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Session 4: PROs in Regulatory Decision Making
Session Chair(s)
Nathalie Bere, MPH
Patient Engagement
European Medicines Agency, Netherlands
PROs can be used to capture the everyday experience, outside the clinician’s office, and the effects of a treatment on their daily activities. Furthermore, in some cases, PROs enable the measurement of important health status information that cannot yet be detected by other measures, such as pain. According to FDA, "for regulatory purposes, high-quality information from PRO measures can provide valuable evidence for benefit-risk assessments and can be used in labelling to communicate the effect of a treatment on patients' symptoms, functioning and quality of life." In this session, we will hear from EMA, FDA and HTA bodies representatives about the learnings, current challenges, and future goals for the inclusion of PROs in regulatory decision making.
Speaker(s)
Learnings from the FDA Journey to Include PROs
Michelle Campbell, PhD
FDA, United States
Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER
PROs in Regulatory Decision Making: the perspective from EMA
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
PROs in Regulatory Decision Making: the HTA Perspective
Beate Wieseler
IQWiG, Germany
Head of Department, Institute for Quality and Efficiency in Health Care
Panel Discussion with Q&A
Tony Humphreys, MPharm
European Medicines Agency, Netherlands
Head of the Regulatory Science and Innovation Task Force
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