This course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products. Clinical data is required for all medical devices and the emphasis on high quality, appropriate clinical evidence has grown substantially in the last few years. Clinical evidence is key to bringing a device to market and is a very important aspect of post market evidence gathering to meet the legislation. The collection of clinical data to demonstrate safety and performance of a device is pivotal to CE marking a medical device. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market.
This course will cover the full range of activities that should be applied during the collection of clinical evidence for both pre and post market studies. It will provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies and help them to run studies in Europe and other countries.
Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant.
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
Programme Day One
Welcome, Introductions and Course Objectives
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/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 Investigations
- 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 Researth Ethics approval
- How to obtain National Competent Authority approvals
- Other necessary approvals
- What to provide, timescales and practicalities
The Differences between Drugs and Devices
Programme Day Two
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
Post Market Clinical Follow Up Studies
- Practical considerations for conducting post market clinical follow up studies
- The differences between PMCFU and regulatory studies
- When to conduct PMCFU studies and other PMC data requirements
What about In-Vitro Diagnostic Devices
- Clinical data for IVDs; what and when
- The regulations and guidance applicable to IVDs
Current key issues affecting clinical evidence for medical devices
- This presentation will provide an update on the current issues affecting medical device clinical data. It will include the effect of changes to the Directives and current initiatives throughout Europe.
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
Janette Benaddi is the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.
She has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. She 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.
She is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies, she 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. She has published several articles relating to medical device regulation and clinical studies.
Mr Robin Stephens,
Senior Director of Regulatory Affairs ,
Robin Stephens is Senior Director of Regulatory Affairs at Novella Clinical. He has more than 25 years’ experience in clinical research and regulatory affairs for medical devices throughout the world, but principally in Europe.
Prior to his role in Novella Clinical, he was the Director of QA/RA/CA for Apica Cardiovascular that is now part of the Thoratec Corporation. He was the Owner & Managing Director at Psephos Biomedica: a clinical, regulatory and quality consultancy in client-partnerships and/or interim management relationships with entrepreneurial corporations and venture-backed companies since 2001. He was the Director, International Clinical Research & Regulatory Affairs for Medtronic Vascular (previously AVE); the Managing Director of Global Regulatory Associates Limited and before that held several positions with CR Bard.
He has been Scientific Adviser to a medical technology publishing house as well as being an author on regulatory matters and editor for a series of books on biomaterials. He has a BSc in Applied Chemistry and is a member of the Royal Society of Chemistry.
- Setting up, managing and monitoring studies
- Regulatory Affair
- Those who conduct clinical evaluations/investigations/post market follow up studies
- Those moving from Pharma to Medical Device studies
The Cavendish Hotel
81 Jermyn Street