Program Overview

Introduction to the Nonclinical Course

The Nonclinical Course is a four and one-half day training program offered annually, utilizing expert faculty from the U.S. Food and Drug Administration, other government agencies, academia, and business and industry. The course focuses on achieving data quality and integrity in maximum containment laboratories.

Course Description

The course description highlights the importance of conducting high-quality studies in high/maximum containment laboratories. 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.

Target Audience

The target audience for the course includes:

• Scientists
• Principal Investigators
• Veterinarians
• Veterinary Pathologists
• Study Sponsors
• Contracting Officers
• Quality Assurance Personnel
• Biosafety Professionals
• Physicians
• Research Nurses
• Graduate Students
• Regulators
• Agency Reviewers
• Policymakers

Course Topics and Schedule

The 2026 course topics are to be announced, with the course schedule spanning from April 20-24, 2026. The course organizers are finalizing the agenda, but a tentative schedule is available for reference.

Course Faculty

The Nonclinical Course includes expert faculty from various institutions, including AAALAC, BARDA, Battelle, CEPI, Commonwealth Scientific and Industrial Research Organization (CSIRO - Australia), FDA, NIAID, NIH, Texas Biomedical Research Institute, UK Health Security Agency, USAMRIID, USDA, UTMB, University of Georgia, and other institutions.

Prerequisite Knowledge

A basic understanding of the FDA Good Laboratory Practice regulations (21 CFR Part 58) is highly recommended. To meet this need, access to two free online courses will be provided to course attendees: GLP Basic Training and GLP Refresher Training.

Course Certification, Learning Objectives, and Learning Outcomes

The course offers a certificate of completion for attendees who participate in the full course. The learning objectives include determining requirements for high-quality studies, identifying criteria for evaluating Medical Countermeasures (MCMs), resolving complexities of performing studies under the Animal Rule, and leveraging One Health initiatives. The learning outcomes focus on applying strategies for assessing data quality and integrity, principles of good documentation practices, and strategies for communicating One Health initiatives.

Course Location and Logistics

The course will take place at the University of Texas Medical Branch in Galveston, Texas. Course organizers utilize the Whova event management software for hosting the course. Additional logistics information, including parking and hotel details, will be provided to registered attendees.

Frequently Asked Questions

A comprehensive list of frequently asked questions is available, covering topics such as course registration, attendance, certification, and logistics.

Past Courses

The course has been held annually since 2013, with previous locations including the National Bio and Agro-Defense Facility, the University of Texas Medical Branch, and the National Institutes of Health.

Testimonials

Previous course participants have praised the course, highlighting the excellent presentations, engaging speakers, and valuable hands-on experience.

2026 Highlighted Speakers

Exciting new changes to the speaker lineup are to be announced, with updates available on the course website.

Other Scientific Symposiums

Information on other scientific symposiums will be announced in the future.