Clinical evidence is crucial to bringing a device to market and is a very important aspect of post-market compliance to meet the requirements of current legislation. The collection of clinical data to demonstrate safety and performance is pivotal to CE marking a medical device and the collection of post-market data is key to the continued safety and performance considerations once the device is on the market.
This practical and intensive two-day course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices. It will cover the full range of activities that should be applied during the collection of clinical evidence for both pre- and post-market studies and will also provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies. Participants will benefit from advice and tips from industry experts on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant with the new MDR.
Benefits of attending
- Understand the regulatory requirements and guidance applicable to clinical evidence
- Clarification on Clinical Evaluations (Literature Reviews)
- Understand what is required in terms of clinical data prior to CE marking and post-CE mark
- Know what documentation is needed for the pre-and post-market phases of clinical data collection
- Discover how to conduct a clinical investigation and post-market clinical follow-up study
- Plan how to prepare regulatory notifications to the competent authorities and obtain other necessary approvals
- Understand the key aspects of pre and post-market study setup, management, monitoring and close down
- Discuss how to prepare a paper or presentation for publication and marketing
- Understand the differences between drugs and devices
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
- Personnel involved in setting up, managing and monitoring studies
- Setting up, managing and monitoring studies
- R&D
- Marketing
- Regulatory Affair
- Those who conduct clinical evaluations/investigations/post market follow up studies
- Those moving from Pharma to Medical Device studies
