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Lessons Learned from PROs in FDA and EMA Label Claims

1 Presentation 0 Sections

Description
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.


Presenters
  • 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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    ISOQOL members receive a discounted rate. To view membership rates, click  here.

    $25.00 - $100.00
    Member
    $75.00
    Non-Member
    $100.00
    Member: Student/Special/Retired
    $25.00
    Non-Member: Student/Special/Retired
    $100.00
    Patient Research Partner: Regular
    $75.00
    Patient Research Partner: Affiliate
    $75.00
    Member: Honorary
    $75.00
    Items Included in the Purchase of this Event

    Lessons Learned from PROs in FDA and EMA Label Claims

    Presentation: 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, 89 min 56 sec
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