DESCRIPTION: As part of a broader strategy of content development, Value in Health has commissioned a series of 'Themed Sections' on important topics. This session discusses the first themed section, on Patient-Focused Benefit-Risk Analysis to Inform Regulatory Decisions. Regulatory agencies around the world are increasingly seeking information from patients about their conditions and how they consider benefit-risk tradeoffs with new drugs and devices to inform approval and coverage decisions.  In May 2015, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research issued draft guidance on submitting patient preferences to inform regulatory decisions. The FDA’s work with the Medical Device Innovation Consortium to develop a framework to generate high-quality evidence on patient preferences signals the Agency’s commitment to the patient perspective.  In Europe, the European Medicines Agency has commissioned several completed and ongoing projects to better understand alternative methods for measuring patient preferences and their use benefit-risk analysis. Recent legislative amendments and developments in Canada indicate heightened interest in transparency and consideration of the patient perspective in regulatory work of Health Canada.  In turn, advocacy groups, developers and researchers are partnering to design studies to elicit patient preferences throughout product development lifecycles. This forum features experts in stated-preference methods who authored papers for a themed issue in Value in Health conceived to cover the latest developments in generating evidence on patient preferences to inform regulatory decisions in the US, Europe and Canada.