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An International Approach to Benefit-Risk Assessment of Medicines: An Evaluation by a Consortium of Established Agencies
Session Chair(s)
Stuart Russel Walker, PHD
Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Four regulatory agencies, Therapeutic Goods Administration (TGA), Health Canada, SwissMedic and Health Science Authority (HSA), formed a consortium for the purpose of shared and joint review and identified a need for an aligned approach for benefit-risk assessment. This session will focus on the Heads of Agencies Consortium, which consists of the TGA , Health Canada, and the HSA to review the challenges and opportunities for developing a systematic structured approach to the benefit-risk assessment of medicines and the outcome of their studies.
Learning Objective : Discuss the need for a common framework and approach to the review of medicines by four established regulatory authorities; Assess the current status of benefit-risk assessment of medicines and its implementation; Evaluate how the application of a common agreed benefit-risk framework and language enables more effective decision-making and communication between stakeholders.
Speaker(s)
John Skerritt, PHD
Enterprise Professor, Health Research Impact, University of Melbourne, Australia
TGA Perspective
Barbara J Sabourin, FACP
Director General, Health Products and Food Branch, Health Canada, Canada
Health Canada Perspective
Petra Doerr, PHARMD, RPH
Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), France
SwissMedic Perspective
Raymond Chua, MD, MBA, MPH, FRCP
Chief Executive Officer, Health Sciences Authority, Singapore
HSA Perspective
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