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Session 3
Session Chair(s)
Georgy Genov, MD
Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
European Medicines Agency, Netherlands
Session 3 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. Specific questions from the audience will be addressed as part of a panel discussion.
Speaker(s)
Overview of the MedDRA Data Retrieval and Presentation: Points to Consider document including Standardised MedDRA Queries (SMQs)
Judy Harrison, MD
United States
Chief Medical Officer
MedDRA for signal detection in EudraVigilance
Aniello Santoro
European Medicines Agency, Netherlands
MedDRA for signal detection by Health Canada
Heather Sutcliffe
Health Canada, Canada
Director, Marketed Health Products Safety & Effectiveness Information Bureau
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