Transcript Parallel Session 01Intro - American Statistical Association

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
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.
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
Postmarket Surveillance of
Medical Device Adverse
Events
Hesha Jani Duggirala, PhD
Epidemiology Branch
Division of Postmarket Surveillance
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Using Disproportionality Analysis to
Systematically and Simultaneously
Detect Safety Signals in AERS
Jonathan G. Levine, PhD
FDA/CDER
Office Of Pharmacoepidemiology &
Statistical Science
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
Classification rules for high
dimensional markers: searching
for complementary marker pairs
Stuart G. Baker, et al
[email protected]
Biometry Research Group,
Division of Cancer Prevention,
National Cancer Institute,
Bethesda, MD, USA
Computer Simulation in
Medical Diagnostic Assay
Calibration Evaluation
Ping Shi Ph.D
Abbott Laboratories
Sept. 16, 2005