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European Medicines Agency

    https://www.ema.europa.eu/en/documents/other/meddra-important-medical-event-terms-list-version-250_en.xlsx
    PT Head crushing injury was added in V25.0 and meets the ICH definition of seriousness and of an “important medical event”: "A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: * results in death, * is life …

Inclusion/exclusion criteria for the “Important Medical …

    https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf
    always fulfil the definition of an IME. Certain categories of events that could be considered medically important but are not likely to be relevant in the context of …

EUDRAVIGILANCE IMPORTANT MEDICAL EVENT …

    https://eudravigilance.ema.europa.eu/human/docs/Explanatory_note_IME_list.pdf
    May 2007, the EudraVigilance Expert Working Group (EV-EWG) initiated the Idevelopment of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the …

Important Medical Events list – version 23.1 – Updates

    https://allaboutpharmacovigilance.org/important-medical-events-list-version-23-1-updates/
    Important Medical Events list - version 23.1 - Updates | Pharmacovigilance. The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development …

EudraVigilance - Pharmacovigilance in EEA

    https://eudravigilance.ema.europa.eu/human/textforIME.asp
    2000. 2000. 1999. 1999. General. EudraVigilance (EV) Pharmacovigilance. The EudraVigilance Expert Working Group (EV-EWG) has co-ordinated the development of …

Important medical event terms list (MedDRA version …

    https://www.alims.gov.rs/wp-content/uploads/2022/02/IME_list_version_241.pdf
    IME; Relevant forms of eye disorders such as retinopathies, glaucoma, keratitis, and cataracts. X 10086436 Anaemic retinopathy Eye disorders New term for v24.1. The term …

EMA Releases List of Medical Events for …

    https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/8/ema-releases-list-of-medical-events-for-pharmacovigilance-monitoring
    EMA also maintains a separate list of what it considers to be important medical events (IME) intended to assist with the classification of adverse events based …

Definitions and difference in PVG terms: Designated …

    https://www.linkedin.com/pulse/definitions-difference-pvg-terms-designated-medical-dr-aditi
    Important medical event (IME): • The EudraVigilance Expert Working Group has coordinated the development of an important medical event (IME) terms list …

MedDRA Important Medical Events (IME) in the EU

    https://admin.meddra.org/sites/default/files/page/documents_insert/mozzicato_ime_in_eu_june2010.pdf
    Initial Development of IME List (cont) • All terms. in three SOCs initially INCLUDED: – SOC . Congenital, familial and genetic disorders – SOC . Infections and infestations – …

PHARMACOVIGILANCE GLOSSARY Section 1 …

    https://www.emwa.org/media/2640/pv-sig-glossary-august-2017.pdf
    Designated medical event (DME) DMEs are serious and rare medical events that are often causally associated with drugs across multiple pharmacological/therapeutic classes. …



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