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Balancing Animal Welfare and Regulatory Compliance Issues in Preclinical Studies
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Preclinical safety studies required for regulatory approval of new drugs and chemicals have different
scientific objectives than efficacy studies and pose challenges for scientists, regulators, and the public
concerned about animal welfare. International efforts have greatly reduced animal use both through
standardization of regulations and study designs and by promoting the principles of reduction,
replacement, and refinement (the 3Rs). These efforts continue, but animal studies will continue to play an
important role in safety assessment and risk management well into the 21st century. Though scientists,
veterinarians, regulators, and the public will determine how those research activities are conducted, current
positions and thinking within and between these stakeholders are not congruent and potentially impact
research quality, animal welfare standards and public trust. This conference brings together internationally
recognized leaders of the scientific and regulatory communities to identify the issues and to propose
harmonization of animal welfare in biomedical research.
Target audience: study directors, investigators, veterinarians, animal facility managers, quality
assurance, IACUC members and staff, regulators
Sponsored by:
NIH Office of Laboratory Animal Welfare
USDA Animal and Plant Health Inspection Service, Animal Care
AstraZeneca Pharmaceuticals
Michigan State University
Association for Assessment and Accreditation of Laboratory Animal Care International
Michigan Society for Medical Research
Additional support provided by:
Eli Lilly and Company
Safety Pharmacology Society
Sanofi-Synthelabo
US Food & Drug Administration
Location: The Westin Detroit Michigan Metropolitan Airport Hotel
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