2023 Japan Interchange Presentation Archive
Session 1: Opening Plenary
Akira Soma, J3C Chair, Oracle
Welcome Address: CDISC Strategy and the Future
Dave Evans, CDISC President and CEO
Presentation Files
ICH M11 Clinical Protocol Template
Dr. Ron Fitzmartin, FDA-CBER
Presentation Files
Advancing Pre-Market Safety Analytics
Dr. Veronica Pei, FDA-CDER
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FDA-CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chrissie Cai, FDA-CTP; and Christine Connolly, CDISC
Session 2: Second Plenary
Dr. Hideto Yokoi, Kagawa University Hospital
Opening Keynote Presentation
Dr. Wenjun Bao, CDISC Board of Directors, JMP Clinical
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PMDA Presentation
Dr. Yuki Ando, PMDA
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CDISC Standards Update
Peter Van Reusel, CDISC
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Session 3: Academic Research
Yoshiteru Chiba, University Hospital Medical Information Network
SDTM Modeling in Investigator-Initiated Clinical Trials for Solid Tumors: A Case Study by CJUG-SDTM
Matsuo Yamamoto, National Hospital Organization Nagoya Medical Center
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Why is CDASH Needed to Map eCRF Data to SDTM?
Dr. Anna Tsutsui, Toho University
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Team Activity Progression of “Beginner’s Initiative Mock Clinical Trial ~ New Duck team~” in CJUG SDTM Subteam
Megumi Kitayama, Wakayama Medical University Hospital
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Session 4: Real World Data & Regulatory Presentations/Perspectives
Hidetoshi Misawa, Pfizer
Lessons Learned from Sharing Clinical Trial Data Using Vivli
Azusa Tsukida, Vivli
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CDISC RWD Activities Update
Rhonda Facile, CDISC
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PMDA and RWD
Dr. Daisuke Iwata, PMDA
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Data Submission and Evidence Generation in Europe - an EMA Update
Dr. Marcia Rueckbeil, EMA
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Evening Networking Event
Session 5: Data Science
Naoto Awaji, Chugai
Update on CDISC Data Science Activities
Dr. Sam Hume, CDISC
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Integrated Process of aCRF with Dual Bookmarking and TOC for SDTM-MSG-V2.0
Xinran Luo, Everest Clinical Research
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Blockchain Technology for Clinical Data Sharing
Kentaro Arai, Novartis
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PHUSE/CDISC Collaboration
Yoshiko Kitagawa, ONO Pharmaceutical Co., Ltd.
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Session 6: Standards Implementation and Driving Automation
Daisuke Hisada, GlaxoSmithKline K.K.
Automating SDTM and ADaM Creation in Clinical Trials
Rie Ichihashi, Sanofi
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Populating DDF Study Definitions Repository from study protocol using AI
Kunihito Ebi, Fujitsu Limited
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The Development of CDISC Biomedical Concepts: Update and Next Steps
Bess LeRoy and Jon Neville, CDISC
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Session 7: Global Regulatory Submissions
Takako Nozaki, Gilead Sciences
Our Guide On Creating A Successful BIMO Data Package
Arvind Sri Krishna Mani, Zifo Scientific Informatics
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Using R to Generate Analysis Results Metadata (ARM)
Aik Hoe Seah, Cytel
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Unlocking the Potential: Exploring Overlooked FDA Guidance for CDISC Implementers
Angelo Tinazzi, Europe Coordinating Committee
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Session 8: Closing Plenary
Akira Soma, Oracle
Closing Keynote Presentation: Health Datalink for 15 Years with Standards
Dr. Michio Kimura, Kawasaki Medical University, Dept. of Medical Informatics
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Closing Panel
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Closing Remarks
Akira Soma, Oracle
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