Adverse Event Terminology

Working Group Chair(s)
Andrea Hanson
Health Products Regulatory Authority (HPRA), Ireland
European Union
Evan Jacobs
Food and Drug Administration (US FDA)
United States of America
Katie Burns (Maintenance Chair)
Therapeutic Goods Administration (TGA)
Australia
Membership
Regulators
Status
Current

The purpose of this working group is to:

  • establish IMDRF adverse event terminology including terms for medical device malfunction, evaluation result/conclusion, patient/user outcome, and part/component of a medical device
  • support the implementation and the use of the terminology through the provision of guidance documents and training materials
  • improve, harmonize and where necessary expand the terminology and systems being used to code information relating to medical device adverse events.

Do you want to find a code? Browse the terms now

Are you looking for guidance on adverse event terminology ? Browse here

Do you wish to submit a request to change the AET Terminology? See this page

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

Participants

Amanda Craig
Therapeutic Goods Administration (TGA)
Katie Burns
Therapeutic Goods Administration (TGA)

Maria Gloria Vicente
Brazilian Health Regulatory Agency (ANVISA)
Stela Candioto Melchior
Brazilian Health Regulatory Agency (ANVISA)

Leanne Moore
Health Canada
Richard McAteer
Health Canada
Taran Nagra
Health Canada

Lamiaa Attia
Egyptian Drug Authority (EDA)
Yomna Hamad
Egyptian Drug Authority (EDA)

Katherine Alexia Funes Calderon
Sanitary Regulation Superintendency (SRS)
Wendy Villalta
Sanitary Regulation Superintendency (SRS)

Andrea Hanson
Health Products Regulatory Authority (HPRA), Ireland
Jean-Francois Roche
European Commission
Kathrin Doerr
Federal Institute for Drugs and Medical Devices (BfArM-Germany)

Coco Nakamichi
Pharmaceuticals and Medical Devices Agency (PMDA)
Morikazu Seki
Pharmaceuticals and Medical Devices Agency (PMDA)

Lailing Liew
Health Sciences Authority (HSA)

Hyung-Beom Kim
Ministry of Food and Drug Safety (MFDS)
Hyunjin Kim
Ministry of Food and Drug Safety (MFDS)
Jiyeong Im
Ministry of Food and Drug Safety (MFDS)
Rosa Da-yeong Ryoo (Ms)
Ministry of Food and Drug Safety (MFDS)

Cyrill Reber
Swissmedic
Eva Brombacher
Swissmedic
Sandra Tanner
Swissmedic

Paras Shah
Medicines and Healthcare products Regulatory Agency (MHRA)

Deepa Peck
Food and Drug Administration (US FDA)
Evan Jacobs
Food and Drug Administration (US FDA)

Anita Sands
World Health Organization (WHO)
Leticia Josefina Megias Lastra
World Health Organization (WHO)