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Session 2: Real World Evidence for Risk Management and Support of Regulatory Decisions
Session Chair(s)
Marcia Bailey, BSN, MHS, RN
Safety Evaluation and Risk Management Scientific Director
GSK, Canada
Although evidence from randomized controlled trials is required to establish the safety and efficacy of products for market approval, real world evidence (RWE) is essential to the risk management of marketed products. In this session, you will learn about uses of RWE and how it can help inform Canadian pharmacovigilance practices and support regulatory decisions.
Learning Objective : Upon completion of this session, the participant should be able to:- Define RWE
- Describe how RWE can enhance risk management of marketed products, including Canadian, US, and EU examples
- Discuss how Canadian RWE can help Canadian regulatory decisions
Speaker(s)
Speaker
Jacques Le Lorier, MD, PhD, FACP
Universite de Montreal, Canada
Speaker
Priscilla Velentgas, PhD
Aetion, United States
Senior Director, Science at Aetion