Transcription of PIC/S GMP DATA INTEGRITY PQSに関する取り組み …
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PIC/S GMP DATA INTEGRITY PQSに関する取り組み …
PIC/S GMP DATA INTEGRITY PQS 2017 9 1 2017 9 5 1 44 2017 GMP GMP pmda Annex 1 WG INTEGRITY 4. 5. GMP pmda Annex 1 WG INTEGRITY 4. 5. 29 1 pmda pmda (2006 -2016 ) 50204060801001201401601802002006(H18)200 7(H19)2008(H20)2009(H21)2010(H22)2011(H2 3)2012(H24)2013(H25)2014(H26)2015(H27)20 16(H28)DomesticChinaIndiaAsia othersAfricaSouth AmericaNorth AmericaEurope(1%)(6%)(21%)(24%)(26%)(43% )(35%)
2 1.PMDAのGMP調査状況 2.PIC/S加盟当局としてのPMDAの活動 Annex1改訂WG データの完全性WG 3.DataIntegrityに関する指摘事項例
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