Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual

Sep 13, 2021 10:00 AM - Sep 14, 2021 3:15 PM

(US Eastern Standard Time)

Global Clinical Trial Disclosure and Data Transparency Conference

Learn about the latest requirements in clinical trial disclosure and data transparency, share best practices, and engage in in-depth discussions on hot topics.

Session 8: The Evolution of Health Canada’s Public Release of Information & Closing Remarks

Session Chair(s)

Nancy  Williams

Nancy Williams

Associate Director, RSMO Document Publishing Solutions

Janssen Pharmaceuticals, United States

Health Canada Public Release of Information (PRCI) was released in March of 2019 and was temporarily paused in 2020 in order to focus on COVID-19 efforts. However, Health Canada has resumed PRCI and is moving forward with implementation of Stage 2 for proactive release, which includes all NDS-type submissions. Industry has also had to implement, pause, and re-start their internal processes to deliver PRCI submissions. The session will provide lessons learned and refinement of process both from the very first to the more seasoned PRCI experience

Learning Objective : At the conclusion of this session, participants should be able to:
  • Understand PRCI guidance and scope moving forward
  • Identify actions to prepare for initial PRCI submissions
  • Considerations for refinement of existing PRCI processes

Speaker(s)

George  Allan, PhD

Speaker

George Allan, PhD

Janssen Research & Development, United States

Associate Director, Regulatory Document Lead

Nicole  Hinton

Speaker

Nicole Hinton

Ultragenyx Pharmaceutical, United States

Executive Director, Clinical Trial Transparency

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.