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
Agenda
Day 1
The regulatory aspects of gathering clinical evidence for devices
- An overview of the regulations governing the clinical evidence aspects of devices
- How the regulations impact on clinical data for regulatory studies and post market studies
- Standards and guidelines applicable to medical device clinical evidence, ISO, GHTF (IMDRF), MEDDEV and NBMED
Conducting a pre-market clinical evaluation and the literature review
- The Clinical Evaluation (Literature Review)
- What’s involved and how it should be conducted
- What documents are required - how is clinical data used?
- Example documents and templates will be provided to help delegates understand this process
Conducting a pre-market (regulatory) clinical investigation
- What types of studies and study designs are applicable to pre-market studies?
- What to consider in designing and implementing appropriate pre-market studies
Documentation for pre-market (regulatory) clinical investigation
- What documentation is needed?
- How this should be produced and what detail is required
- This presentation will include template documentation for clinical investigation plans, investigator brochures, case report forms and consent forms
How to obtain the necessary approvals for pre-market studies
- How to obtain Research Ethics approval
- How to obtain National competent authority approvals
- Other necessary approvals
- What to provide, timescales and practicalities
Day 2
Study management and monitoring of regulatory clinical investigation
- Key aspects study set up
- Management, monitoring and close down
- Getting the best data
How to write a final study report for a regulatory clinical investigation pre-market study
- Practical considerations for final study reports, publications and presentations of study results
- Examples and templates will be provided to help delegates understand the processes
- How to prepare a paper or presentation for publication and marketing
PMCF
- Practical considerations for conducting PMCF studies
- The differences between PMCF and regulatory studies
- When to conduct PMCF studies and other PMC data requirements
Current key issues affecting clinical evidence for medical devices
- The effect of changes to the directives and current initiatives throughout Europe
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
