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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)
How Should Unmet Medical Needs be Addressed in the US?
Kenneth I. Kaitin, PHD
Tufts Center for the Study of Drug Development, United States
Professor and Senior Fellow
Criteria Developed Between Stakeholders in Europe in the DIA Working Group
Claudine Sapède, PHARMD
NOVARTIS INTERNATIONAL, Switzerland
Director, Global HTA Policy
CIRS Experience and Outcomes of Stakeholder Discussions
Lawrence Liberti, PHD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science