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 […]
Compliance Officers
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
Life Cycle of a Drug
This module explains the drug development process, from discovery to post-market monitoring, including FDA involvement, industry structure, and key regulations
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
Risk Evaluation and Mitigation Strategy (REMS)
Explains the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program, including requirements for high-risk drugs, compliance, and post-market safety monitoring.
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
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
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
History of Pharmaceutical Regulations
Traces the evolution of U.S. pharmaceutical regulations, from the 1906 Pure Food and Drug Act to modern FDA frameworks. Suggested
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