Medical Review – Basics

VigiServe Foundation is a registered Non-Profit in India (CIN U85300MH2020NPL339935) with a mission of Empowering Public Health by ensuring safe medicines and promoting a culture for reporting Adverse Drug Experiences and Side Effects.
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/
The role of medical reviewers and safety physicians in Pharmacovigilance