A Cross-Disciplinary Training Program for the Advancement of Medical Countermeasures.

In September 2012, the United States Department of Health and Human Services Food and Drug Administration's (FDA) Office of Counterterrorism and Emerging Threats and the University of Texas Medical Branch at Galveston entered into a collaborative educational partnership for the academic development of a robust training program for good laboratory practices in high-biocontainment environments. The implementation of problem-based learning techniques encouraged researchers and regulators to cross-educate each other on the challenges related to the conduct of regulated studies in biological safety level 4 (BSL-4) laboratories and identified solutions that were acceptable from scientific and regulatory perspectives. The result was the development of a face-to-face course entitled Achieving Data Quality and Integrity in Maximum Containment Laboratories and an additional online companion course covering the FDA regulation, Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58).