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Session Chair(s)
Neil McAuslane, PHD, MSC
Scientific Director
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Learning Objective : Compare and contrast differences in structured decision making by regulatory and health technology assessment (HTA) agencies; Identify how agencies are working to align common elements/evidence across the different frameworks which can aid development decisions; Discuss how to achieve a consensus on a scientifically acceptable framework for making decisions that are broadly applicable to both HTA and regulatory agencies.
Speaker(s)
EMA Perspective
Hans-Georg Eichler, MD, MSC
Austrian Association of Social Security Bodies, Austria
Consulting Physician
Health Canada Perspective
Barbara J Sabourin, FACP
Health Canada, Canada
Director General, Health Products and Food Branch
Industry Perspective
Edward Reilly, PHARMD, MSC
GSK Vaccines, Belgium
Vice President, Global Regulatory Affairs
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