This course examines life science companies’ obligations under laws designed to detect and respond to bribery, fraud, waste and abuse. Topics covered include the Anti-Kickback Act, the False Claims Act, the Foreign Corrupt Practices Act and other international anti-bribery legislation, enforcement mechanisms, corporate compliance programs, and transparency and disclosure requirements.
Upon completion of this certificate program, you will be able to:
- Describe the primary legal, regulatory and ethical standards with which pharmaceutical and medical device companies must comply, particularly with respect to companies’ sales and marketing activities
- Analyze real-world situations raising compliance issues, in order to spot legal issues and formulate options
- Develop strategies for avoiding legal problems by designing policies and practices in light of legal requirements
- Use Internet-based research tools to find authoritative statements of the law and answers to legal questions
- Evaluate proposed changes in the law related to pharmaceutical and medical device compliance and assess their implications for the pharmaceutical and medical device industries
- Recognize situations in which professional legal advice is necessary and communicate effectively with legal counsel
The Compliance Issues in the Life Sciences program can be completed in just 8 weeks. Coursework must be completed in the sequence in which it is offered. You should plan to spend about 6-8 hours per week on online coursework, including reading assignments, research and writing projects, and online discussions.
Seton Hall Law's online graduate certificate programs are offered during our spring, summer and fall semesters. New course sessions begin five times per year.