Brookings: Series - Active Medical Product Surveillance Roundtables

Highlights from the Fifth Annual Sentinel Initiative Public Workshop

Thu, 07 Mar 2013 14:30:00 -0500

Event Information

March 7, 2013
2:30 PM - 3:30 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On March 7, the Engelberg Center for Health Care Reform at Brookings hosted a roundtable webinar, “Highlights from the Fifth Annual Sentinel Initiative Public Workshop.” This webinar featured presentations from Dr. Patrick Archdeacon, a medical officer in the Office of Medical Policy at the U.S. Food and Drug Administration, and Dr. Richard Platt, professor and chair of the Department of Population Medicine at Harvard Medical School and executive director of the Harvard Pilgrim Health Care Institute.

This webinar provided an opportunity for stakeholders to revisit the discussions from the Fifth Annual Sentinel Initiative Public Workshop, which included an update on the status of Mini-Sentinel activities and the progress and future directions of the Sentinel Initiative.

Audio

Highlights from the Fifth Annual Sentinel Initiative Public Workshop

Event Materials

Presentation

Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

Tue, 16 Oct 2012 13:00:00 -0400

Event Information

October 16, 2012
1:00 PM - 2:00 PM EDT

Online
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On October 16, 2012, the Engelberg Center for Health Care Reform at Brookings held a webinar on “Findings from a Mini-Sentinel Medical Product Assessment.” Mini-Sentinel investigators have recently completed an assessment that examined a possible association between use of certain antihypertensive medications and angioedema events. This protocol-based assessment compared the incidence of angioedema with drugs that target the renin-angiotensin-aldosterone system using beta blockers as comparators. While not intended to provide a definitive conclusion on the association, the results will help to interpret the larger context of what is known about the drugs from various sources. The assessment also enabled Mini-Sentinel investigators to build general strategies to assess suspected associations of selected medical products and adverse events.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

Event Materials

MiniSentinel Medical Product Assessment

Participants

Panelists

Gregory W. Daniel

Managing Director for Evidence Development & Innovation, Engelberg Center for Health Care Reform
Fellow, Economic Studies

Brookings Roundtable on Active Medical Product Surveillance: Findings from a Mini-Sentinel Medical Product Assessment

Tue, 16 Oct 2012 00:00:00 -0400

Event Information:

October 16, 2012, 1:00 PM - 2:00 PM EDT

Brookings Roundtable on Active Medical Product Surveillance European Medicines Agency’s Postmarket Drug Safety Activities: Overview of PROTECT

Wed, 20 Jun 2012 11:30:00 -0400

Event Information

June 20, 2012
11:30 AM - 12:30 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

Coordinated by the European Medicines Agency, the Pharmacoepidemiological Research on Outcomes of Therapeutics by a European Consortium (PROTECT) project 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. This framework focuses on data collection and the early detection and assessment of adverse events. Dr. Xavier Kurz, Principal Scientific Administrator at the Post-Authorisation, Pharmacovigilance, and Risk Management Sector of the European Medicines Agency, provided an overview of this project. Dr. Kurz discussed PROTECT’s governance, innovative tools, methods that are currently being or have recently been developed, and the project’s future direction.

Audio

Webinar Audio

Event Materials

PROTECT slides final

Participants

Panelists

Mark B. McClellan

Director, Engelberg Center for Health Care Reform
Senior Fellow, Economic Studies
Leonard D. Schaeffer Chair in Health Policy Studies

Xavier Kurz

Principal Scientific Administrator

Developing the Capabilities for Device Surveillance through the Medical Device Epidemiology Network

Mon, 09 Apr 2012 03:30:00 -0400

Event Information

April 9, 2012
3:30 AM - 4:30 PM EDT

Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

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.

The roundtable featured presentations from Danica Marinac-Dabic, Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration; Mary Beth Ritchey, Associate Division Director, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA; Benjamin (Ben) Eloff, Senior Scientific Program Manager, Division of Epidemiology, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, FDA; Frederic (Fred) Resnic, Director, Cardiac Catheterization Laboratory, Brigham and Women’s Hospital and Assistant Professor of Medicine, Harvard Medical School; and Art Sedrakyan, Associate Professor of Public Health, Director, Patient-Centered Comparative Research Program, Weill Cornell Medical College. The presentations included a discussion about MDEpiNet’s role as part of a comprehensive postmarket national medical product surveillance strategy, an update on the current status of MDEpiNet, an overview of its methods and infrastructure work streams, and a discussion about its future direction.

Participants

Panelists

Danica Marinac-Dabic

U.S. Food and Drug Administration

Mary Beth Ritchey

U.S. Food and Drug Administration

Benjamin Eloff

U.S. Food and Drug Administration

Fred Resnic

Brigham and Women’s Hospital and Harvard Medical School

Art Sedrakyan

Weill Cornell Medical College

Sentinel Active Surveillance Roundtable: Highlights from the Sentinel Initiative Public Workshop

Wed, 01 Feb 2012 16:00:00 -0500

Event Information

February 1, 2012
4:00 PM - 5:00 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

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.

This webinar was an opportunity for interested stakeholders to revisit discussions from the Sentinel Initiative Public Workshop regarding an update on Mini-Sentinel’s progress and plans for the future and a discussion about strategies for communicating the expectations of, and findings from, Sentinel.

Audio

Sentinel Active Surveillance Roundtable: Highlights from the Sentinel Initiative Public Workshop

Transcript

Slide Presentation (.pdf)

Event Materials

Public WS Recap_distribution 20120131

Participants

Panelists

Richard Platt

Harvard Medical School and Harvard Pilgrim Health Care Institute

Ed Staffa

U.S. Food and Drug Administration

Sentinel Active Surveillance Roundtable: Multi-Payer Claims Database

Mon, 07 Nov 2011 14:30:00 -0500

Event Information

November 7, 2011
2:30 PM - 3:30 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

The American Recovery and Reinvestment Act of 2009 (ARRA) made possible substantial investments in comparative effectiveness research (CER), particularly in the areas of improving the data infrastructure and methods for research. As part of these investments, the Assistant Secretary for Planning and Evaluation (ASPE) within the U.S. Department of Health and Human Services (HHS) has been collaborating with the Centers for Medicare and Medicaid Services, OptumInsight, and other healthcare industry and research leaders to develop a Multi-Payer Claims Database (MPCD), which is envisioned as an important new resource for CER.

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. The presentations included an overview of the project, recently achieved milestones, and the project’s future direction.

Audio

Sentinel Active Surveillance Roundtable: Multi-Payer Claims Database

Transcript

Presentation by Dave Knutson and Andre Chappel (.pdf)

Event Materials

MPCD Webinar_20111107

Participants

Panelists

Andre Chappel

Office of Health Policy, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services

David Knutson

Division on Health Care Quality and Outcomes, Office of Health Policy, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services

Brookings Roundtable on Active Medical Product Surveillance: Overview of Additional Sentinel Activities

Wed, 21 Sep 2011 11:00:00 -0400

Event Information

September 21, 2011
11:00 AM - 12:00 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

The third and concluding webinar of the Sentinel Initiative 101 Series provided overviews of the Federal Partners Collaboration, the Observational Medical Outcomes Partnership (OMOP), and the Brookings Institution’s convening activities.

The webinar featured presentations from Melissa Robb, Project Director for the Sentinel Initiative, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Paul Stang, Senior Director of Epidemiology, Johnson & Johnson, and Principal Investigator at OMOP; and Josh Benner, Fellow in Economic Studies and Managing Director, Engelberg Center for Health Care Reform at Brookings. Presentations provided an overview of each activity and defined each activity’s role within the broader Sentinel Initiative.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Overivew of Additional Sentinel Activities

Transcript

Presentation (.pdf)

Event Materials

other sentinel activities_20110919_BR

Participants

Panelists

Judy Racoosin

U.S. Food and Drug Administration

Paul Stang

Johnson & Johnson and Observational Medical Outcomes Partnership

Brookings Roundtable on Active Medical Product Surveillance: Overview of the Mini-Sentinel Pilot

Thu, 15 Sep 2011 16:00:00 -0400

Event Information

September 15, 2011
4:00 PM - 5:00 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On September 15, the Engelberg Center hosted the second webinar in the Sentinel Initiative 101 Webinar Series, “Overview of FDA’s Mini-Sentinel Pilot.” This webinar featured a presentation from the Mini-Sentinel principal investigator, Dr. Richard Platt, Professor and Chair of the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care.

Dr. Platt’s presentation described Mini-Sentinel’s capabilities and lessons learned since the contract was awarded in October, 2009. Specific topics included:

Governance principles and policies,
Key achievements from the Mini-Sentinel Data Core, Methods Core, and Protocol Core, and
An example of a recent rapid query assessment conducted by Mini-Sentinel.

The third and final webinar will cover other Sentinel Initiative activities: Federal Partners Collaboration, the Observational Medical Outcomes Partnership (OMOP), and the Brookings Institution’s broader convening activities.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Overview of the Mini-Sentinel Pilot

Transcript

Presentation (.pdf)

Event Materials

Mini Sentinel Overview Presentation_20110914

Participants

Panelists

Rich Platt

Harvard Pilgrim Health Care and Harvard Medical School

Brookings Roundtable on Active Medical Product Surveillance: Overview of FDA’s Sentinel Initiative

Wed, 07 Sep 2011 10:00:00 -0400

Event Information

September 7, 2011
10:00 AM - 11:00 AM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

It has been three years since FDA launched the Sentinel Initiative and, since then, FDA has made significant progress. On September 7, the Engelberg Center hosted the first of the three-part Sentinel Initiative 101 Webinar Series, “Overview of FDA’s Sentinel Initiative” to review ongoing activities and accomplishments. The roundtable featured a presentation from Dr. Judy Racoosin, Sentinel Initiative Scientific Lead, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration.

Dr. Racoosin’s presentation provided a high-level review of the Sentinel Initiative’s scope and achievements including:

FDA’s 3-year vision for the Sentinel Initiative
A brief overview of the role of the Mini-Sentinel pilot, the Observational Medical Outcomes Partnership, the Federal Partners Collaboration, and the Brookings Institution cooperative agreement
Next steps for the Sentinel Initiative

Subsequent webinars in this series will provide a more in-depth overview of these pilot activities.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Overview of FDA’s Sentinel Initiative

Transcript

Presentation Slides (.pdf)

Event Materials

Sentinel Update_Brookings 20110907

Participants

Panelists

Judy Racoosin

U.S. Food and Drug Administration

Brookings Roundtable on Active Medical Product Surveillance: Learnings from the Department of Veterans Affairs Active Surveillance Activities

Mon, 20 Jun 2011 13:30:00 -0400

Event Information

June 20, 2011
1:30 PM - 2:30 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On June 20, the Engelberg Center hosted a roundtable webinar, "Learnings from the Department of Veterans Affairs Active Surveillance Activities." The roundtable featured presentations from Dr. Fran Cunningham, associate chief consultant, Center for Medication Safety program manager, Outcomes Research, Department of Veterans Affairs (VA) and Dr. Chester B. (Bernie) Good, associate professor of Medicine and Pharmacy, staff physician, VA Pittsburgh Healthcare System, co-director, Center for Medication Safety.

The VA has been conducting a number of activities related to active surveillance within their own databases, which contain clinically enriched data for war veterans, a population that may differ in important ways from the general population. Dr. Cunningham and Dr. Good discussed methods used and lessons learned from three of the VA’s active surveillance activities:

Signal refinement studies conducted to evaluate safety concerns arising within the VA population.
Conducting risk reduction and intervention assessments to enhance patient safety, prevent untoward outcomes, and assess outcomes of specific VA interventions (e.g., formulary decisions).
Assessing and operationalizing the common data model used by the Observational Medical Outcomes Partnership (OMOP).

Audio

Brookings Roundtable on Active Medical Product Surveillance: Learnings from the Department of Veterans Affairs Active Surveillance Activities

Transcript

Presentation Slides (.pdf)

Event Materials

VAMedSAFE ActiveSurveillanceLessonsBrookingsSeminiarJune20_FINAL_for distribution

Participants

Panelists

Fran Cunningham

Department of Veterans Affairs

Chester B. Good

VA Pittsburgh Healthcare System and Center for Medication Safety

Brookings Roundtable on Active Medical Product Surveillance: Highlights from the Observational Medical Outcomes Partnership's Annual Symposium

Thu, 17 Mar 2011 13:00:00 -0400

Event Information

March 17, 2011
1:00 PM - 2:00 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On March 17, 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 for the past two years has been to research 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 is researching multiple methods and a range of potential operating characteristics by which to evaluate and compare these methods. To ensure confidence in the results when using these methods, it is important to understand which characteristics are most relevant under varying circumstances.

Patrick Ryan – associate director of analytical epidemiology at Johnson & Johnson Pharmaceutical Research and Development, and co-investigator, Observational Medical Outcomes Partnership – offered remarks describing OMOP’s approach to evaluating the performance of methods for conducting active medical product safety surveillance. He also touched on the implications of OMOP’s research for actually conducting active surveillance and OMOP’s planned research to build on these findings.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Highlights from the Observational Medical Outcomes Partnership's Annual Symposium

Transcript

Presentation Slides (.pdf)

Event Materials

OMOP March 17 Webinar Complete Deck

Participants

Panelists

Judy Racoosin

Sentinel Initiative Scientific Lead, U.S. Food and Drug Administration

Patrick Ryan

Associate Director of Analytical Epidemiology, Johnson & Johnson Pharmaceutical Research and Development
Co-Investigator, Observational Medical Outcomes Partnership

Brookings Roundtable on Active Medical Product Surveillance: Mini-Sentinel Accomplishments and Plans for Year Two

Mon, 31 Jan 2011 14:30:00 -0500

Event Information

January 31, 2011
2:30 PM - 3:30 PM EST

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On January 31, the Engelberg Center for Health Care Reform hosted the live webinar, "Mini-Sentinel Accomplishments and Plans for Year Two," as part of the Brookings Roundtable on Active Medical Product Surveillance series.

The webinar served as an opportunity for interested stakeholders to revisit discussions from the Sentinel Initiative Public Workshop, and focused on Mini-Sentinel's progress and plans for the upcoming year.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Mini-Sentinel Accomplishments and Plans for Year Two

Transcript

Presentation Slides (.pdf)

Event Materials

MiniSentinel Webinar 20110128_compiled slides

Participants

Panelists

Judy Racoosin

Sentinel Initiative Scientific Lead
U.S. Food and Drug Administration

Richard Platt

Chair, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute

Lesley Curtis

Associate Professor of Medicine, Center for Clinical and Genetic Economics
Duke University School of Medicine

Deven McGraw

Director, Health Privacy Project
Center for Democracy and Technology

Bruce Fireman

Biostatistician and Research Scientist
Kaiser Permanente Northern California

Brookings Roundtable on Active Medical Product Surveillance: Conducting Real-Time Safety Evaluation with Medicare Data: Learnings from the SafeRx Project

Mon, 04 Oct 2010 14:30:00 -0400

Event Information

October 4, 2010
2:30 PM - 3:30 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On October 4, the Engelberg Center for Health Care Reform hosted a roundtable webinar, "Conducting Real-Time Safety Evaluation with Medicare Data: Learnings from the SafeRx Project."

Download presentation slides » (PDF)

The roundtable featured a presentation by Dr. Judy Racoosin of the Food and Drug Administration (FDA), who discussed a study conducted in the Medicare database that evaluated the impact of lags in claim processing and claim information updates (claims adjudication) on real-time evaluation of drug safety signals. This 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 medical product active surveillance. Mini-Sentinel collaborators – including Dr. Jeff Brown of Harvard Medical School and Harvard Pilgrim Health Care Institute, and Dr. Jennifer Nelson of Group Health Research Institute and University of Washington School of Public Health – made additional comments regarding how the Mini-Sentinel Coordinating Center will evaluate similar issues in the Mini-Sentinel Distributed Dataset.

Audio

Conducting Real-Time Safety Evaluation with Medicare Data

Event Materials

FDA slidesroundtable 100410 final 2

Participants

Panelists

Judy Racoosin

Scientific Lead, Sentinel Initiative, Office of Medical Policy
Center for Drug Evaluation and Research, Food and Drug Administration

Jeff Brown

Assistant Professor, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

Jennifer Nelson

Associate Investigator, Biostatistics Unit, Group Health Research Institute
Affiliate Assistant Professor, Biostatistics, School of Public Health, University of Washington

Brookings Roundtable on Active Medical Product Surveillance: Learning from the Observational Medical Outcomes Partnership (OMOP)

Thu, 01 Jul 2010 12:00:00 -0400

Event Information

July 1, 2010
12:00 PM - 1:00 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On July 1, the Engelberg Center for Health Care Reform hosted the roundtable webinar, "Learning from the Observational Medical Outcomes Partnership (OMOP)."

Download presentation slides » (pdf)

Discussion featured presentations from Patrick Ryan, Manager, Drug Development Sciences, GlaxoSmithKline Research and Development and Co-Investigator, Observational Medical Outcomes Partnership; and Dr. David Madigan, Professor and Chair of Statistics, Columbia University and Research Investigator, Observational Medical Outcomes Partnership.

Presentations 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. Mr. Ryan provided an overview of the OMOP methods program, and Dr. Madigan 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.

Event Materials

OMOP methods review

Participants

Panelists

Patrick Ryan

Manager, Drug Development Sciences, GlaxoSmithKline Research and Development
Co-Investigator, Observational Medical Outcomes Partnership

David Madigan

Professor and Chair of Statistics, Columbia University
Research Investigator, Observational Medical Outcomes Partnership

Roundtable on Active Medical Product Surveillance: Learning from The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project

Fri, 07 May 2010 12:00:00 -0400

Event Information

May 7, 2010
12:00 PM - 1:00 PM EDT

Live Webinar
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

On May 7, the Engelberg Center for Health Care Reform hosted the roundtable webinar, "The DELTA System and the Massachusetts Interventional Cardiology Device Safety Surveillance Pilot Project."

Download presentation slides » (pdf)

Discussion featured presentations from Dr. Thomas P. Gross, Deputy Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health (CDRH), Food and Drug Association (FDA), and Dr. Fredric S. Resnic, Medical Director, Cardiac Catheterization Laboratory, Brigham and Women’s Hospital. Panelists focused on the ongoing post-market surveillance work being done at CDRH and the Massachusetts interventional cardiology device safety surveillance pilot project using the Web-based DELTA (data extraction and longitudinal time analysis) system for identifying low frequency safety signals.

Audio

Roundtable on Active Medical Product Surveillance: Learning from The DELTA System

Event Materials

May 7 DELTARoundtablePresentation

Participants

Panelists

Thomas Gross

Deputy Director, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration

Frederic S. Resnic

Medical Director, Cardiac Catheterization Laboratory, Brigham and Women's Hospital

Roundtable on Active Medical Product Surveillance: Learning from SCHIEx, South Carolina's Statewide Distributed Data Integration

Mon, 15 Mar 2010 16:00:00 -0400

Event Information

March 15, 2010
4:00 PM - 5:00 PM EDT

Teleconference call
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

The Engelberg Center hosted a roundtable webinar on "SCHIEx: South Carolina's Distributed Data Integration Strategy." The roundtable featured 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.

Full audio is available below; presentation slides are available here.

Presenters discussed their model for integrating disparate data sources for the South Carolina statewide health information exchange. A moderated question and answer period followed the presentation.

Audio

Brookings Roundtable on Active Medical Product Surveillance: Learning from SCHIEx, South Carolina's Statewide Distributed Data Integration

Event Materials

SCHIExRoundtableSlides

Participants

Panelists

David Patterson

Section Chief, Health and Demographic Products, Office of Research and Statistics, South Carolina Budget and Control Board

Sue Veer

President and Chief Executive Officer, Carolina Health Centers

Vik Kheterpal

President and Chief Executive Officer, CareEvolution

Brookings Roundtable on Active Medical Product Surveillance: Learnings from H1N1 Vaccine Surveillance

Thu, 03 Dec 2009 16:00:00 -0500

Event Information

December 3, 2009
4:00 PM - 5:00 PM EST

Teleconference Call
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

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.

A moderated question and answer period followed the presentation.

Convened by the Engelberg Center for Health Care Reform at Brookings, roundtable teleconferences provide a forum to discuss public and private initiatives in which methods, data sources, and technology related to active medical product safety surveillance are being developed. These roundtables are intended to engage a broad range of stakeholders in productive discussions that reflect the current state and growing activity around medical product surveillance.

Event Materials

Dec 3 Slides

Participants

Panelists

Terri Madison

President, i3 Drug Safety

Brookings Roundtable on Active Medical Product Surveillance

Fri, 30 Oct 2009 11:00:00 -0400

Event Information

October 30, 2009
11:00 AM - 12:00 PM EDT

Teleconference Call
The Brookings Institution
1775 Massachusetts Ave., NW
Washington, DC

This event was 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.

The call featured an update from FDA leaders on their active surveillance activities, as well as a moderated question and answer period following the FDA's presentations.

Convened by the Engelberg Center for Health Care Reform at Brookings and suppored by a grant from the Food and Drug Administration.

Event Materials

Participants

Panelists

Judy Racoosin

Scientific Lead, Sentinel Initiative, Office of Medical Policy
Center for Drug Evaluation and Research, FDA

Judy Staffa

Associate Director for Regulatory Research, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, FDA

Bob Ball

Medical Officer IV, Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, FDA

Tom Scarnecchia

Executive Director, Observational Medical Outcomes Partnership, FNIH