Achieving Data Quality & Integrity In Maximum Containment Laboratories

A FDA-UTMB Collaborative Education Program on Achieving Data Quality & Integrity In Maximum Containment Laboratories Non-Clinical Course will be held 15-19 April 2024 in Galveston, Texas and online.

The four and one-half day training program is offered annually utilizing expert faculty from the U.S. Food and Drug Administration, other government agencies, academia, and business and industry. In-person attendees participate in laboratory activities conducted in mock Biosafety Level (BSL) 2, 3, and 4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.

The Nonclinical Course includes expert faculty from AAALAC, BARDA, Battelle, CEPI, FDA, NIAID, NIH, MRI Global, Pfizer, Texas Biomedical Research Institute, UK Health Security Agency, USAMRIID, USDA, UTMB, Yale University School of Medicine and other institutions.

Highlighted topics include:

• Clinical Research at the Ebola Virus Disease Bedside
• Applying One Health Principles for Outbreak Response
• Regulatory Mechanisms to Facilitate Development/Approval/Licensure of Medical Countermeasures
• Life in a BSL-4 Suit
• Development, Characterization and Standardization of Bacterial and Viral Stocks
• Animal Models for COVID
• Animal Rule and Product Development
• Data Standards for Animal Rule Studies
• Operationalizing BSL-4 in the Field
• Pivotal Studies for NIAID Sponsored Animal Model Development
• Quality System Expectations for BARDA-sponsored studies
• Quality Assurance Auditing in BSL-4 laboratories
• Unforeseen Circumstances: Emergency Response in BSL-4 Laboratories
• Aerosol Systems – Aerobiology with High Containment
• The Role of the USDA National Bio and Agro-Defense Facility (NBAF)
• Public Health Emergencies and Data Quality: Your Data Can Save Lives
• Conducting Clinical Research in the Setting of an Outbreak: From HIV to Ebola to COVID-19
• Interactive Exercises in a Mock BSL-4 Training Laboratory
• BSL-4 Lab Tour

There are no fees associated with course attendance; however, seating for in-person attendance is limited and interested participants will be placed on a wait-list once seats are filled.

Please visit UTMB’s Achieving Data Quality & Integrity In Maximum Containment Laboratories course page for more information and to register to attend.