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Session Chair(s)
Stuart Russel Walker, PHD
Professor and Consultant
Centre for Innovation In Regulatory Science (CIRS), United Kingdom
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)
TGA Perspective
John Skerritt, PHD
University of Melbourne, Australia
Enterprise Professor, Health Research Impact
Health Canada Perspective
Barbara J Sabourin, FACP
Health Canada, Canada
Director General, Health Products and Food Branch
SwissMedic Perspective
Petra Doerr, PHARMD, RPH
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Director
HSA Perspective
Raymond S.B. Chua, MD, MBA, MPH, FRCP
Ministry of Health, Singapore
Deputy Director of Medical Services, Health Regulation Group
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