2024 Japan Interchange Presentation Archive
Session 1: Opening Plenary and Keynote Presentation
Akira Soma, J3C Chair, Oracle
CDISC Strategy: Rebuilding our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President and CEO
Presentation Files
Document
Opening Keynote Presentation
Dr. Shusaku Tsumoto, Professor of Medical Informatics, Shimane University; President, Japanese Society of Artificial Intelligence (JSAI)
Presentation Files
Document
Session 2: Second Plenary- Updates from CDISC
Hidemi Hasegawa, Boehringer Ingelheim
CDISC Roadmap: Focus on the First Steps to Realize the Long-Term Vision
Chris Decker, CDISC President and CEO
Presentation Files
Document
Digital Health Technologies (DHTs): A Path to Data Standardization
Christine Connolly, CDISC
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CDISC Technical Landscape
Anthony Chow, CDISC
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Session 3: CDISC Implementation and Use Cases
Akari Kamitani, Shionogi & Co., Ltd.
Examination of 42 Cases of Blunders in CDISC/SDTM in Physician-led/Industry-led Clinical Trials: Insights from the Field
Shizuko Takahara, University of Fukui Hospital
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Document
Challenge in utilizing CDISC standards for integrating individual participants’ data from cohort studies in Japan: the EPOCH-JAPAN Study
Dr. Anna Tsutsui and Dr. Yoshitaka Murakami, Toho University
Presentation Files
Unveiling Efficiency: Automated SAS Macros for aCRF Annotation and Bookmarking
Sarani Selvakumar, Zifo RnD Solutions
Presentation Files
Streamlining e-Data Submission Process with Evolving PMDA Regulations
Koichi Yamaguchi, Eli Lilly
Presentation Files
Session 4: Regulatory & Healthcare Interoperability
Chair: Dr. Yuki Ando, PMDA
Overview of HL7 FHIR Accelerator Vulcan, for Bringing Interoperability to Clinical Research
Mika Ogasawara, Pfizer
Presentation Files
PMDA Presentation
Dr. Yoshinori Ochiai, PMDA
Presentation Files
Supporting Submission and Standardisation of Data, an EMA Presentation
Eftychia-Eirini Psarelli, EMA
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Session 5: Regulatory Updates, Part II
Yoshiko Kitagawa, ONO Pharmaceutical Co.
US FDA’s Study Data Policy Framework and Recent Activities
Helena Sviglin, FDA-CDER
Presentation Files
Dataset-JSON Pilot Report and Next Steps
Jesse Anderson, FDA-CDER; Dr. Sam Hume, CDISC
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Session 6: Data Science
Yoshiteru Chiba, UMIN Center
Feedback from Dataset-JSON Submission Pilot Workshop and Prospects of Adoption in Japan
Yuichi Nakajima, Novartis Pharma K.K.
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Document
Creating Dataset-JSON Using proc JSON and Extended Attribute in SAS
Yutaka Morioka and Yuki Nakagawa, EPS Corporation
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Document
Data Standards Governance, Challenges and MDR
Miho Hashio, GSK
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Session 7: TMF Topics
Dr. Toshiki Saito, NHO Headquarters & Nagoya Medical Center
How we are Navigating Global TMF Regulations and inspections: A Real example on How a Japanese Sponsor Address Diverse Regulatory TMF Requirements and Overcome Disparities
Yuto Kanda, Chugai
Presentation Files
Unleashing Your eTMF with Advanced TMF Metrics and KPIs Framework
Franciska Darmer, Independent
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People in TMF Management
Miyuki Taguchi, InSeption Group
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Session 8: Novelty in Clinical Trials and CDISC Standards
Chair: Hidetoshi Misawa, Pfizer
Making the Electronic Protocol a Reality: The TransCelerate/CDISC Digital Data Flow Project, ICH M11 Protocol, and How They Work Together
Chris Decker, CDISC CEO & President
Presentation Files
DDF: The Art of the Possible Becomes Reality
Barrie Nelson and Frederik Malfait, Nurocor
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Integrating Digital Data Flow with Generative AI for Enhanced Clinical Trial Automation
Kunihito Ebi and Daisuke Seyama, Fujitsu Limited
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Delivering a Data-Driven Clinical Protocol - ICH M11
Dr. Ron Fitzmartin, FDA
Presentation Files
Session 9: Closing Plenary
Dr. Hideto Yokoi, Kagawa University Hospital
ICH M11 Guideline: A Breakthrough for Future Clinical Trials in the Data Society
Satoru Tsuchiya, Sumitomo Pharma
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Closing Remarks
Akira Soma, J3C Chair
Presentation Files