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Session 5, Track A: Transform Canadian Regulatory Decision-Making - Real-World Data Integration and the Future of Patient-Centered Market Access
Session Chair(s)
Oxana Iliach, PhD
Senior Director Regulatory Strategy, Certara, Canada
Myriam Salem
National Supervisor, Regulatory Operations and Enforcement Branch, Health Canada, Canada
As Canada's drug regulatory and health technology assessment (HTA) landscape evolves, the integration of real-world data (RWD) and real-world evidence (RWE) into regulatory and market access decision-making is emerging as a critical lever for timely, patient-centered outcomes. This session brings together perspectives from Health Canada, the Canadian Drug Agency (CDA), and the pharmaceutical industry to examine the current state of RWD/RWE acceptance in Canadian regulatory submissions and reimbursement decisions, and to explore the policy reforms needed to close the gap between evidentiary standards and real-world clinical practice. Speakers will address the practical, methodological, and governance considerations that regulators and industry face in generating and applying RWE that is credible, actionable, and aligned across agencies. Attendees will leave with a clearer understanding of how collaborative frameworks and evolving policy can accelerate patient access to innovative therapies in Canada.
Learning Objective : At the conclusion of this session, participants should be able to: - Evaluate best practices for generating regulatory-grade RWE that meets evolving Canadian submission standards
- Apply a multi-stakeholder framework to advance patient-centered market access strategies within Canadian drug development programs
- Identify current Health Canada and CDA policy gaps in RWD/RWE acceptance and the changes needed to strengthen cross-agency alignment
Speaker(s)
From Theory to Tangible: Integrating Real-World Data into Canadian Regulatory Submissions to Drive Decision-Making
Sehir Ahmad
Group Regulatory Excellence Lead, Roche, Canada
Speaker
Andrew Raven, MSc
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB, Health Canada, Canada
Speaker
Saunya Dover, MSc
Director, Science and Methods, Canada's Drug Agency, Canada
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