Demystifying MedDRA: Understanding the Language of Adverse Event Reporting
Key Concepts and Terminology Explained
MedDRA(Medical Dictionary for Regulatory Activities) provides a standard and globally recognized terminology for describing adverse events and medical conditions. This standardization ensures that all stakeholders in the pharmaceutical and healthcare industries use a common language when reporting and analyzing safety data. The purpose of this article is to provide a comprehensive understanding of MedDRA and discuss its importance in pharmacovigilance and regulatory reporting. The high-level focus points in this article are:
Understanding MedDRA
MedDRA Structure and Organization
MedDRA Versioning and Updates
SMQs
Understanding MedDRA — What it is and what is its need?
Human Languages, by nature, are verbose and ambiguous. One word can have multiple meanings, can be used in different contexts, and can convey different intentions. This allows people to express themselves, adapt to different contexts…
