Presented by
Management Forum
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
★★★★★ "Understanding what requirements for RA through the cases of Medical Devices studies is very importan... more"
18-19 September 2023
from £1099
- Format: Live online
- 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
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
Graeme Ladds
PharSafer Associates Ltd
Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety & Medical Information, he went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals. He then set up his consultancy and specialist CRO company, PharSafer Associates Ltd, where he has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.
Book Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
18-19 September 2023
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 14120
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 14 Aug
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's Medical Device Studies: Regulatory Requirements and Adverse Event Reporting training course
Understanding what requirements for RA through the cases of Medical Devices studies is very important for me to deal with Korean Medical devices. So this course make me more knowlegable about Europe's MD handling and also distinguish how to adapt on some agenda between Korean and Europe Medical Devices.
Oct 3 2022
Heejun Hong 
Student, Dongguk University, Republic of Korea
Mar 9 2022
Fantastic speaker. I truly enjoyed listening to Janette, her ability to relate real life examples helped make sense of the topics.
Melissa Patterson 
Associate Manager, Corporate Clinical Compliance, Edwards Lifesciences
Mar 9 2022
Excellent course, excellent trainer. Found it very valuable and will be taking away knowledge gained to further improve processes and understanding within my department.
Sarah Collins 
Pharmacovigilance Manager, PharSafer
Sep 22 2021
Great speaker, flexible attitude, and inclusive.
Syeda Ameernaz
Clincal safety Physician, Novocure
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 Supervisor, 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 
EU Affairs Advisor, 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
United Kingdom
- 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
- PharSafer
- ProductLife
- Sinclair Pharmaceuticals
- Sinclair Pharmaceuticals Ltd
- Syneos Health
- Thornton & Ross Ltd
- University of Cambridge
- University of Cambridge Metabolic Research Laboratories
- Xiros Ltd
Denmark
- Contura International A/S
- Cook Medical
- Cook Research Institute
- Ferring Pharmaceuticals A/S
- Larix A/S
- Oticon Medical
- William Cook Europe
- Zealand Pharma
Switzerland
- BIOTRONIK AG
- Cochlear AG
- Geistlich Pharma
- Hamilton Medical AG
- Institut Straumann AG
- Novocure
- Spineart SA
Belgium
- Genae Associates
- Simmons & Simmons LLP
Croatia
- Croatian Agency for Medicinal Products and Medical Devices
- HALMED
Korea, Republic Of
- Dongguk University
- Dongguk University, Republic of Korea
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
Italy
- Anelli Marco
Netherlands
- Interdos Pharma bv
Poland
- Premier Research Poland Sp. z o.o.
Sweden
- Oticon Medical AB
Run Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
