U.S. Healthcare Compliance Certificate Program
[email protected] | 973-642-8382 or 973-761-9000 ext. 8382
PROGRAM SCHEDULED for June 2-5, 2025 | In-Person
PROGRAM SCHEDULED for October 6-9, 2025 | In-Person/Hybrid
The Healthcare Compliance Certificate Program 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:
- Understand the role and ethical norms of the compliance professional in the life sciences
context
- Explain the ethical concerns that provide the backdrop for life science corporate
compliance policies
- 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
- Articulate the difference between the legal and compliance function
- 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
- Understand the framework to assess a potential compliance problem
- Identify interdisciplinary approaches to develop alternative means to accomplish business
goals
- 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
- Identify conflicts of interest, analyze whether they present harm to any constituency,
and weigh alternatives for managing conflicts of interest
- 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
- Understand the Physician Sunshine Act as well as the regulations and best practices
governing Open Payments reporting
- Identify the primary industry codes and their key components, and discuss how they
relate to a company’s compliance program
- Be aware of how a government investigation of a company proceeds, and the possible
outcomes
