[e-med] Signification des sigles anglophone ICH/GCP

["barennes.hubert" <barennes.hubert@wanadoo.fr>]

E-MED: Signification des sigles anglophone  ICH/GCP
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avez vous une idée de ce que signifie à propos des essais cliniques le sigle
anglophone : ICH/GCP

(Good clinical practice? et ICH???

merci
hubert

Docteur H.Barennes
Epidémiologiste, Pédiatre, MPH, Ph D
Mail : barennes.hubert@wanadoo.fr
1 impasse Larrodé 64200 Biarritz
tel: 0033559439082
port: 0613650883

*****************
Réponse ci-dessous : désolée, tout est en anglais...
Carinne Bruneton

ICH International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use

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.ich.org/

E6: GOOD CLINICAL PRACTICE
E6  http://www.ich.org/pdfICH/e6.pdf
GCP: Consolidated Guideline
Step 5
 The tripartite harmonised ICH guideline was finalised (Step 4) in May 1996.
This is a consolidated document setting out a tripartite standard for the
conduct of clinical trials, covering aspects of preparation, monitoring,
reporting and archiving of clinical trials and incorporating addenda on the
Essential Documents and on the Investigator?s Brochure which had been agreed
earlier through the ICH process.  Implementation (Step 5):
 EU: Adopted by CPMP, July 96, issued as CPMP/ICH/135/95/Step5, Explanatory
Note and Comments to the above, issued as CPMP/768/97 MHLW: Adopted March
97, PAB Notification No.430, MHLW Ordinance No.28
 FDA: Published in the Federal Register, Vol. 62, No. 90, May 9, 1997, pages
25691-25709


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