Joint MHRA/MedDRA Information Day - MedDRA in the Pharmacovigilance Regulatory Process

This session will provide important insight into the use of MedDRA for signal detection and data analysis including an overview of the key aspects described in the ICH-endorsed “MedDRA Data Retrieval and Presentation: Points to Consider” document. Various approaches to data analysis such as the use of the MedDRA hierarchy and secondary System Organ Class (SOC) analyses will be presented. Standardised MedDRA Queries and their application in case identification and signal detection will be discussed. The presentations will provide both a regulatory and industry perspective on this topic.