DUBLIN, March 10, 2023 /PRNewswire/ — The “An Essential Overview of the Medical Device Industry Training Course” conference has been added to ResearchAndMarkets.com’s offering.
Course Overview
The medical device and diagnostics sectors are entering a period of regulatory change with the 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.
Agenda:
- The An Essential Overview of the Medical Device Industry course will cover:
- 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 – Including implementation of the MDR and the IVDR
- 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 – new procedures for Great Britain and for Northern Ireland
- 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 the latest guidance
- The key interface with digital technology
- Future developments and convergence of approaches
Key Topics Covered:
- 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 the latest guidance
- Building a global approval strategy on an EU CE mark approval
- The key interface with digital technology
Speakers:
David Jefferys
Senior Vice President
Eisai
Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine 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, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.
Theresa Jeary
Technical Manager for Medical Devices
Lloyds Register Quality Assurance (LRQA)
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 a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
For more information about this conference visit https://www.researchandmarkets.com/r/ghr7ys
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SOURCE Research and Markets
