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Session 6 Track B: Evolving Use of Real World Evidence Across the Therapeutic Product Life-Cycle to Support Decision-making: Challenges with Opportunities to Grab
Session Chair(s)
Rania Mouchantaf, PhD
A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Marc Poitras, PhD, MBA
Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada, Canada
There is increasing interest in utilizing real world data (RWD) to produce real world evidence (RWE) to inform on the benefits and risks of therapeutic products that could support decision-making. The goal of this session is to provide the current Canadian and International landscape and future directions as it relates to the use of RWE.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe activities and ongoing efforts taken to meet this charge
- Discuss opportunities to incorporate RWE into regulatory decisions to inform on safety and/or effectiveness
- Determine what lessons can be learnt from the challenges encountered and outline areas of focus to continue enhancing the use of RWE
Speaker(s)
Xavier Kurz, MD, PhD, MSc
Head of Data Analytics Workstream, European Medicines Agency, Netherlands
Lisa Currie, MSc
Acting Manager/Senior Epidemiologist, Health Canada, Canada
Speaker
Nicole Mittmann, MSc
Chief Scientist and Vice President of Evidence Standards , Canadian Agency for Drugs and Technologies in Health (CADTH), Canada
Health Technology Assessment and Real World Evidence
Robert W Platt, PhD
Albert Boehringer Chair in Pharmacoepidemiology, McGill University, Canada
CNODES Common Data Model Project
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