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

 

MEETING PARTICIPANTS

 

FDA CONSULTANTS

(Voting)

 

 

 

Elizabeth Andrews, M.P.H., Ph.D.

Vice President

Research Triangle Institute Health Solutions

3040 Cornwallis Rd

Herbert Bldg, Room 225

Research Triangle, NC 27709

 

 

 

              Sean Hennessy, Pharm.D., Ph.D.

              Assistant Professor of Epidemiology

              University of Pennsylvania School of Medicine

              423 Guardian Drive

              803 Blockley Hall

              Philadelphia, PA 19104

 

 

 

              Allen Mitchell, M.D.

              Professor of Epidemiology and Pediatrics

              Boston University

              1010 Commonwealth Ave

              Boston, MA  02215

 

 

    

 

 

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

 

MEETING PARTICIPANTS

 

INDUSTRY


 

 

 

              Gretchen S. Dieck, Ph.D.

              Vice President

              Risk Management Strategy,

              Pfizer, Inc.

              New York, NY

 

 

     A. Lawrence Gould, Ph.D.

              Senior Director, Scientific Staff,

              Biostatistics and Research Decision Sciences

              Merck Research Laboratories

              Westpoint, PA    

 

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

 

MEETING PARTICIPANTS

 

FDA STAFF

 

 

Mark Avigan, M.D., C.M.

Director

Division of Drug Risk Evaluation (DDRE)

Office of Drug Safety (ODS)

 

Julie Beitz, M.D.

Deputy Director

Office of Drug Evaluation III (ODE III)

 

Jonca Bull, M.D.

Deputy Director

Office of Pharmacoepidemiology and Statistical Science (OPaSS)

 

Gerald DalPan, M.D., M.H.S.

Director

Division of Surveillance, Research and Communication Support (DSRCS), ODS

 

David Graham, M.D., M.P.H.

Medical Officer

OPaSS, ODS

 

Carol Holquist, R.Ph.

Director

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

 

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

Epidemiologist

DDRE, ODS

 

 

 

Aaron Mendelsohn, Ph.D., M.P.H.

Epidemiologist

DSRCS, ODS

 

Paul Seligman, M.D., M.P.H.

Director

OPaSS

 

Judy A. Staffa, Ph.D., R.Ph.

Epidemiology Team Leader,

DSRCS, ODS

 

Anne Trontell, M.D., M.P.H.

Deputy Director

ODS

 

Kathleen Uhl, M.D.

Pregnancy and Lactation Team

Office of New Drugs

 

Joyce Weaver, Pharm.D., B.C.P.S.

Safety Evaluator

DDRE, ODS

 

Mary Willy, Ph.D.

Epidemiology Team Leader

DDRE, ODS