The FDA and the University of Texas Medical Branch, Galveston National Laboratory (UTMB – GNL) will host a training course April 25-29, 2016 in how to meet Good Laboratory Practice (GLP) requirements in high biocontainment security level (BSL)-4 laboratory facilities.
This annual course, held in Bethesda, Md., 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.
The four and one-half day training program is offered annually utilizing expert faculty from the Food and Drug Administration, academia, and business and industry. The course includes laboratory activities conducted in mock 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 BSL4 laboratory environment.
An on-line training module on the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) is included as a course pre-requisite.
Advance registration is required, and seats are limited and course attendees are invited based upon diversity of roles, responsibilities, and organization.
