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Institute of Medicine (US) Committee to Study New Research on Vaccines; Stratton KR, Howe CJ, Johnston RB Jr., editors. Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary. Washington (DC): National Academies Press (US); 1994.

Cover of Research Strategies for Assessing Adverse Events Associated with Vaccines:

Research Strategies for Assessing Adverse Events Associated with Vaccines: A Workshop Summary.

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Workshop on Research Strategies for Assessing Adverse Events Associated with 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 Dimes Birth Defects Foundation, and Adjunct Professor of Pediatrics, Yale University School of Medicine

E. Russell Alexander, Chief of Epidemiology, Seattle-King County Health Department

Richard T. Johnson, Professor of Microbiology and Neuroscience, Chairman of the Department of Neurology, Johns Hopkins University School of Medicine

Michael S. Kramer, Professor, Departments of Pediatrics and of Epidemiology and 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 Disease Prevention

Christopher Howson, Deputy Director, Division of International Health

Dorothy Majewski, Project Assistant

Invited Guests

Bascom Anthony, Director, Division of Bacterial Products, Center for 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 Immunization Research, Johns Hopkins University

Elias Durry, Medical Epidemiologist, National Immunization Program, Centers for Disease Control and Prevention

Kathryn Edwards, Professor, Department of Pediatrics, Vanderbilt University

Susan Ellenberg, Director, Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Gerald Fenichel, Professor of Neurology and Pediatrics, Chairman of 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 Immunization Program, Centers for Disease Control and Prevention

Karen Goldenthal, Acting Director, Division of Vaccines and Related Products 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, Biologicals Clinical Research, Lederle Laboratories

Neal Halsey, Professor, Department of International Health, Johns Hopkins University School of Hygiene and Public Health

Carolyn Hardegree, Director, Vaccines Research and Review, Center for 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, Center for 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 Compensation Program

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 Program Liaison, 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, Centers for 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 Compensation Program

Robert Wise, Epidemiologist, Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Copyright 1994 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK231541

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