A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course
Where are we now and the future developments in the EU 27 and the UK
This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.
Stay informed on the significant changes since the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR), adopted in May 2017.
The landscape of medical device and in-vitro diagnostic regulations in the EU and UK has undergone significant transformation in recent years. With the adoption of the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR) in May 2017, the regulatory framework has become more rigorous and complex. Staying abreast of these changes is crucial for professionals involved in regulatory affairs, quality assurance, and related fields to ensure compliance and maintain market access.
This course is essential for those seeking to stay fully updated on the latest regulatory developments.
Key topics to be addressed:
Comprehensive insights into the rephrased implementations of MDR and IVDR
Understand the new guidelines
Learn about the role and output of the Medical Device Coordination Group (MDCG)
Recent medical device regulatory developments in the UK, providing a comparative perspective on the evolving regulatory landscape
Explore potential future developments and the evolving role of the European Medicines Agency (EMA) in the context of medical device regulations
This course offers a unique opportunity to hear from regulatory experts, discuss the implications of current and forthcoming regulations on working practices, and understand the potential impact on future regulatory strategies.
This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.
Stay updated on MDR and IVDR implementations, new guidelines, and recent UK regulatory developments
Explore the changes in the UK regulation as its system becomes independent and moves away from the EU rules
Navigate the increasingly complex world of device and diagnostic regulations
Gain insights into future changes to the regulations and how "digital medicine" may be regulated in the future
Learn from leading regulatory experts and gain practical advice
Who should attend?
This training course has been designed for all those working or interested in the medical device and diagnostic market in the EU and the UK, including medical device and in-vitro diagnostic professionals from the following areas:
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.
Ian Sealey graduated with a BEng (Hons) in Medical Engineering in 2003 and, after a taking a year out to study for a Graduate Diploma in Law, held health-related engineering and policy roles in the private sector, local government, and the National Health Service.
In 2012 he joined the Civil Service as a Medical Device Specialist at the Medicines and Healthcare products Regulatory Agency and, in 2015, was appointed assistant secretary at the Department of Health, with responsibility for running its Departmental Board.
Since leaving the Civil Service in 2017 he has provided regulatory, quality, technical, and policy consultancy services to multinational and start-up medical device and in vitro diagnostic medical device manufacturers. His specialist interests include the risk management of electromedical devices, multi-legislative CE marking, and training delivery.
Sue Spencer New: Compliance Connextions | Prev: Qserve Group UK, Ltd
Sue Spencer BSc (Hons) is Head IVD, Principal Consultant and UK Country Manager.
Sue leads Qserve’s IVD service, she has over 37 years’ experience in the Medical Device and IVD industries including extensive notified body experience.
Key areas of expertise include
·IVDD and IVDR regulations and transitions
·UKCA
·QMS implementation
·Internal, supplier and compliance audits
·Risk Management
·CDx
·Training
·Working with small start-up and multinationals
·Notified Body interaction
Sue has worked for several IVD companies ranging from start up to large multinationals, where she has held positions in R&D, manufacturing, and quality assurance. Sue worked for 3 notified bodies establishing two from scratch.
Sue has worked for Qserve for 4 years helping manufacturers transition to the IVD Regulation and leading a team specialising in both European and FDA submission and quality systems, with special interests in CDx.
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.
* 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.
Reviews of IPI's A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK training course
Very good course.
Oct 22 2024
Richard Jones Senior Medical Device Auditor, Eurofins E&E CML Limited
Sep 24 2019
Very well run, met my objectives, and speakers were interesting, approachable and very knowledgeable.
Lucie Green QA Manager, Vyaire Medical Products
Mar 6 2019
Excellent training performed by very knowledgeable speakers.
Marie-Pierre Hontas Senior Director Scientific & Clinical Affairs, Vexim SA – Stryker IVS
Sep 24 2019
Management Forum have become my go-to provider of life science training. They always find excellent speakers who present their subject matter in a very knowledgeable, complete and thoroughly enjoyable way. I have always found Management Forum courses to be excellent value for money and the New Medical Device Regulation course was no exception.
Stephen Matthews Validation Consultant, Smart Process Solutions Ltd.
Sep 24 2019
A relaxed, open forum where you felt comfortable to ask any questions you needed through the presentations and the day. The speakers were all very clear, concise, factual and interactive.
The speakers were very professional and knowledgeable. They delivered the content in an easy format and allowed plenty of time for questions and interaction from the attendees.
I particularly liked the section regarding the context of the regulation and background to its development which will help me when explaining this to my clients.
Stephen Rowe Managing Director, SGR Consulting Services Ltd
Sep 25 2018
[The speakers were] all very knowledgeable. The whole course was very reassuring with the 'big monster' of the MDR being broken down so that it appears manageable and less scary. It was full of helpful advice both general and specific to my products.
Samantha Workman ISO Manager, Torbay and South Devon NHS Foundation Trust
Sep 25 2018
Good, complete coverage of the new regulations. Good anticipating on discussed items.
Marcel Steenhof Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV
Feb 26 2018
Excellent speakers
Iva Ujevic Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Feb 26 2018
Excellent speakers
Iva Ujevic Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Feb 26 2018
Very good.
Marie-Cécile Lerat RA Manager MPS Europe, Becton Dickinson
Sep 26 2017
This was an excellent introduction to the Medical Device Regulation, focussing on the key changes and considerations to prepare for compliance with the new requirements. The experienced speakers provided much needed guidance and expertise.
Kate Cole Regulatory Affairs Manager, Xiros Ltd
Sep 26 2017
Excellent, both content and speaker line up
Zinovia Chatzidimitriadou Associate, Bristows LLP
Sep 26 2017
The speakers were very knowledgeable and lovely people and on the forefront of the devices industry. The presentations were very clear and interactive. The course was excellent and I would highly recommend to anyone wanted to learn about the new MDR.
Daniel Terzian Project Assistant, NDA Regulatory Science Ltd
Feb 8 2017
Great content
Andrew Whitton Medtrade Products Ltd
Feb 8 2017
The speakers all did a great job, they were committed and inspiring.
Dorte Reland Director, PV Operations, LEO Pharma A/S
Feb 8 2017
Good interactions and good speakers
Katja Gauci Device Quality Engineer, Mundipharma International Services Ltd
United Kingdom
Baxter
Becton Dickinson
Bedfont Scientific Ltd
Besins Healthcare
Blue Reg
Bristows LLP
Eurobio Scientific UK
Eurofins E&E CML Limited
Industrial Technology Systems Limited (ITS)
Johnson & Johnson Medical Ltd.
Kimberly-Clark Europe Ltd
Latham & Watkins LLP
LifeScan Scotland
MAGSTIM CO LTD
Magstim Company Ltd.
Mayborn Group
Medtrade Products Ltd
Mundipharma International Services Ltd
NDA Regulatory Science Ltd
Norgine Ltd
Occuity Limited
Pioneer Regulatory
Precipio Consulting
Presspart
Proctor & Gamble Technical Centres Ltd
SGR Consulting Services Ltd
Sinclair Pharma Plc
Smart Process Solutions Ltd.
sphere medical ltd
Stryker
Stryker/HeartSine
Torbay and South Devon NHS Foundation Trust
Vision RT Ltd
Vyaire Medical Products
Xiros
Xiros Ltd
Germany
Bayer Pharma AG
BEGO Implant Systems GmbH & co. KG
Edwards Lifesciences
Grunenthal GmbH
Croatia
Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
Croatian Agency for Medicinal Products and Medical Devices
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