UNIT 10: Medical Coding and Dictionaries
This unit explains how adverse events and medicinal products are standardized using globally accepted medical dictionaries to ensure consistency, accuracy, and regulatory compliance in Pharmacovigilance. It provides a clear understanding of MedDRA and WHO Drug Dictionary, their structures, coding principles, and real-world application in case processing.
Medical coding in pharmacovigilance is the process of translating verbatim reported medical information into standardized medical terminology using approved dictionaries. Coding ensures uniformity of data across cases, enables meaningful analysis, and supports regulatory reporting and signal detection.
Key Points
Standardizes safety data across reports.
Supports data analysis and signal detection.
Ensures regulatory consistency and compliance.
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