How to Document Rationale for RBM Strategies
How to Document Rationale for RBM Strategies Documenting and Justifying Your RBM Strategy for Regulatory Success Introduction: Why Documenting RBM Strategy Matters Risk-Based Monitoring (RBM) is not simply about choosing a decentralized or hybrid monitoring model—it’s about proving that your approach is deliberate, data-driven, and defensible. Regulatory authorities such as the FDA and EMA expect…