The Healthcare Compliance Certificate Program, held twice yearly in Newark, New Jersey, is designed for newer to mid-level compliance professionals, attorneys new to the life sciences industry, compliance professionals who seek to expand their areas of competence, and other life science professionals, such as medical writers, CRO professionals, and third party vendors, whose work requires an understanding of the ethical norms and laws that comprise the foundation of compliance in the life science industry.

Program Learning Objectives. At the conclusion of the one-week immersion program, participants should be able to:

1. Understand the role and ethical norms of the compliance professional in the life sciences context
2. Explain the ethical concerns that provide the backdrop for life science corporate compliance policies
3. Discuss the relationship among ethical norms, corporate values, industry codes, law, and corporate compliance policies and procedures, and how values and rules interact to accomplish overall compliance
4. Articulate the difference between the legal and compliance function
5. Know the seven elements of an effective compliance program, and how OIG guidance and the Federal Sentencing Guidelines inform the creation of compliance programs, policies, and procedures
6. Understand the framework to assess a potential compliance problem
7. Identify interdisciplinary approaches to develop alternative means to accomplish business goals
8. Articulate a basic knowledge of the US review and approval processes for new drugs/new devices, as well as the laws and regulations that govern advertising and promotion
9. Identify conflicts of interest, analyze whether they present harm to any constituency, and weigh alternatives for managing conflicts of interest
10. Discuss the core elements of, and defenses to, the major laws that inform corporate compliance policies in the life sciences industry, with particular focus on fraud, waste, and abuse, including their relationship to off-label promotion
11. Understand the Physician Sunshine Act as well as the regulations and best practices governing Open Payments reporting
12. Identify the primary industry codes and their key components, and discuss how they relate to a company’s compliance program
13. Be aware of how a government investigation of a company proceeds, and the possible outcomes