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Session 6 Track B: Real-World Data and Real-World Evidence
Session Chair(s)
Judith Mergl, MSC
Head of Regulatory Affairs and Operational Services, Canada, AbbVie Corporation, Canada
In a market that is constantly adapting and adjusting to healthcare needs, real-world evidence (RWE) is increasingly becoming important for regulatory and reimbursement decision-making. RWE, in relation to the real-world data that is collected in combination with the advancement of artificial intelligence-based analytics platforms, has led to the real-time analysis of data to better understand and gain insights on disease, approaches to treatment, and how to substantiate coverage decisions. RWE is now becoming integrated throughout the product development lifecycle, and this session will explore new and innovative applications of RWE and provide insights through case examples and practical applications on how stakeholders are leveraging RWE to advance healthcare knowledge and decision-making. This session will provide a high-level overview of the evolving regulatory landscape for RWD/RWE from a Health Canada, CADTH, and industry perspective.
Learning Objective : - Gain a greater awareness of Health Canada’s international collaborations in the COVID-19 space that are leveraging RWE and observational studies
- Provide an overview of premarket challenges with RWE as well as a high-level overview on details and limitations regarding some recent examples submitted by sponsors in the premarket setting
- Discuss “lessons learned” from current uses of RWE, and how these can be applied for other future HTA applications
Speaker(s)
Melissa Kampman, PHD, MS
Manager and Senior Epidemiologist, Marketed Health Products Directorate, Health Canada, Canada
Post-Market Utilization of RWE at Health Canada: Progress to Date and International Collaborations Leveraging RWE for COVID-19
Andrew Raven, MSC
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB, Health Canada, Canada
Premarket RWE Examples and Challenges: Regulatory Perspective
Nicole Mittmann, MSC
Chief Scientist and Vice President of Evidence Standards , Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Speaker
Yonghua Jing, PHD, MS
Senior Director/Team Lead, Real-World Evidence Analytics, AbbVie, United States
Speaker
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