Expedited reporting | ICH Guidelines for Pharmacovigilance | MCQ | Pharmacovigilance Notes & Lecture for BPharm 8th Semester
STANDARDS FOR EXPEDITED REPORTING A. What Should be Reported? 1. Single Cases of Serious, Unexpected ADRs All adverse drug reactions (ADRs) that are both serious and unexpected are subject to expedited reporting. This applies to reports from spontaneous sources and […]