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Balancing Animal Welfare and Regulatory Compliance Issues
in Preclinical Studies
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Registration Map
Program Tuesday, June 29, 2004
Viewpoints on Animal Studies Required for Human Protection
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8:00 |
Registration
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9:00 |
Welcome
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9:30 |
Keynote
Balancing Animal Welfare with Scientific Need Using an Ethical Cost-Benefit Assessment
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10:15 |
Break
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10:30 |
Panel 1:
Agency perspectives on regulatory and compliance issues: FDA, EPA, NIH, USDA, AAALAC
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12:00 |
Lunch |
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1:00 |
Keynote:
Animal Efficacy & Safety Studies: Criteria for Experimental Endpoints
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1:45 |
Panel 2:
Principal investigators perspectives on regulatory and compliance issues: GLP safety studies, Toxicology, Safety pharmacology, Devices
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3:15 |
Break
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3:30 |
Panel 3:
Roles & Responsibilities in regulatory and compliance issues: Study Director, Attending Veterinarian, Quality Assurance, IACUC
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5:00 |
Wrap-up of Day 1 |
Wednesday, June 30, 2004
Related and Emerging Issues
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8:00 |
Recap & Summary of Day 1
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8:30 |
Keynote
Public Perceptions
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9:15 |
Panel 4:
International Perspectives on the Application of GLPs to Animal Studies: Compliance, Animal Welfare, and Harmonization Issues
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10:45 |
Break
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11:00 |
Panel 5:
Integration of Academic, Contract, and Industrial Animal Research Activities: Entrepreneurial academic initiatives focusing on cooperative programs with biotechnology and pharmaceutical companies, GLP in the academic research environment, Industrial research perspectives, Contract facility perspectives
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12:30 |
Lunch |
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1:30 |
Keynote:
Bioterrorism Research: What can we expect?
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2:15 |
Panel 6:
Animal Welfare Issues in Research in Homeland Defense, Security and Bioterrorism: Terrorism and its effects on Biomedical Research Facilities; Bioterrorism and the Subpart 1 "animal rule" exception effect on development of vaccines: the risk-rewards in creating them; Bioterrorism risks for America: real or imagined threat; Bioterrorism Research: a Pandora's box or a future insurance policy ?
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3:45 |
Break
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4:00 |
Conference conclusions and future directions
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5:00 |
Adjournment
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Program Committee:
Co-Chairs: Lewis B Kinter PhD, Senior Director, Safety Assessment, AstraZeneca Pharmaceuticals
J R Haywood PhD, Chair, Pharmacology & Toxicology, Michigan State University
- Michael Ballinger DVM MS, Director, Global Laboratory Animal Resources, Amgen Inc.
- Awadh Binhazim DVM PhD, Director, Animal Care Facility, Meharry Medical College
- Marilyn Brown DVM MS, Director, Animal Welfare and Training, Charles River Inc.
- Rebecca Ellish-Stengle MPH, Ex Director, Michigan Society for Medical Research
- Stephen Frantz PhD DABT, Senior Study Director, MPI Research
- Nelson L Garnett DVM, DACLAM, Director, Office of Laboratory Animal Welfare, NIH
- Chester Gipson DVM, USDA, APHIS, Animal Care
- Betty Goldentyer DVM, USDA, APHIS, Animal Care
- Molly Greene, IACUC Advisor
- Steven W Hachtman, VP of Business Development, Data Sciences International
- Herod Howard DVM MPVM DACLAM, Director, LAMD, SRI International
- Mary Lou James, Consultant, Regulatory Compliance, Research Animal Welfare
- David K Johnson DVM, Scientific Advisor, Harlan
- James F. McCormack, PhD, Director, Nonclinical Laboratory Compliance, US Food & Drug Administration
- Virginia Moser PhD DABT, Neurotoxicology Division, US Environmental Protection Agency
- William Stokes DVM DACLAM, Director, National Toxicology Program, ICCVAM, NIEHS
- Carol Wigglesworth, Senior Policy Analyst, Office of Laboratory Animal Welfare, NIH
Tentative and Partial List of Conference Faculty
A Aldridge
Lynn C Anderson DVM DACLAM
Michael Ballinger DVM
Marilyn Brown DVM MS
Gilles Demers DVM MSc
Louis J DeTolla VMD PhD
Stephen Frantz PhD
Nelson Garnett DVM
Steven Hachtman PhD
Elizabeth Hausner
J R Haywood PhD
Herod Howard DVM
Kirk Huber
David Johnson DVM
Lewis Kinter PhD
Jodie Kulpa-Eddy DVM
James McCormack PhD
Ginger Moser PhD
Ernest Prentice PhD
Barbara Rich BA
Robert Shade PhD
Kathleen Smiler DVM
Nugahally Srinivas
William Stokes DVM DACLAM
Kirk Tarlo MPH PhD DABT
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