검색어: harmoniseringskonference (덴마크어 - 영어)

31 international harmoniseringskonference............................................................................................
operation of the committee on orphan medicinal products............... 31 applications for orphan designation............................................................... ..32

international harmoniseringskonference (ich)
international conference on harmonisation (ich)

international harmoniseringskonference om veterinærlægemidler
it was decided to wait for the outcome of the community review of eu pharmaceutical legislation before making any recommendations to the european commission on changes to the structure of the fee system.

det paneuropæiske kontrolforum international harmoniseringskonference
1.3

emea/ mb/ 050/ 00 Årsberetning 2000 international harmoniseringskonference
international conference on harmonisation

det paneuropæiske kontrolforum international harmoniseringskonference international harmoniseringskonference om veterinærlægemidler
progress was also made in the vich process, with a number of guidelines released for consultation in 2001.

det paneuropæiske kontrolforum international harmoniseringskonference international harmoniseringskonference om veterinærlægem.
commission and to ensure that the structures of the emea involving the national competent authorities of the eu are able to meet the future challenges of science and the associated countries (bulgaria, cyprus, czech republic, enlargement of the european union.

international harmoniseringskonference international harmoniseringskonference om veterinærlægemidler verdenssundhedsorganisationen europa- kommissionens generaldirektorat for forskning
structure of the current fee system to take into account the impact of the revision of the european pharmaceutical legislation

Øsu anbefaler, at de omtalte procedurer og definitioner bringes i overensstemmelse med den internationale harmoniseringskonference.
the committee recommends that procedures and definitions be made consistent with the ich text.

det paneuropæiske kontrolforum international harmoniseringskonference international harmoniseringskonference om veterinærlægemidler emea' s websted vedrørende elektronisk indsendelse
pan-european regulatory forum international conference on harmonisation veterinary international conference on harmonisation emea electronic submissions web site

harmoniseringen af tekniske krav til udvikling af lægemidler bør derfor foregå inden for de egnede fora, herunder den internationale harmoniseringskonference.
the harmonisation of technical requirements for the development of medicinal products should therefore be pursued through the appropriate fora, in particular the international conference on harmonisation.

i sidstnævnte definition skal der tages højde for risikoen for sammenblanding med definitionen fra den internationale harmoniseringskonference (ich).
its definition should take account of the risk of confusion with the international conference on harmonisation (ich) definition.

udvalget, der støtter forslaget, op fordrer kommissionen til at foretage en terminologisk tilpasning til den internationale harmoniseringskonference af de tekniske krav i forbindelse med registrering af lægemidler til human brug.
7/8-1993, point 1.2.5 proposal subject to the codecision procedure since 1 november 1993 economic and social committee opinion: oj c 195, 18.7.1994; bull.

god klinisk praksis er blevet internationalt harmoniseret i form af retningslinjer, som er vedtaget under den internationale harmoniseringskonference, som har repræsentanter fra den europæiske union, usa og japan.
good clinical practice has been the subject of international harmonisation, in the form of guidelines adopted by the international harmonisation conference involving representatives of the european union, the united states and japan.

der havde hun bl. a. ansvaret for at koordinere de europæiske procedurers forskriftsmæssige aspekter og aktiviteterne i forbindelse med den internationale harmoniseringskonference (ich) .
her responsibilities there included coordination of regulatory aspects of european procedures and international conference on harmonisation (ich) activities.

det elektroniske ctd-format blev godkendt i 2002 på den internationale trepartsbaserede (eu, japan og usa) harmoniseringskonference (ich) .
the electronic ctd format was approved in 2002 through the trilateral eu-japan-us international conference on harmonisation (ich) .

det er desuden vigtigt, at direktivet tilpasses retningslinjerne for den internationale harmoniseringskonference, for kliniske afprøvninger, der foretages i europa, må ikke være underlagt strengere krav end de, der foretages andre steder i verden.
another important aspect is that the directive approximates good clinical practice rules with the guidelines laid down by the international conference on harmonisation, because clinical trials conducted in europe must not be subject to stricter requirements than those carried out in the rest of the world.

agenturets deltagelse i eu's team i den internationale harmoniseringskonference for henholdsvis human -og veterinærmedicinske lægemidler (ich og vich) fortsætter i 2001-2002.
in the pre-authorisation field:to continue the quality assurance exercise through continuous monitoring of the centralised marketing authorisation procedure by means of the emea-european federation of pharmaceutical industries and associations (efpia) survey.

emea vil fortsat støtte initiativer i forbindelse med de to internationale harmoniseringskonferencer for human - og veterinærmedicinske lægemidler (ich og vich).
the emea will continue to support initiatives under the two international conferences for harmonisation for human and for veterinary medicines (ich and vich).