Building on the ethical-frameworks foundation of the Introductory level, this Advanced course develops the specific integrity, accountability and professional-code disciplines that arise in FDA-regulated work.

This 32-hour Professional Certificate Course covers the ethics of off-label promotion and advertising, data integrity and research conduct (FDA inspection obligations and the Application Integrity Policy), whistle-blower accountability and corporate responsibility (including the False Claims Act), and the professional codes of conduct (AdvaMed Code, PhRMA Code, RAPS Code of Ethics).

By the end, participants can draft their own professional code of conduct, argue position statements on conflict of interest, off-label promotion and data integrity, and sustain ethical decisions in day-to-day regulated work.

The Advanced course connects specific integrity and accountability challenges to the professional codes of conduct, preparing participants to lead with values across devices, pharma and combination products.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.