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Adverse Event Terminology Maintenance

  • The terms in the Annexes of the final version of the guideline document are maintained by the AE Working Group (AE WG) as a pilot in accordance with the "Maintenance of IMDRF AE Terminologies" (IMDRF/AE WG/N44)FINAL:2017).
  • Proposal of addition/modification/deletion of the terms must be submitted to AE WG by either National Competent Authorities or Stakeholder Organizations, using the Change Request form. No proposal from an individual will be accepted.

Change Request form (IMDRF/AE WG/N44FINAL:2017 – Appendix A) - XLSX (12kb)