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Ottawa Marriott Hotel

Oct 29, 2018 7:00 AM - Oct 29, 2018 5:30 PM

100 Kent Street , Ottawa, ON K1P5R7 , CANADA

Canadian Pharmacovigilance and Risk Management Strategies Conference

Session 2: Real World Evidence for Risk Management and Support of Regulatory Decisions

Session Chair(s)

Marcia  Bailey, BSN, MHS, RN

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


Jacques  Le Lorier, MD, PhD, FACP


Jacques Le Lorier, MD, PhD, FACP

Universite de Montreal, Canada

Priscilla  Velentgas, PhD


Priscilla Velentgas, PhD

Aetion, United States

Senior Director, Science at Aetion

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