Presented by
Management Forum
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.
23 May 2022 + 1 more date
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.
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.
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.
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.
23 May 2022
Live online
09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11626
Until 18 Apr
2 Nov 2022
Live online
00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
20:00-20:00 New York (UTC-04)
Course code 11732
Until 28 Sep
Theresa was an excellent presenter. She presented her topic on regulatory submission and notified bodies really well. The content was clear and she had a good engagement with the delegates.
May 21 2019
Yulia Degtyareva 
Scientist, Philips
Nov 23 2017
Both speakers were excellent and obviously knew their subject in great depth
Peter Davies
Quality Engineer, Bespak Europe Ltd
Nov 23 2017
Enjoyed the course, felt the topics were covered in enough detail given the subject matter. Informal atmosphere with a small number of delegates meant opportunity for questions which were welcomed. Both speakers were clearly passionate about their subject and this was evident during their presentations.
Gillian Hakewill
Regulatory Affairs Officer, SPD Development Company Limited
Nov 23 2017
The course was delivered by highly educated industry experts who shared their extensive knowledge in a clear and entertaining manner. The delegate numbers were small which allowed for a very personal service. I will be recommending Management Forum courses to my colleagues.
Stephanie Kirby
Senior Regulatory Affairs Officer, Bells Healthcare
May 19 2017
Just brilliant – speakers were so very knowledgeable
Valentina Curran
Senior Medical Affairs Executive, Norgine Ltd.
May 19 2017
The course material is very good. The speakers were excellent and the manner in which they presented.
Jovana Jevtic
Bard Pharmaceuticals Ltd
May 19 2017
The course is great for people having no idea about the medical device industry. Makes you understand the key differences between pharmaceuticals and medical devices in terms of regulations and vigilance.
Francois Rugiero
Convergence Pharmaceuticals
Nov 23 2017
Very nice overview
Camiel Kulker 
Senior Regulatory Affairs Manager , Astellas Pharma Europe B.V.
May 19 2017
Well presented - clear and concise.
Paul Glennie
Project Manager, Napp Pharmaceuticals Ltd
Nov 11 2016
Good content
Anna Somuyiwa
Regulatory Affairs Consultant , Segulah Consulting Limited
Nov 11 2016
Did what it said on the tin - personally would like to see more of a marketing focus than regulatory but the day delivered what it promised.
Richard Addy
Senior Director, Customer Success, Veeva
Nov 11 2016
Excellent course, pitched at the right level for people new to this area of work.
Dolores Cassidy 
Patent Examiner, Irish Patents Office
Nov 11 2016
Excellent course, pitched at the right level for people new to this area of work
Dolores Cassidy
Patent Examiner, Irish Patents Office
UK
Ireland
France
Belgium
Switzerland
Denmark
Germany
Isle of Man
Netherlands
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