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Session 4 – New Data Sources
Session Chair(s)
William Gregory, PHD
Senior Director, Safety and Risk Management
Pfizer Inc, United States
Despite limitations, the Spontaneous Reporting System has been a valuable tool in the discovery of important safety signals since the 1960s. In recent years, however, rapidly evolving digital technology has spawned extensive exploratory work with the goal of uncovering new and potentially impactful patterns of harms. This session will explore three emerging tools: The voice of the patient from the perspectives of patient advocacy and FDA; a new surveillance system that allows FDA to collect AEs in real time during emergencies; and vision for an MHRA-led, public-private partnership that would harness mobile technologies and the Internet for pharmacovigilance.
Speaker(s)
Perspectives on the Voice of the Patient: Patients Like Me
Sally Okun, BSN, MHS, MBA, RN
Clinical Trials Transformation Initiative (CTTI), United States
Executive Director
Patients Like Me and FDA Research Collaboration – Regulatory Perspective
Marni Hall, PHD, MPH
IQVIA, United States
Vice President and General Manager, Global Regulatory Science and Strategy
Real-time Applications for Programmable Interactive Devices (RAPID) System at FDA
Henry "Skip" Francis, MD
FDA/CDER/OTS/IO, United States
The Promise of Social Media for Pharmacovigilance as Envisioned by WEB-ADR
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery