FDA's Sentinel Initiative - News and 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

Brookings Roundtable on Active Medical Products
"Developing a Taxonomy of Surveillance Methods for a Medical Product Safety"Live Webinar
Friday, December 7, 2012 | 2:00 - 3:00 P.M. EDT

The classification of surveillance methods for medical products allows for researchers to determine the most suitable methodolgy for monitoring product and outcome pair combinations. Given the variety of characterisitcs among products and outcomes, no single methodological approach can be applied to all scenarios. Mini-Sentinel's taxonomy report provides a useful guide for U.S. Food and Drug Administration scientists to select apropriate methods for proceeding with medical product surveillance, based on the characteristics of each product and outcome pair.

The Mini-Sentinel Taxonomy Workgroup was established to develop a taxonomy of surveillance methods for conducting signal refinement, a process for evaluating the magnitude, and clinical significance of a suspected association. The workgroup also seeks to provide advice on the most suitable methodologies for medical product safety scenarios.

Dr. Joshua Gagne will provide an overview of the taxonomy workgroup's progress of categorizing potential medical product safety scenarios, identifying methods for active safety surveillance, and mapping product-outcome pair characteristics with approaches for active safety surveillance. Dr. Meghan Baker will discuss her work in developing a framework of surveillance methods for vaccine-specific medical products.

View the full webinar agenda²

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Registration for this webinar is required. You may register at http://www.cvent.com/d/jcq3pc⁴

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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/roundtables⁶
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.

Use the link⁷

⁸provided to view event summary and materials.

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.

Use the link

provided to view event summary and materials.

2nd 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.

Use the link⁹

¹⁰ provided to view event summary and materials

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 notice¹¹, meeting agenda¹² and transcript¹³ 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 notice¹⁴, meeting agenda¹⁵ and transcript (March 7¹⁶ and March 8¹⁷) of the March 7 and 8, 2007 meeting are available in the links provided.

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