FDA-UTMB Collaborative Education Program

In September 2012, the United States Department of Health and Human Services Food and Drug Administration's (FDA) Office of Counterterrorism and Emerging Threats (OCET) 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). The course offers a unique opportunity for members of the regulatory and scientific communities to solve complex issues in an interactive educational environment, especially for the advancement of medical countermeasures (MCMs) via the FDA Animal Rule (21 CFR Parts 314 and 601 (2002)).

In 2017, the collaborative educational program expanded by developing a partnering course entitled Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens and in 2021 an online companion course covering Good Clinical Practices.

The overall goal of this unique educational program is to provide a learning environment that promotes collaboration of ideas, provides tools for clinical study conduct, enhances mutual understanding of clinical, scientific and regulatory complexities, and promotes the data quality and integrity derived from these regulated studies. The result is a better prepared, cohesive community of clinical, scientific and regulatory experts mutually engaged in, and committed to, the research, development, and regulatory evaluation and approval of medical countermeasures for high consequence pathogens.

Course Registration Information

To learn more about each course and to express an interest in attending, please select the course below:

Scientific Publications

Eitzen M, Jones E, McCowan J, Brasel T. A Cross-Disciplinary Training Program for the Advancement of Medical Countermeasures. Health Secur. 2019 Jul/Aug;17(4):344-351. https://www.liebertpub.com/doi/10.1089/hs.2019.0032

Poster – Measuring the Success of the UTMB-FDA Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories, presented in August 2017 (PDF, 833 KB)

Funding

This program is funded by a collaborative educational grant from the US Department of Health and Human Services Food and Drug Administration:

Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24), Federal Register, 18 June 2012. Grant numbers 1U24FD004652-01 (2012-2017), and 5U24FD006294-02 (2017-2022).

An Educational Program to Enhance Data Quality and Integrity for Regulated Studies Supporting the Advancement of Medical Countermeasures for High Consequence Pathogens. Award number 1U24FD007821 (2022- 2027)

Follow the program on Twitter for updates: glp@bsl4