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 (Media)
ICH M11 Clinical Protocol Template
Dr. Ron Fitzmartin, FDA-CBER
Presentation Files (Media)
Advancing Pre-Market Safety Analytics
Dr. Veronica Pei, FDA-CDER
Presentation Files (Media)
FDA-CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chrissie Cai, FDA-CTP; and Christine Connolly, CDISC
Presentation Files (Media)
Session 2: Second Plenary
Dr. Hideto Yokoi, Kagawa University Hospital
Opening Keynote Presentation
Dr. Wenjun Bao, CDISC Board of Directors, JMP Clinical
Presentation Files (Media)
Document
PMDA Presentation
Dr. Yuki Ando, PMDA
Presentation Files (Media)
CDISC Standards Update
Peter Van Reusel, CDISC
Presentation Files (Media)
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
Presentation Files (Media)
Document
Why is CDASH Needed to Map eCRF Data to SDTM?
Dr. Anna Tsutsui, Toho University
Presentation Files (Media)
Team Activity Progression of “Beginner’s Initiative Mock Clinical Trial ~ New Duck team~” in CJUG SDTM Subteam
Megumi Kitayama, Wakayama Medical University Hospital
Presentation Files (Media)
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
Presentation Files (Media)
Evening Networking Event
Session 5: Data Science
Naoto Awaji, Chugai
Update on CDISC Data Science Activities
Dr. Sam Hume, CDISC
Presentation Files (Media)
Integrated Process of aCRF with Dual Bookmarking and TOC for SDTM-MSG-V2.0
Xinran Luo, Everest Clinical Research
Presentation Files (Media)
Blockchain Technology for Clinical Data Sharing
Kentaro Arai, Novartis
Presentation Files (Media)
PHUSE/CDISC Collaboration
Yoshiko Kitagawa, ONO Pharmaceutical Co., Ltd.
Presentation Files (Media)
Session 6: Standards Implementation and Driving Automation
Daisuke Hisada, GlaxoSmithKline K.K.
Automating SDTM and ADaM Creation in Clinical Trials
Rie Ichihashi, Sanofi
Presentation Files (Media)
Populating DDF Study Definitions Repository from study protocol using AI
Kunihito Ebi, Fujitsu Limited
Presentation Files (Media)
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
Presentation Files (Media)
Using R to Generate Analysis Results Metadata (ARM)
Aik Hoe Seah, Cytel
Presentation Files (Media)
Unlocking the Potential: Exploring Overlooked FDA Guidance for CDISC Implementers
Angelo Tinazzi, Europe Coordinating Committee
Presentation Files (Media)
Document
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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