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3 thoradh

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #641187

    IATE #2251252
    staidéar sábháilteachta iarúdaraithe Tagairt ---
    ga
    staidéar sábháilteacht iarúdarú
    ga
    Unbedenklichkeitsstudie nach der Zulassung
    de
    Sainmhíniú Studie zur Unbedenklichkeit zugelassener Arzneimittel, bei der es sich nicht um klinische Prüfungen handelt (insbesondere um sicherzustellen, dass sie nicht Werbezwecken dient), sowie zur Überwachung der Folgemaßnahmen hinsichtlich der aus solchen Studien hervorgehenden Sicherheitsdaten Tagairt "Vorschlag für eine Richtlinie zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz, CELEX:52008PC0665"
    Nóta Verfahren zur Änderung der genannten Richtlinie läuft (Stand: 31.8. 2010).
    post-authorisation safety study | PASS | post-marketing safety study
    en
    Sainmhíniú pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product Tagairt "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Nóta "A PASS may be a clinical trial or a non-interventional study.For more information, see: European Medicines Agency, Guideline on good pharmacovigilance practices (GVP). Module VIII – Post-authorisation safety studies. 2012 (15.3.2023)"
    étude de sécurité post-autorisation
    fr
    Sainmhíniú étude portant sur un médicament autorisé et visant à identifier, décrire ou quantifier un risque de sécurité, à confirmer le profil de sécurité du médicament ou à mesurer l’efficacité des mesures de gestion des risques Tagairt COM-Document interne: ENTR/2008/80076/02/02
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648542

    IATE #3542053
    staidéar sábháilteachta iar-údarúcháin neamh-idirghabhálach Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Comhthéacs 'Maidir le staidéir shábháilteachta iar-údarúcháin neamh-idirghabhálacha a bhaineann le táirgí íocshláinte lena n-úsáid ag an duine ar táirgí iad atá údaraithe i gcomhréir leis an Rialachán seo agus a chomhlíonann ceann de na ceanglais dá dtagraítear in Airteagal 10 agus in Airteagal 10a den Rialachán seo, beidh feidhm ag an nós imeachta dá bhforáiltear i mír 3 go mír 7 d’Airteagal 107m, in Airteagal 107n go hAirteagal 107p agus in Airteagal 107q (1) de Threoir 2001/83/CE.' Tagairt "Rialachán (AE) Uimh. 1235/2010 lena leasaítear, maidir le cógas-aireachas ar tháirgí íocshláinte lena n-úsáid ag an duine, Rialachán (CE) Uimh. 726/2004 lena leagtar síos nósanna imeachta Comhphobail maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus le haghaidh úsáide tréidliachta agus lena mbunaítear Gníomhaireacht Leigheasra Eorpach, agus Rialachán (CE) Uimh. 1394/2007 maidir le táirgí íocshláinte ardteiripe, CELEX:32010R1235/GA"
    nicht-interventionelle Unbedenklichkeitsstudie nach der Zulassung
    de
    non-interventional post-authorisation safety study | non-interventional PASS
    en
    Sainmhíniú safety studies of authorised products that are not clinical trials and that involve collection of data from patients and health care professionals, thus falling outside the scope of Directive 2001/20/EC (Clinical Trials Directive) Tagairt "COM-EN based on: Sabine Straus, Stella Blackburn. EC Implementing Measure The format of protocols, abstracts and final study reports for the non-interventional post- authorisation safety studies. European Medicines Agency http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/04/WC500105324.pdf [29.3.2012]& Proposal for a Directive of the European Parliament and of the Council amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use, CELEX:52008PC0665/EN & Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Text with EEA relevance, CELEX:32010L0084/EN"
    Nóta "See also: post-authorisation safety study [ IATE:2251252 ] and non-interventional trial [ IATE:1270043 ]. A post-authorisation safety study is non-interventional if the following requirements are cumulatively fulfilled:- the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation; - the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study; and- no additional diagnostic or monitoring procedures are applied to the patients and epidemiological methods are used for the analysis of collected data.Reference: 'Guideline on good pharmacovigilance practices (GVP): Module VIII – Post-authorisation safety studies'. European Medicines Agency; 2012, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02/WC500123204.pdf [20.4.2012]"
    étude de sécurité post-autorisation non interventionnelle
    fr
    Sainmhíniú étude de sécurité de médicaments autorisés qui ne sont pas des essais cliniques, dans le cadre de laquelle le ou les médicaments sont prescrits de la manière habituelle conformément aux conditions fixées dans l'autorisation de mise sur le marché Tagairt "TERM-FR, d'après notamment:Directive 2001/20/CE du Parlement européen et du Conseil du 4 avril 2001 concernant le rapprochement des dispositions législatives, réglementaires et administratives des États membres relatives à l'application de bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain, CELEX:32001L0020/FR & Proposition de directive du Parlement européen et du Conseil modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituantun code communautaire relatif aux médicaments à usage humain, CELEX:52008PC0665/FR"
  3. SOCIAL QUESTIONS|health|pharmaceutical industry|pharmaceutical product|vaccine

    #630221

    IATE #1528795
    éifeachtacht vacsaíne Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    éifeachtacht vacsaíne tar éis margaíochta Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    éifeachtacht vacsaíne tar éis a údaraithe Tagairt Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Impfeffektivität | Impfstoffeffektivität
    de
    Sainmhíniú die Gesamtauswirkungen des Einsatzes eines Impfstoffs Tagairt "Robert-Koch-Institut > Service > Publikationen > Fachwörterbuch Infektionsschutz und Infektions­epidemiologie. Fachwörter – Definitionen – Interpretationen (25.3.2021)"
    Nóta neben der direkten Impfstoffwirksamkeit können die indirekten Wirkungen der Impfung (wie die Reduktion der Inzidenz, Krankenhausbehandlungen, tödliche Ausgänge der Zielkrankheit) nach breiter Anwendung des Impfstoffs in einer Population unter Alltagsbedingungen in Studien ermittelt werden
    vaccine effectiveness | post-marketing vaccine effectiveness | post-authorisation effectiveness | post-authorisation efficacy
    en
    Sainmhíniú ability of a vaccine to protect against the disease for which it is administered Tagairt "COM-Terminology Coordination, based on:CDC. 'Vaccine Effectiveness: How Well Do the Flu Vaccines Work?' (18.5.2021)"
    Nóta "1) No vaccine is 100% effective. To make vaccines safer than the disease, the bacteria or virus is killed or weakened (attenuated). For reasons related to the individual, not all vaccinated persons develop immunity. Most routine childhood vaccines are effective for 85% to 95% of recipients.2) Before a vaccine is granted a market authorisation, vaccine efficacy is measured."
    efficacité réelle du vaccin
    fr
    Sainmhíniú efficacité d'un vaccin mesurée par l’observation de la protection que le vaccin apporte à des communautés dans leur ensemble Tagairt "Organisation mondiale de la santé > Centre des médias > Reportages > Détail > Efficacité potentielle, efficacité réelle et protection des vaccins (11.11.2021)"