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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: Industry Perspective
Jeremy Jokinen, PhD, MS
Bristol-Myers Squibb Company, United States
Vice President and Head, Safety Evidence and Sciences
Beyond Signal Detection: Use Case
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP
Consultant, United Kingdom
Cnsultant Pharmacovigilance and Pharmacoepidemiology
FDA Perspective
Representative Invited
FDA, United States
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