Nonclinical Regulation of Biomedical Products

The Graduate Certificate in Nonclinical Biomedical Products provides students with an opportunity to understand, develop, and apply global compliance standards in 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.

In this program, students will have the opportunity to achieve the following learning outcomes:

• 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