Drug Safety
and Risk Management Advisory Committee (DSaRM)
Slides
WEDNESDAY MAY 18, 2005
Using the FDA’s Adverse Event Joyce Weaver, Pharm.D., B.C.P.S.
Reporting System (AERS) in Safety Evaluator,
Postmarketing Surveillance Division of Drug Risk Evaluation
[HTML) [PPT] (DDRE),
Office of Drug Safety (ODS)
Epidemiologic Analysis of Mary Willy, Ph.D.
Spontaneous Adverse Reports Epidemiology Team Leader,
Using FDA’s AERS in Postmarketing Carol Holquist, R.Ph
Surveillance for Medication Errors Director
[HTML) [PPT] Division
of Medication Errors and Technical
Support
(DMETS), ODS
Available Types of National Judy Staffa, Ph.D., R.Ph.
Drug Use Data Epidemiology
Team Leader,
[HTML) [PPT] Division
of Surveillance, Research and
Communication
Support (DSRCS), ODS
Issues
in the Practical Application of A.
Lawrence Gould, Ph.D.
Data Mining Techniques to Senior
Director, Scientific Staff,
Pharmacovigilance Biostatistics
and Research Decision Sciences
[HTML) [PPT] Merck
Research Laboratories
Data Mining AERS, FDA’s Carolyn McCloskey, M.D., M.P.H.
(Spontaneous) Adverse Event Epidemiologist
Reporting System DDRE,
ODS
Open Public Hearing Speakers
Charles
L. Bennett, M.D., Ph.D., MPP
Feinberg
School of Medicine, Northwestern University
Midwest
Center for Health Services Policy Research
Alexander
M. Walker, M.D., DR.PH
Sr
VP Epidemiology
13
Magnifi
Active Surveillance for Drug Safety Mary Willy, Ph.D.
Signals: Past, Present and Future Epidemiology Team Leader
*NEISS:CADES Active Surveillance Aaron Mendelsohn, Ph.D.,
M.P.H.
System Epidemiologist
Active Surveillance Using Longitudinal David Graham, M.D., M.P.H.
Data: A Pilot Project Medical
Officer, OPaSS
Questions to
the Committee