CADTH Webinar: Consultation on Real-World Evidence Guidance
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 CADTH’s 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.
- Nicole Mittmann, Chief Scientist and Vice-President, Evidence Standards, CADTH
- Melissa Hunt, Director, Pharmaceutical Drugs Directorate, Health Products and Food Branch, 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
To register click here.