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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)
Post-Market Utilization of RWE at Health Canada: Progress to Date and International Collaborations Leveraging RWE for COVID-19
Melissa Kampman, PhD, MS
Health Canada, Canada
Manager and Senior Epidemiologist, Marketed Health Products Directorate
Premarket RWE Examples and Challenges: Regulatory Perspective
Andrew Raven, MSc
Health Canada, Canada
Manager for Biostatistics, Epidemiology, and Pharmacometrics Unit, HPFB
Speaker
Nicole Mittmann, MSc
Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Chief Scientist and Vice President of Evidence Standards
Speaker
Yonghua Jing, PhD, MS
AbbVie, United States
Senior Director/Team Lead, Real-World Evidence Analytics
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