Systematic MedDRA Upgrade in Clinical and Post-marketing Safety Databases

Time

Tue, Jun 26 11:00AM
T 18

Title

Systematic MedDRA Upgrade in Clinical and Post-marketing Safety Databases

Abstract Summary

Over 4 years 10 MedDRA upgrades were performed in safety databases for MedDRA versions 6.0 through 14.1. The records in each upgrade ranged from approximately 1,000 to 50,000. Methods used include: 1) Impact analysis; 2) Medical review; 3) Improved code search; 4) Re-label/code terms; 5) Verify.

Poster Presenter

Susan Li
DrMed, PhD,
Manager, Drug Safety Systems,
Kai Research, Inc.
United States

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