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 […]
Medical Affairs Personnel
Continuing Medical Education Programs
This training clarifies the role of pharmaceutical companies in supporting independent CME programs. Topics include ACCME accreditation, permissible funding, and
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
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
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
Pharmacovigilance
This module explains U.S. pharmacovigilance systems, emphasizing adverse event (AE) reporting timelines, serious AE criteria, and FDA’s FAERS database. Participants
Medical Affairs and MSL interactions with HCPs
This module defines compliant scientific exchange vs. promotional activity for MSLs, covering unsolicited off-label requests, KOL engagement, and collaboration with