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Unmet Medical Need: Diversity of Definitions and Viewpoints – Detangling the Challenge
Session Chair(s)
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Part 1 of the DIA-CIRS Workshop
Unmet medical need drives decisions across value chain from investment and prioritization to approval timelines and access discussions but is very vaguely defined. Learn why interpretation matters and how decision makers view the concept.
Learning Objective : Demonstrate how unmet medical need is defined in different countries or regions; Identify how different stakeholders perceive unmet medical need; Discuss the scope of what is defined as unmet medical need based on situational context, issues, concerns, and dilemmas each stakeholder faces in prioritization
Speaker(s)
Larry Bauer, MA, RN
Senior Regulatory Drug Expert, Hyman, Phelps & McNamara, P.C., United States
Karen Lee
Director, Health Economics, Canadian Agency For Drugs & Technologies In Health (CADTH), Canada
Marc M. Boutin, JD
Global Head of Patient Engagement and Advocacy, Novartis , Switzerland
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