UNMC’s Global Center for Health Security and the FDA-University of Texas Medical Branch Collaborative Education Program are hosting the FDA-sponsored “Achieving Data Quality and Integrity in Clinical Trials Involving High Consequence Pathogens” clinical course from Aug. 13-14.
There are no fees associated with course attendance, and the event is in-person with limited access to selected virtual sessions. Seating is limited.
This two-day interactive course presents a valuable opportunity for participants to enhance their understanding of the FDA’s Good Clinical Practice (GCP) regulations. It is designed to guide effective integration of these principles into the planning, execution, and oversight of clinical research focused on medical countermeasures for high-consequence pathogens.
Throughout the course, participants will engage in a blend of informative lectures, innovative learning platforms, and practical problem-based scenarios. This approach will prepare participants with tools to identify and address challenges related to GCP compliance ensuring data quality and integrity in biosafety level 4 clinical environments.
Participants will explore constructive strategies for implementing GCP principles in a variety of settings, including complex and resource-limited conditions, both domestically and internationally. This hands-on learning experience will provide attendees with applicable considerations and solutions that can be tailored to their worksites.
Course activities will take place at UNMC’s Training, Simulation and Quarantine Center inside the Davis Global Center. The Training, Simulation and Quarantine Center provides a six-bed, high-fidelity simulated biocontainment unit training center, emergency operations center, laboratory, multipurpose room for incident management and skills training. It is the only federally-funded, 20-bed National Quarantine Unit in the United States.
The target audience for this event includes physicians, scientists, principal investigators, physician assistants, nurse practitioners, nurses, pharmacists, clinical laboratorians, clinical research staff and students, students interested in clinical research, regulators, policy-makers, clinical monitors, regulatory reviewers, biosafety professionals, IRB professionals and sponsors.
This course is submitted for continuing education credits.
For more information, course learning objectives and registration, click here.