REGULATORY PRACTICE AND COMPLIANCE

Prerequisites & course information

Requisites: ABT 700 , 705 , and 710 Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Describe and contrast the FDA, ICH, EMA, and Japanese PMDA Audience: Graduate 2. Justify the importance of regulatory affairs in biotechnology Audience: Graduate 3. Develop a meeting and communication strategy for interacting with the FDA and submitting appropriate documentation Audience: Graduate 4. Analyze the regulations that impact drug and biologics development, medical devices and diagnostics, agricultural biotechnology, and industrial biotechnology Audience: Graduate 5. Analyze and compare nonclinical and clinical testing and the regulations that govern the use of animals and humans in research Audience: Graduate 6. Describe genome editing and regulatory considerations that impact its applications in agriculture and humans Audience: Graduate Learning Outcomes: 1. Describe and contrast the FDA, ICH, EMA, and Japanese PMDA Audience: Graduate 2. Justify the importance of regulatory affairs in biotechnology Audience: Graduate 3. Develop a meeting and communication strategy for interacting with the FDA and submitting appropriate documentation Audience: Graduate 4. Analyze the regulations that impact drug and biologics development, medical devices and diagnostics, agricultural biotechnology, and industrial biotechnology Audience: Graduate 5. Analyze and compare nonclinical and clinical testing and the regulations that govern the use of animals and humans in research Audience: Graduate 6. Describe genome editing and regulatory considerations that impact its applications in agriculture and humans Audience: Graduate