Blank Report TemplateEudraVigilance空白报表模板库.docVIP

IF STYLEREF Doc title (Agency) \* MERGEFORMAT Inclusion/exclusion criteria for the “Important Medical Events” list Error* STYLEREF Doc title (Agency) \* MERGEFORMAT Inclusion/exclusion criteria for the “Important Medical Events” list \* MERGEFORMAT Inclusion/exclusion criteria for the “Important Medical Events” list EMA/80437/2014 IF DOCPROPERTY DM_emea_doc_ref_id \* MERGEFORMAT Error* DOCPROPERTY DM_emea_doc_ref_id \* MERGEFORMAT \* MERGEFORMAT Page PAGE 5/ NUMPAGES 5 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8668 E-mail info@ema.europa.eu Website www.ema.europa.eu ? European Medicines Agency, DATE \@ yyyy \* MERGEFORMAT 2014. Reproduction is authorised provided the source is acknowledged. 05 March 2014 EMA/80437/2014 Inspections and Human Medicines Pharmacovigilance Division IF DOCPROPERTY DM_emea_doc_ref_id \* MERGEFORMAT Error* DOCPROPERTY DM_emea_doc_ref_id \* MERGEFORMAT \* MERGEFORMAT Inclusion/exclusion criteria for the “Important Medical Events” list Introduction The EudraVigilance Expert Working Group (EV-EWG) has co-ordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day to day pharmacovigilance activities of stakeholders in the EU. The IME list is intended for guidance purposes only. Inclusion/exclusion criteria for the IME list were developed during review of the current list for maintenance related to MedDRA Version 12.1. They have been updated to the current version of MedDRA. The criteria – and the proposed additions and deletions to the upversioned list – were based on the official ICH definition of seriousness and of an “important medical event” as noted below: A serious adverse event (experience) or reaction is any unto