PSII-B-21 - Development of an Industry Relevant Graduate Certificate for Regulatory Affairs in Animal Health

Seven years of data collection and industry collaboration identified a longstanding need from the animal health corridor for educational offerings focused on regulatory affairs for animal health products. The animal health corridor, anchored by Manhattan, Kansas and Columbia, Missouri, is home to more than 300 animal health companies, representing the largest concentration in the world. When surveying industry needs, Kansas State University received 446 responses from individuals in this area and found 40% indicated interest in “policy and regulations,” with 64% of interested respondents showing strong interest with programming at the graduate level. Meetings with industry representatives further confirmed results of the survey by highlighting a need for educational programming focused on animal health product license requirements with USDA, FDA, and EPA. At a roundtable with 22 Animal Health organizations, 64% of attendees had strong interest in a program focused on “regulatory aspects of drug and vaccine development in animal health.” In response to these findings, a graduate certificate was launched in 2019 encompassing regulatory development and management of animal health products. Curriculum was crafted in close collaboration with an industry advisory panel, because comparable academic models were not available. Interests to maintain industry contacts within the courses have led to integration of notable engagement techniques as the course format moves toward asynchronous delivery. Curriculum encompasses regulatory development of animal pharmaceuticals, pesticides, biologics, and diagnostics from pre- to post- licensure. The presentation will explain objectives of the certificate, data gathered regarding industry need, process of certificate design and curriculum co-creation with industry partners, and resulting curriculum. Additionally, since the new courses in the regulatory affairs certificate have been offered since spring 2020, the presentation will examine strategies for working with subject matter experts in the online classroom, plans for assessment of student learning, and educational background of enrolled students.