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DTSTART;VALUE=DATE:20200420
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UID:35622-1587340800-1587772799@globalbiodefense.com
SUMMARY:POSTPONED | NO NEW DATE - BSL-4 Training: Achieving Data Quality and Integrity in Maximum Containment Laboratories
DESCRIPTION:The FDA and the University of Texas Medical Branch\, Galveston National Laboratory (UTMB) will host this year’s annual training course on how to meet GLP requirements in BSL-4 facilities from April 20-24\, 2020 at the National Institutes of Health (NIH) in Bethesda\, Maryland. \nScientists working to develop Medical Countermeasures (MCMs) against several high-priority biological threat agents are at high risk of aerosol-transmitted laboratory infection and life-threatening disease\, as there are no vaccines or treatments for these agents. Accordingly\, much of the work to develop MCMs for these high-priority agents must be done in high and maximum biosafety level (BSL)-4 laboratories to prevent the agents from being released into the environment\, and to provide maximum safety for the scientists. \nThe unique challenges of BSL-4\nWhile necessary to ensure lab worker safety and prevent accidental release of dangerous pathogens\, BSL-4 environments pose unique challenges to developing MCMs. For example\, data generated to support a regulatory submission to FDA must be collected in accordance with quality systems\, like good laboratory practice (GLP) regulations\, to be useful and reliable\, and to facilitate FDA review to ensure safety and efficacy. \nHowever\, meeting data quality and integrity standards like GLP in a BSL-4 environment is challenging. Current practice is often inconsistent among laboratories due to technological infrastructure\, available internal standard operating procedures\, level of regulatory awareness\, and individual breadth of experience and training. And completing even routine lab tasks in a protective BSL-4 suit can be difficult—imagine\, for example\, trying to pick up a small item\, like a toothpick\, while wearing two pairs of thick gloves. \nTo help address the challenges associated with ensuring data quality and integrity in regulated studies conducted in BSL-4 laboratories to support MCM development\, FDA and the University of Texas Medical Branch\, Galveston National Laboratory (UTMB) collaborate to provide an annual training course on how to meet GLP requirements in BSL-4 facilities (“data quality course”). \n\nThis popular course offers a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities. \n\nIn addition to UTMB and FDA\, other federal partners from the National Interagency Confederation for Biological Research (NICBR) provide support and resources for this course. These partners include: \n\nFrom the National Institutes of Health\n\nOffice of the Director\nNational Institute of Allergy and Infectious Diseases (NIAID)\nNational Cancer Institute (NCI)\n\n\nFrom the Department of Defense\n\nU.S. Army Medical Research and Materiel Command (USAMRMC)\n\n\n\n\nFrom the Department of Homeland Security\n\nNational Biodefense Analysis and Countermeasures Center (NBACC)\n\n\n\nHistory and new additions\nSince the data quality course began in 2013\, it has quickly reached capacity each year. In its first five years\, 269 participants completed the course. \nIn September 2017\, the FDA Medical Countermeasures Initiative (MCMi) renewed the grant  to continue the data quality course for an additional five years\, from 2018-2022. UTMB and FDA will also expand on-demand online offerings\, adding data quality-related good clinical practices (GCP) training and other courses to meet the needs of researchers responding to emerging infectious disease outbreaks. \nCourse description\nThe week-long\, data quality course is designed to help researchers who conduct studies intended to support approval under the Animal Rule\, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible. \nThe course includes expert lectures and hands-on laboratory activities conducted in BSL-2 and BSL-4 training laboratories to emphasize the differences between biosafety levels\, and the complexity of conducting laboratory activities in a BSL-4 environment. An online training module on GLP regulations (21 CFR Part 58) is included as a course pre-requisite. For additional information\, visit the official UTMB course website \nTopics covered include: \n\nAnimal Rule regulations\, and clinical applications of Animal Rule studies\nAssay validation\nBSL-2/3/4 comparison\, with hands-on simulations\nBSL-4 equipment\, with hands-on work in a BSL-4 training lab\nDisease agent characterization\nGLP regulations\nGood documentation practices\nInstitutional Animal Care and Use Committee (IACUC) protocols\nTelemetry\nSupportive care\nSurrogate endpoints\nTesting facility management\nVeterinary pathology\nIntegration of quality assurance (QA) in BSL-4 studies\nAdvancement of MCMs on the international stage\n\nWho may attend?\nFDA welcomes participants from government\, industry\, and academia. We welcome international participation as well; attendees in previous years have included representatives from international public health agencies. Attendees typically include: \n\nPolicy-makers\nMCM product sponsors (industry)\nQuality assurance personnel\nRegulators\nReviewers\nScientists\nVeterinarians\n\nPre-requisites include GLP and IACUC training that are available to course attendees. \nCourse Cost and Availability\nThere are no registration fees for this FDA-sponsored course\, however\, seats are limited\, and course attendees are invited based upon diversity of roles\, responsibilities\, and organization. Interested participants will be placed on a waitlist once seats are filled. \nRELATED INFORMATION \n\nInformation about the course from UTMB\nSister course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens\nPrevious course offerings\nView photos from the 2015 course on Flickr
URL:https://globalbiodefense.com/event/bsl-4-training-achieving-data-quality-and-integrity-in-maximum-containment-laboratories/
LOCATION:National Institutes of Health (NIH)\, Bethesda\, MD\, United States
CATEGORIES:Training
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