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regulatory-reporting
Does Burna AI support E2B(R3) submissions?
Yes, through the postmarket pharmacovigilance module. E2B(R3) is the ICH electronic standard for individual case safety report (ICSR) submissions to regulators (FDA FAERS, EMA EudraVigilance, PMDA in Japan). The Burna AI postmarket module formats structured adverse event data into E2B(R3), generates MedWatch forms for US submissions and CIOMS reports for international submissions, and supports periodic safety reporting (DSURs for development phase, PSURs for postmarket).