INTRODUCTION TO REGULATORY PRACTICE
Identifies and examines the key regulatory agencies and practices that govern the highly regulated and diverse pharmaceutical industry. Highlights current and emerging FDA and ICH regulations and guidance documents to successfully navigate meeting with the agencies and to submit required documentation for successful product development.
Prerequisites & course information
Requisites: Declared in MS Pharmaceutical Sciences or Capstone Certificate in Applied Drug Development Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Describe the laws and regulations associated with drugs, biologics, and medical devices in the United States. Audience: Graduate 2. Justify the importance of regulatory affairs in Life Sciences. 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, dietary supplements, medical devices, and diagnostics. Audience: Graduate 5. Analyze and compare nonclinical and clinical product development. Audience: Graduate Learning Outcomes: 1. Describe the laws and regulations associated with drugs, biologics, and medical devices in the United States. Audience: Graduate 2. Justify the importance of regulatory affairs in Life Sciences. 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, dietary supplements, medical devices, and diagnostics. Audience: Graduate 5. Analyze and compare nonclinical and clinical product development. Audience: Graduate
Sources
- Course catalogue ↗2026-2027