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.
★★★★★ "The presentations were very informative and both Theresa and David had made the course very interest... more (14)"
Grasp the evolving landscape of 'Life Sciences', where pharmaceuticals, medical devices, and diagnostics converge. Gain insights into combination products, companion diagnostics, digital medicines, and AI-enabled innovations.
Designed to offer a comprehensive update on the medical device industry, this training is indispensable for pharmaceutical professionals seeking insights into the intricacies of the medical device sector and its interface with pharmaceuticals. Whether you are new to medical devices or seeking a refresher on recent changes, this course equips you with essential knowledge.
Learn about the evolving regulatory landscape, including significant changes post-Brexit affecting devices and diagnostics in the UK. Our expert-led sessions address critical questions about regulatory shifts and provide a platform to navigate the complexities of this rapidly evolving sector.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
This course is a must for:
• Personnel from the pharmaceutical industry who want to learn more about the devices and diagnostic sectors
• All those who want to understand the interface between devices and pharmaceuticals
• Those who require a refresher on recent changes in the medical device sector
• What is a Notified Body?
• How to work with a Notified Body
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.
Theresa Jeary is Principal Technical Specialist, Medicinal and Biologics, with BSi.
Theresa holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. She has over 25 years of 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 of Notified Body experience working at BSi as a technical expert and previously 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 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.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
14 March 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
05:00-13:00 New York (UTC-04)
Course code 14567
Until 07 Feb
Not ready to book yet?
for 7 days, no obligation
3 July 2025
Live online
Course code 14811
Until 29 May
Not ready to book yet?
for 7 days, no obligation
7 November 2025
Live online
09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15049
Until 03 Oct
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
The presentations were very informative and both Theresa and David had made the course very interesting. They are both very knowledgeable end experienced and delivered an excellent course.
Dec 2 2022
Lenka Elshouly
Administrative Assistant, The European Medicines Agency (EMEA)
May 21 2019
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.
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
United Kingdom
France
Ireland
Netherlands
Belgium
Isle of Man
Switzerland
Denmark
Germany
United States of America
1 day
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: