Oct 11 2023, 12:00pm – 1:00pm
Virtual

Join us for an informative workshop on Health Canada regulations and guidelines for clinical research on medical devices. Clinical researchers and staff must be familiar with the requirements to apply to obtain an Investigational Testing Authorization (ITA) and with their roles and responsibilities related to this authorization. This workshop will provide an overview of the application requirements and will outline how research staff can ensure that best practices are implemented into clinical studies.

This workshop is part of our VCHRI Research Training Series. This series is designed to support the acquisition of advanced skills, techniques and knowledge and lead to enhanced practices in the conduct of research.

Learning objectives 

In this workshop you will learn:

  • A brief overview of the regulations and guidelines related to the study of medical devices in clinical research
  • When and how to apply for an ITA and communicate revisions and amendments to Health Canada
  • Roles and responsibilities related to an ITA
About the speakers
Marie-Pierre Desrosiers holds a bachelor's degree in biopharmaceutical sciences from the University of Ottawa and a master's degree in human genetics from McGill University. She has gained experience in research including laboratory research as well as clinical trials within the hospital setting and the private pharmaceutical industry. She is currently working as a scientific evaluator in the Medical Devices Directorate at Health Canada, where she reviews applications for ITA and verifies that investigational medical devices meet the safety and effectiveness requirements outlined in the medical devices regulations. 
Amanda Jones is acting manager of the Investigational Testing Authorization Section in the Medical Devices Directorate at Health Canada and substantive manager in the Post-Market Surveillance Section. With an educational background in biomaterials, she has worked as a medical device evaluator and as a manager at Health Canada for almost 20 years. She has evaluated a wide spectrum of medical devices, including Class I-IV, pre-market, post-market, ITA, SAP and COVID files, as well as a wide range of medical device technologies.

Registrants will receive information on joining the virtual event two days prior to the event date.

Primary health service delivery area