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Pharmacovigilance: Beyond Signal Detection and Spontaneous Reporting
Session Chair(s)
Alicia Gilsenan, PHD, MS, RPH, FISPE
Vice President, Epidemiology
RTI Health Solutions, United States
An introduction to pharmacovigilance activities (with a focus of those beyond signal detection) along with considerations and approaches to mitigate, monitor, and evaluate potential signals in a real-world setting with use cases will be provided.
Learning Objective : Explain the stages of Pharmacovigilance Beyond Signal Detection and Spontaneous Reporting; Describe Considerations for Planning for and Evaluating Post-Marketing Safety in a Real-World Setting.
Speaker(s)
Beyond Signal Detection: Design and Considerations for Evaluating Effectiveness of Risk Minimization Activities
Alicia Gilsenan, PHD, MS, RPH, FISPE
RTI Health Solutions, United States
Vice President, Epidemiology
Beyond Signal Detection: Signal Management at FDA - From Identification to Action Using Multiple Data Sources
Lisa Wolf, PHARMD
FDA, United States
Deputy Director, Division of Pharmacovigilance I, CDER
Beyond Signal Detection: Progress of the Use of Real World Evidence (RWE) in Pharmacovigilance
Saad Shakir, MD, FFPM, FISPE, FRCP
ADROITVIGILANCE, United Kingdom
Pharmacovigilance Physician and Pharmacoepidemiologist
Beyond Signal Detection: Aligning Observational Research Teams Within Patient Safety to Minimize Risk
Jeremy Jokinen, PHD, MS
Argenx, United States
Vice President and Head Global Patient Safety
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