Identify the primary legal, regulatory, and ethical standards with which pharmaceutical and medical device companies must comply
Articulate best practices in corporate compliance
Assess the risks of various business strategies and transactions from a fraud and abuse perspective
This course explores the value of fraud and abuse laws from a policy perspective. After careful analysis of this body of laws, students evaluate the variety of mechanisms the government uses to enforce the fraud and abuse laws and the implications of those mechanisms for individuals and companies. Topics covered include compliance fundamentals, the federal Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices Act and other international anti-bribery legislation, the Racketeer Influenced and Corrupt Organizations Act (RICO), and enforcement mechanisms. Online discussions and practical exercises allow students to apply newly-acquired knowledge to real-world situations. Students will complete the fraud and abuse class with a comprehensive understanding of life science companies’ obligations under laws designed to detect and respond to fraud, waste, and abuse.