Aggregate Spend for States
Provides an overview of state-specific aggregate spend laws governing reporting and compliance for transfers of value to healthcare professionals. Covers […]
Marketing Personnel
State Consumer Privacy Laws
An overview of state consumer privacy laws, including GDPR-inspired regulations and health data acts like Washington’s My Health, My Data
The FDA’s Office of Prescription Drug Promotion (OPDP)
Learn about FDA regulations for prescription drug advertisements, including risk disclosure requirements, fair balance, and differences between broadcast and print
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
False Claims Act (FCA)
Provides an overview of the FCA, including false claim standards, whistleblower provisions, penalties, and its impact on the pharmaceutical industry.
Dissemination of Materials
This training provides an overview of FDA regulations (21 CFR Part 99) governing the dissemination of information about unapproved/new uses
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,
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
Patient Protection and Affordable Care Act Sections 6002 & 6004
Covers the Sunshine Act’s reporting requirements for payments to HCPs (Section 6002) and drug sample disclosures (Section 6004). Suggested For: