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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

  • Associate Director, Regulatory Document Lead
  • Janssen Research & Development, United States
Nicole  Hinton

Speaker

Nicole Hinton

  • Director, Clinical Trial Transparency
  • Ultragenyx Pharmaceutical, United States