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
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Opening Keynote Presentation
Dr. Shusaku Tsumoto, Professor of Medical Informatics, Shimane University; President, Japanese Society of Artificial Intelligence (JSAI)
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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
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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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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
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Unveiling Efficiency: Automated SAS Macros for aCRF Annotation and Bookmarking
Sarani Selvakumar, Zifo RnD Solutions
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Streamlining e-Data Submission Process with Evolving PMDA Regulations
Koichi Yamaguchi, Eli Lilly
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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
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PMDA Presentation
Dr. Yoshinori Ochiai, PMDA
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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
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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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Creating Dataset-JSON Using proc JSON and Extended Attribute in SAS
Yutaka Morioka and Yuki Nakagawa, EPS Corporation
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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
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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
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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
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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
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