Sentinel Initiative Public Workshop The Brookings Institution - PowerPoint PPT Presentation

Sentinel Initiative Public Workshop The Brookings Institution Marriott Wardman Park Washington, DC January 31, 2013

Development of the Sentinel System through Public-Private Collaboration FDA awards Mini-Sentinel Brookings able to query FDAAA convener grant Sentinel Initiative data from 126 announced million individuals FDA awards HPHC Brookings Brookings Brookings Mini-Sentinel Public Public Public contract Workshop Workshop Workshop FDASIA 2007 2008 2009 2010 2011 2012 2013 Brookings Brookings OMOP FDA awards 8 Public Public launched small project Workshop Workshop contracts Assessment Assessment completed: initiated: Angioedema events and Myocardial drugs that target the renin- Infarction and Oral angiotensin-aldosterone Hypoglycemics system

Public Workshop Agenda •The Sentinel Initiative: Ongoing Progress and Future Directions •State of Mini-Sentinel Activities •Selected Mini-Sentinel Protocol Driven Evaluations •Collaborations Supporting Active Surveillance Research •Planned Expansion of Prospective Surveillance Program •Opportunities to Expand the Public Health Impact of the Sentinel Initiative •Stakeholder Feedback: Mini-Sentinel as a Tool for Evaluating Drug Safety Issues that Require Regulatory Action