Program Overview

Department of Clinical and Diagnostic Sciences

The Department of Clinical and Diagnostic Sciences offers a Biotechnology Regulatory Affairs Graduate Certificate program.

Program Overview

The Biotechnology Regulatory Affairs Graduate Certificate program curriculum is designed to prepare students to help ensure that their company's therapeutics, biologics, diagnostics, or medical device products progress successfully through the development, manufacturing, and marketing processes.

Curriculum

The program curriculum includes the following courses:

• BTR 605: Biotechnology Regulatory & Quality Systems (3 Hours)
  • This course covers U.S. and European Union regulatory affairs frameworks and practices governing the development, approval, manufacturing, and surveillance of pharmaceuticals and medical devices.
• BTR 615: Applications of Biological Processes in Drug Development (3 Hours)
  • This course provides an overview of biological processes and laboratory techniques for discovery, development, and evaluation of therapeutic drugs.
• BTR 620: Food and Drug Law (3 Hours)
  • This course covers administrative procedures followed by the FDA, including searches, seizure actions, injunctions, criminal prosecutions, and civil penalties authorized under the Food, Drug, and Cosmetic Act.
• BTR 640: Clinical Development of Drugs, Biologics, Diagnostics, and Medical Devices (3 Hours)
  • This course focuses on major concepts under which clinical trials are designed and run, including phases of clinical trial development and the role of the U.S. Food and Drug Administration.
• BTR 690: Clinical Trial Implementation (3 Hours)
  • This course covers activities involved in running a clinical trial from study initiation to study close-out.

Program Details

For the most up-to-date curriculum information, please refer to the Graduate Catalog.

Resources

Additional resources are available for students, including financial aid information and student resources.