FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Drug Safety and Risk Management Advisory Committee (DSaRM)

 

Holiday Inn

8777 Georgia Avenue

Silver Spring, Maryland

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 FDAs 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

 

8:00 Call to Order and Introductions Peter Gross, M.D., Chair, DSaRM

Conflict of Interest Statement Shalini Jain, PA-C

Executive Secretary, DSaRM

8:15 Opening Remarks Paul Seligman, M.D.

Director

Office of Pharmacoepidemiology and

Statistical Science (OPaSS)

 

8:30 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 (DDRE),

Office of Drug Safety (ODS)

9:00 Epidemiologic Analysis of Mary Willy, Ph.D.

Spontaneous Adverse Reports Epidemiology Team Leader,

DDRE, ODS

9:15 Using FDAs AERS in Postmarketing Carol Holquist, R.Ph

Surveillance for Medication Errors Director

Division of Medication Errors and Technical Support (DMETS), ODS

9:30 Available Types of National Judy Staffa, Ph.D., R.Ph.

  Drug Use Data Epidemiology Team Leader,

Division of Surveillance, Research and Communication

Support (DSRCS), ODS

 

 

9:45 Question and Answer Period

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

 

Drug Safety and Risk Management Advisory Committee (DSaRM)

 

Holiday Inn

8777 Georgia Avenue

Silver Spring, Maryland

May 18 & 19, 2005

 

AGENDA (cont.)

 

DAY 1 WEDNESDAY MAY 18, 2005 (cont.)

 

10:00 Break

 

10:15 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

Merck Research Laboratories

 

10:35 Data Mining AERS, FDAs Carolyn McCloskey, M.D., M.P.H.

(Spontaneous) Adverse Event Epidemiologist

Reporting System DDRE, ODS

 

10:45 Question and Answer Period

 

11:00 Open Public Hearing

12:00 Lunch

 

1:00 Active Surveillance for Drug Safety Mary Willy, Ph.D.

Signals: Past, Present and Future Epidemiology Team Leader

DDRE, ODS

 

1:30 *NEISS:CADES Active Surveillance Aaron Mendelsohn, Ph.D., M.P.H.

System Epidemiologist

DSRCS, ODS

 

 

1:45 Active Surveillance Using Longitudinal David Graham, M.D., M.P.H.

Data: A Pilot Project Medical Officer, OPaSS

2:05 Question and Answer Period

 

2:30 Break

 

2:45 Questions to the Committee

 

5:00 Adjourn

*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

8777 Georgia Avenue

Silver Spring, Maryland

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 FDAs 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

 

8:00 Call to Order and Introductions Peter Gross, M.D., Chair, DSaRM

Conflict of Interest Statement Shalini Jain, PA-C, Executive Secretary, DSaRM

 

8:15 Opening remarks Paul Seligman, M.D., M.P.H., Director, OPaSS

8:20 Overview of Drug Safety Challenges Gerald DalPan, M.D., M.H.S., Director, DSRCS, ODA

ODS

 

8:50 Pregnancy Exposure Registries Kathleen Uhl, M.D.

Pregnancy & Lactation Team, Office of New Drugs

9:10 Postmarketing Studies from Julie Beitz, M.D. Deputy Director,

OND Perspective Office of Drug Evaluation III

 

9:40 Post marketing Studies from the Gretchen S. Dieck, Ph.D., Vice President,

Industry Perspective Management Strategy, Worldwide Development,

Pfizer, Inc.

 

10:10 Population-Based Epidemiologic Safety David Graham, M.D., M.P.H., Medical Officer, ODS

Studies Overview Challenges

10:40 Question and Answer Period

 

11:00 Break

 

11:10 Open Public Hearing

 

11:40 Lunch

 

12:40 Questions to the Committee

 

5:00 Adjourn