Workshop 6: Pharmacovigilance. Familiarity and use of medical coding
PATH & DCVMN
11:00 – 1:00 pm CET
1. Introduction to MedDRA coding procedure
2. Medical assessment of ICSR, including use of Brighton case definitions
Pre-readings:
· Basics of MedDRA®. Available at: https://www.meddra.org/basics
· MedDRA® Term Selection, Points to Consider. Available at: https://www.meddra.org/
· Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2) https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf
· CIOMS Working Group Report V 2001: Current Challenges in Pharmacovigilance: Pragmatic Approaches. Available at Current Challenges in Pharmacovigilance: Pragmatic Approaches – Report of CIOMS Working Group V – CIOMS
· Brighton Collaboration Brighton Collaboration – Home Page – Brighton Collaboration
· Guide for Case Definitions: available at Brighton Collaboration Publications – Google Tabellen
