Federal Agencies
Introduces key federal agencies (FDA, DEA, OIG, FTC, CMS) and their roles in drug commercialization, enforcement, and compliance. Suggested For: […]
Marketing Personnel
FCC Laws and the Junk Fax Rules
This module outlines JFPA restrictions on unsolicited fax ads, opt-out requirements, and EBR exceptions. State-specific rules and penalties are also
Package Inserts and Boxed Warnings
Focuses on FDA labeling requirements, including package inserts, boxed warnings, and medication guides. Reviews real-world FDA warning letters and their
HIPAA Privacy Rule
This module details HIPAA Privacy Rule requirements for protecting PHI, patient rights, and permitted disclosures. Safeguards and breach penalties are
PhRMA Code
Explores the PhRMA Code on Interactions with Healthcare Professionals, covering ethical guidelines for gifts, consulting agreements, speaker programs, and CME
Speaker Programs
This training outlines compliant speaker program practices under the Anti-Kickback Statute and PhRMA Code. Topics include speaker selection, fair market
Regulatory Foundations & Drug Lifecycle
This group introduces the structure of pharmaceutical regulation in the U.S., covering the lifecycle of a drug and the roles
Foreign Corrupt Practices Act (FCPA)
This module covers the FCPA’s anti-bribery provisions, focusing on interactions with foreign officials and healthcare professionals (HCPs). Participants will learn
FDA’s Marketing and Labeling Laws
This training covers FDA regulations for drug/device promotion, including labeling requirements, advertising rules and social media compliance. Suggested For: Compliance
The CAN-SPAM Act
This training explains CAN-SPAM rules for commercial emails, including opt-out requirements, sender identification, and penalties. Suggested For: Compliance Officers Field