Medical Device Studies: Clinical Evidence

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

14-15 Nov 2019

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

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 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 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 and help them to run studies in Europe and other countries. Delegates will 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 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

Who should attend

  • Personnel involved in:
    • 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

Programme day one

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 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

Current key issues affecting clinical evidence for medical devices

  • The effect of changes to the directives and current initiatives throughout Europe

Presenters

Janette Benaddi

Janette Benaddi is an Independent Consultant and previously 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.

Janette has over 20 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.

Janette is a registered nurse, 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.

Robin Stephens

Robin Stephens is CEO & Principal Consultant, Psephos Biomedica a clinical, regulatory & quality consultancy in client-partnerships and/or interim management relationships with entrepreneurial corporations and venture-backed companies since 2001. Robin has more than 30 years experience in clinical research and regulatory affairs for medical devices throughout the world, but principally in Europe. Prior to his role with Psephos Biomedicca, Robin was the Director of QA/RA/CA for Apica Cardiovascular that is now part of the Thoratec Corporation. He was held senior roles with Conor Medsystems as well as Medtronic Vascular (previously AVE); and before that held several positions with CR Bard. Robin 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 holds a Masters Degree in Applied Theology from University of Wales, Bangor, a Bachelor of Science degree in Applied Chemistry from Northumbria University and is a member of the Royal Society of Chemistry.

Book now

14-15 Nov 2019
14-15 Nov 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now

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Excellent

David Browne, Development Technician, Biovotec

Very well organised. Speaker is really experienced and knows how to teach in a friendly manner.

Diana Villanueva, Clinical Operations Manager, Transplant Biomedicals

I am very happy about the training, the atmosphere and the venue. Janette was great and very friendly.

Sébastien Malaise, R&D Manager, Sinclair

I got what I needed. Theory and practical examples, Thank you!

Karmela Kopcic, Senior Associate for Medical Devices, Croatian Agency for Medicinal Products and Medical Devices (HALMED)

Very experienced and knowledgable [speakers]. Excellent.

Dawn Chesher, Regulatory Affairs Director Consumer Healthcare, GlaxoSmithKline (GSK)

This course was very beneficial for me. Overall the information given and the way the speakers shared that information was very satisfactory.

Marguerite Rizkallah, MD Regulatory Affairs Manager, Benta SAL

Open, knowledgable and clear with good detail

Mina Patel, RA Manager, Medtrade Products Limited

Effective overview of clinical investigation, quite intensive

Gianluca Colucci, In-House Clinician, Intertek

Knowledgable speakers

Faye Murray, Product Manager Diagnostics, Owen Mumford Ltd

Good overall overview of clinicals

Julie Eyers, Regulatory Affairs Manager, Boston Scientific

Very useful course with excellent speakers

Suna Horner, Associate Medical Manager, HRA Pharma UK & IE Ltd.

Gives a good overview and interesting discussions. Lots of uncertainties in the business but good to discuss

Åsa Odhagen Rosvall, Evidence Strategist, Mölnlycke

Excellent, really enjoyed the course.

Jenny Nilsson, Medical Co-ordinator, Glycorex Transplantation AB

Great course - ticked all the boxes I had - would definitely recommend it to anyone starting out in this field - only wish I'd known about this and the other courses you offer earlier

Julia Herbert, Clinical Director, Femeda Ltd.

This is the best course I have attended for a long time! Well done!

Phil Rosher, Head of Regulatory Affairs, Dermal Laboratories Ltd

Course was tailored to suit the needs to the the group. And personal requests were taken into account. Presentation was good, and broken up into easy digestible parts

Tony Wilson, Clinical Research Associate, Biomet UK Healthcare Ltd

Content was good within the objectives of the course. Well presented. Good speakers

Teresa Lopes, Manager Medical Devices, BioTop Medical

the course was excellent, due to small group size (9+2) discussion and interaction with presenters and participants was possible all the time and also allowed customising of its content. A stimulating meeting.

Mirko Hechenberger, Regulatory Affairs Manager, Merz Pharmaceuticals GmbH

I really enjoyed my two days. I am much clearer on my understanding of the Clinical requirements for a medical device and the sequence of events and steps that need to be followed.

Priti Darjee, Associate Director Regulatory Affairs, UK, Teva UK Ltd

Overall, it was a really good course and the speakers were really good as well

Sandra Beltran-Rodil, Manager, Regulatory Affairs , TEVA UK Ltd