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 course, 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 course 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.
New course sessions begin five times per year.