Mentioned in 2 AI use cases across 2 industries
AI helps check whether drug safety cases are complete and consistent, keeps a record of why decisions were made, and prepares reports in the right format for different regulators.
FDA used the safety-review workflow to decide whether Entresto's pediatric warning label needed changes, and the reviewed data did not show a new problem.
A setup workflow decides how a company will send safety data to EudraVigilance and gathers the technical details needed to activate that connection.