Regulatory Guidelines on RBM Monitoring Plans
Regulatory Guidelines on RBM Monitoring Plans Understanding Global Regulatory Expectations for RBM Monitoring Plans Introduction: Why Regulatory Clarity Matters in RBM Risk-Based Monitoring (RBM) is no longer a novel concept—it’s a regulatory expectation. Global authorities like the U.S. FDA, EMA, and ICH have incorporated RBM into Good Clinical Practice (GCP) frameworks, urging sponsors and CROs…