Presented by
Management Forum

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.

9-10 Mar 2022 + 2 more dates

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  • Format: Live online, Classroom
  • CPD: 12 hours for your records
  • Certificate of completion

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

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The Medical Device Studies: Regulatory Requirements and Adverse Event Reporting course will cover:

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

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Janette Benaddi

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.

More details

Book Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Live online/Classroom training

9-10 Mar 2022

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11554

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 02 Feb

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7-8 Jun 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11375

  • GBP 1,299 1,499
  • EUR 1,819 2,099
  • USD 2,026 2,338

Until 03 May

  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

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19-20 Sep 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11697

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 15 Aug

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Reviews of IPI's Medical Device Studies: Regulatory Requirements and Adverse Event Reporting training course


Great speaker, flexible attitude, and inclusive.

Sep 22 2021

Syeda Ameernaz
Clincal safety Physician, Novocure

Feb 23 2021

Great presentation!

Alina Cezar
Project Coordinator, University of Cambridge

Feb 23 2021

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 23 2021

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 25 2020

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

Anthony Hugill
Clinical Safety Specialist, Novocure

Feb 25 2020

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 25 2020

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

Oct 1 2019

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 12 2018

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

Apr 13 2018

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

Iris Koenig
Director , Larix A/S

Apr 13 2018

Very useful course, excellent speaker.

Gianluca Musolino
Clinical Research Fellow, University of Cambridge

Oct 12 2018

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 12 2018

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 12 2018

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 12 2018

Speaker was very knowledgeable.

Tracy Best
Quality Assurance Manager, Flexicare Medical Limited

Apr 7 2017

Speakers were friendly, patient and easy to approach

Imogen Burkinshaw
Safety Reporting Manager, Novella Clinical

Apr 7 2017

Very well structured. Did well to present this content in one day.

Goranka Marusic Kontent
European Affairs Advisor , Agency for Medicinal Products and Medical Devices of Croatia (HALMED)

Apr 7 2017

Very detailed and informative presentation

Rukhnoor Mahmood
Project Manager, Emas Pharma Ltd

Apr 7 2017

Very clear and understandable

Alison Etchells
Regulatory Affairs Officer, Thornton & Ross Ltd

Apr 7 2017

It was good and the content gave a lot of information on medical devices. The speaker was very knowledgeable about topic.

Roshini Nellailingam
Regulatory Affairs Manager, Emas Pharma Ltd

Apr 7 2017

Well prepared speaker - Good use of subjects

Emil Hofdahl
Specialist, Clinical Safety Reporting, William Cook Europe

UK

  • Bedfont Scientific
  • Bedfont Scientific Limited
  • Bionical Emas
  • Emas Pharma Ltd
  • Flexicare Group Ltd
  • Flexicare Medical Limited
  • GlaxoSmithKline
  • GlaxoSmithKline Consumer Healthcare
  • Medpace UK
  • Nottingham Clinical Trials Unit
  • Novella Clinical
  • ProductLife
  • Syneos Health
  • Thornton & Ross Ltd
  • University of Cambridge
  • University of Cambridge Metabolic Research Laboratories
  • Xiros Ltd

Denmark

  • Contura International A/S
  • Cook Medical
  • Ferring Pharmaceuticals A/S
  • Larix A/S
  • Oticon Medical
  • William Cook Europe
  • Zealand Pharma

Switzerland

  • BIOTRONIK AG
  • Cochlear AG
  • Geistlich Pharma
  • Institut Straumann AG
  • Novocure
  • Spineart SA

Belgium

  • Genae Associates
  • Simmons & Simmons LLP

Croatia

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Croatian Agency for Medicinal Products and Medical Devices

United States of America

  • Edwards Lifesciences
  • Novocure

France

  • Guerbet

Germany

  • Boehringer Ingelheim Corporate Center GmbH

Hungary

  • Gedeon Richter Plc.

Ireland

  • National University of Ireland, Galway

Israel

  • Teva Pharmaceuticals Industries Ltd

Poland

  • Premier Research Poland Sp. z o.o.

Sweden

  • Oticon Medical AB

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy