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Lessons Learned from PROs in FDA and EMA Label Claims

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This webinar includes presentations from industry sponsors that have interacted with the FDA or EMA to support labeling of their products. The webinar includes a review of PRO measures and determination of how to move them forward and/or revise them as appropriate to support labeling claims. Specifically, the webinar addresses how to conduct a gap analysis and how to adapt or modify existing measures to assess and/or confirm the validity of the measure. FDA and EMA considerations of PRO measures are addressed through the use of case studies.

  • Kathy Beusterien, MPH, Senior Director, Oxford Outcomes
  • Thomas Hare, Vice President, Development Operations, Incyte
  • William Lenderking, PhD, Senior Research Leader, United BioSource
  • Linda Abetz-Webb, EU Practice Lead, PRO Adelphi Values

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