Webinar: Consultation on Real-World Evidence Guidance

Event date: Friday, December 2, 2022
Time: 1:00 p.m. to 2:00 p.m. ET

This webinar is part of a public consultation on draft guidance that will inform the generation and use of real-world evidence (RWE) in regulatory and reimbursement decision-making in Canada.

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Regulators and health-technology assessment (HTA) agencies have recognized the need to integrate high-quality RWE into HTA to help address evidence gaps for decision-making. However, as capacity and expertise in the generation of RWE increase, there is a need to standardize  reporting for RWE studies that are submitted to inform regulatory and HTA decision-making.

A key component of ours strategic plan is to be a leader in the practice of evidence appraisal and to optimize the integration of RWE into our work. To deliver on this ambition and facilitate the submission of RWE, we have collaborated with the RWE Steering Committee  and the RWE Guidance Working Group to develop pan-Canadian guidance about the reporting of RWE that may be considered in decision-making.

This webinar will describe the process used to develop the draft RWE guidance document, discuss its purpose, and highlight how stakeholders can provide feedback throughout the consultation process. Participants will have the opportunity to ask questions about the guidance document and the feedback process during the session.

Panellists:

• Nicole Mittmann, Chief Scientist and Vice-President, Evidence Standards
• Kelly Robinson, Director General, Marketed Health Products Directorate, Health Canada, Government of Canada
• Mina Tadrous, University of Toronto; Lead, Core Working Team for the RWE Guidance Working Group
• Kaley Hayes, Brown University; Member, Core Working Team for the RWE Guidance Working Group