Patient Preferences Through a Regulatory Lens: Expert Perspectives from the FDA & EMA

This webinar will explore regulatory perspectives on Patient Preference Information (PPI), including its possible relevance and roles in the scientific evaluation of medical product applications. Experts working at the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will share their views on recent developments in regulatory guidance, discuss how PPI has been considered and used in regulatory evaluations, and consider when and how it may inform or support future evaluations. The webinar will feature presentations from: • 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. • Francesco Pignatti, who will discuss the EU experience and assessors’ attitudes towards the role of PPS. The session will be moderated by Caitlin Thomas (Thermo Fisher Scientific) and will conclude with an audience Q&A.