An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting
25-26 Feb 2020
& 22-23 Sep 2020
This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.
Clinical evaluation – an overview
Clinical investigations – an overview
PMS and PMCF
Quiz on clinical evaluation, clinical investigation and PMCF
New requirements of the MDR
The competent authority and the Notified Body
Workshop on the new requirements of the MDR
Review of day one
How to define and classify adverse events
The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies
The MDR – clinical elements
Discussion session and end of seminar
Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 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. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she 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.