An Essential Overview of the Medical Device Industry Training Course
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.
Details
Course overview
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.
Who should attend?
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.
Programme
What is a medical device and an IVD?
How is the device market developing?
An overview of the MDR and IVD Directives and the Regulations
- Challenges of MDR implementation – May 2020
- Preparation for IVDR implementation
What are the key differences in approach from pharmaceuticals?
Who are the key actors?
The role of the competent authority and authorised representative
Brexit update – impact on the medical device industry
What is a Notified Body?
How to work with a Notified Body
How are medical devices and IVDs evaluated?
What are the data requirements?
Clinical trial controls for devices
Device vigilance versus pharmacovigilance
Device/drug combination products and companion diagnostics
- The operation of Article 117 and latest guidance
Building a global approval strategy on an EU CE mark approval
The key interface with digital technology
Presenters
Theresa Jeary (More...)
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.
David Jefferys (More...)
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.
Book now
Book now
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23 May 2022 Live webinar |
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23 May 2022 Live webinar |
GBP 599 499 EUR 859 719 USD 970 814 Until 18 Apr 22* |
Enrol now
to attend Live webinar |
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2 Nov 2022 Live webinar |
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2 Nov 2022 Live webinar |
GBP 599 499 EUR 859 719 USD 970 814 Until 28 Sep 22* |
Enrol now
to attend Live webinar |
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* Note the early booking discount cannot be combined with any other offers or promotional code