Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.
The New Medical Device Regulation (MDR) brings about a period of great change, uncertainty and opportunity within the medical technology and diagnostics sectors. This seminar will help you embrace these changes and operate successfully in the new environment in Europe. It will cover in depth the new regulations and their implementation by the Member States and Notified Bodies. You will get to hear the latest thoughts on clinical development, safety monitoring and the implications of Brexit.
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 in 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.
Introduction and background to the new regulation
Key preparation for successful implementation
Notified Bodies: how the changes will impact NBs and manufacturers – including the new rules for IVD conformity assessment
Clinical investigations – what is required?
Increased vigilance and post-market surveillance – how to comply
IVDs and companion diagnostics
Other essential considerations
Panel discussion and key take-home messages
Janette Benaddi
Janette Benaddi is an Independent Consultant and previously the 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.
Janette has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette 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.
Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, 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. Janette has published several articles relating to medical device regulation and clinical studies.
| 24-25 Sep 2019 | |||
| 24-25 Sep 2019 | DoubleTree by Hilton London-West End, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
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“Good, complete coverage of the new regulations. Good anticipating on discussed items.”
Marcel Steenhof, Toxicologist and Regulatory Affairs Profesisonal, Keystone Europe BV
“[The speakers were] all very knowledgeable. The whole course was very reassuring with the 'big monster' of the MDR being broken down so that it appears manageable and less scary. It was full of helpful advice both general and specific to my products. ”
Samantha Workman, ISO Manager, Torbay and South Devon NHS Foundation Trust
“Excellent speakers”
Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
“Excellent speakers”
Iva Ujevic, Senior Advisor in the Department for Medical Devices , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
“Very good. ”
Marie-Cécile Lerat, RA Manager MPS Europe, Becton Dickinson
“This was an excellent introduction to the Medical Device Regulation, focussing on the key changes and considerations to prepare for compliance with the new requirements. The experienced speakers provided much needed guidance and expertise.”
Kate Cole, Regulatory Affairs Manager, Xiros Ltd
“The speakers were very knowledgeable and lovely people and on the forefront of the devices industry. The presentations were very clear and interactive. The course was excellent and I would highly recommend to anyone wanted to learn about the new MDR.”
Daniel Terzian, Project Assistant, NDA Regulatory Science Ltd
“Excellent, both content and speaker line up”
Zinovia Chatzidimitriadou, Associate, Bristows LLP
“The speakers all did a great job, they were committed and inspiring. ”
Dorte Reland, Director, PV Operations, LEO Pharma A/S
“Great content”
Andrew Whitton, , Medtrade Products Ltd
“Good interactions and good speakers”
Katja Gauci, Device Quality Engineer, Mundipharma International Services Ltd