developments in the region
  • Opportunities to meet, network and share experiences with other industry colleagues

Programme

This course will cover Regulatory Activities in:
Algeria, Bahrain, Egypt, Israel, Iran, Iraq, Israel, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, Yemen & Jordan

Welcome and Introduction

The Medical Device Markets in the Middle East and North Africa
  • 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
  • Country presentations
Medical Devices and their Classification
  • What is a medical device
  • Different classes of products
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 will take place throughout the two days

Presenters

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.

Book now

19-20 Jun 2019
19-20 Jun 2019 Cavendish Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 3 May
Enrol now

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Previous customers include...

  • Asahi Intecc Co., Ltd.
  • Bayer Medical Care B.V.
  • Biotronik AG
  • Britannia Pharmaceuticals Ltd
  • BSN medical GmbH
  • Cochlear Limited
  • Coloplast A/S
  • CooperVision Manufacturing Ltd
  • DextReg
  • Fresenius HemoCare Netherlands BV
  • Ginsana SA
  • IBA
  • Institut Straumann AG
  • ISS AG, Integrated Scientific Services
  • Johnson & Johnson
  • MEDRAD Europe BV
  • Medtronic Ireland
  • Merit Medical Nederland BV
  • Nobel Biocare Holding AG
  • Novo Nordisk Gulf Health Care
  • Olympus Surgical Technologies America
  • Omron Healthcare Europe BV
  • Paul Hartman Middle East FZE
  • Sinclair Pharmaceuticals
  • Sorin Group Italia
  • STERIS
  • Sybermedica Ltd
  • TUV RheinlandInternational GmbH
  • Varian Medical Systems
  • Varian Medical Systems Int AG

Generally the content flowed well, but there was a couple occasions where the slides were changed a little too quickly...

Kelly Jeffs, Regulatory Affairs Specialist, CooperVision Manufacturing Ltd

It was good. The flow was very nice.

Stephanie de Souza, Regulatory Officer, Vertex-Dental B.V.

All great

Simona Fiori, Regulatory Market Specialist, Orthofix Srl

I found the day engaging and helpful. The willingness from the speakers for us to learn was evident, and I appreciated that they asked from the beginning what our expectations were for the day, and aimed to meet these.

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA

Very good presentations and binder

Anette Hulstrøm, Specialist Regulatory Affairs, William Cook Europe ApS

Very good, covered many countries in a short time. Will recommend the course.

Manuela Müller-Maissen, Senior Regulatory Affairs Specialist, Varian Medical Systems

Great day, informative and good interaction – would recommend

Elaine Gibbons, Regulatory Affairs Specialist, Merit Medical EMEA

Good structure

David Owolabi, Senior Regulatory Specialist, Steris Ltd