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A Common Decision Framework for Health Technology Assessment and Regulatory Agencies: Is This of Benefit to Stakeholders?
Session Chair(s)
Neil McAuslane, PhD, MSc
Director
Centre for Innovation in Regulatory Science (CIRS), United Kingdom
It is essential that there is a common framework for health technology assessment and regulatory agencies to enable efficient drug development. This session will present the rationale for why this is critical for stakeholders involved in the development and review of medicines.
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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