PHPM 507 Interventional Infectious Disease Clinical Trials
Instructor(s): Peter O'Hanley, PhD, MD, MPHCourse Description This course provides insights into the fundamental principles of anti-infectives, irrespective of whether it is a vaccine, biologic, or drug. Furthermore, it provides a clear overview of the impact of epidemiology, health management, and patient behaviors that affect clinical development of anti-infectives. There is an emphasis on the rational planning, preparation, initiation, conduct, and close-out of clinical trials. Finally, it covers FDA and other major regulatory body regulations, ICH GCP guidelines, practical regulatory affairs procedures, and ethical considerations of conducting interventional infectious disease clinical trials.
Term Offered varies