Master of Science in Quality Assurance and Regulatory Science
QARS 430-0
( Core Course ) Ethical and Legal Issues in Regulation and Quality
All regulatory affairs issues are also legal ones, and they are fraught with ethical questions. This course goes beyond reading FDA, Federal Trade Commission, and other rules merely as requirements and challenges students to engage with the complex legal and ethical ramifications of these regulations. Topics include advertising, promotion, and labeling; health and disease prevention claims; dietary supplements; biotechnology labeling issues; intellectual property; the Sarbanes-Oxley Act; conflicts of requirements among different countries and industries; consent and use of samples; criminal liability and enforcement issues. Case studies serve as the primary teaching materials. Prerequisite: none. This class may be taken as an elective for MCRRA.
