Topics to be covered include:
- Gain an overview of the medical device industry and clarify the differences in approach from pharmaceuticals
- Learn about medical device CE marking
- Gain an overview of medical device and IVD regulation and the new Medical Device Regulation
- Understand clinical trial controls and device vigilance
- Discuss device/drug combination products
- Understand the differences from the pharma industry
Why you should attend
The Pharmaceutical Industry is increasingly developing Device combination products and looking to use novel methods of drug delivery to enhance the performance of medicine and as a part of life cycle management. Medical Devices are also being employed to monitor compliance in clinical trials and post marketing as well as being used to monitor patients in trials. 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.
* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
- What is a medical device?
- What are the differences in approach from pharmaceuticals
- How is the device market developing
- An overview of the medical device and in-vitro diagnostics legislation, including the implementation of the 2017 Medical Device and IVD Regulations
- The role of the Competent Authority and Authorised Representative
- Brexit an update – what might happen
- What is a Notified Body and how are medical devices and IVDs evaluated
- What are the data requirements?
- How to work with a Notified Body
- Clinical trial controls for devices
- Device vigilance versus pharmacovigilance
- Device/drug combination products and companion diagnostics
- Building a global approval strategy on an EU CE Mark Approval
Mr David Jefferys,
Senior Vice President ,
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.
Ms 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.
The course has been specifically designed to meet the needs of those working in Pharmaceuticals and in allied business functions who need to understand this sector. The course will be particularly relevant for regulatory staff, those in clinical research, medical affairs and business development.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.