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Unmet Medical Need: Can the Stakeholders Align? Progress to Date
Session Chair(s)
Inka Heikkinen, MBA, MSC
Regulatory Policy Lead, Lundbeck, Denmark
Part 2 of the DIA-CIRS Workshop
Unmet medical need definition has been attempted to detangle by different groups. Different elements of a possible criteria is presented as a background for the discussion on Day 3.
Learning Objective : Describe criteria currently used and identify a core list of criteria that should be used to identify and prioritize unmet medical need; Discuss what constitutes an unmet medical need and determine universal agreement on key characteristics
Speaker(s)
Kenneth I. Kaitin, PHD
Professor and Senior Fellow, Tufts Center for the Study of Drug Development, United States
Claudine Sapède, PHARMD
Director, Global HTA Policy, NOVARTIS INTERNATIONAL, Switzerland
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
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