CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Drug Safety and Risk Management Advisory
Committee (DSaRM)
Holiday Inn
May 18 & 19, 2005
AGENDA
This the first in a series of meetings
related to issues in drug safety and the FDA. This two-day meeting will explore
issues related to FDA’s risk assessment program for marketed drugs. There are a
number of methods that FDA uses in risk assessment of marketed drugs, including
review and analysis of spontaneous reports of adverse events, drug use data,
healthcare administrative data, epidemiologic and observational studies,
clinical trials, and active surveillance systems. Considerations will include
the advantages and disadvantages of the current system for safety signal
detection, and proposals for short-term and long-term
ways to improve the current system.
DAY 1 WEDNESDAY MAY 18, 2005
Conflict
of Interest Statement
Executive
Secretary, DSaRM
Director
Office
of Pharmacoepidemiology and
Statistical
Science (OPaSS)
Reporting
System (AERS) in Safety
Evaluator,
Postmarketing
Surveillance Division
of Drug Risk Evaluation (DDRE),
Office
of Drug Safety (ODS)
Spontaneous
Adverse Reports Epidemiology
Team Leader,
DDRE, ODS
Surveillance
for Medication Errors Director
Division of Medication
Errors and Technical Support (DMETS), ODS
Drug Use Data Epidemiology
Team Leader,
Division
of Surveillance, Research and Communication
Support (DSRCS), ODS
FOOD AND
DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
(CDER)
Drug Safety and Risk Management
Advisory Committee (DSaRM)
Holiday Inn
May 18 & 19,
2005
AGENDA
(cont.)
DAY 1
Data
Mining Techniques to Senior
Director, Scientific Staff,
Pharmacovigilance Biostatistics
and Research Decision Sciences
Merck
Research Laboratories
(Spontaneous)
Adverse Event Epidemiologist
Reporting
System
DDRE, ODS
Signals: Past, Present and Future Epidemiology Team Leader
DDRE, ODS
System Epidemiologist
DSRCS,
ODS
Data:
A Pilot Project Medical
Officer, OPaSS
*NEISS:CADES-National Electronic Injury Surveillance System: Cooperative
Adverse Drug Events Surveillance System
FOOD AND
DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
(CDER)
Drug Safety and Risk Management
Advisory Committee (DSaRM)
Holiday Inn
May 18 & 19,
2005
AGENDA
This the first in a series of meetings related to issues in drug safety
and the FDA. This two-day meeting will explore issues related to FDA’s risk
assessment program for marketed drugs. There are a number of methods that FDA
uses in risk assessment of marketed drugs, including review and analysis of
spontaneous reports of adverse events, drug use data, healthcare administrative
data, epidemiologic and observational studies, clinical trials, and active
surveillance systems. Considerations will include the advantages and
disadvantages of the current system for safety signal detection, and proposals
for short-term and long-term ways to improve the current system.
DAY 2 THURSDAY MAY 19, 2005
Conflict
of Interest Statement
ODS
Pregnancy
& Lactation Team, Office of New Drugs
OND
Perspective Office of Drug Evaluation III
Industry Perspective Management
Strategy, Worldwide Development,
Pfizer,
Inc.
Studies – Overview Challenges