Medical Review - Basics

Four Minimum Criteria:

Identifiable Patient

Identifiable Reporter

Suspected Drug

Adverse Event

Learn about the difference between an Adverse Event and an Adverse Drug Reaction

Adverse Events can be Serious!

Important Medical Event List: https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview

The Important Medical Event (IME) and the Designated Medical Event (DME) in Pharmacovigilance.

Useful links:

EMA Webpage for accessing the IME List:

https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance/eudravigilance-system-overview

Send Queries on the IME List:

https://www.ema.europa.eu/en/about-us/contact/send-question-european-medicines-agency

Inclusion / Exclusion Criteria: https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf

IME List:

https://www.ema.europa.eu/documents/other/meddra-important-medical-event-terms-list-version-250_en.xlsx

DME List: https://www.ema.europa.eu/en/documents/other/designated-medical-event-dme-list_en.xlsx

Relatedness assessment - To evaluate the relationship between the suspect drug and the adverse event.

Link to WHO-AEFI Causality Assessment: https://www.who.int/publications/i/item/9789241516990

Link to WHO-UMC Causality:https://www.who.int/publications/m/item/WHO-causality-assessment

Medical Coding - MedDRA, VeDDRA, WHO DD, Snomed CT, CTCAE

Relevant Links:

CTCAE: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm

SNOMED CT: https://browser.ihtsdotools.org/

VeDDRA: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/combined-veterinary-dictionary-drug-regulatory-activities-veddra-list-clinical-terms-reporting_en.pdf

MedDRA: https://www.meddra.org/

Medical review in Argus

The role of medical reviewers and safety physicians in Pharmacovigilance