This one day course is designed to provide an overview of the features of MedDRA that relate to the analysis and retrieval of MedDRA-encoded data. The course focuses on the use of MedDRA to retrieve and present aggregated data, based on the principles outlined in the “ MedDRA Data Retrieval and Presentation: Points to Consider ” document. A few real-life examples and hands-on query development exercises are included. The course also includes a thorough overview of Standardised MedDRA Queries (SMQs) and their application in the investigation of drug safety issues. Participants learn about the development, testing and maintenance of SMQs and see detailed examples of individual SMQs. Examples of practical applications of SMQs for case identification and safety signal detection are presented.

This course is beneficial to anyone who works with and interprets MedDRA-encoded data, especially from the point of view of case review and retrieval.

MedDRA Overview

“MedDRA Data Retrieval and Presentation: Points to Consider” document

Developing Queries using MedDRA

Examples and Hands-on Exercises

Background of SMQ Development

SMQ Data Characteristics

SMQs Development Status

SMQ Testing and Production Maintenance

SMQ Versioning

SMQ Applications

Customized Searches

Query Exercises: Comparison vs . SMQs