BIOL 516 - Clinical Trials & Qual Assuran

Description

Hours: Three hours lecture per week Prerequisite: Admission to the Biotechnology & Bioinformatics, M.S. or the Biotechnology, M.S. & M.B.A. Dual Degree program Description: An introduction to the foundational knowledge and skills necessary to successfully conduct clinical trials for new drugs, biologics, and medical devices, including in vitro diagnostics. Topics include a broad overview of the product development process in the pharmaceutical, biopharmaceutical, and medical device industries, the regulatory and operational requirements for clinical study setup and management, monitoring, data management, and closure of clinical trials, the principles of Good Clinical Practice (GCP), and the applications of quality control and quality assurance. The integration of quality assurance throughout the medical product development process will be discussed.

Meeting Information

Status: Open
Class Number: 2711
Session: Extended Session 1
Units: 3.00
Class Components: Lecture
Career: Postbaccalaureate
Dates: 1/19/2019 - 5/18/2019
Grading: Letter Grade

Class Availability

Information below is 24 hours old.
Enrollment Total: 19
Available Seats: 11
Wait List Capacity: 0
Wait List Total: 0

Enrollment Information

• Graduate Division