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Session 4 Track B: RWE Use in Safety and Efficacy Monitoring
Session Chair(s)
Melissa Hunt, MSc
Director
Health Canada, Canada
Lisa Chartrand
Director, Regulatory Strategy and Policy
Hoffmann-La Roche Limited, Canada
This session is designed to provide an overview of the evolution of Real World Evidence used in regulatory decision making and will focus on what all stakeholders are interested in learning through the more recent announcements through FDA, Health Canada, and EMA.
Learning Objective : At the conclusion of this session, participants should be able to:- Understand the evolution of where we have come and various perspectives of how RWE could be used in regulatory decision making
- The considerations needed in building the infrastructure, data collection, and methodology to ensure consistent interpretation for decision making along the product’s access lifecycle (HC, HTA, payer)
Speaker(s)
Speaker
Christopher Gravel, PhD
Health Canada, Canada
Senior Epidemiologist/Biostatistician
Speaker
David Sealey, PhD
AstraZeneca Canada, Canada
Director, Regulatory Affairs
Speaker
Lisa Chartrand
Hoffmann-La Roche Limited, Canada
Director, Regulatory Strategy and Policy