翻訳と辞書 Words near each other ・ Good Friday (album) ・ Good Friday (song) ・ Good Friday Agreement ・ Good Cities ・ Good Citizen (album) ・ Good citizenship ・ Good Clean Family Entertainment You Can Trust ・ Good Clean Fun ・ Good Clean Fun (band) ・ Good Clean Fun (production company) ・ Good Clean Fun (The Allman Brothers Band song) ・ Good Clean Fun (The Monkees song) ・ Good clinical data management practice ・ Good Clinical Laboratory Practice ・ Good clinical practice ・ Good Clinical Practice Directive ・ Good Company ・ Good Company (production company) ・ Good Company (song) ・ Good Company (TV series) ・ Good conduct loop ・ Good Conduct Medal ・ Good Conduct Medal (Ireland) ・ Good Conduct Medal (United States) ・ Good Conduct stripe ・ Good conduct time ・ Good Cop ・ Good cop bad cop (disambiguation) ・ Good Cop Bad Dog ・ Good Cop, Bad Cop (NCIS) Dictionary Lists mini英和辞書 mini和英辞書 Webster 1913 Latin-English FOLDOC Wikipedia English ウィキペディア

翻訳と辞書　辞書検索 [ 開発暫定版 ] スポンサード リンク Good Clinical Practice Directive ： ウィキペディア英語版 Good Clinical Practice Directive The Good Clinical Practice Directive (Directive 2005/28/EC of 8 April 2005 of the European Parliament and of the Council) lays down principles and detailed guidelines for good clinical practice as regards conducting clinical trials of medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. The directive deals with the following items: *Good clinical practice for the design, conduct, recording and reporting of clinical trials: * *Good Clinical Practice (GCP) * *The Ethics Committee * *The sponsors *Investigator's Brochure *Manufacturing or import authorisation * *Exemption for Hospital & Health Centres and Reconstitution * *Conditions of Holding a Manufacturing Licence *The trial master file and archiving * *Format of Trial Master File * *Retention of Essential and Medical Records *Inspectors *Inspection procedures *Final provisions ==References== * Text of the directive: (Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products ) * (National implementing measures of the EU-countries ) 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Good Clinical Practice Directive」の詳細全文を読む スポンサード リンク 翻訳と辞書 : 翻訳のためのインターネットリソース Copyright(C) kotoba.ne.jp 1997-2016. All Rights Reserved.