(WINTER 2010)

A required course in the Certificate Program in Clinical Trials: Medical Device and Drug Development, and an elective course in the Certificate Program in Medical Product Development.
Gain an understanding of the accepted good principles and practices applicable to the development and implementation of drugs and medical devices in a research environment. Enhance your knowledge of topics including: definition of GCPs; the affect of GCPs on the conduct of a clinical trial; applicable regulations from ICH, HHS, FDA, and the state; obligations of investigators, sponsors, monitors, SMOs, CROs, and IRBs in a research environment; and compliance and accountability during a clinical trial. Learn about the basic elements of the clinical data management process. Prerequisite: BIOSCI X450, Fundamentals of Clinical Trials, or equivalent experience. Provider approved by the California Board of Registered Nursing, Provider Number 00093, for 30 contact hours. See enrollment confirmation for login information.

Nancy A. Schwartz, M.B.A., RN, is a medical industry consultant for SearchLight Consulting. Her 12 years of experience in clinical research has been focused on specialized projects and programs dealing with regulatory and product liability issues. The therapeutic areas she has been involved with include cardiology, obstetrics/gynecology, and oncology. Schwartz has also consulted on all aspects of clinical coordination, monitoring, and managing clinical studies. She is a guest lecturer on these topics at the USC School of Pharmacy.