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Certificate in Regulatory Compliance

Interim Program Director: Steve Giardina, Ph.D.;  (301) 696-3650 

This certificate program is designed to train scientists interested in developing regulatory expertise necessary for a career in regulatory affairs, pharmaceutical or healthcare industries. The eight courses in this program will provide the foundation needed to prepare for the Regulatory Affairs Certification examination sponsored by the Regulatory Affairs Professional Society.

Candidates must have a science background and be eligible for admission to the Graduate School. The courses to be completed for the certificate program are:

Regulatory Compliance Core Courses - 9 credits 

  • BMS 545 Product Development
  • BMS 546 Good Manufacturing Practice
  • BMS 548 Good Clinical Practice

Regulatory Compliance Electives - 6 credits (Two courses from below) 

  • BMS 513 Biostatistics in Regulatory Applications
  • BMS 544 Good Laboratory Practices
  • BMS 547 Development of Pharmaceuticals and Regulatory Environment
  • BMS 549 Regulation of Medical Devices
  • BMS 550 Food and Drug Law