Parallel Session 1 Post Market Adverse Events: FDA Reporting Systems and Surveillance

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Parallel Session 1Post Market Adverse Events
FDA Reporting Systems and Surveillance
Jane Woo (CBER)Hesha Duggirala (CDRH) Jonathan
Levine (CDER)
Chairs Gene Pennello (CDRH) Jingyee Kou (CBER)
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SESSION ABSTRACT FDA devotes considerable
resources to maintaining and analyzing databases
of post-market adverse events. The databases are
explored for signals of associations between
approved medical products and adverse events. The
task is daunting for many reasons.  For one, many
false signals are expected by chance because of
the enormous number of combinations of medical
product and adverse event.  This session offers a
sampling of the databases available at CDER,
CDRH, and CBER.  The speakers will describe the
unique characteristics of the databases,
epidemiological and statistical methods used to
mine them, and limitations of the databases and
the methods.
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The Vaccine Adverse Event Reporting System A
Tool for Safety and Surveillance

• Jane Woo, MD, MPH
• Vaccine Safety Branch
• Division of Epidemiology
• Office of Biostatistics and Epidemiology
• Center for Biologics Evaluation and Research
• September 16, 2005

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Postmarket Surveillance of Medical Device Adverse
Events
Hesha Jani Duggirala, PhDEpidemiology Branch
Division of Postmarket SurveillanceOffice of
Surveillance and BiometricsCenter for Devices
and Radiological Health
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Using Disproportionality Analysis to
Systematically and Simultaneously Detect Safety
Signals in AERSJonathan G. Levine,
PhDFDA/CDEROffice Of Pharmacoepidemiology
Statistical Science

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Comparing Diagnostic Accuracies of Two Tests in
the Studies with Verification Bias
Marina Kondratovich, Ph.D. Division of
Biostatistics, Center for Devices and
Radiological Health, U.S. Food and Drug
Administration.
No official support or endorsement by the Food
and Drug Administration of this presentation is
intended or should be inferred.
September, 2005
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Classification rules for high dimensional
markers searching for complementary marker pairs

• Stuart G. Baker, et al
• sb16i_at_nih.gov
• Biometry Research Group, Division of Cancer
  Prevention, National Cancer Institute, Bethesda,
  MD, USA 

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Computer Simulation in Medical Diagnostic Assay
Calibration Evaluation

• Ping Shi Ph.D
• Abbott Laboratories
• Sept. 16, 2005