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Workshop Presentations
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Please note: Some of the presentations are large files that may take several minutes to
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Welcoming Remarks and Workshop Introduction
[PDF]
William Stokes, D.V.M., RADM, USPHS, NICEATM
Session 1: Overview of Public Health Needs and Regulatory Requirements for Vaccine Safety
and Potency Testing
- History and Overview of Human Vaccines and Their Importance to Public Health
[PDF]
Anne Schuchat, M.D., RADM, USPHS, U.S. Centers for Disease Control and Prevention
- Veterinary Vaccines and Their Importance to Animal Health and Public Health
[PDF]
James Roth, D.V.M., Ph.D., College of Veterinary Medicine, Iowa State University
- U.S. FDA Requirements for Human Vaccine Safety and Potency Testing
[PDF]
Theresa Finn, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
- Veterinary Biologics in the U.S.: Strategies to Reduce, Refine, and Replace Animal Use
[PDF]
Richard Hill, U.S. Department of Agriculture
- International Regulatory Requirements for Vaccine Safety and Potency Testing: Roundtable Discussion
- Health Canada’s Human Vaccine Lot Release Program
[PDF]
Richard Isbrucker, Ph.D., Health Canada, Canada
- European Regulatory Requirements for Vaccine Safety and Potency Testing
[PDF]
Ralph Woodland, Ph.D., Veterinary Medicines Directorate, United Kingdom
- Strategic Approaches for Developing Alternative Tests for Vaccine Safety and Potency (Japan)
[PDF]
Yoshinobu Horiuchi, Ph.D., Pharmaceuticals and Medical Devices Agency, Japan
- International Regulatory Requirements for Vaccine Safety and Potency Testing: A WHO Perspective
[PDF]
Jinho Shin, World Health Organization
- U.S. FDA
Theresa Finn, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA.
- USDA
Richard E. Hill Jr., D.V.M., Center for Veterinary Biologics, USDA
Session 2: Replacement Methods for Vaccine Potency Testing: Current State of the Science and Knowledge Gaps
- Overview of Currently Approved Veterinary Vaccine Potency Testing Methods and
Methods in Development that Do Not Require Animal Use
[PDF]
Hans Draayer, M.Sc., Pfizer Animal Health
- Case Study of Development, Validation, and Acceptance of a Non-Animal Method for Assessing Veterinary Vaccine Potency
[PDF]
Ivo Claassen, Ph.D., Central Veterinary Institute, The Netherlands
- Overview of Currently Approved Human Vaccine Potency Test Methods
that Do Not Require Animal Use: Release Testing of Polysaccharide Based Vaccines
[PDF]
Willie Vann, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
- Overview of the Current Status of Human Vaccine Potency Test Methods in Development That May Replace Animals
[PDF]
Robin Levis, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
- Lessons from the past: Development, Validation and Acceptance of a Non-animal
Method for Assessing Human Vaccine Potency — Case Study of Hepatitis B Vaccine
[PDF]
Johan Descamps, Ph.D., GlaxoSmithKline Biologicals, Belgium
Session 3: Animal Use for Vaccine Potency Testing: Refinement and Reduction Alternatives
Session 3A: Refinement Alternatives: Using Serological Methods to Avoid Challenge Testing
- Overview of Currently Approved Serological Methods with a Focus on Diphtheria and Tetanus Toxoid Potency Testing
[PDF]
James Keller, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
- Refinement Alternatives for Veterinary Vaccine Potency Testing: Overview of Currently Approved Serological Methods
[PDF]
Geetha Srinivas, D.V.M., Ph.D., Center for Veterinary Biologics, USDA
- Animal Refinement and Reduction Alternative Approaches for Vaccine Potency Testing of Diphtheria and Tetanus Vaccines
Dorothea Sesardic, Ph.D., National Institute for Biological Standards and Control, United Kingdom
Note: At the speaker's request, this presentation is not available for public viewing and/or distribution. We apologize for the inconvenience.
- Development and Validation of Serological Methods for Human Vaccine Potency Testing: Case Study of an Anthrax Vaccine
[PDF]
Juan Arciniega, D.Sc., Center for Biologics Evaluation and Research, U.S. FDA
- Development and Validation of Serological Methods for Veterinary Vaccine Potency Testing: Case Study of a Veterinary Vaccine
[PDF]
Jeffrey Galvin, Ph.D., Pfizer Animal Health
Session 3B: Using Earlier Humane Endpoints to Avoid or Minimize Animal Pain and Distress in Vaccine Potency Challenge Testing
- Humane Endpoints in Vaccine Potency Testing
Coenraad Hendriksen, D.V.M., Ph.D., Netherlands Vaccine Institute, The Netherlands
Note: This presentation is not available for public viewing and/or distribution. We apologize for the inconvenience.
Session 3C: Reduction Alternatives: Strategies to Further Reduce Animal Numbers for Vaccine Potency Testing
- Overview of Reduction Methods Currently Available or in Development for Vaccine Potency Testing
[PDF]
Jodie Kulpa-Eddy, D.V.M., Animal & Plant Health Inspection Service, USDA
- Application of the Consistency Approach for Reducing Animal Use in Vaccine Potency Testing
[PDF]
Jodie Kulpa-Eddy, D.V.M., Animal & Plant Health Inspection Service, USDA
Session 4: Vaccine Safety Testing: Post-Licensing Reduction, Refinement, and Replacement Methods and Strategies
- Human Vaccine Post-Licensing Safety Testing: Overview of Current Regulatory Requirements and Accepted Alternatives
[PDF]
Theresa Finn, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
- Veterinary Vaccine Post-Licensing Safety Testing: Overview of Current Regulatory Requirements and Accepted Alternatives
[PDF]
Glen Gifford, D.V.M., M.Sc., Canadian Food Inspection Agency, Canada
- Target Alternative Vaccine Safety Testing Strategies for Pertussis Toxin
[PDF]
Juan Arciniega, D.Sc., Center for Biologics Evaluation and Research, U.S. FDA
- Current Research and Development Activities Directed Toward Replacement of the Neurovirulence Test in Vaccine Safety Testing
[PDF]
Steven Rubin, Ph.D., Center for Biologics Evaluation and Research, U.S. FDA
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