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Session 7 Track B: The Regulatory Review of Drugs and Devices (R2D2) Project Wrap-up
Session Chair(s)
Melissa Hunt, MSc
Director, Health Canada, Canada
The Regulatory Review of Drugs and Devices is an initiative that aims to build an agile regulatory system supporting better access to therapeutic products based on healthcare system needs. This initiative consisted of 15 individual projects. Since its beginning in 2017 there have been many successes. This session will give a general update of the initiative as it enters its final stages, as well as dive deeper into 4 of the projects (transparency, early parallel scientific advice, expansion of Priority Review pathways, and the Special Access Programme renewal). Many of the other projects and their progress will also be discussed in other session throughout the meeting.
Learning Objective : At the conclusion of this session, participants should be able to:
- Explain what the R2D2 initiative was and the progress it has made
- Discuss the current and future state of transparency initiatives, early parallel scientific advice and the Special Access Programme
- State the next steps for the expansion of Priority Review pathways project
Speaker(s)
Megan Bettle, PhD
, Health Canada, Canada
Year Three Status - Regulatory Review of Drugs and Devices
David Southam, PhD
Senior Clinical Evaluator, Health Canada, Canada
Accelerated Review of Human Drug Submissions: An Update
Carole Legare, MD
Director, Office of Clinical Trials, TPD, Health Canada, Canada
Special Access Programme Renewal
Neerja Goyal, MS
Director, Regulatory Strategy and Policy, GlaxoSmithKline, Inc., Canada
Speaker
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