Gaois

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7 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry

    #681973

    IATE #2251252
    staidéar sábháilteachta iarúdaraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'I gcás ina bhforchuireann an Coimisiún an oibleagáid chun staidéar sábháilteachta iarúdaraithe a dhéanamh ar níos mó ná sealbhóir údaraithe margaíochta amháin, i gcás ina mbaineann na hábhair imní chéanna le níos mó ná táirge íocshláinte amháin agus ina ndéanann na sealbhóirí údaraithe margaíochta lena mbaineann staidéar sábháilteachta iarúdaraithe comhpháirteach ...' Reference "Rialachán (AE) 2024/568 maidir le táillí agus muirir is iníoctha leis an nGníomhaireacht Leigheasra Eorpach, lena leasaítear Rialacháin (AE) 2017/745 agus (AE) 2022/123 ó Pharlaimint na hEorpa agus ón gComhairle agus lena n-aisghairtear Rialachán (AE) Uimh. 658/2014 ó Pharlaimint na hEorpa agus ón gComhairle agus Rialachán (CE) Uimh. 297/95 ón gComhairle, CELEX:32024R0568/GA"
    Unbedenklichkeitsstudie nach der Zulassung
    de
    Definition 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 Reference "Vorschlag für eine Richtlinie zur Änderung der Richtlinie 2001/83/EG zur Schaffung eines Gemeinschaftskodexes für Humanarzneimittel hinsichtlich der Pharmakovigilanz, CELEX:52008PC0665"
    Comment Verfahren zur Änderung der genannten Richtlinie läuft (Stand: 31.8. 2010).
    post-authorisation safety study | PASS | post-marketing safety study
    en
    Definition 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 Reference "Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    Comment "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
    Definition 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 Reference COM-Document interne: ENTR/2008/80076/02/02
  2. SOCIAL QUESTIONS|health|pharmaceutical industry

    #648542

    IATE #3542053
    staidéar sábháilteachta iar-údarúcháin neamh-idirghabhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '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.' Reference "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
    Definition 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) Reference "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"
    Comment "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
    Definition 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 Reference "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 Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    éifeachtacht vacsaíne tar éis margaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    éifeachtacht vacsaíne tar éis a údaraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Impfeffektivität | Impfstoffeffektivität
    de
    Definition die Gesamtauswirkungen des Einsatzes eines Impfstoffs Reference "Robert-Koch-Institut > Service > Publikationen > Fachwörterbuch Infektionsschutz und Infektions­epidemiologie. Fachwörter – Definitionen – Interpretationen (25.3.2021)"
    Comment 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
    Definition ability of a vaccine to protect against the disease for which it is administered Reference "COM-Terminology Coordination, based on:CDC. 'Vaccine Effectiveness: How Well Do the Flu Vaccines Work?' (18.5.2021)"
    Comment "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
    Definition efficacité d'un vaccin mesurée par l’observation de la protection que le vaccin apporte à des communautés dans leur ensemble Reference "Organisation mondiale de la santé > Centre des médias > Reportages > Détail > Efficacité potentielle, efficacité réelle et protection des vaccins (11.11.2021)"
  4. SOCIAL QUESTIONS|health|pharmaceutical industry

    #683141

    IATE #3544244
    staidéar éifeachtúlachta iar-údarúcháin Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Déanfar an oibleagáid go ndéanfaí an staidéar éifeachtúlachta iar-údarúcháin a bhunú ar na gníomhartha tarmligthe a ghlactar de bhun Airteagal 10b, agus an treoraíocht eolaíoch dá dtagraítear in Airteagal 108a de Threoir 2001/83/CE á cur san áireamh.' Reference "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"
    post-authorisation efficacy study | post-marketing efficacy study | post-authorisation efficacy studies
    en
    Definition study conducted after a product has been placed on the market when the understanding of the disease or the clinical methodology indicate that previous efficacy evaluations might have to be revised significantly Reference "COM-Terminology Coordination, based on: Directive 2001/83/EC on the Community code relating to medicinal products for human use"
    étude d'efficacité postautorisation | étude d'efficacité post-commercialisation | PAES | étude d'efficacité post-autorisation
    fr
    Definition étude effectuée après qu'un produit a été mis sur le marché lorsque la compréhension de la maladie ou la méthodologie clinique indique que les évaluations d'efficacité antérieures pourraient devoir être revues de manière significative Reference "Conseil-FR, d'après la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain"
  5. SOCIAL QUESTIONS|health|pharmaceutical industry

    #688183

    IATE #3639829
    staidéar iar-údarúcháin ar mheasúnú riosca comhshaoil Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    post-authorisation environmental risk assessment study
    en
    Definition evaluation of risks posed to human health and the environment, whether direct or indirect, if there are concerns about the risks to the environment or public health, including antimicrobial resistance, due to an authorised medicinal product in the European Union, or related active substance Reference "COM-Terminology Coordination, based on: Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC, COM(2023) 192"
  7. SOCIAL QUESTIONS|health|pharmaceutical industry

    #687799

    IATE #3638719
    staidéar iarmhargaíochta Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context '... an oibleagáid staidéir iarmhargaíochta a dhéanamh lena n‑áirítear staidéir sábháilteachta iarúdaraithe agus staidéir éifeachtúlachta iarúdaraithe, agus iad a chur isteach lena n‑athbhreithniú, dá bhforáiltear in Airteagal 20 ...' Reference "Togra le haghaidh Rialachán lena leagtar síos nósanna imeachta Aontais maidir le húdarú agus maoirseacht táirgí íocshláinte lena n-úsáid ag an duine agus lena mbunaítear rialacha lena rialaítear an Ghníomhaireacht Leigheasra Eorpach, lena leasaítear Rialachán (CE) Uimh. 1394/2007 agus Rialachán (AE) Uimh. 536/2014 agus lena n-aisghairtear Rialachán (CE) Uimh. 726/2004, Rialachán (CE) Uimh. 141/2000 agus Rialachán (CE) Uimh. 1901/2006, CELEX:52023PC0193/GA"
    staidéar iarúdaraithe Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Context 'Féadfar cur chun feidhme beart nó staidéar iarúdaraithe a bhreithniú ar bhonn cás ar chás chun aghaidh a thabhairt ar bhearnaí sna sonraí nó éiginnteachtaí tráth údaraithe an táirge.' Reference "Rialachán Tarmligthe (AE) 2021/805 lena leasaítear Iarscríbhinn II a ghabhann le Rialachán (AE) 2019/6 ó Pharlaimint na hEorpa agus ón gComhairle, CELEX:32021R0805/GA"
    post-authorisation study | post-marketing study
    en
    Definition "a post-authorisation efficacy study or a post-authorisation safety study or a post-marketing surveillance study or any other study requested after a medicinal product has been granted marketing authorisation" Reference "COM-Terminology Coordination, based on: - Regulation (EC) No 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency- Regulation (EC) No 1901/2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004- Implementing Regulation (EU) 2021/1281 laying down rules for the application of Regulation (EU) 2019/6 as regards good pharmacovigilance practice and on the format, content and summary of the pharmacovigilance system master file for veterinary medicinal products"