Diploma in #Pharmacovigilance #MedDRA Causality & Reporting - #ICSR Processing & Regulatory Timeline

Diploma in #Pharmacovigilance #MedDRA Causality & Reporting - #ICSR Processing & Regulatory Timeline
This lecture details the systematic management of Individual Case Safety Reports (ICSRs) within the field of pharmacovigilance. It defines an ICSR as a standardized report of an adverse event linked to a specific patient and medication, which must meet four validity criteria to be processed. The core of the document outlines a nine-step workflow, ranging from initial case receipt and duplicate checking to data entry, medical review, and final submission. Key technical components are highlighted, such as the use of MedDRA for standardized coding and the strict regulatory timelines required for reporting serious reactions. Ultimately, the source serves as a comprehensive guide for ensuring drug safety through rigorous data collection and assessment.

Видео Diploma in #Pharmacovigilance #MedDRA Causality & Reporting - #ICSR Processing & Regulatory Timeline канала London HeartbeatsZ Academy