False Claims Act (FCA)
Provides an overview of the FCA, including false claim standards, whistleblower provisions, penalties, and its impact on the pharmaceutical industry. […]
Regulatory Affairs
Dissemination of Materials
This training provides an overview of FDA regulations (21 CFR Part 99) governing the dissemination of information about unapproved/new uses
Prescription Drug Marketing Act (PDMA)
This training covers PDMA rules for drug sample distribution, including practitioner validation, inventory tracking, and FDA reporting for thefts/losses. Suggested
Pharmacovigilance
This module explains U.S. pharmacovigilance systems, emphasizing adverse event (AE) reporting timelines, serious AE criteria, and FDA’s FAERS database. Participants