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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:|
- Contribute to this entry
- Include in personal glossary
|English to Polish translations [PRO]|
|English term or phrase: International Conference on Harmonization E6 Good Clinical Practice guidelines|
|International Conference on Harmonization E6 Good Clinical Practice guidelines|
Selected response from:
Local time: 22:06
|Dziekuje bardzo, chodzilo mi wlasnie o to "E6",|
a nie mam czasu na Goooooooogling...
4 KudoZ points were awarded for this answer
21 mins confidence: 31 mins confidence:
a propos ICH
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.
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.
Wytyczne E6 można sobie ¶ci±gn±ć st±d:
Local time: 22:06
Native speaker of: Polish
PRO pts in pair: 1199
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