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Vaccine Safety Forum: Summaries of Two Workshops (1997)

Chapter:WORKSHOP AGENDA

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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×

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

Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×

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

Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×

 

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

Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×

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

Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×

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

Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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Suggested Citation:"WORKSHOP AGENDA." Institute of Medicine. 1997. Vaccine Safety Forum: Summaries of Two Workshops. Washington, DC: The National Academies Press. doi: 10.17226/5881.
×
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On November 6, 1995, the Institute of Medicine's Vaccine Safety Forum convened a workshop on detecting and responding to adverse events following vaccination. Workshop speakers and participants discussed the difficulties in detecting adverse events, current adverse events detection and response methods and procedures, suggestions for improving the means of detecting and responding to adverse events following vaccination, and future areas of research. This document represents a summary of that workshop.

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