We can customise this course to meet the requirements of your organisation.
This is a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you prepare for these changes and operate successfully in the changed environment in Europe. The seminar will cover in depth the new regulations and how they will be implemented by Member States and Notified Bodies. You will hear the latest thoughts on clinical development, safety monitoring and the implications of Brexit.
This is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
Personnel from the following departments:
This seminar will provide key guidance and interpretation of the changes to the regulation and will be of value to all those who are involved with placing a medical device on the market, and anyone who requires an essential overview of the new medical device regulation and its impact on the industry and working practices.
09.30 Chairman’s welcome and introduction
Dr David Jefferys
09.45 Introduction and background to the new regulation
11.30 Key Preparation for successful implementation
13.45 Notified Bodies: How the changes will impact NBs and manufacturer’s – including the new rules for IVD conformity assessment
15.30 Increased vigilance and Post Market Surveillance – how to comply
17.00 Close of day one
09.00 Welcome to day two
Dr David Jefferys
09.30 Clinical investigations – what is required?
11.15 IVDs and companion diagnostics
13.45 Other essential considerations
15.15 Other essential considerations (continued)
16.15 Panel discussion and key take home messages
16.30 Close of forum
Janette Benaddi is an Independent Consultant and previously Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.
She has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. She has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
She is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies, she holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. She has published several articles relating to medical device regulation and clinical studies.
Theresa Jeary is Head of the Notified Body for Medical Devices at LRQA, where she is 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. She 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.
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.