An E2B(R3) toolkit for individual case safety reports,
now running inside the PV agent.
The Individual Case Safety Report is the atomic unit of pharmacovigilance: one patient, one drug, one reaction. Reports travel as E2B(R3) XML, an ICH standard specified across hundreds of pages of PDF, with EMA business rules on top. The tooling to read and validate them is mostly proprietary. Without it, an agent can talk about aggregate counts but cannot open the case file a user drops in.
A toolkit that parses and validates E2B(R3) messages. The reference engine is written in Zig and tested against a conformance corpus built from EMA material. The rules come straight from the ICH specifications, extracted with a purpose-built PDF parser. A TypeScript port was then proven against the Zig engine, used as an oracle: same input, same output, or the port is wrong. That port is integrated into the PV Safety Agent, which can now read deposited case files and reason on real reports.