Gaois

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2 results

  1. SOCIAL QUESTIONS|health|pharmaceutical industry
    frithghníomh díobhálach in aghaidh druga Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    frithghníomh díobhálach Reference Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    negative Auswirkung | adverse Reaktion | Nebenwirkung
    de
    adverse reaction | adverse drug reaction | adverse reactions | adverse drug reactions | ADR
    en
    Definition response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function Reference Directive 2001/83/EC on the Community code relating to medicinal products for human use CELEX:32001L0083/EN
    effet nocif | effet indésirable
    fr
    Definition une réaction nocive et non voulue à un médicament, se produisant aux posologies normalement utilisées chez l'homme pour la prophylaxie, le diagnostic ou le traitement d'une maladie ou pour la restauration, la correction ou la modification d'une fonction physiologique Reference Directive 2001/83/CE du Parlement européen et du Conseil du 6 novembre 2001 instituant un code communautaire relatif aux médicaments à usage humain CELEX:32001L0083/FR
    Comment Les termes "réaction indésirable" et "effet indésirable" ne sont pas synonymes: un produit exerce un "effet" qui se manifeste par une "réaction" chez le patient.
  2. PRODUCTION, TECHNOLOGY AND RESEARCH|research and intellectual property|research|scientific research · SOCIAL QUESTIONS|health|pharmaceutical industry
    scagthástáil a dhéanamh ar fhrithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta Reference Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA Faomhadh an téarma seo mar chuid de Thionscadal Lex
    ga
    Definition frithghníomhartha díobhálacha tromchúiseacha neamhthuartha amhrasta a shainaithint go córasach, ar frithghníomhartha iad lena gceanglaítear measúnú as a dtiocfaidh cinneadh maidir leis an ngá atá le fógra a thabhairt do na Ballstáit tuairiscithe agus do na Ballstáit lena mbaineann Reference Rialachán Cur Chun Feidhme (AE) 2022/20 lena leagtar síos rialacha maidir le cur i bhfeidhm Rialachán (AE) Uimh. 536/2014 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le bunú na rialacha agus na nósanna imeachta um chomhar idir na Ballstáit sa mheasúnú sábháilteachta ar thrialacha cliniciúla, CELEX:32022R0020/GA
    Überprüfung von mutmaßlichen unerwarteten schwerwiegenden Nebenwirkungen
    de
    Definition systematische Feststellung von mutmaßlichen unerwarteten schwerwiegenden Nebenwirkungen, die eine Bewertung und anschließende Entscheidung darüber erfordern, ob eine Unterrichtung der berichterstattenden Mitgliedstaaten sowie der betroffenen Mitgliedstaaten erforderlich ist Reference COM-internes Dokument: SANTE-2021-81060 (klinische Prüfungen)
    screening of suspected unexpected serious adverse reactions
    en
    Definition systematic identification of suspected unexpected serious adverse reactions that require an assessment leading to a decision on the need to notify the reporting Member States and Member States concerned Reference Commission Implementing Regulation (EU) 2022/20 laying down rules for the application of Regulation (EU) No 536/2014 as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials