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The Intersection of Patient-Experience Data and Benefit-Risk Analysis
Session Chair(s)
Allison Martin, MS
Director, Regulatory Science and Policy, North America
Sanofi, United States
Pujita Vaidya, MPH
North America Lead, Regulatory Science and Policy
Sanofi, United States
This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.
Learning Objective : Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.
Speaker(s)
The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD
FDA, United States
Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER
The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS
Accelerated Cure Project, United States
Vice President of Scientific Operations
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