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Medical Device Studies: Clinical Evidence

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

Customised in-house training course

The content, presenters and format of this course are customised to your requirements.

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Details

Course overview

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

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

Programme

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

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

Presenter

Janette Benaddi (More...)

Janette 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 has 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.

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Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 9-10 May 2022
  • 15-16 Aug 2022
  • 14-15 Nov 2022

Book now

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Previous customers include...

  • iLine Microsystems S.L
  • Abiogen Pharma S.p.A.
  • Allergan
  • Allergan UK Limited
  • American Express Global Business Travel Espana
  • Atos Medical
  • BBI Solutions
  • Benta SAL
  • Biomet UK Healthcare Ltd
  • Dermal Laboratories Ltd
  • Ekso Bionics
  • Emergo Consulting UK Ltd
  • FIND
  • Fisher & Paykel Health Care
  • GlaxoSmithKline (GSK)
  • GSK Consumer Health
  • Laboratorios CINFA SA
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mölnlycke
  • Novo Nordisk A/S
  • Omron Healthcare Europe BV
  • Precision for Medicine
  • Quanta Dialysis Technologies Ltd
  • Radiometer Medical Aps
  • Research Instruments Ltd
  • Saudi Food and Drug Authority
  • SPD Development Company Limited
  • SSI Diagnostica
  • Thornton & Ross Ltd
  • USGI Medical

Very good course! It worked very well to have it online and be able to see the speaker and the presentation at the same time!

Christa Myhre, RA Specialist, Radiometer Medical Aps, Nov 20

Very good course ! It worked very well to have it online and be able to see the speaker and the presentation at the same time!

Christa Myhre, RA Specialist, Radiometer Medical Aps, Nov 20

A very interesting course, good for networking. Speakers were very prepared and good in enhancing discussions.

Barbara Acca, CRA Lead/ CTM, Cepheid, Nov 19

I appreciated the interactive way of presenting and the incorporation of questions and examples. I learned a lot.

Sandra Tobisch, Clinical Trial Manager, BSN medical GmbH / Essity, Nov 19

This course was extremely helpful and relevant. The trainers were very knowledgeable and experienced.

Jessica Allen, Regulatory Affairs Specialist, JRI, May 19

For me the course content was pitched well for the time allowed. I thought the presenters did a great job of managing the participants expectations.

Stephen Rowe, Managing Director, SGR Consulting Services Ltd, Nov 18

Overall it was a great opportunity to get more awareness on clinical studies with medical devices. The documentation provided was very clear and provided valuable input for setting procedures in my company. The speakers were very open to interaction and there was enough time for discussion. The combination with hands-on tasks was also key to understand the content.

Ricardo De Sa, Regulatory Affairs Manager, Definiens AG, Nov 18

Great course to give an overview of a very big topic

Louise Corcoran, Director of Quality and Regualtory Affairs, FIRE1, Nov 18

Great knowledge within the area of clinical studies and MDs. Interactive and willing to share their knowledge and experience. Entertaining to listen to, I never got bored despite listening for 2 days. Great!

Anne-Christine Nilsson, COO, Glycobond, Nov 18

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

Sébastien Malaise, R&D Manager, Sinclair, May 18

Excellent

David Browne, Development Technician, Biovotec, May 18

Very experienced and knowledgable [speakers]. Excellent.

Dawn Chesher, Regulatory Affairs Director Consumer Healthcare, GlaxoSmithKline (GSK), May 18

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), May 18

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

Diana Villanueva, Project Manager, Precision for Medicine, May 18

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), May 18