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1–7/7
good clinical practice inspection
1 Pravna redakcija
DRUGO
on the Mutual Recognition of Good Clinical Practice and Inspections Relating thereto
o vzajemnem priznavanju dobre klinične prakse in z njo povezanih inšpekcij
2 Pravna redakcija
DRUGO
Joint Declaration on the mutual recognition of good clinical practice and inspections relating thereto,
Skupna izjava o vzajemnem priznavanju dobre klinične prakse in z njo povezanih inšpekcij,
3 Pravna redakcija
finance
CELEX: 32003L0063
(9) Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice laid down in Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances(4) and 88/320/EEC on the inspection and verification of good laboratory practice (GLP)(5).
(9) Neklinične (farmokološko-toksikološke) študije se izvajajo v skladu z določbami o dobri laboratorijski praksi iz Direktive Sveta 87/18/EGS o uskladitvi predpisov in administrativnih določb o uporabi načel dobre laboratorijske prakse in preverjanju uporabe načel za preskuse kemičnih snovi fn, ter 88/320/EGS o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) fn.
4 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
and (f) a reference to the inspections carried out on conformity with good clinical practice.
in (f) navedbo pregledov o skladnosti z dobro klinično prakso.
5 Prevajalska redakcija
RS
EMEA
An inspection of some of the study sites showed that the study had not been conducted in compliance with ‘ good clinical practice’ (GCP).
Pregled nekaterih točk študije je namreč razkril, da študija ni bila izvedena v skladu z dobro klinično prakso.
6 Prevajalska redakcija
izobraževanje
CELEX: 32001L0020
The verification of compliance with the standards of good clinical practice and the need to subject data, information and documents to inspection in order to confirm that they have been properly generated, recorded and reported are essential in order to justify the involvement of human subjects in clinical trials.
Preverjanje skladnosti s standardi dobre klinične prakse in potreba, da se podatki, informacije in dokumenti pregledajo, da bi se potrdilo, da so bili pravilno pripravljeni, zapisani in da so o njih pravilno poročali, sta bistvena za to, da se upraviči vključevanje ljudi v klinično preskušanje.
7 Prevajalska redakcija
izobraževanje
CELEX: 32003L0063
Non-clinical (pharmaco-toxicological) studies shall be carried out in conformity with the provisions related to Good Laboratory Practice laid down in Council Directives 87/18/EEC on the harmonisation of regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests in chemical substances(4) and 88/320/EEC on the inspection and verification of good laboratory practice (GLP)(5).
Neklinične (farmokološko-toksikološke) študije se izvajajo v skladu z določbami o dobri laboratorijski praksi iz Direktive Sveta 87/18/EGS o uskladitvi predpisov in administrativnih določb o uporabi načel dobre laboratorijske prakse in preverjanju uporabe načel za preskuse kemičnih snovi [6], ter 88/320/EGS o inšpekcijskih pregledih in preverjanju dobre laboratorijske prakse (DLP) [7].
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good clinical practice inspection