Results for eudravigilance translation from English to Maltese

eudravigilance
eudravigilance

eudravigilance development
Żvilupp tal-eudravigilance

eudravigilance clinical trial module
modulu eudravigilance tal-provi kliniċi

this statistical signal was also confirmed in eudravigilance, based on prr analysis.
is-sinjal statistiku kien ikkonfermat ukoll fil eudravigilance, ibbażat fuq analiżi tal-prr.

eudravigilance has to be regularly updated and easily and fully accessible by patients.
il-bażi tad-data tal-eudraviġilanza għandha tiġi aġġornata regolarment u l-pazjenti għandu jkollhom aċċess faċli u sħiħ għaliha.

marketing authorisation holders shall access those reports through the eudravigilance database.
id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq għandhom jaċċessaw dawn ir-rapporti permezz tad-database eudravigilance.

individual adverse reaction reports held on the eudravigilance database may be requested by the public.
ir-rapporti individwali dwar reazzjonijiet ħżiena miżmuma fuq id-database tal-eudraviġilanza jistgħu jintalbu mill-pubbliku.

direct reporting of suspected unexpected serious adverse reactions by the sponsor to the european database eudravigilance;
ir-rappurtar dirett dwar reazzjonijiet avversi serji mhux mistennija suspettati mill-isponser permezz tal-bażi ta' dejta ewropea eudravigilance;

the data held on the eudravigilance database shall be made publicly accessible in an aggregated format together with an explanation of how to interpret the data.
id-dejta miżmuma fuq id-database tal-eudraviġilanza għandha ssir aċċessibbli pubblikament f’format aggregat flimkien ma’ spjegazzjoni ta’ kif għandha tiġi interpretata d-dejta.

monitor the data in the eudravigilance database to determine whether there are new or changed risks or whether there are changes to the risk benefit balance.
is-sorveljanza tad-dejta fid-database eudravigilance biex ikun jista' jiġi ddeterminat jekk hemmx riskji ġodda jew li nbidlu jew jekk hemmx bidliet fil-bilanċ bejn il-benefiċċju u r-riskju.

during routine signal detection activities, a review of five case reports of high level term amyloidosis cases related to enfuvirtide was extracted from eudravigilance.
matul attivitajiet ta’ rutina ta’ skoperta ta’ sinjali, ħarġet analiżi ta’ rapporti ta’ ħames każijiet ta’ avvenimenti ta’ amilojdosi ta’ terminu ta’ livell għoli relatati ma’ enfuvirtide minn eudravigilance.

finally, the policies concerning public access to the data included in eudravigilance will be defined, taking into account the protection of individual and commercially confidential data.
fl- aħħar, għandha tiġi definita l- politika dwar l- aċċess pubbliku għad- data f' l- eudravigilance, waqt li jiġi kkunsidrat il- ħarsien ta 'data kunfidenzjali individwali u kummerċjali.

disseminate information on adverse reactions to medicines authorised in the eu by means of the eudravigilance database, which can be consulted on a permanent basis by all member states;
twassal l-informazzjoni dwar reazzjonijiet ħżiena għal prodotti mediċinali awtorizzati fl-ue permezz ta’ bażi ta’ data, l-eudravigilance, li l-istati membri għandhom aċċess kontinwu għaliha.

the agency expects that all national competent authorities will be reporting electronically to the eudravigilance system by the end of 2006, which is reflected in the forecast increase of electronic reports in the chart below.
l- aġenzija tistenna li l- awtoritajiet kompetenti nazzjonali kollha ser jibdew jirrapportaw elettronikament lis- sistema eudravigilance sat- tmiem ta 'l- 2006, li hija riflessa fiż- żjieda ta' rapporti elettroniċi mbassra fil- grafika li tinsab hawn taħt.

4.7 the extended eudravigilance medicinal product dictionary (xevmpd) is an extended version of the evmpd medicinal product dictionary, which was closed in july 2011.
4.7 l-extended eudravigilance medicinal product dictionary (xevmpd) hu verżjoni estiża tad-dizzjunarju tal-prodotti mediċinali evmpd adottat f'lulju 2011.

two to three new upgrade versions of the main eudravigilance application (7.1, 7.2, 7.3) will be released in the course of 2006.
matul l- 2006 għandhom jinħarġu bejn tnejn u tlett verżjonijiet ġodda li jaġġornaw l - applikazzjoni ewlenija ta 'l- eudravigilance (7. 1, 7. 2, 7. 3).

at the same time, five of the eu telematics systems — eudranet, eudravigilance, eudract, the database of authorised medicinal products in the eu, and the product-information- management application, pim, — will have to be operated, supported, maintained and further developed.
fl- istess ħin, ħamsa mis- sistemi telematiċi ta 'l- ue — eudranet, eudravigilance, eudract, il- bażi tad- data ta' prodotti mediċinali awtorizzati fl- ue, u l - applikazzjoni għall- ġestjoni ta 'informazzjoni dwar il- prodott, pim, — ser ikollhom jiġu mħaddma, sostnuti, mantnuti u żviluppati aktar.