17th JBF Symposium
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Session Details

SymposiumSymposium : JSQA(DI)

[D2-A3]Issues and Solutions for Data Integrity in GLP: Exploring Best Practices through Discussions with PMDA, JSQA, and Bioanalysis Facilities

Thu. Mar 5, 2026 2:45 PM - 4:10 PM JST
Thu. Mar 5, 2026 5:45 AM - 7:10 AM UTC
Medium Hall(2nd Floor)
Chairman:Nozomu Koseki(Sunplanet Co.,Ltd.), Takeshi Okuzono(Sekisui Medical Co., Ltd.)
2:45 PM - 3:10 PM JST(5:45 AM - 6:10 AM UTC)

[D2-A3-01]The points which PMDA expects to the test facility

*Kenji Nakano1 (1. Pharmaceuticals and Medical Devices Agency)
Comment()
3:10 PM - 3:35 PM JST(6:10 AM - 6:35 AM UTC)

[D2-A3-02]Addressing OECD GLP Data Integrity Guidance
- Case Studies Using DI Risk Management -

*Tomoharu Shimokawa1,2 (1. Japan Society of Quality Assurance GLP Division, 2. Toray Research Center, Inc.)
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3:35 PM - 4:10 PM JST(6:35 AM - 7:10 AM UTC)

[D2-A3-03]Issues and Solutions for Data Integrity in GLP: Exploring Best Practices through Discussions with PMDA, JSQA, and Bioanalysis Facilities

*Nozomu Koseki1, *Takeshi Okuzono2 (1. Sunplanet Co., Ltd., 2. Sekisui Medical Co., Ltd.)
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