Certificate in Regulatory Affairs

In the certificate in regulatory affairs, students will explore the impact of regulatory and policy issues on domestic and international affairs in biotechnology, clinical trials and various aspects of a product’s life cycle, good laboratory and manufacturing practices, quality control and assurance, bioethics, and the business of global biotechnology.

Total Semester Hours: 18

Students must take the following courses:

  • UCSP 615 Orientation to Graduate Studies at UMUC (0) Must complete with first 6 credits of study.
  • BTMN 636 Biotechnology and the Regulatory Environment (3)
  • BTRA 640 Preclinical and Clinical Research Design (3)
  • BTRA 641 Product Life Cycle–Approval, Production, and Marketing for Devices and Drugs (3)
  • BTRA 642 Global Biotechnology Business Issues (3)
  • BTRA 643 Practical Applications of Biotech Regulatory Affairs (6)

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