Sentinel Initiative for Active Medical Product Surveillance
In May 2008, the FDA announced the
Sentinel Initiative, a national, integrated, electronic system for active surveillance of medical product safety that utilizes the capabilities of multiple, existing data systems. FDA awarded the Center a grant in September 2009 to address the need for this drug safety monitoring system and to craft practical implementation pathways for FDA drug safety legislation. Through a series of meetings that encourage collaboration among academics, public and private partners, papers that address the key challenges involved in building a more effective system of post-market evidence, and analyses that build on the lessons learned for this effort, the Center aims to improve the public's confidence in drug safety and to maximize the benefits of approved medications.
The Center convenes multiple activities, described below, related to medical product safety. For each meeting, Center staff will summarize, synthesize, and communicate findings from these discussions to a broad range of organizations and individuals that can use the information to further develop active medical product surveillance methods and systems.
Active Medical Product Surveillance Roundtables »
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.
Expert Workshops »
As part of its portfolio of active medical product surveillance activities, the Engelberg Center for Health Care Reform will convene a series of discussions among experts to help inform development of the Sentinel System. Such discussions are needed on a range of issues, and the expertise required to inform them will change based upon the topic. To help plan these events, the Center will assemble planning committees comprised of subject matter experts and FDA staff on topics critical to implementing active medical product surveillance. Deliverables from these events include pre-meeting issue briefs and summary reports for public dissemination.
Public Stakeholder Workshops »
On an annual basis, the Engelberg Center for Health Care Reform convenes a large, public, multi-stakeholder event spanning a variety of topics related to active medical product surveillance. This event is an opportunity for FDA and contractors working for FDA to provide an update on the progress of the Sentinel Initiative, and to engage the public in a discussion of the issues most pressing for the coming year.
Brookings Active Surveillance Implementation Council (BASIC) Meetings »
The Engelberg Center for Health Care Reform convenes BASIC meetings to bridge discussions and insights from ongoing pilot projects and expert workshops to the actual implementation of a national system for postmarket active surveillance of drugs and other medical products. BASIC meetings are comprised of 20-25 thought leaders with broad expertise in public health policy, safety science, informatics, and related fields. The Council includes individuals directly involved with FDA's active surveillance pilot projects as well as experts working on related projects not funded by FDA. During semi-annual meetings, council members discuss high-level implementation issues that need to be addressed in the next one to two years for successful implementation of active surveillance.
Discussing Medical Product Safety Initiatives with Additional Audiences »
The Engelberg Center is pursuing additional opportunities to advance active medical product surveillance efforts with a variety of stakeholders beyond FDA. These efforts are largely focused on convening panel discussions and presentations at relevant public forums, where the Center can highlight its work as well as contribute to broader conversation about medical product safety.
Back to Engelberg Center Projects »