This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.
12 Oct 2020
& 13 May 2021 , 18 Oct 2021
The medical device and diagnostics sectors are entering a period of regulatory change with implementation of the new Medical Device Regulation (MDR) in 2020. This interactive one-day course will provide you with the key information necessary to understand the regulation of medical devices and diagnostics, and to appreciate the key differences from pharmaceutical regulation. Our expert trainers will discuss the transition and implementation of the MDR and will cover the new rules and approaches to developing combination products. The important interface with digital technology will also be explored, alongside the impact of Brexit. There will be ample opportunity for discussion throughout the day to ensure you come away with a good understanding of the medical device industry.
This meeting runs back-to-back with An Essential Overview of the Pharmaceutical and Biotech Industries and there is a £100/€140 discount off when booked with together with An Essential Overview of the Pharmaceutial and Biotech Industries
To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail firstname.lastname@example.org
The course has been specifically designed to meet the needs of those working in pharmaceuticals and in allied business functions who need to understand the medical device sector. It will be particularly relevant for regulatory staff and those in clinical research, medical affairs and business development.
Dr David Jefferys is Senior Vice President for Global Regulatory,Government Relations, Public Affairs and Patient Safety (EMEA, Russia
and Australasia) at Eisai. After qualifying, he worked in clinical and academic medicine before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA and joint CEO of the MHRA. He was involved in the establishment of the European Medicines Agency, is a CPMP/CHMP member and Chair of the MRFG and PER scheme. For the last ten years he has worked in industry and chairs several key committees for ABPI,EFPIA and IFPMA.
Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.
Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been involved in the development of many commercially available medicinal and medical device products.
She has over 10 years Notified Body experience working at BSi as a technical expert and until January held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.
Theresa now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.