Safety
FDA's Sentinel Initiative - Events
FDA is committed to an open public process that will enable information to be disseminated and stakeholder contributions to be gathered as it explores the scientific, technical, and policy issues that will affect the Sentinel System’s development.
Upcoming Events
Please check back later for updates on planned Sentinel events or join FDA’s listserv and receive notifications on updates.
Past Events
Sentinel Initiative: Structure, Function, and Scope: December 16, 2008
A day-long public workshop on FDA's Sentinel Initiative was held in Washington D.C. on December 16, 2008. The workshop was co-sponsored by the Food and Drug Administration and the eHealth Initiative Foundation and convened by the Engelberg Center for Health Care Reform at the Brookings Institution. The workshop brought together a diverse group of stakeholders, including academia, government, patient, consumer, and provider groups, payers, industry, and other interested organizations. Participants were given an update on the Sentinel Initiative’s status and their comments were welcomed. Discussion topics ranged from potential governance models and their implications to approaches for ensuring continued involvement of all stakeholders as the Initiative evolves.
The Federal Register notice, meeting agenda and transcript of the December 16, 2008 meeting are available in the links provided.
Sentinel Network Public Meeting: March 7 and 8, 2007
A two-day public meeting that brought together stakeholders to begin discussions on creating a Sentinel system was held in Washington D.C. on March 7 and 8, 2007. The meeting’s purpose was to:
- evaluate current needs in postmarket medical product adverse-event data collection, risk identification and analysis;
- better understand and identify gaps between what a range of stakeholders are doing and what they would like to do; and
- determine obstacles to facilitating or providing incentives for the creation of components needed to close the gaps and connect these various efforts into a Sentinel system.
The meeting also sought to identify opportunities for public-private collaborations for assembling data and conducting research and analysis.
The Federal Register notice, meeting agenda and transcript (March 7 and March 8) of the March 7 and 8, 2007 meeting are available in the links provided.