Which safety reports does pharmacovigilance require, from ICSRs to DSURs and PBRERs?

Pharmacovigilance runs on two kinds of report. Individual case safety reports (ICSRs) describe one patient's suspected adverse reaction and are submitted case by case, on expedited clocks for serious unexpected reactions. Aggregate reports review a product's safety data over a period: the DSUR (ICH E2F) during development and, after approval, the PBRER (ICH E2C(R2)), the format the EU uses for its PSUR. In the US the postmarketing periodic report is the PADER under 21 CFR 314.80, for which FDA can accept a PBRER under a waiver. Sponsors and marketing authorization holders write and submit them. Burna AI supplies what they are built from: each adverse event graded to CTCAE, coded to MedDRA and attributed per drug with WHO-UMC and Kramer, with the source line attached. The reports Burna AI generates are the FDA MedWatch 3500A, the IRB unanticipated problem report and the sponsor SAE report. A side-by-side of the periodic reports: burna.ai/blog/dsur-psur-pbrer-pader-compared.