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日本代购-日米欧に対応した治験薬の製造と品質管理
  • ecompliance:10000030
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日本代购-講師 ナノキャリア株式会社 宮嶋 勝春(みやじま まさはる) 氏 総収録時間 293分 納品方法 セミナー映像・資料はDVDで納品いたします。 出版社 株式会社イーコンプレス 出版年月日 2020年6月9日 内容情報 1.はじめに   1.1 新薬開発の基本的なプロセスと治験薬の位置付け    1.2 薬機法上の治験薬とそれが意味するもの ‐治験と臨床試験‐   1.3 マイクロドーズ試験と治験薬   1.4 臨床薬理試験、探索的臨床試験、検証的臨床試験と治験薬   1.5 治験薬に求められる包装   1.6 治験薬に係る過去の話題 ‐Phase 1用治験薬はcGMPの対象外?‐ 2.治験薬と品質リスクマネジメント   2.1 リスクとは何か ‐リスク管理?危機管理?‐   2.2 治験薬に対する品質リスクマネジメント   2.3 医薬品のライフサイクルマネジメントにおける治験薬の位置付け 3.治験薬製造におけるポイント ‐その1:治験を開始するまでプロセス‐   3.1 日米欧規制当局が求める治験階までのプロセス   3.2 原料の入手と品質管理 ‐原材料の安定供給‐   3.3 治験薬の品質規格をどう設定するか 4.治験薬製造におけるポイント ‐その2:治験薬GMPを理解する‐   4.1  治験薬GMPのポイント ‐医薬品GMPと何が異なるか‐   4.2 開発段階で治験薬も変わっていく? ‐一貫性と同等性‐ 5.治験薬製造のポイント ‐その3:バリデーションかベリフィケーションか‐   5.1 治験薬GMP及びQ&A集に見る治験薬のプロセス管理の特徴   5.2 バリデーション/ベリフィケーションかの判断基準とは? 6.治験薬製造のポイント ‐その4:有効期間をどう設定するか?‐   6.1 治験薬に求められる有効期間とは? ‐再製造可、延長か‐   6.2 治験薬の有効期間をどう設定するか?   6.3 治験薬の輸送中の安定性をどう担保するか  7.治験薬製造のポイント ‐その5:委託製造への対応‐   7.1 委託製造先をどうやって決めるか?   7.2 技術移転のポイント ‐技術の移転から知識の移転へ‐   7.3 製造で問題が発生した時の対応 ‐トラブル事例を中心に‐ 8.バイオ医薬品の治験薬   8.1 カルタヘナ法とは何か   8.2 バイオ医薬品の品質管理と治験開始までのプロセス ‐経験を基に‐   8.3 バイオ医薬品の品質管理上のポイント ‐規制当局の視点‐ 9.まとめ 注意事項 納品後のキャンセルはお受けできませんので予めご了承ください。イーコンプレスVOD配信セミナー セミナー映像・資料はDVDで納品 自主学習・企業内でのグループ研修におすすめ 新人社員研修などに最適 地方や自宅(テレワーク)でも受講できる
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请求时间 : 2025-07-15 13:06:29
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加载类库 : 37
模板编译 : 重新编译
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[ 25-07-15 13:06:29 ] RunTime:0.000295s SQL = SELECT * FROM bio_agent WHERE ( `isViews` = 1 ) AND ( `domain` LIKE '%test.ripai.com' )
[ 25-07-15 13:06:29 ] RunTime:0.000193s SQL = SELECT * FROM bio_agent WHERE ( `domain` = 'www.jp-daigou.com' )
[ 25-07-15 13:06:29 ] RunTime:0.000246s SQL = select * from bio_siteparams where FIND_IN_SET('081',AgentID)
[ 25-07-15 13:06:29 ] RunTime:0.000299s SQL = SHOW COLUMNS FROM bio_point
[ 25-07-15 13:06:29 ] RunTime:0.000874s SQL = SHOW COLUMNS FROM bio_user
[ 25-07-15 13:06:29 ] RunTime:0.000702s SQL = SELECT * FROM bio_goods WHERE `isView` = 1 and gType<=3 ORDER BY created DESC LIMIT 15
[ 25-07-15 13:06:29 ] RunTime:0.000326s SQL = SHOW COLUMNS FROM bio_syscolumn
[ 25-07-15 13:06:29 ] RunTime:0.000234s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = 17 ) AND ( `column_open` = 1 ) ORDER BY column_order asc
[ 25-07-15 13:06:29 ] RunTime:0.000339s SQL = SELECT * FROM bio_syscolumn WHERE ( `column_leftid` = '19' ) AND ( `column_open` = 1 ) ORDER BY column_order asc
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错误记录 : 107条错误
[ 25-07-15 13:06:29 ] 注意:[8] A session had already been started - ignoring session_start() App.class.php 第 115 行.
[ 25-07-15 13:06:29 ] 注意:[8192] Assigning the return value of new by reference is deprecated apiExecuter.php 第 253 行.
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[ 25-07-15 13:06:29 ] 注意:[2048] Redefining already defined constructor for class Net_URL URL.php 第 122 行.
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[ 25-07-15 13:06:29 ] 注意:[8192] Assigning the return value of new by reference is deprecated Unserializer.php 第 693 行.
[ 25-07-15 13:06:29 ] 注意:[8192] Assigning the return value of new by reference is deprecated Unserializer.php 第 852 行.
[ 25-07-15 13:06:29 ] 注意:[2048] Redefining already defined constructor for class XML_Parser Parser.php 第 206 行.
[ 25-07-15 13:06:29 ] 注意:[8192] Assigning the return value of new by reference is deprecated Parser.php 第 576 行.
[ 25-07-15 13:06:29 ] 注意:[2048] Declaration of XML_Parser::raiseError() should be compatible with that of PEAR::raiseError() Parser.php 第 634 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: openid BaseAction.class.php 第 72 行.
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[ 25-07-15 13:06:29 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 179 行.
[ 25-07-15 13:06:29 ] 注意:[8192] Assigning the return value of new by reference is deprecated Client.php 第 228 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-07-15 13:06:29 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: isDebugMe forbidcates.php 第 108 行.
[ 25-07-15 13:06:29 ] 注意:[2] shuffle() expects parameter 1 to be array, boolean given BaseAction.class.php 第 418 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined property: RakutenApiExecuter::$ApiDataWorker RakutenApiExecuter.php 第 346 行.
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[ 25-07-15 13:06:29 ] 注意:[8] Undefined variable: options Unserializer.php 第 448 行.
[ 25-07-15 13:06:29 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 503 行.
[ 25-07-15 13:06:29 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context getApiData.php 第 509 行.
[ 25-07-15 13:06:29 ] 注意:[2048] Non-static method PEAR::isError() should not be called statically, assuming $this from incompatible context RakutenAction.class.php 第 595 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: isDebugMe RakutenAction.class.php 第 607 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: categoryPath RakutenCategoryGetter.class.php 第 55 行.
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[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: _imgserver YahooAction.class.php 第 1014 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: descpre RakutenAction.class.php 第 645 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined variable: agentId common_inc.php 第 3135 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined index: isDebugMe forbidcates.php 第 108 行.
[ 25-07-15 13:06:29 ] 注意:[8] Undefined variable: type_ BaseAction.class.php 第 649 行.
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[ 25-07-15 13:06:30 ] 注意:[8] Undefined offset: 0 ThinkTemplate.class.php 第 578 行.
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[ 25-07-15 13:06:30 ] 注意:[8] Undefined variable: meta_keyword 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 7 行.
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[ 25-07-15 13:06:30 ] 注意:[8] Undefined variable: shopcode 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 296 行.
[ 25-07-15 13:06:30 ] 注意:[8] Undefined index: minPrice 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 300 行.
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[ 25-07-15 13:06:30 ] 注意:[8] Undefined index: wrappingicon 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 520 行.
[ 25-07-15 13:06:30 ] 注意:[8] Undefined index: buynow 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 523 行.
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[ 25-07-15 13:06:30 ] 注意:[8] Undefined variable: urlpre 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
[ 25-07-15 13:06:30 ] 注意:[8] Undefined index: chkjp 7e3578d85670e1bc8aad2b48d2c6a90d.php 第 536 行.
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