An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow up requirements and adverse event and vigilance reporting
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.
Who should attend?
- Regulatory affairs specialists
- Quality assurance specialists
- Clinical research associates
- Junior clinical research associates
- Professionals involved in reporting adverse events during pre- and post-market clinical studies
Programme Day One
Clinical evaluation – an overview
- What is clinical evaluation?
- How do you conduct a clinical evaluation?
- The regulatory requirements pertaining to clinical evaluation
Clinical investigations – an overview
- What is a clinical investigation?
- When are clinical investigations needed?
- The regulatory requirements
PMS and PMCF
- What is PMS?
- What is PMCF?
- When are PMCF studies necessary?
Quiz on clinical evaluation, clinical investigation, and PMCF
New requirements of the MDR
- Summary of safety and clinical performance
- Periodic safety update report (PSUR)
The competent authority and the Notified Body
- What is their role in the above processes?
- What are the responsibilities of the manufacturer?
- What to communicate and when
Workshop on the new requirements of the MDR
Programme Day Two
Review of day one
- What is vigilance?
- The requirements for vigilance reporting during medical device studies
How to define and classify adverse events
- Types of events
- Determining categories
The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies
- MEDDEV guidance document
- ISO 14155 harmonised standard
The MDR – clinical elements
- Focus on changes in the clinical arena
- Chapter 6: clinical evaluation and investigation
- Annex 14: clinical evaluation and post-market clinical follow-up
Discussion session and end of seminar
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
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 ahs 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.
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.