Samples / OBX-319 / regulatory/m1/mfds/RMP-KR_risk_management_plan.md

Module 1 (KR) — Risk Management Plan (OBX-319)

Document ID: M1-KR-RMP
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): MFDS / ICH E2E

Korea (MFDS) Risk Management Plan — OBX-319

Korea-specific RMP for OBX-319: safety specification, pharmacovigilance plan, and risk-minimisation aligned to MFDS expectations and the EU RMP.