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Advancing Patient Science Workshop

Session 4: PROs in Regulatory Decision Making

Session Chair(s)

Nathalie  Bere, MPH

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.


Michelle  Campbell, PhD

Learnings from the FDA Journey to Include PROs

Michelle Campbell, PhD

  • Senior Clinical Analyst for Stakeholder Engagement, ON, OND, CDER
  • FDA, United States
Francesco  Pignatti, MD

PROs in Regulatory Decision Making: the perspective from EMA

Francesco Pignatti, MD

  • Head of Oncology and Hematology
  • European Medicines Agency, Netherlands
Beate  Wieseler

PROs in Regulatory Decision Making: the HTA Perspective

Beate Wieseler

  • Head of Department, Institute for Quality and Efficiency in Health Care
  • IQWiG, Germany
Anthony  Humphreys, MPharm

Panel Discussion with Q&A

Anthony Humphreys, MPharm

  • Head of the Regulatory Science and Innovation Task Force
  • European Medicines Agency, Netherlands