Adverse Event Terminology
Work items
Finalisation of the Guidance Document on “Consideration for the selection of IMDRF Adverse Event Terminology (AET) codes and terms”
Development of training material to support the introduction of the Guidance Document on “Consideration for the selection of IMDRF Adverse Event Terminology codes and terms"
Finalisation of the updated Annual Maintenance Standard Operating Procedure (SOP)
Review of the N43 Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes and N44 Maintenance of IMDRF AE Terminologies