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.
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
The Medical Device Studies: Regulatory Requirements and Adverse Event Reporting course will cover:
Clinical evaluation - An Overview- What is a clinical evaluation?
- How do you conduct a clinical evaluation?
- The regulatory requirements pertaining to clinical evaluation
- What is a clinical investigation?
- When are clinical investigations needed?
- The regulatory requirements
- What is PMS?
- What is PMCF?
- When are PMCF studies necessary?
- Summary of safety and clinical performance
- Periodic safety update report (PSUR)
- What is their role in the above processes?
- What are the responsibilities of the manufacturer?
- What to communicate and when
- What is vigilance?
- The requirements for vigilance reporting during medical device studies
- Definitions
- Types of events
- Determining categories
- MEDDEV guidance document
- ISO 14155 harmonised standard
- Responsibilities
- Templates
- Focus on changes in the clinical arena
- Chapter 6: clinical evaluation and investigation
- Annex 14: clinical evaluation and post-market clinical follow-up
Speakers
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
NAMSAJanette 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.
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
