Safety

FDA's Sentinel Initiative - News and Events

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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

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9th Annual Sentinel Initiative Public Workshop
Thursday, February 2, 2017; 9:00 am to 4:00 pm
Barbara Jordan Conference Center disclaimer icon
1330 G St NW, Washington, DC 20005

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Ninth Annual Sentinel Initiative Public Workshop.”  Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance.  Topics will include an update on the state of FDA’s Sentinel Initiative, including an overview of the current state of Sentinel System safety surveillance activities, and uses of the Sentinel System accomplished in 2016.  In addition, panelists will discuss the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities. 

Further information about the event and registration is available at: 9th Annual Sentinel Initiative Public Workshopdisclaimer icon


Past Events

Brookings Roundtables on Active Medical Products
Convened by the Engelberg Center for Health Care Reform at Brookings, roundtables provide a forum to discuss public and private initiatives that are developing methods, data sources, and technology relevant to active medical product surveillance.  These roundtables are intended to ensure that a broad range of stakeholders are informed about and engaged in current and upcoming activities related to medical product surveillance.  These one-hour conference calls/webinars are free and open to the public.

To view previous webinars, please click on the link below:
http://www.brookings.edu/about/centers/health/projects/surveillance/roundtables


8th Annual Sentinel Initiative Public Workshop
Wednesday, February 3, 2016 from 9:00 AM to 4:00 PM (EST)
Renaissance Washington, DC Dupont Circle Hotel | 1143 New Hampshire Avenue Northwest | Washington, DC 20037

The public workshop was convened by the Duke-Margolis Center for Health Policy, under cooperative agreement with FDA, and brought together stakeholders engaged with active medical product surveillance. Topics included an update on the state of FDA’s Sentinel Initiative, including an overview of the transition from the Mini-Sentinel pilot to the full Sentinel System, and key activities and uses of the Sentinel System accomplished in 2015. In addition, panelists also discussed the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities.

Event summary and materials are available at: 8th Annual Sentinel Initiative Public Workshopdisclaimer icon


Seventh Annual Sentinel Initiative Public Workshop
Thursday, February 5, 2015, 9:00 a.m. - 4:00 p.m.
Washington Plaza Hotel | 10 Thomas Circle NW | Washington, DC

The Engelberg Center for Health Care Reform at The Brookings Institution brought together stakeholders engaged and interested in the work of the U.S. Food and Drug Administration's (FDA) Sentinel Initiative.  This event included presentations and panel discussions on a variety of topics in active medical product surveillance.  Topics included an overview of the transition from the Mini-Sentinel pilot program to the full Sentinel System and what that means for patients and other critical stakeholders.  Panelists also discussed the future of the Sentinel System and opportunities to expand its medical product surveillance capabilities.  Additionally, the workshop also engaged stakeholders to discuss current and emerging Sentinel projects.

Event summary and materials are available at http://events.SignUp4.com/sentinel2015disclaimer icon.


Sixth Annual Sentinel Initiative Public Workshop
Tuesday, January 14, 2014, 9:00 a.m. - 4:00 p.m.
Marriott at Metro Center | 775 12th St NW | Washington, DC

This public workshop, hosted by the Engelberg Center for Health Care Reform at The Brookings Institution, brought together stakeholders engaged and interested in the work of the U.S. Food and Drug Administration's (FDA) Sentinel Initiative.  This year's event included presentations and panel discussions on a variety of topics including:

  • An overview of the state of the Mini-Sentinel pilot program;
  • Next steps for the Sentinel Initiative;
  • Sentinel as a critical component of the emerging national health infrastructure; and
  • Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety.

Event summary and materials are available at http://www.brookings.edu/events/2014/01/14-sentinel-initiative-public-workshop disclaimer icon


Fifth Annual Sentinel Initiative Public Workshop
Thursday, January 31, 2013, 9:00 a.m. - 4:00 p.m.
Washington Marriott Wardman Park | 2660 Woodley Road | Washington, D.C.

Hosted by the Engelberg Center for Health Care Reform at Brookings, this public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including the following:
 

  • An update on the U.S. Food and Drug Administration's Sentinel Initiative, including current activities and future plans;
  • An overview of findings from Mini-Sentinel protocol based evaluations;
  • Discussion of current and future collaborations and initiative expansions; and
  • Stakeholder feedback on Mini-Sentinel as a tool for evaluating drug safety issues that require regulatory actions.

Event summary and materials are available at http://www.brookings.edu/events/2013/01/31-sentinel-public-workshop disclaimer icon


Fourth Annual Sentinel Initiative Public Workshop
Wednesday, January 18, 2012, 8:30 a.m. - 12:30 p.m.
Washington Marriott at Metro Center | 775 12th Street NW | Washington, DC

Hosted by the Engelberg Center for Health Care Reform at Brookings, this half-day public workshop brought together the stakeholder community for a productive discussion on the future direction of the U.S. Food and Drug Administration's (FDA) Sentinel Initiative, including remarks from FDA leadership about near-term priorities; an update on Mini-Sentinel's accomplishments in 2011; and comments from stakeholder representatives on Sentinel's progress.

Event summary and materials are available at http://www.brookings.edu/events/2012/01/18-sentinel-public-workshop disclaimer icon


Third Annual Sentinel Initiative Public Workshop
Wednesday, January 12, 2011, 8:30 a.m. – 4:30 p.m.

Hosted by the Engelberg Center for Health Care Reform at Brookings, this one-day public workshop brought together the stakeholder community for a productive discussion on a variety of topics in active medical product surveillance, including:
– An update on Mini-Sentinel and related activities;
– Near-term plans for FDA's Sentinel Initiative; and
– Opportunities for coordination with other U.S. Department of Health and Human Services’ efforts that use distributed systems of automated health care data.

Event summary and materials are available at http://www.brookings.edu/events/2011/01/12-sentinel-workshopdisclaimer icon
 


Second Annual Sentinel Initiative Public Workshop
January 11, 2010, 8:30 a.m. – 4:45 p.m.
Washington Marriott at Metro Center, 775 12th St, NW, Washington DC

On January 11, 2010, the Engelberg Center for Health Care Reform at Brookings will convene the 2nd Annual Sentinel Initiative Public Workshop in Washington, DC. Supported by a grant from Food and Drug Administration (FDA), this one-day workshop will communicate the current status and future vision of active medical product surveillance activities and explore stakeholder perspectives on a broad range of issues. The workshop will feature:

  • a series of presentations on recently completed FDA contracts to inform various aspects of the Sentinel System's development 
  • an update on FDA’s ongoing pilot projects in active surveillance of medical product safety 
  • a discussion of three issues of broad interest: 
    • maintaining patient privacy while conducting medical product safety surveillance 
    • developing the Sentinel System as a national resource for medical product safety surveillance that would allow access to others beyond FDA 
    • creating a multi-purpose distributed system to conduct safety surveillance work, comparative effectiveness research, and product quality assessment, as well as address other types of public health questions.

Event summary and materials are available at http://www.brookings.edu/events/2010/01/11-sentinel-workshopdisclaimer icon
 


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 cosponsored 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.

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