BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Global Biodefense - ECPv6.18.2//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Global Biodefense
X-ORIGINAL-URL:https://globalbiodefense.com
X-WR-CALDESC:Events for Global Biodefense
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Chicago
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20190310T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20191103T070000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20200308T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20201101T070000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0600
TZOFFSETTO:-0500
TZNAME:CDT
DTSTART:20210314T080000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0500
TZOFFSETTO:-0600
TZNAME:CST
DTSTART:20211107T070000
END:STANDARD
END:VTIMEZONE
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
END:VCALENDAR