Active Medical Product Surveillance Roundtables
Progress from the Patient-Centered Outcomes Research Institute
July 12, 2012
On July 12, The Engelberg Center for Health Care Reform at Brookings hosted a webinar on progress from the Patient-Centered Outcomes Research Institute (PCORI). Established by the Affordable Care Act of 2010, PCORI was launched to promote evidence-based information to help people make informed health care decisions and to improve health care delivery and outcomes.
Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) Overview
June 20, 2012
On June 20, the Engelberg Center for Health Care Reform held a webinar on the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project. Coordinated by the European Medicines Agency, PROTECT was launched to strengthen the monitoring of the benefit-risk of medical products in Europe. A methodological framework for the project is currently being developed through public and private partnerships.
Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network
April 9, 2012
On April 9, the Engelberg Center for Health Care Reform hosted a roundtable, “Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network.” The Medical Device Epidemiology Network (MDEpiNet) was launched by FDA to develop the infrastructure and methodological approaches for conducting robust analytic studies that will improve FDA’s understanding of medical device performance.
Highlights from the Sentinel Initiative Public Workshop
February 1, 2012
On February 1, the Engelberg Center for Health Care Reform hosted a roundtable, “Highlights from the Sentinel Initiative Public Workshop.” The roundtable featured presentations from Dr. Richard Platt, professor and chair, Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute, and Ed Staffa, writer and editor, Office of Communications, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
Supporting Comparative Effectiveness Research with Claims Data: Developing ASPE's Multi-Payer Claims Database
November 7, 2011
On November 7, the Engelberg Center hosted a rountable webinar on federal efforts to develop a multi-payer claims database to support comparative effectiveness reseach, featuing presentations by Dave Knutson and Andre Chappel from the U.S. Department of Health and Human Services.
Webinar 3: Overview of Additional Sentinel Initiative Activities: Federal Partners Collaboration, the Observational Medical Outcomes Partnership, and Brookings Convening Activities
September 21, 2011
The final webinar of the series provided additional detail about FDA’s other activities informing the Sentinel Initiative. Members of FDA's Core Team spoke about the Federal Partners Collaboration; Paul Stang, from Johnson & Johnson and the Observational Medical Outcomes Partnership (OMOP), gave an update on OMOP’s accomplishments and future plans; and Joshua Benner, from the Engelberg Center for Healthcare Reform at Brookings, provided an overview of Brookings Convening Activities.
Webinar 2: Overview of FDA’s Mini-Sentinel Pilot
September 15, 2011
The second webinar in the series featured a more in-depth description of the Mini-Sentinel pilot by Richard Platt, the principal investigator of the Mini-Sentinel pilot, from Harvard Pilgrim Health Care and Harvard Medical School.
Webinar 1: Overview of FDA’s Sentinel Initiative
September 7, 2011
This first webinar, featured presentations from FDA's Core Team, provided an overview of the Sentinel Initiative’s scope and achievements.
Learnings from the Department of Veterans Affairs Active Surveillance Activities »June 20, 2011
The Engelberg Center hosted a roundtable webinar focused on methods used and lessons learned in the Department of Veterans Affairs active medical product surveillance activities, touching on topics including signal refinement studies, and conducting risk reducition and intervention assessments to enhance patient safety and prevent untoward outcomes.
Highlights from the Observational Medical Outcomes Partnership's Annual Symposium »
March 17, 2011
The Engelberg Center hosted a live webinar to discuss highlights from the Observational Medical Outcomes Partnership's (OMOP) Annual Symposium. OMOP is a public-private partnership whose mission is to evaluate methods that can be applied to analyze existing health care databases with the goal of better understanding the safety and effectiveness of approved medical products. OMOP investigators are currently assessing multiple methods for conducting active medical product surveillance, using a range of potential operating characteristics by which to evaluate and compare these methods.
Mini-Sentinel Accomplishments and Plans for Year Two »
January 31, 2011
This live webinar revisited discussions from the Sentinel Initiative Public Workshop, with stakeholders coming together to discuss Mini-Sentinel's progress and plans for the upcoming year.
Monitoring the Safety of the 2009 H1N1 Influenza Vaccine in Near Real-Time: Learnings from PRISM »
October 22, 2010
This live webinar focused on lessons learned from implementation of the Post-Licensure Rapid Immunization Safety Monitoring (PRISM) project, a coordinated federal strategy to monitor the safety of the 2009 H1N1 influenza vaccine using observational data from large health plans.
Conducting Real-Time Safety Evaluation with Medicare Data: Learnings from the SafeRx Project »
October 4, 2010
This live webinar focused on a study conducted on the Medicare database that evaluated the impact of lags in claim processing and claim information updates on real-time evaluation of drug safety signals. The study was performed as part of the SafeRx project, a collaboration between FDA and the Centers for Medicare & Medicaid Services to utilize Medicare data for active medical product surveillance. Presentations also focused on how the Mini-Sentinel Coordinating Center will evaluate similar issues in the Mini-Sentinel Distributed Dataset.
Learning from the Observational Medical Outcomes Partnership (OMOP) »
July 1, 2010
This roundtable focused on OMOP’s research into observational methods for analyzing existing health care databases to evaluate the safety and benefit of drugs already on the market, as well as the results of the recent methods competition, the OMOP Cup. Presentations provided an overview of the OMOP methods program, and discussed the simulated data set that was used for the competition, the prize-winning methods, implications for active medical product surveillance, and ideas for future methods work.
Learning from the DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project »
May 7, 2010
The Engelberg Center hosted a roundtable webinar, "The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project," featuring presentations on ongoing post-market surveillance work being done at the FDA's Center for Devices and Radiological Health, as well as a surveillance pilot project using the Web-based DELTA system for identifying low frequency safety signals.
Learning from SCHIEx: South Carolina's Statewide Distributed Data Integration Strategy »
March 15, 2010
The Engelberg Center hosted a roundtable webinar on "SCHIEx: South Carolina's Distributed Data Integration Strategy," featuring presentations by Sue Veer, President and CEO of Carolina Health Centers, David Patterson, Section Chief of Health and Demographic Products, Office of Research and Statistics, South Carolina Budget and Control Board, and Vik Kheterpal, CEO of CareEvolution. Presenters discussed their model for integrating disparate data sources for the South Carolina statewide health information exchange.
Learnings from H1N1 Vaccine Surveillance »
December 3, 2009
This roundtable teleconference featured a presentation from i3 Drug Safety President Terri Madison, who provided an overview of the organization's self-sponsored H1N1 vaccine safety surveillance program and preliminary results, including lessons learned.
Roundtable on Active Medical Product Surveillance »
October 30, 2009
The Engelberg Center for Health Care Reform hosted the first of a new series of roundtable teleconferences on active medical product surveillance -- providing a forum to discuss public and private initiatives in which methods, data sources, and technology related to active medical product surveillance are being developed.