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Session 8: The Evolution of Health Canada’s Public Release of Information & Closing Remarks
Session Chair(s)
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)
Speaker
George Allan, PhD
Janssen Research & Development, United States
Associate Director, Regulatory Document Lead
Speaker
Nicole Hinton
Ultragenyx Pharmaceutical, United States
Sr Director, Clinical Trial Transparency
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