Federal Agencies
Introduces key federal agencies (FDA, DEA, OIG, FTC, CMS) and their roles in drug commercialization, enforcement, and compliance. Suggested For: […]
Compliance Officers
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
Continuing Medical Education Programs
This training clarifies the role of pharmaceutical companies in supporting independent CME programs. Topics include ACCME accreditation, permissible funding, and
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
Corporate Integrity Agreements (CIA)
Covers the purpose and structure of Corporate Integrity Agreements, including common elements, enforcement, and reporting. Ideal for compliance and legal
AdvaMed
This training provides a concise overview of the AdvaMed Code of Ethics, which governs ethical interactions between medical device/technology companies
HIPAA Privacy Rule
This module details HIPAA Privacy Rule requirements for protecting PHI, patient rights, and permitted disclosures. Safeguards and breach penalties are
Electronic Records and Electronic Signatures (21 CFR Part 11)
Explains FDA requirements for electronic records and signatures, focusing on validation, audit trails, access controls, and compliance practices for regulated
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