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

机译：促进医学对策的跨学科培训计划

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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). 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)). The program occurs annually and is expanding in 2019 to include a course addressing data quality and integrity in clinical trials involving the evaluation of MCMs for high-consequence pathogens. To date, 311 individuals have attended the course. Based on attendance numbers, diversity of participation (by affiliation and area of expertise), and self-reported evaluation results, course attendees indicate that the training program addresses a knowledge gap and that they will implement knowledge gained.
机译：2012年9月，美国卫生与公共服务部食品与药物管理局（FDA）的反恐和新威胁办公室与德克萨斯大学加尔维斯顿分校的医学分部建立了合作的教育合作伙伴关系，以期制定强有力的培训计划在高生物污染环境中获得良好的实验室实践。以问题为基础的学习技术的实施鼓励研究人员和监管机构就开展生物安全4级（BSL-4）实验室的规范化研究所面临的挑战进行相互教育，并从科学和监管的角度确定了可以接受的解决方案。结果是开发了一个名为“在最大收容实验室中实现数据质量和完整性”的面对面课程，以及一个涵盖FDA法规的在线辅助课程，即非临床实验室研究的良好实验室规范（21 CFR第58部分）。该课程为监管和科学界的成员提供了一个独特的机会，可以在交互式教育环境中解决复杂的问题，尤其是通过FDA动物法规（21 CFR第314和601部分（2002））推进医疗对策（MCM）。 。该计划每年进行一次，并将在2019年进行扩展，以涵盖涉及临床后果的数据质量和完整性的课程，该课程涉及对高后果病原体的MCM评估。迄今为止，已有311人参加了该课程。根据参加人数，参与的多样性（按隶属关系和专业领域划分）以及自我报告的评估结果，参加课程的人员表明，培训计划解决了知识缺口，并将实施所学知识。

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