Building on the CSR and CTD foundation of the Introductory level, this Advanced course develops the post-approval, labeling, promotional and ethical disciplines that complete a regulatory-writing practice.

This 32-hour Professional Certificate Course covers periodic safety reports (PSUR, PADER); plain-language patient labeling under 21 CFR Part 201 (Physician Labeling Rule, Patient Package Insert); advertising and promotion under the Office of Prescription Drug Promotion (OPDP) and 21 CFR Part 202; and ethics in regulatory communication (bias, data integrity, disclosure).

By the end, participants have produced a plain-language labeling section, a safety-report element and an integrated portfolio of regulatory writing samples.

The Advanced course connects safety reports, labeling, promotion and ethics into an integrated portfolio, preparing participants for medical-writing and regulatory-writing roles with document ownership.

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