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International Conference on Harmonization E6 Good Clinical Practice guidelines

Polish translation: wytyczne Międzynarodowej Konferencji ds. Harmonizacji: E6 - Dobra Praktyka Kliniczna

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:International Conference on Harmonization E6 Good Clinical Practice guidelines
Polish translation:wytyczne Międzynarodowej Konferencji ds. Harmonizacji: E6 - Dobra Praktyka Kliniczna
Entered by: Hanna Burdon
Options:
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10:15 Nov 9, 2001
English to Polish translations [PRO]
Medical
English term or phrase: International Conference on Harmonization E6 Good Clinical Practice guidelines
International Conference on Harmonization E6 Good Clinical Practice guidelines
Natalie
Poland
Local time: 12:11
wytyczne E6 Międzynarodowej Konferencji ds. Harmonizacji: Dobra Praktyka Kliniczna
Explanation:
Good Clinical Practice = Dobra Praktyka Kliniczna
http://www.mzios.gov.pl/kom_odw_270901.html
albo bardziej opisowo:
Dobra Praktyka Prowadzenia Badań Klinicznych
http://www.gcppl.com.pl/badania.htm

ICH podzieliło swoje wytyczne na 4 grupy, każda ma swoj± literkę. Dokładniejszy opis:
http://www.ifpma.org/ich5.html
Ja bym zostawiła E6.
Selected response from:

Hanna Burdon
United Kingdom
Local time: 11:11
Grading comment
Dziekuje bardzo, chodzilo mi wlasnie o to "E6",
a nie mam czasu na Goooooooogling...
Natalia
4 KudoZ points were awarded for this answer

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Summary of answers provided
4a propos ICH
Hanna Burdon
4wytyczne E6 Międzynarodowej Konferencji ds. Harmonizacji: Dobra Praktyka Kliniczna
Hanna Burdon


Discussion entries: 2





  

Answers


21 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
wytyczne E6 Międzynarodowej Konferencji ds. Harmonizacji: Dobra Praktyka Kliniczna


Explanation:
Good Clinical Practice = Dobra Praktyka Kliniczna
http://www.mzios.gov.pl/kom_odw_270901.html
albo bardziej opisowo:
Dobra Praktyka Prowadzenia Badań Klinicznych
http://www.gcppl.com.pl/badania.htm

ICH podzieliło swoje wytyczne na 4 grupy, każda ma swoj± literkę. Dokładniejszy opis:
http://www.ifpma.org/ich5.html
Ja bym zostawiła E6.


    Reference: http://www.gcppl.com.pl/badania.htm
Hanna Burdon
United Kingdom
Local time: 11:11
Native speaker of: Polish
PRO pts in pair: 1199
Grading comment
Dziekuje bardzo, chodzilo mi wlasnie o to "E6",
a nie mam czasu na Goooooooogling...
Natalia
Login to enter a peer comment (or grade)

31 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
a propos ICH


Explanation:
Po namy¶le stwierdziłam, że moja odpowiedĽ jest nieco enigmatyczna. Oto więcej informacji nt. konferencji:

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. This Mission is embodied in the Terms of Reference of ICH.

http://www.ifpma.org/ich1.html


The ICH Topics are divided into four major categories and ICH Topic Codes are assigned according to these categories. The Guidelines deriving from the Topics are frequently referred to using the ICH Codes.

Q = "Quality" Topics, i.e., those relating to chemical and pharmaceutical Quality Assurance.
S = "Safety" Topics, i.e., those relating to in vitro and in vivo pre-clinical studies.
***E = "Efficacy" Topics, i.e., those relating to clinical studies in human subject. Example: E6 Good Clinical Practices.***
M = Multidisciplinary Topics, i.e., cross-cutting Topics which do not fit uniquely into one of the above categories.

http://www.ifpma.org/ich5.html

Wytyczne E6 można sobie ¶ci±gn±ć st±d:

http://www.ifpma.org/ich5e.html

HTH!


    Reference: http://www.ifpma.org/ich1.html
Hanna Burdon
United Kingdom
Local time: 11:11
Native speaker of: Polish
PRO pts in pair: 1199
Login to enter a peer comment (or grade)




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