The professional practice of nonclinical regulatory affairs involves understanding, developing, and applying global compliance standards to the biomedical product commercialization process in several cross-functional areas that are separate and distinct from direct clinical patient care. This includes, but is not limited to, design and preclinical development processes, including in vitro and in vivo animal testing, in silico testing, small-scale/large-scale manufacturing process development and validation, development and maintenance of supply chains, as well as product handling and distribution. The Graduate Certificate in Nonclinical Biomedical Product Regulation introduces students to the practice of understanding, developing, and effectively applying global nonclinical compliance standards to new healthcare technologies. Students in the certificate program have the opportunity to:
- Differentiate between the nonclinical vs. clinical aspects of the global biomedical product commercialization process from a regulatory compliance perspective
- Explain the compliance-associated requirements needed to successfully practice professional nonclinical work within the global biomedical products industry
- Describe the nonclinical regulatory standards utilized by the United States Food and Drug Administration (FDA) and other global regulatory agencies to evaluate the safety and efficacy of new and existing biomedical products employed by healthcare practitioners in various patient settings
- Apply fundamental global nonclinical regulations to the biomedical product commercialization process, including therapy design, manufacturing process development and validation, cybersecurity, and supply chain risk management
Students that successfully complete this certificate may apply their courses toward the Master of Science in Regulatory Affairs.
Complete all courses and requirements listed below unless otherwise indicated.
Required Courses
| Code | Title | Hours |
|---|---|---|
| RGA 6207 | Global Impact of Electronic Common Technical Document (eCTD) Submissions | 4 |
| RGA 6233 | Application of Quality System Regulation in Medical Device Design and Manufacturing | 4 |
| RGA 6405 | Nonclinical Regulations in Biomedical Product Commercialization | 4 |
| RGA 6420 | Global IVD Regulations and Submissions | 4 |
Program Credit/GPA Requirements
16 total quarter hours required
Minimum 3.000 GPA required