A Cross-Disciplinary Training Program for the Advancement of Medical Countermeasures.
A Cross-Disciplinary Training Program for the Advancement of Medical Countermeasures.
复制标题
促进医疗对策的跨学科培训计划。
DOI：
10.1089/hs.2019.0032
复制
发表时间：
2019
期刊：
影响因子：
3.3
通讯作者：
Brasel,Trevor
中科院分区：
文献类型：
--
作者：
Eitzen,MelissaM;Jones,EstellaZ;McCowan,Jayco;Brasel,Trevor
2012年9月，美国卫生与公众服务部食品和药物管理局（FDA）反恐和新出现威胁办公室与德克萨斯大学加尔维斯顿医学分支建立了合作教育伙伴关系，以便为高度生物防护环境中的良好实验室做法制定一个强有力的培训方案。采用基于问题的学习方法，鼓励研究人员和监管人员就在生物安全4级实验室开展受监管研究所面临的挑战相互进行交叉教育，并确定了从科学和监管角度可以接受的解决方案。其结果是开发了一个名为“在最大封闭实验室中实现数据质量和完整性”的面对面课程，以及一个额外的在线配套课程，涵盖FDA法规，非临床实验室研究的药物非临床研究质量管理规范（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，可以在互动的教育环境中解决复杂的问题，特别是通过FDA动物规则（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，并在2019年扩大，包括一门课程，解决临床试验中的数据质量和完整性，涉及对高后果病原体的MCM进行评估。迄今为止，已有311人参加了培训班。根据出席人数、参与的多样性（按隶属关系和专业领域）和自我报告的评估结果，课程参与者表示，培训计划解决了知识差距，他们将实施所获得的知识。
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.