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DTSTART;VALUE=DATE:20220418
DTEND;VALUE=DATE:20220520
DTSTAMP:20220323T164348Z
CREATED:20220323T164348Z
LAST-MODIFIED:20220323T164348Z
UID:54551-1650240000-1653004799@globalbiodefense.com
SUMMARY:ICE\, ICE\, Data: Using NICEATM’s Integrated Chemical Environment to Support Chemical Evaluations
DESCRIPTION:Join us April 18-19 for a special training session featuring experts from the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). \nNICEATM’s Integrated Chemical Environment is a free online suite that houses curated toxicity and physicochemical property data\, integrated into a variety of tools to analyze and visualize chemical data. These tools provide data access adhering to FAIR principles: data that is Findable\, Accessible\, Interoperable\, and Reusable for chemical characterization\, PBPK\, IVIVE\, and more! \nAt this two-day event\, you will learn directly from NICEATM developers how to use the Integrated Chemical Environment and have the opportunity to have your questions answered in the Q&A session. For your convenience\, a printable agenda is available for download below. You will receive session materials through the Zoom Webinar platform ahead of the event. Recordings and other materials will be made available shortly after the sessions. Registration is free\, but required to attend.
URL:https://globalbiodefense.com/event/ice-ice-data-using-niceatms-integrated-chemical-environment-to-support-chemical-evaluations/
CATEGORIES:Conference,Training
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2022/03/NURA-ICE.jpg
LOCATION:https://us06web.zoom.us/webinar/register/WN_UK_LklHqT5iGGtBgCy_Cjg
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20200727
DTEND;VALUE=DATE:20200731
DTSTAMP:20191225T203815Z
CREATED:20191225T203815Z
LAST-MODIFIED:20191225T203815Z
UID:35853-1595808000-1596153599@globalbiodefense.com
SUMMARY:Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens
DESCRIPTION:The FDA and the University of Texas Medical Branch\, Galveston National Laboratory (UTMB) are sponsoring an annual training course 27-30 July 2020 on how to meet good laboratory practice (GLP) requirements in biosafety level (BSL)-4 facilities. \nThe event will be hosted at the National Ebola Training and Education Center in Omaha\, Nebraska. \nThis  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 nonclinical data quality and integrity in BSL-4 facilities. \nPurpose of course\nThe purpose of this unique educational course is to provide a learning environment that: \n\nPromotes collaboration\nProvides tools for conducting clinical studies\nEnhances mutual understanding of clinical\, scientific\, and regulatory complexities\, and\nPromotes the data quality and integrity derived from these regulated studies.\n\nA heightened awareness of the complexities and uniqueness of high- and maximum-containment environments for high-consequence pathogens is the first step in initiating a dialog to find solutions for the planning and execution of studies where data generated will be used to support a regulatory decision. The result is a better-prepared cohesive community of clinical\, scientific\, and regulatory experts mutually engaged in\, and committed to\, the development\, research\, and approval of medical countermeasures for high-consequence pathogens. \nProfessionals who have experience with high-consequence pathogen clinical trials are encouraged to register\, including: \n\nPhysicians\nScientists\nPrincipal investigators\nPhysician assistants\nNurses and nurse practitioners\nPharmacists\nClinical laboratorians\nClinical research staff and clinical monitors\nRegulators and regulatory reviewers\nPolicy-makers\nIRB professionals\nIndustry sponsors\n\nCourse objectives and curriculum\nObjectives\n\nFormulate solutions to regulatory\, operational\, and cultural challenges for the conduct of clinical trials of medical countermeasures for high-consequence pathogens\nIdentify and mitigate risks to data quality and integrity\nResolve complexities of performing clinical trials in biocontainment / barrier nursing environment under good clinical practices (GCPs)\nGain experience conducting clinical research tasks in a mock biocontainment environment while wearing high-level personal protective equipment (PPE)\n\nCourse curriculum\n\nAddressing cultural and language barriers\nEthical considerations for placebo-controlled studies\nRegulatory expectations\nStudy monitoring\nBarrier nursing challenges\nSample integrity\nProtocol development\nOperationalizing a protocol\nProtocol driven data collection vs. clinical data\nGood documentation practices\nReporting adverse events\nInternational issues\nStakeholder roles and responsibilities\n\nBenefits of attending\n\nAttend this free course and earn continuing education (CE) credits.\nLearn from world-renowned faculty members and subject matter experts.\nApply best practices for clinical trials during an outbreak involving high-consequence pathogens.\nRecognize and prevent potential risks to data quality and integrity.\nEnhance cultural awareness and diversity involving clinical trials in geographic locations where outbreaks caused by high-consequence pathogens are frequent.\n\nAttendees will also learn from integrated scenarios\, case studies based on real-life experiences\, and expert panels\, along with lectures from experts from FDA\, the National Institutes of Health\, the NETEC\, and clinical biocontainment units (BCUs). \nPlease visit the FDA website Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens for more information and UTMB’s Registration Page. \n 
URL:https://globalbiodefense.com/event/achieving-data-quality-and-integrity-in-clinical-trials-involving-high-consequence-pathogens/
LOCATION:National Ebola Training and Education Center (NETEC)\, Omaha\, NE\, United States
CATEGORIES:Training
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20200420
DTEND;VALUE=DATE:20200425
DTSTAMP:20200323T183614Z
CREATED:20191219T152600Z
LAST-MODIFIED:20200323T183614Z
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20200326T130000
DTEND;TZID=America/New_York:20200326T143000
DTSTAMP:20200324T160955Z
CREATED:20200324T160607Z
LAST-MODIFIED:20200324T160955Z
UID:42206-1585227600-1585233000@globalbiodefense.com
SUMMARY:APIC AIHA Webinar - Ventilation\, Surface Disinfection and PPE Considerations for the IP and IH
DESCRIPTION:Amidst the flood of information about the COVID-19 pandemic\, one of the greatest risks is missing key intelligence that can protect health and save lives. This town hall-style webinar\, co-hosted by AIHA and the Association for Professionals in Infection Control and Epidemiology (APIC)\, will address occupational health and safety professionals’\, industrial hygienists’ and infection preventionists’ questions about ventilation\, surface disinfection\, respirators\, construction issues\, occupational health and safety during the COVID-19 pandemic.\nFull webinar description. \nAre you a 2020 Full eLearning Subscriber? This webinar is included in your subscription.\nIf you are purchasing this registration for another person\, please contact the eLearning staff at 1-703-849-8888. \nREGISTRATION INFORMATION\nEach person interested in attending needs their own registration. If you are unable to participate live\, you will have access to the recording for 90 days\, and you’ll be notified via email once the recording is available in the Online Classroom.When registering\, please only register once. Once you checkout\, the system will prompt you to sign in with your AIHA credentials\, or to create a new account. Once you complete either process\, you will checkout\, verify your information\, and confirm your order. \nDue to an increased volume of registrations\, please allow an hour to receive the confirmation message. You may need to check your junk folder.
URL:https://globalbiodefense.com/event/apic-aiha-webinar-ventilation-surface-disinfection-and-ppe-considerations-for-the-ip-and-ih/
LOCATION:Webinar
CATEGORIES:Conference,Training,Webinar-Webcast
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Denver:20190924T080000
DTEND;TZID=America/Denver:20190925T170000
DTSTAMP:20190906T132235Z
CREATED:20190906T132235Z
LAST-MODIFIED:20190906T132235Z
UID:30250-1569312000-1569430800@globalbiodefense.com
SUMMARY:Medical Countermeasures Point of Distribution (POD)
DESCRIPTION:The National Center of Excellence At Texas A&M (TEEX) will be delivering their two day course on Point of Distribution (POD) Medical Countermeasures on Sept 24 and 25. \nThis a rare training opportunity as the course is being taught in Western Montana and being offered at no cost! \nClass size is limited\, register quickly!
URL:https://globalbiodefense.com/event/medical-countermeasures-point-of-distribution-pod/
LOCATION:Salish Kootenai College\, 58138 U.S. 93\, Pablo\, MT\, 59855\, United States
CATEGORIES:Conference,Training
ATTACH;FMTTYPE=image/jpeg:https://globalbiodefense.com/wp-content/uploads/2019/09/df7e419f5f73e5fb3e28da32e23bd8c1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20190128
DTEND;VALUE=DATE:20190202
DTSTAMP:20190125T021908Z
CREATED:20190125T021908Z
LAST-MODIFIED:20190125T021908Z
UID:21876-1548633600-1549065599@globalbiodefense.com
SUMMARY:BSL-3 Laboratory Training
DESCRIPTION:UC Irvine will host an integrated course for high containment laboratory safety practices 28 Jan – 1 Feb 2019 in Irvine\, CA. \nBSL-3 Laboratory Training is a five-day intensive training for laboratory staff\, managers\, biosafety professionals\, and individuals with direct or indirect involvement with work in high-containment. These courses are designed to prepare individuals for the basics of safely working in and around BSL-3 laboratories and includes a mixture of practical and classroom courses covering: \n\nReview of biosafety principles and levels\nRisk assessment and management\nWaste management\nLaboratory management\nSafety procedures\nEmergency management\nBiosafety cabinet practices and procedures\nSmall and large spill decontamination\nDonning and doffing PPE\nLaboratory operations and preventative maintenance\nData and material management\nInventory and records management\nBiosecurity\n\nContact course coordinator for more information: Tran Phan\, 949-824-9536\, bl3train@uci.edu
URL:https://globalbiodefense.com/event/bsl-3-laboratory-training/
LOCATION:UC Irvine BSL-3 Training Center\, 4600 Health Sciences Rd.\, Irvine\, CA\, 92697\, United States
CATEGORIES:Continuing Education,Training
ATTACH;FMTTYPE=image/png:https://globalbiodefense.com/wp-content/uploads/2019/01/bsl-3-uc-irvine-training.png
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