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EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) est le réseau européen de traitement des données et le système de gestion pour la notification et l'évaluation des effets indésirables suspectés de médicaments qui ont été autorisés ou en cours d'étude dans des essais cliniques dans l'Espace économique européen (EEE). L'Agence européenne des médicaments (EMA) exploite le système au nom du réseau de réglementation des médicaments de l'Union européenne (UE). Le système européen EudraVigilance traite :
* Échange électronique de rapports de sécurité individuels (ICSR, sur la base des spécifications ICH E2B) :
* Module d'essais cliniques EudraVigilance (EVCTM) pour signaler les effets indésirables graves inattendus suspectés (SUSAR).
* Module de post-autorisation EudraVigilance (EVPM) pour les ICSR post-autorisation.
* Détection précoce des signaux d'innocuité possibles des médicaments commercialisés à usage humain.
* Surveillance et évaluation continues des problèmes de sécurité potentiels liés aux effets indésirables signalés.
* Processus de prise de décision, basé sur une connaissance plus large du profil des effets indésirables des médicaments. L'EMA publie les données d'EudraVigilance dans la base de données européenne pour les rapports sur les effets indésirables suspectés des médicaments. La politique d'accès à EudraVigilance régit le niveau d'accès des différents groupes de parties prenantes aux rapports sur les effets indésirables des médicaments.r les effets indésirables des médicaments.
, EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network. The European EudraVigilance system deals with the:
* Electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2B specifications):
* EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs).
* EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs.
* Early detection of possible safety signals from marketed drugs for human use.
* Continuous monitoring and evaluation of potential safety issues in relation to reported adverse reactions.
* Decision-making process, based on a broader knowledge of the adverse reaction profile of drugs. EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports. The EudraVigilance access policy governs the level of access different stakeholder groups have to adverse drug reactions reports.ps have to adverse drug reactions reports.
, EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) ist ein Informationsnetzwerk und Managementsystem, das als zentraler Dienst von der europäischen Arzneimittelagentur betrieben wird mit dem Ziel einer sicheren Arzneimittelanwendung im europäischen Wirtschaftsraum (EWR). Es dient der Verwaltung und Analyse von Meldungen über vermutete Nebenwirkungen von Arzneimitteln, die im EWR zugelassen sind oder in klinischen Studien geprüft werden. EudraVigilance dient insbesondere:
* der elektronischen Übermittlung von Berichten über Nebenwirkungen vor und nach der Zulassung eines Arzneimittels (auch von Verdachtsfällen) und deren systematischer Sammlung in einer gemeinsamen europäischen Datenbank
* der Bereitstellung dieser Informationen in unterschiedlichem Umfang für verschiedene Nutzergruppen (Behörden, Öffentlichkeit, Pharmazeutische Industrie)
* der Erkennung von Arzneimittelrisiken)
* der Erkennung von Arzneimittelrisiken
, EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) è un database dell'Agenzia europea per i medicinali, operativo da dicembre 2001, per raccogliere segnalazioni di sospette reazioni indesiderate a farmaci. Il sistema europeo EudraVigilance si occupa di:
* Scambio elettronico di rapporti sulla sicurezza dei casi individuali (ICSR, in base alle specifiche ICH E2B):
* EudraVigilance Clinical Trial Module (EVCTM) per la segnalazione di sospette reazioni avverse gravi e impreviste (SUSAR).
* EudraVigilance Post-Authorization Module (EVPM) per ICSR post-autorizzazione.
* Rilevamento precoce di possibili segnali di sicurezza da farmaci per uso umano commercializzati.
* Monitoraggio e valutazione continui di potenziali problemi di sicurezza in relazione alle reazioni avverse segnalate.
* Processo decisionale, basato su una più ampia conoscenza del profilo delle reazioni avverse dei farmaci. Tali segnalazioni sono usate per valutare i benefici e i rischi dei medicinali durante la fase di sviluppo degli stessi e per monitorarne la sicurezza dopo che sono stati autorizzati nello Spazio economico europeo. Nel dicembre 2015 il consiglio di amministrazione dell'agenzia ha revisionato l'accesso al sito, sulla base della legislazione sulla farmacovigilanza del 2010. Questo fornisce accesso alle segnalazioni dei sospetti effetti indesiderati alle parti interessate, come le autorità nazionali di regolamentazione dei medicinali del SEE, la Commissione europea, gli operatori sanitari, i pazienti e i consumatori, l'industria farmaceutica e le organizzazioni di ricerca.rmaceutica e le organizzazioni di ricerca.
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EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) est le réseau européen de traitement des données et le système de gestion pour la notification et l'évaluation des effets indésirables suspectés de médicaments qui ont été autorisés ou en cours d'étude dans des essais cliniques dans l'Espace économique européen (EEE). L'Agence européenne des médicaments (EMA) exploite le système au nom du réseau de réglementation des médicaments de l'Union européenne (UE). Le système européen EudraVigilance traite :e système européen EudraVigilance traite :
, EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) è un database dell'Agenzia europea per i medicinali, operativo da dicembre 2001, per raccogliere segnalazioni di sospette reazioni indesiderate a farmaci. Il sistema europeo EudraVigilance si occupa di: Tali segnalazioni sono usate per valutare i benefici e i rischi dei medicinali durante la fase di sviluppo degli stessi e per monitorarne la sicurezza dopo che sono stati autorizzati nello Spazio economico europeo.utorizzati nello Spazio economico europeo.
, EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network. The European EudraVigilance system deals with the: EMA publishes data from EudraVigilance in the European database for suspected adverse drug reaction reports.r suspected adverse drug reaction reports.
, EudraVigilance (European Union Drug Regula … EudraVigilance (European Union Drug Regulating Authorities Pharmacovigilance) ist ein Informationsnetzwerk und Managementsystem, das als zentraler Dienst von der europäischen Arzneimittelagentur betrieben wird mit dem Ziel einer sicheren Arzneimittelanwendung im europäischen Wirtschaftsraum (EWR). Es dient der Verwaltung und Analyse von Meldungen über vermutete Nebenwirkungen von Arzneimitteln, die im EWR zugelassen sind oder in klinischen Studien geprüft werden. EudraVigilance dient insbesondere:werden. EudraVigilance dient insbesondere:
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