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.
14 Oct 2019
& 7 May 2020
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 workshop will highlight the transition to the new Medical Device Regulation (MDR) and discuss the new rules and approaches to developing combination products. The key interface with digital technology will also be discussed.
This meeting runs back-to-back with An Essential Overview of the Pharmaceutical and Biotech Industries and there is a £100/€140 discount off when booked with together with An Essential Overview of the Pharmaceutial and Biotech Industries
To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail firstname.lastname@example.org
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. The course will be particularly relevant for regulatory staff and those in clinical research, medical affairs and business development.
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.
David Jefferys (14 Oct 2019)
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 (14 Oct 2019)
Theresa Jeary works for SFL as Head of Combination Products. She was previously Head of the Notified Body for Medical Devices at LRQA, where she was responsible for Devices Drug products and Class III Medical Conformity Assessment for a wide range of medical devices, including In-Vitro Fertilization Media and Solutions for Organ Preservation. 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.
Theresa 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, she 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, she 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. She holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.