Fund. of Clin Trials Mgmt ( 2.00 credits )
|Exception dates & alternate classrooms:||Class will be held in 8290 Gibbon.|
This course introduces key principles and practical applications for the development of new pharmaceutical compounds. It will 1) introduce the student to the total clinical research process from the perspective of the current Good Laboratory Practices (GLP) and the current Good Clinical Practices (GCP), including specific global regulatory guidelines frame-working the development and approval of new pharmaceuticals; 2) focus on the responsibilities and effective interactions between the investigating research site and the various regulatory entities charged with ensuring the protection of the human research subject as well as the overall integrity of the clinical trial and the sponsor; 3) ensure that the student will be able to relate 'real world' experiences and techniques to regulatory requirements, necessary to effectively prepare for and conduct a variety of clinical trials from the perspective of the investigator and sponsor.