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PAPERBACK list:$26.00 Web:$23.40 add to cart Rights & Permissions Free PDF Access Free Resources Sign in to download PDF book and chapters PDF EXECUTIVE SUMMARY Display this book on your site! Related Titles Immunization Safety Review: Vaccines and Autism Immunization Safety Review: Influenza Vaccines and Neurological Complications Other Related Titles Vaccine Safety Forum: Summaries of Two Workshops (1997) Institute of Medicine (IOM) Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Page 23   E-mail  Facebook  Digg  Stumble  Twitter More The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. Workshop Agenda INSTITUTE OF MEDICINE VACCINE SAFETY FORUM Workshop on Detecting and Responding to Adverse Events Following Vaccination November 6, 1995 Washington, D.C. I. Introduction to Adverse Events: The Questions 8:30–8:45 a.m. Gerald Fenichel (Workshop Chair) Vanderbilt University School of Medicine II. Detecting Adverse Events 8:45–9:45 Surveillance for Vaccine Adverse Events Rohert Chen, Centers for Disease Control and Prevention 9:45–10:00 Description of Data in the Vaccine Adverse Event Reporting System (VAERS) Miles Braun, Food and Drug Administration 10:00–10:15 BREAK III. Responding to Adverse Events 10:15–10:45 Epidemiologic Methods and the Study of Adverse Events Samy Suissa, McGill University 10:45–11:15 Epidemiologic Methods Applied to Vaccine Adverse Events Marie Griffin, Vanderbilt University Medical Center Page 23 FRONT MATTER (R1-R8) EXECUTIVE SUMMARY (1-1) INTRODUCTION (2-2) DIFFICULTIES IN DETECTING ADVERSE EVENTS FOLLOWING VACCINATION (3-4) CURRENT ADVERSE EVENT DETECTION AND RESPONSE PROCEDURES (5-8) IMPROVING DETECTION OF AND RESPONSE TO ADVERSE EVENTS (9-17) ADDITIONAL AREAS FOR RESEARCH (18-20) REFERENCES (21-22) WORKSHOP AGENDA (23-28) EXECUTIVE SUMMARY (29-29) INTRODUCTION (30-30) IMMUNE RESPONSE TO VACCINE ANTIGENS (31-34) GENETIC FACTORS AFFECTING DEVELOPMENT OF AUTOIMMUNITY (35-36) RESEARCH ON IDENTIFYING POPULATIONS AT RISK FOR ADVERSE EVENTS (37-43) RESEARCH OPPORTUNITIES (44-50) REFERENCES (51-56) WORKSHOP AGENDA (57-63)

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OCR for page 23
Vaccine Safety Forum: Summaries of Two Workshops Workshop Agenda INSTITUTE OF MEDICINE VACCINE SAFETY FORUM Workshop on Detecting and Responding to Adverse Events Following Vaccination November 6, 1995 Washington, D.C. I. Introduction to Adverse Events: The Questions 8:30–8:45 a.m. Gerald Fenichel (Workshop Chair) Vanderbilt University School of Medicine II. Detecting Adverse Events 8:45–9:45 Surveillance for Vaccine Adverse Events Rohert Chen, Centers for Disease Control and Prevention 9:45–10:00 Description of Data in the Vaccine Adverse Event Reporting System (VAERS) Miles Braun, Food and Drug Administration 10:00–10:15 BREAK III. Responding to Adverse Events 10:15–10:45 Epidemiologic Methods and the Study of Adverse Events Samy Suissa, McGill University 10:45–11:15 Epidemiologic Methods Applied to Vaccine Adverse Events Marie Griffin, Vanderbilt University Medical Center

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Vaccine Safety Forum: Summaries of Two Workshops 11:15–11:45 Detection and Response Activities of Vaccine Manufacturers Luc Hessel, Pasteur Mérieux Connaught Robert Levine, Lederle-Praxis Biologicals Robert Sharrar, Merck Research Laboratories 11:45–12:15 p.m. Experiences of Consumers with Adverse Event Detection and Response Barbara Loe Fisher, National Vaccine Information Center Mark Geier, Medical/Legal Consultant Kathy Schaus, Little Rock, Arkansas Jack Sexton, Woodbridge, Virginia 12:15–1:15 LUNCH IV. Examples of Methodologies Applied to Research on Vaccine Adverse Events 1:15–1:30 Vaccine Lot Surveillance Susan Ellenberg, Food and Drug Administration 1:30–1:45 Reviewing Case Reports Frederick Varricchio, Food and Drug Administration 1:45–2:00 Analysis of Seizure Reports in LLDBs Robert Davis, Group Health Cooperative, Seattle 2:00–2:15 Studying Immune-mediated Disorders John Martin, University of Southern California School of Medicine 2:15–2:30 BREAK V. Panel Discussions 2:30–3:15 Panel 1—Reporting and Data Collection Moderator: Linda Cowan, University of Oklahoma Health Sciences Center Panelists: Barbara Loe Fisher, National Vaccine

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Vaccine Safety Forum: Summaries of Two Workshops   Information Center; Luc Hessel, Pasteur Mérieux Connaught; Gina Terracciano, Centers for Disease Control and Prevention; Frederick Varricchio, Food and Drug Administration 3:15–4:00 Panel 2—Detection Methodologies Moderator: Paul Stolley, University of Maryland School of Medicine Panelists: Bart Classen, Classen Immunotherapies; Susan Ellenberg, Food and Drug Administration; Barbara Loe Fisher, National Vaccine Information Center; James Singleton, Centers for Disease Control and Prevention; Robert Wise, Food and Drug Administration 4:00–4:45 Panel 3—Response Methodologies Moderator: Paul Stolley, University of Maryland School of Medicine Panelists: Barbara Loe Fisher, National Vaccine Information Center ; John Glasser, Centers for Disease Control and Prevention; Marie Griffin, Vanderbilt; John Martin, University of Southern California 4:45–5:30 Panel 4—Summation Panel: Where do we stand? Moderator: Gerald Fenichel (Workshop Chair), Vanderbilt University School of Medicine Panelists: Robert Chen, Centers for Disease Control and Prevention; Susan Ellenberg, Food and Drug Administration; Barbara Loe Fisher, National Vaccine Information Center; Robert Kohberger, Lederle-Praxis Biologicals PARTICIPANTS M. Miles Braun, Medical Officer, Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Robert T. Chen, Chief, Vaccine Safety and Development Activity, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia

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Vaccine Safety Forum: Summaries of Two Workshops J. Barthelow Classen, President and Chief Executive Officer, Classen Immunotherapies, Inc., Baltimore, Maryland Linda D. Cowan, Professor, Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma Robert Davis, Assistant Professor, Department of Pediatrics, University of Washington Medical School; and Assistant Professor, Department of Epidemiology, University of Washington School of Public Health and Community Medicine, Seattle, Washington Susan Ellenberg, Director, Division of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Gerald M. Fenichel, Professor of Neurology and Pediatrics, and Chair, Department of Neurology, Vanderbilt University School of Medicine, Nashville, Tennessee Barbara Loe Fisher, President, National Vaccine Information Center, Vienna, Virginia Mark Geier, Medical/Legal Consultant, Silver Spring, Maryland John W. Glasser, Epidemiologist, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia Marie R. Griffin, Professor, Department of Preventive Medicine, Vanderbilt University Medical Center, Nashville, Tennessee Luc Hessel, Pasteur Mérieux: Connaught, Lyon, France Robert C. Kohberger, Director, Statistics and Data Management, Wyeth-Lederle Vaccines and Pediatrics, Pearl River, New York Robert Levine, Director, Worldwide Safety Surveillance, Lederle-Praxis Biologicals, Philadelphia, Pennsylvania W. John Martin, Department of Pathology, University of Southern California School of Medicine, Los Angeles, California Kathy Schaus, Little Rock, Arkansas Jack Sexton, Woodbridge, Virginia Robert G. Sharrar, Director, Report Evaluation and Safety Surveillance, Worldwide Product Safety and Epidemiology, Merck Research Laboratories, West Point, Pennsylvania James Singleton, Statistician, Klemm Analysis Group, Centers for Disease Control and Prevention, Atlanta, Georgia Paul D. Stolley, Professor and Chairman, Department of Epidemiology and Preventive Medicine, University of Maryland School of Medicine, Baltimore, Maryland Samy Suissa, Associate Professor, Pharmacoepidemiology Research Unit, McGill University, Montreal, Quebec

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Vaccine Safety Forum: Summaries of Two Workshops Gina Terracciano, Medical Officer, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, Georgia Frederick Varricchio, Medical Officer, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland Robert P. Wise, Medical Epidemiologist, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland

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Vaccine Safety Forum: Summaries of Two Workshops This page in the original is blank.

Representative terms from entire chapter:

national vaccine