Drug Safety and Risk Management Advisory Committee (DSaRM)

 

Slides

WEDNESDAY MAY 18, 2005

 

Using the FDAs 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,

[HTML) [PPT] DDRE, ODS

 

Using FDAs 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, FDAs Carolyn McCloskey, M.D., M.P.H.

(Spontaneous) Adverse Event Epidemiologist

Reporting System DDRE, ODS

[HTML) [PPT]

 

Open Public Hearing Speakers

[HTML) [PPT]

 

Charles L. Bennett, M.D., Ph.D., MPP

Feinberg School of Medicine, Northwestern University

Midwest Center for Health Services Policy Research

[HTML) [PPT]

 

Alexander M. Walker, M.D., DR.PH

Sr VP Epidemiology

13 Magnifi

[HTML) [PPT]

 

Active Surveillance for Drug Safety Mary Willy, Ph.D.

Signals: Past, Present and Future Epidemiology Team Leader

[HTML) [PPT] DDRE, ODS

 

*NEISS:CADES Active Surveillance Aaron Mendelsohn, Ph.D., M.P.H.

System Epidemiologist

[HTML) [PPT] DSRCS, ODS

 

Active Surveillance Using Longitudinal David Graham, M.D., M.P.H.

Data: A Pilot Project Medical Officer, OPaSS

[HTML) [PPT]

 

Questions to the Committee

[HTML) [PPT]