CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
Drug Safety and Risk Management Advisory
Committee (DSaRM)
Holiday Inn
May 18 & 19, 2005
MEETING PARTICIPANTS
FDA CONSULTANTS
(Voting)
Elizabeth Andrews, M.P.H., Ph.D.
Vice President
Research Triangle Institute Health Solutions
Herbert Bldg, Room 225
Research
Sean Hennessy, Pharm.D., Ph.D.
Assistant
Professor of Epidemiology
University
of
803
Blockley Hall
Allen Mitchell, M.D.
Professor
of Epidemiology and Pediatrics
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
MEETING PARTICIPANTS
INDUSTRY
Gretchen S. Dieck, Ph.D.
Vice
President
Risk Management
Strategy,
Pfizer,
Inc.
A. Lawrence Gould, Ph.D.
Senior
Director, Scientific Staff,
Biostatistics
and Research Decision Sciences
Merck
Research Laboratories
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
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