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FDA Sentinel Initiative
Session Chair(s)
Marsha E. Reichman, PhD
Sr. Advisor/Scientific Lead Surveillance Programs, Sentinel Initative Lead, CDER
FDA, United States
The session will provide an overview to the FDA Sentinel Initiative. This initiative was launched in 2008 to build a postmarket risk identification and analysis system to complement FDA’s existing postmarketing surveillance capabilities. The basis of the Sentinel Initiative was the pilot, Mini-Sentinel, which originated in 2009 through a contract with Harvard Pilgrim. Mini-Sentinel developed and tested the capabilities for using electronic health care data for safety surveillance of approved medical products. In 2014, Mini-Sentinel was transitioned to a sustainable surveillance system, the Sentinel System. This transition focuses on establishing policies, procedures, and organization for the Sentinel System.
Learning Objective : Provide an overview and latest developments to the FDA Sentinel initiative.
Speaker(s)
FDA Mini-Sentinel: Past, Present, and Future
Jeffrey Brown, PhD, MA
Harvard Pilgrim Health Care Institute/Harvard Medical School, United States
Associate Professor, Department of Population Medicine
Overview of Sentinel Query Tools
Azadeh Shoaibi, MHS, PhD, MS
FDA, United States
Associate Director Post-Market Surveillance, OBPV,CBER
CDER Use of Mini-Sentinel Tools/Resources
Marsha E. Reichman, PhD
FDA, United States
Sr. Advisor/Scientific Lead Surveillance Programs, Sentinel Initative Lead, CDER
CBER Perspective
Steven A. Anderson, PhD
FDA, United States
Director, Office of Biostatistics and Epidemiology, CBER
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