Safety

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.

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Upcoming Events

Eleventh Annual Sentinel Initiative Public Workshop

The Sentinel Initiative was launched in response to the Food and Drug Administration Amendments Act of 2007 (FDAAA) and is comprised of several components including the Sentinel Systemdisclaimer icon, the Active Risk Identification and Analysisdisclaimer icon, the Biologics Effectiveness and Safety System (BEST IDIQ #1, BEST IDIQ #2) and FDA Catalystdisclaimer icon. The Food and Drug Administration (FDA) is committed to facilitating stakeholder engagement on approaches to modernize the Sentinel Initiative’s capabilities. The Annual Public Workshop is a gathering of the Sentinel community and leading experts to share recent developments within the Sentinel Initiative, provide training on Sentinel System’s tools and data infrastructure, and promote engagement and collaboration with patients, industry, academia, and consumers. This year marks the Eleventh Annual Sentinel Initiative Public Workshop and will be a two-day event. Please note that there are separate registrations for each day of the meeting and there are two different locations for Days 1 and 2. Day 3 is by invitation only for international regulators.

DAY 1 | Sentinel Initiative Public Workshop, April 3, 2019

Registration: Open to everyone. Please register through this Duke Margolis linkdisclaimer icon.
Location: Hyatt Regency Bethesda
1 Bethesda Metro Center
Bethesda, MD 20814

Agenda and Details: Day 1 will be convened by the Robert J. Margolis, MD, Center for Health Policy at Duke University under a cooperative agreement with FDA. The workshop will feature updates on how the Sentinel Initiative is being used by FDA as a core safety surveillance program from leaders at FDA and from investigators within the Sentinel Initiative. Discussion will also highlight strategic initiatives and potential future directions for continued improvements to the distributed data infrastructure. There will be opportunities throughout the day’s discussion for stakeholders to provide input and ask questions.

DAY 2 | Sentinel System Analysis Tools Training: Hands-On Workshop, April 4, 2019

Registration: Open to everyone. Please register through this Day 2disclaimer icon link.
Location: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503 A (the Great Room)
Silver Spring, MD 20993

Agenda and Details: Day 2 will be the third public training sponsored by FDA and the Sentinel Operations Center targeting researchers who have prior experience executing epidemiologic analyses with claims data using SAS statistical packages and programming. Registrants are expected to have either attended the prior Sentinel Public Training Events held in July 2017 (Part 1)disclaimer icon and February 2018 (Part 2)disclaimer icon or viewed the recorded contents online prior to attending. This workshop will build on these prior trainings using a hands-on laboratory format. Attendees should bring a laptop to the training to participate. Due to the interactive nature of the training, no online participation will be available.

Agenda (PDF-361KB)

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Day 3: International Regulator’s Forum on the Sentinel System, April 5, 2019

The U.S. Food and Drug Administration (FDA) will be hosting a forum on April 5, 2019 on the Sentinel System for other regulatory agencies immediately following the two-day Sentinel Annual Meeting. This training was developed in response to requests for further information on how FDA operationalizes Sentinel to meet its legislative mandate in the FDA Amendments Act 2007 and other key legislative commitments. Day 3 is by invitation only for international regulators.

Registration: Open to staff from regulatory agencies worldwide. Please register through the Sentinel link disclaimer icon
Location: FDA White Oak Campus 10903 New Hampshire Avenue Building 31, Room 1503 A (the Great Room) Silver Spring, MD 20993

Agenda and Details: This is a forum designed for staff from regulatory agencies worldwide: it is a meeting by regulators, for fellow regulators. The intent is to create a full three-day intensive experience on Sentinel where participants would attend Day 1disclaimer icon and Day 2disclaimer icon of the Sentinel Annual Meeting to understand the current state of the system and obtain technical training, and then attend the International Regulator’s Forum on Day 3. The aim of Day 3 is to provide a dedicated time and place for all regulators to learn about how FDA operationalizes and implements the Sentinel System to inform regulatory decision making. The training will address procedural and policy topics starting from the process for how FDA determines when to use the capabilities in the Active Risk Identification and Analysisdisclaimer icon (ARIA) system, to the development of safety analyses, and communication of results. ARIA is the system comprised of the electronic data in the Sentinel Common Data Model and the suite of predefined analysis tools that together meet the legislative mandates in FDA Amendments Act 2007. Both the detection and evaluation of medical product safety concerns will be covered.

Agenda (PDF-375KB)

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Past Events

Please check back later for updates on upcoming events or joindisclaimer icon FDA's listserv and receive notifications on updates.

10th Annual Sentinel Initiative Public Workshop – Day 1
Wednesday February 7, 2018; 9:00 am to 4:00 pm
Hyatt Regency Bethesda disclaimer icon
One Bethesda Metro Center (7400 Wisconsin Avenue)
Bethesda, Maryland 20814

10th Annual Sentinel Initiative Public Workshop – Day 2
Thursday February 8, 2018; 9:00 am to 2:00 pm
U.S. Food and Drug Administration
The Great Room, Building 31, Room 1503B
10903 New Hampshire Avenue
Silver Spring, Maryland 20993

The Food and Drug Administration (FDA) is announcing the following public workshop entitled: "Tenth Annual Sentinel Initiative Public Workshop."  The purpose of this two day public workshop is to bring the stakeholder community together to discuss a variety of topics on active medical product surveillance.

Day 1 will be convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with the FDA. Key discussion topics will include an update on the state of FDA’s Sentinel Initiative, key safety surveillance activities, and emerging uses of the Sentinel System.  In addition, panelists, representing diverse stakeholder perspectives, will provide comments on Sentinel and opportunities to expand its analytic capabilities.  This workshop will also provide an opportunity for stakeholder engagement and input on Sentinel’s continued modernization.

Day 2 will be a public workshop sponsored by the FDA targeting researchers who are experienced in using claims data and will build upon the prior public training conducted by FDA on July 10, 2017 (82 FR 19063, April 25, 2017).  This second day of the workshop will address more advanced topics, including Sentinel’s inferential analytic capabilities, and methods of identifying unexpected safety concerns. Attendees will leave with a deeper understanding of how to use the Sentinel System tools to address safety questions. 

Attendees are encouraged to review the material FDA presented on July 10, 2017 by visiting the website: https://www.sentinelinitiative.org/communications/sentinel-initiative-events/public-sentinel-training-fda
Further information about the event and registration is available at:

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

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

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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.

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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:

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

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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:

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

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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

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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:

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

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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:

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.

  • 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.
  • 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.
  • 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.
  • 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.

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Page Last Updated: 03/19/2019
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