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

Parallel Session 1 Post Market Adverse Events: FDA Reporting Systems and Surveillance . Jane Woo (CBER) Hesha Duggirala (CDRH) Jonathan Levine (CDER ). Chairs: Gene Pennello (CDRH) Jingyee Kou (CBER) . SESSION ABSTRACT

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

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  1. 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)

  2. 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.

  3. 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

  4. 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

  5. Using Disproportionality Analysis to Systematically and Simultaneously Detect Safety Signals in AERSJonathan G. Levine, PhDFDA/CDEROffice Of Pharmacoepidemiology & Statistical Science

  6. 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

  7. Classification rules for high dimensional markers: searching for complementary marker pairs Stuart G. Baker, et al sb16i@nih.gov Biometry Research Group, Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA 

  8. Computer Simulation in Medical Diagnostic Assay Calibration Evaluation Ping Shi Ph.D Abbott Laboratories Sept. 16, 2005

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