Patient Preferences Through a Regulatory Lens: Expert Perspectives from the FDA & EMA
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About the Webinar
Join the International Academy of Health Preference Research (IAHPR) and the IHEA Health Preference Research Special Interest Group for a joint webinar exploring regulatory perspectives on Patient Preference Information (PPI) and its role in the scientific evaluation of medical product applications.
Experts from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will share their perspectives on recent developments in regulatory guidance, discuss how PPI has been considered and used in regulatory evaluations, and explore when and how patient preference evidence may inform or support future regulatory decision-making.
The session will include presentations from:
FDA: David Gebben and Olufemi Babalola, Center for Devices and Radiological Health (CDRH), and Laura Lee Johnson, Center for Drug Evaluation and Research (CDER), who will provide an overview of the 2026 CDRH PPI Guidance, the ICH E22 Draft Guideline on General Considerations for Patient Preference Studies (PPS), and examples of how PPI has been considered in regulatory decision-making.
EMA: Francesco Pignatti, who will discuss the European experience and assessors’ perspectives on the role of Patient Preference Studies (PPS).
The session will be moderated by Caitlin Thomas, Thermo Fisher Scientific, and will conclude with an audience Q&A.
Participants will gain insights into the evolving role of patient preference evidence in regulatory decision-making and how perspectives from both the FDA and EMA may shape its future use.
Speakers:
Laura Lee Johnson –Â FDA, Center for Drug Evaluation and Research (CDER)
David Gebben – FDA, Center for Devices and Radiological Health (CDRH)
Olufemi Babalola – FDA, Center for Devices and Radiological Health (CDRH)
Francesco Pignatti –Â European Medicines Agency (EMA)
Moderator
Caitlin Thomas – Thermo Fisher Scientific