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.