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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

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

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.

Who should attend?

  • Regulatory affairs specialists
  • Quality assurance specialists
  • Clinical research associates
  • Junior clinical research associates
  • Professionals involved in reporting adverse events during pre- and post-market clinical studies

Programme

Clinical evaluation – an overview

  • What is a clinical evaluation?
  • How do you conduct a clinical evaluation?
  • The regulatory requirements pertaining to clinical evaluation

Clinical investigations – an overview

  • What is a clinical investigation?
  • When are clinical investigations needed?
  • The regulatory requirements

PMS and PMCF

  • What is PMS?
  • What is PMCF?
  • When are PMCF studies necessary?

Quiz on clinical evaluation, clinical investigation and PMCF

New requirements of the MDR

  • Summary of safety and clinical performance
  • Periodic safety update report (PSUR)

The competent authority and the Notified Body

  • What is their role in the above processes?
  • What are the responsibilities of the manufacturer?
  • What to communicate and when

Workshop on the new requirements of the MDR

Vigilance reporting

  • What is vigilance?
  • The requirements for vigilance reporting during medical device studies

How to define and classify adverse events

  • Definitions
  • Types of events
  • Determining categories

Vigilance workshop

The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies

  • MEDDEV guidance document
  • ISO 14155 harmonised standard
  • Responsibilities
  • Templates

The MDR – clinical elements

  • Focus on changes in the clinical arena
  • Chapter 6: clinical evaluation and investigation
  • Annex 14: clinical evaluation and post-market clinical follow-up

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 Mar 2022
  • 7-8 Jun 2022
  • 19-20 Sep 2022

Book now

You may also be interested in

Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Bedfont Scientific
  • Bionical Emas
  • BIOTRONIK AG
  • Boehringer Ingelheim Corporate Center GmbH
  • Cook Medical
  • Croatian Agency for Medicinal Products and Medical Devices
  • Edwards Lifesciences
  • Emas Pharma Ltd
  • Ferring Pharmaceuticals A/S
  • Flexicare Medical Limited
  • Gedeon Richter Plc.
  • Geistlich Pharma
  • genae associates
  • GlaxoSmithKline
  • GlaxoSmithKline Consumer Healthcare
  • Institut Straumann AG
  • Medpace UK
  • National University of Ireland, Galway
  • Nottingham Clinical Trials Unit
  • Novella Clinical
  • Novocure
  • Oticon Medical
  • Oticon Medical AB
  • ProductLife Ltd
  • Research and Markets
  • Spineart SA
  • Thornton & Ross Ltd
  • University of Cambridge
  • William Cook Europe

Great speaker, flexible attitude, and inclusive.

Syeda Ameernaz, Clincal safety Physician, Novocure, Sep 21

The overall webinar was informative and easy to follow and understand. Would highly recommend to anyone who has an active role in vigilance or clinical activity processes at your company. Jannette is a wonderful speaker, who is very articulate in putting things simply, but effectively without losing any necessary detail.

Hannah Vince-Drew, Clinical Research Associate, Bedfont Scientific, Feb 21

The group discussion workshop was very intriguing to hear to peoples perspective and experiences.

Hema Sivasubramanian, Clinical Research Coordination Assistant, National University of Ireland, Galway, Feb 21

Great presentation!

Alina Cezar, Project Coordinator, University of Cambridge, Feb 21

The training was PHENOMENAL and I have learned so much regarding various topics in the field.

Anthony Hugill, Clinical Safety Specialist, Novocure, Feb 20

Janette was very knowledgable and enthusiastic and was able to keep the subjects interesting throughout the whole meeting. The content was very relevant.

Liselotte Borup, Clinical Trial Manager, Oticon Medical, Feb 20

The course gave me a good overview of the MDR and the reporting of adverse events: the content was good, the presentations were clear and the speaker was very good. She was open to questions, which she answered in the best way possible.

Valérie Jean, Senior Clinical Research Associate, Spineart SA, Feb 20

I wanted to learn more about device vigilance and reporting and I now feel much more confident in putting these tasks into practice in my workplace. Janette was friendly, approachable and very knowledgeable regarding her course content considering the difficulties with the changes from MDD to MDR. I enjoyed the course and found the content to be interesting and relevant. Any questions asked were answered and all aspects of relevance to the group were covered. Janette took the time to find out about each person's job and responsibilities and, using examples, tailored her explanations so they were relevant.

Nicola Brown, Drug Safety Officer, ProductLife, Oct 19

Speaker was very knowledgeable.

Tracy Best, Quality Assurance Manager, Flexicare Medical Limited, Oct 18

Kath was very welcoming and presented well and in a way which I was able to understand. She used very good examples to help us understand the topic. I really enjoyed the course and felt it gave me a good insight and foundation to medical device studies.

Pavendeep Kumar, Principle Safety Specialist, Syneos Health, Oct 18

Was really good and you could tell it was a passion for the presenter which is always nice and dealt with a difficult person asking questions well at the beginning.

Jason Hemmings, Manager, Syneos Health, Oct 18

The course had a very good structure and the Speaker was excellent. The document we received during the course is very helpful.

Aline Erhart, Clinical Safety Officer, BIOTRONIK AG, Oct 18

Good speaker, highly relevant content. If the data collection definitions were removed, maybe it would make room for more in-depth discussions.

Christoffer Thaysen, Clinical Research Nurse Specialist, William Cook Europe, Oct 18

Very useful course, excellent speaker.

Gianluca Musolino, Clinical Research Fellow, University of Cambridge , Apr 18

[The speaker was] very knowledgable, [and a] clear communicator.

Iris Koenig, Director , Larix A/S, Apr 18