Anti-Kickback Statute (AKS)
This module details AKS prohibitions on remuneration to HCPs, safe harbors, and high-risk activities. Participants will review enforcement cases and […]
Compliance Teams
False Claims Act (FCA)
Provides an overview of the FCA, including false claim standards, whistleblower provisions, penalties, and its impact on the pharmaceutical industry.
STARK Law
Covers the Stark Law’s prohibitions on physician self-referrals for designated health services, exceptions, and penalties for non-compliance. Suggested For: Compliance
Dissemination of Materials
This training provides an overview of FDA regulations (21 CFR Part 99) governing the dissemination of information about unapproved/new uses
HIPAA Security Rule
This module outlines the HIPAA Security Rule’s standards for protecting electronic Protected Health Information (PHI). Participants will learn about administrative,
State Expansions of the Health Insurance Portability and Accountability Act (HIPAA)
This training covers state expansions of HIPAA, focusing on California’s CMIA and Texas’ TMRPA. It outlines requirements for communications, safeguards,
HITECH Act
This course provides an overview of the HITECH Act, its impact on HIPAA protections, and guidelines for compliance. Topics include
General Data Protection Regulation (GDPR)
This training explains GDPR requirements for handling personal data of EU individuals, including patient health records, clinical trial data, and
Prescription Drug Marketing Act (PDMA)
This training covers PDMA rules for drug sample distribution, including practitioner validation, inventory tracking, and FDA reporting for thefts/losses. Suggested
Pharmacovigilance
This module explains U.S. pharmacovigilance systems, emphasizing adverse event (AE) reporting timelines, serious AE criteria, and FDA’s FAERS database. Participants