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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.

20-21 Sep 2021

& 22-23 Sep 2021

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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

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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20-21 Sep 2021
Face-to-face, (venue not yet confirmed)
20-21 Sep 2021
Face-to-face
(venue not yet confirmed)
GBP 1,499 1,299
EUR 2,099 1,819
USD 2,338 2,026
Until 9 Aug*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 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
22-23 Sep 2021
Live webinar
22-23 Sep 2021
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 11 Aug*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

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

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Agency for Medicinal Products and Medical Devices of Croatia (HALMED)
  • Bedfont Scientific
  • Bionical Emas
  • Boehringer Ingelheim Corporate Center GmbH
  • Cochlear AG
  • Contura International A/S
  • Cook Medical
  • Croatian Agency for Medicinal Products and Medical Devices
  • Emas Pharma Ltd
  • Ferring Pharmaceuticals A/S
  • Flexicare Medical Limited
  • genae associates
  • GlaxoSmithKline
  • GlaxoSmithKline Consumer Healthcare
  • Guerbet
  • Institut Straumann AG
  • Larix A/S
  • Medpace UK
  • National University of Ireland, Galway
  • Oticon Medical
  • Oticon Medical AB
  • Premier Research Poland Sp. z o.o.
  • ProductLife Ltd
  • Research and Markets
  • Simmons & Simmons LLP
  • Spineart SA
  • University of Cambridge
  • William Cook Europe
  • Xiros Ltd
  • Zealand Pharma

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

Very clear and understandable

Alison Etchells, Regulatory Affairs Officer, Thornton & Ross Ltd, Apr 17