Applying for Health Canada or US FDA Clinical Trials (hybrid event)

Are you a health tech or biotech startup ready to take your solution to the next level through clinical trials? Do you know whether or not a clinical trial will be required?

Join Michael Jamieson, a regulatory/translational/quality support advisor for Queen’s University, in this workshop to learn the key steps you need to apply for a Health Canada or a US Food and Drug Administration clinical trial.

This session will cover:

• Will you need to do a clinical trial before you can market your technology?
• How to get started
• Types of clinical trials (IDE/ITA, IND/CTA, Investigator/Physician Sponsored)
• Important supporting documents and data (i.e., Risk Assessment, Animal Data, Good Laboratory Practices (GLP), etc.)
• Clinical trial basics
• Good Clinical Practices (GCP)
• How to avoid common pitfalls

Who is it for?

Whether you’re aiming to validate a digital health tool, a medical device, or a therapeutic intervention, this workshop will equip you with the knowledge to confidently move forward and start on your path toward a clinical trial application.

Note: This event will be held at 945 Princess Street, Kingston, however there will be an online option for those who cannot attend in-person.

About Dr. Michael Jamieson – Advisory (Regulatory, Quality, and Translational Affairs), Queen’s Partnerships and Innovation

After spending twenty-five years in the pharmaceutical, biologics and medical device industries, Michael joined the Department of Regulatory and Quality Sciences at the University of Southern California in 2008 where he was the Associate Director of the International Center for Regulatory Science (ICRS) and an Assistant Professor. From 2019-2021, he was the Director for Clinical Translation at the Ottawa Hospital Research Institute. Michael recently joined the Queen’s Partnerships and Innovation team as an advisor providing regulatory/translational/quality support to Queen’s researchers and local companies. I have been working QPI since the summer of 2022 so maybe something like “ has been an advisor for QPI for three years” rather than recently; met some of these companies back when I started in 2021 ex. Smart Biomedical.

About Queen's Partnerships and Innovation

Queen's University’s Partnerships and Innovation (QPI) supports the Research Portfolio’s mission to be an essential catalyst for advancing research and knowledge mobilization, strengthening Queen’s local, national and global impact.

Host or Publisher Queen's University Scale Up Project 2.0