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医薬品・医療機器・再生医療等製品GCP・GPSPガイドブック 2020

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医薬品・医療機器・再生医療等製品GCP・GPSPガイドブック. 2020

Call No. (NDL)
SD61-M22
Bibliographic ID of National Diet Library
030543913
Material type
図書
Author
日本薬剤師研修センター 編
Publisher
薬事日報社
Publication date
2020.7
Material Format
Paper
Capacity, size, etc.
128p ; 26cm
NDC
499.4
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Detailed bibliographic record

Summary, etc.：

製薬企業のモニター・監査担当者等の開発関係者、医療機関における治験責任医師・分担医師およびCRC等に最適な一冊。(Provided by: 出版情報登録センター（JPRO）)

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Table of Contents

  • 本書の内容

  • 1　信頼性調査の最近の動向

  • 2　医療機器の適合性書面調査、GCP実地調査及び製造販売後調査の現状と留意点

  • 3　医薬品の適合性書面調査の現状と留意点

  • 4　医薬品のGCP実地調査の現状と留意点

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Paper

Material Type
図書
ISBN
978-4-8408-1519-2
Title
医薬品・医療機器・再生医療等製品GCP・GPSPガイドブック
Title Transcription
イヤクヒン ・ イリョウ キキ ・ サイセイ イリョウ トウ セイヒン GCP ・ GPSP ガイドブック
Volume
2020
Author/Editor
日本薬剤師研修センター 編
Author Heading
日本薬剤師研修センター ニホン ヤクザイシ ケンシュウ センター ( 00295044 )Authorities
Publication, Distribution, etc.
東京 : 薬事日報社
Publication Date
2020.7
Publication Date (W3CDTF)
2020