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April 28 - May 1, 2015; In partnership with the University of Texas Medical Branch (UTMB), FDA’s Medical Countermeasures Initiative (MCMi) sponsored a week-long training course: Achieving Data Quality and Integrity in Maximum Containment Laboratories. Hosted at the National Institutes of Health in Bethesda, Maryland, this annual course is designed to educate sponsors, scientists, veterinarians, quality assurance personnel, regulators, reviewers, and policy-makers to enable the conduct of regulated studies product approval via the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible.

DA welcomed course faculty and participants from government, industry and academia. International participants in 2015 included representatives from public health agencies in Liberia, Canada and the UK. The course included expert lectures and hands-on laboratory activities conducted in Biosafety Level (BSL) 2 and BSL-4 training laboratories to emphasize the differences between biosafety levels, and the complexity of conducting laboratory activities in a BSL-4 environment.

To learn more about the course, visit: www.utmb.edu/orncs/FDA_Partnership/

To learn more about the FDA MCMi, visit: www.fda.gov/medicalcountermeasures

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