Overview
Medical Device regulations is an evolving era in the MENA region. Most of the MENA governments have published regulatory guidance as registration for some devices is required for importation.
Why you should Attend
To understand the registration requirements for medical devices in the key markets in the MENA region to be able to efficiently plan submission strategies for the region.
Areas Covered in the Session
Overview of the key areas of registration requirements for product and company approvals for medical devices in the Middle East and North Africa.
Learning Objectives
- Gain an introduction to the medical device markets: countries, numbers, economical facts and trends, regulatory environment
- Understand medical device regulations in the MENA region
- Get an overview on registration requirements, timelines, fees
- Clarify procedures for company and product registration
Who Will Benefit
- Anyone involved in Regulatory Affairs for medical devices in the MENA region
- Anyone new to the region
- Anyone interested in an update of recent Developments
Speaker Profile
Ilona Putz founded PULONA Emerging Markets in 2008, based in the UAE. Her company is dedicated to creating and developing tailor-made business concepts and regulatory services for clients in the healthcare sector across the Middle East.
She holds an MBA Degree from George Washington University and attended a finance program at Harvard Business School.
Ilona has worked in the Pharmaceutical Industry since 1988 for companies like MSD, SmithKline Beecham, Karl Engelhard, HEXAL and Sandoz where she has held the position of Regional Head, Middle East, responsible for all commercial, business development and regulatory activities.
Ilona 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 is a Speaker for Management Forum UK on "Pharmaceutical Regulatory Affairs in the Middle East" since 2006, on "Global Manufacturing Site Transfer" since 2009 and on "Medical Device Regulations in the Middle East" since 2012. She spoke also for DIA (Drug Information Association) Switzerland on "Clinical Trials in the Middle East".
Instructor
Ilona Putz