Workshop on Research Strategies for Assessing Adverse Events Associatedwith Vaccines
Institute of Medicine
National Academy of Sciences
Washington, D.C.
December 7, 1993
WORKSHOP PARTICIPANTS
Committee Members
Richard B. Johnston, Jr. (Chair), Medical Director, March of DimesBirth Defects Foundation, and Adjunct Professor of Pediatrics, YaleUniversity School of Medicine
E. Russell Alexander, Chief of Epidemiology, Seattle-King CountyHealth Department
Richard T. Johnson, Professor of Microbiology and Neuroscience, Chairmanof the Department of Neurology, Johns Hopkins University School ofMedicine
Michael S. Kramer, Professor, Departments of Pediatrics and of Epidemiologyand Biostatistics, McGill University Faculty of Medicine
Institute of Medicine Staff
Kathleen Stratton, Study Director
Cynthia Howe, Program Officer
Michael Stoto, Director, Division of Health Promotion and DiseasePrevention
Christopher Howson, Deputy Director, Division of International Health
Dorothy Majewski, Project Assistant
Invited Guests
Bascom Anthony, Director, Division of Bacterial Products, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration
Robert Chen, Chief of Vaccine Safety, National Immunization Program,Centers for Disease Control and Prevention
Mary Lou Clements, Professor and Director, Center for ImmunizationResearch, Johns Hopkins University
Elias Durry, Medical Epidemiologist, National Immunization Program,Centers for Disease Control and Prevention
Kathryn Edwards, Professor, Department of Pediatrics, VanderbiltUniversity
Susan Ellenberg, Director, Biostatistics and Epidemiology, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration
Gerald Fenichel, Professor of Neurology and Pediatrics, Chairmanof the Department of Neurology, Vanderbilt University
Reinhard Fescharek, Drug Surveillance, Behringwerke AG
James Froeschle, Director of Clinical Research, Connaught Laboratories,Inc.
John Glasser, Epidemiologist, Vaccine Safety Activity, National ImmunizationProgram, Centers for Disease Control and Prevention
Karen Goldenthal, Acting Director, Division of Vaccines and RelatedProducts Applications, Center for Biologics Evaluation and Research,U.S. Food and Drug Administration
Steven Gordon, Ogden BioServices Corporation
Marie Griffin, Associate Professor, Department of Preventive Medicine,Vanderbilt University Medical Center
Penina Haber, Public Health Analyst, National Immunization Program,Centers for Disease Control and Prevention
Jill Hackell, Director, Clinical Research and Medical Affairs, BiologicalsClinical Research, Lederle Laboratories
Neal Halsey, Professor, Department of International Health, JohnsHopkins University School of Hygiene and Public Health
Carolyn Hardegree, Director, Vaccines Research and Review, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration
William Jordan, Science Advisor, National Vaccine Program Office
Richard Kapit, Medical Officer, Biostatistics and Epidemiology, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration
David Karzon, Professor of Pediatrics and Microbiology and Immunology,Vanderbilt University
Roland Levandowski, Acting Director, Division of Viral Products,Center for Biologics Evaluation and Research, Food and Drug Administration
Elizabeth Loupi, Drug Safety Monitor, Pharmacovigilance Department,Pasteur Mérieux Connaught Company
Marie Mann, Medical Officer, National Vaccine Injury CompensationProgram
Edgar Marcuse, Director, Ambulatory Care Services, Children's Hospital and Medical Center, Seattle
Sandy Mintz, Director, Parents Concerned about the Safety of Vaccines
J. Anthony Morris, Chairman, The Bell of Atri, Inc.
David Nalin, Director, Clinical Research, Merck Research Laboratories
Regina Rabinovich, Assistant Director and National Vaccine ProgramLiaison, National Institute of Allergy and Infectious Diseases
Suresh Rastogi, Deputy Director, Biostatistics and Epidemiology,U.S. Food and Drug Administration
Steve Rosenthal, EIS Officer, National Immunization Program, Centersfor Disease Control and Prevention
David Salisbury, Principal Medical Officer for Childhood Immunization,Department of Health, London
Kristine Severyn, Director, Ohio Parents for Vaccine Safety
Dirk Teuwen, Director, Medical Affairs, SmithKline Beecham Biologicals
Joel Ward, Director, Center for Vaccine Research, University of California,Los Angeles
Robert Weibel, Medical Officer, National Vaccine Injury CompensationProgram
Robert Wise, Epidemiologist, Biostatistics and Epidemiology, Centerfor Biologics Evaluation and Research, U.S. Food and Drug Administration
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