Medical Device Studies: Regulatory Requirements and Adverse Event Reporting In-house Training

As the person responsible of safety assessment and reporting in my department (clinical), I was hoping to strengthen my knowledge in this area. Especially when it comes to event assessment and classification. This course helped me achieve that goal. [Speaker] is very knowledgeable on several topics.

Sep 16 2024

Stéphanie Trznadel
Clinical Trial Coordinator, SPINEART

Oct 3 2022

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.

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