2024 Japan Interchange Program
Please click on sessions listed below to view all presenters and topics within each session.
2024 CDISC Japan Interchange Program
9:00 - 10:00
Session 1: Opening Plenary and Keynote Presentation
Akira Soma, J3C Chair, Oracle
9:00 - 9:15
Welcome Address: CDISC Strategy and the Future
Chris Decker, CDISC President and CEO
9:15 - 10:00
Opening Keynote Presentation
Dr. Shusaku Tsumoto, Professor of Medical Informatics, Shimane University; President, Japanese Society of Artificial Intelligence (JSAI)
10:00 - 10:30
Morning Break
10:30 - 12:00
Session 2: Second Plenary- Updates from CDISC
Hidemi Hasegawa, Boehringer Ingelheim
10:30 - 11:00
State of CDISC Standards
Chris Decker, CDISC President and CEO
11:00 - 11:30
DHT Presentation
Christine Connolly, CDISC
11:30 - 12:00
CDISC Technical Landscape
Anthony Chow, CDISC
12:00 - 13:30
Lunch Break
13:30 - 15:10
Session 3: CDISC Implementation and Use Cases
Akari Kamitani, Shionogi & Co., Ltd.
13:30 - 13:55
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
13:55 - 14:20
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
14:20 - 14:45
Unveiling Efficiency: Automated SAS Macros for aCRF Annotation and Bookmarking
Sarani Selvakumar, Zifo
14:45 - 15:10
Streamlining e-Data Submission Process with Evolving PMDA Regulations
Koichi Yamaguchi, Eli Lilly
15:10 - 15:40
Afternoon Break
15:40 - 17:10
Session 4: Regulatory & Healthcare Interoperability
Chair: Dr. Yuki Ando, PMDA
15:40 - 16:10
Overview of HL7 FHIR Accelerator Vulcan, for Bringing Interoperability to Clinical Research
Mika Ogasawara, Pfizer
16:10 - 16:40
PMDA Presentation
Dr. Yoshinori Ochiai, PMDA
16:40 - 17:10
EMA Presentation
Marcia Rückbeil, EMA
9:00 - 10:00
Session 5: Regulatory Updates, Part II
Yoshiko Kitagawa, ONO Pharmaceutical Co.
9:00 - 9:30
FDA Presentation
Helena Sviglin, FDA-CDER
9:30 - 10:00
Dataset-JSON Pilot Report and Next Steps
Jesse Anderson, FDA-CDER; Dr. Sam Hume, CDISC
10:00 - 10:30
Morning Break
10:30 - 11:50
Session 6: Data Science
Yoshiteru Chiba, UMIN Center
10:30 - 10:55
Feedback from Dataset-JSON Submission Pilot Workshop and Prospects of Adoption in Japan
Yuichi Nakajima, Novartis Pharma K.K.
10:55 - 11:20
Creating Dataset-JSON Using proc JSON and Extended Attribute in SAS
Yutaka Morioka and Yuki Nakagawa, EPS Corporation
11:20 - 11:50
Data Standards Governance, Challenges and MDR
Miho Hashio, GSK
11:50 - 13:20
Lunch Break
13:20 - 14:35
Session 7: TMF Topics
Dr. Toshiki Saito, NHO Headquarters & Nagoya Medical Center
13:20 - 13:45
Unleashing your eTMF – how to Achieve Real Business Value with an Advanced eTMF Metrics and KPI Framework
Franciska Darmer, Independent
13:45 - 14:10
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
14:10 - 14:35
People in TMF Management
Miyuki Taguchi, InSeption Group
14:35 - 15:05
Afternoon Break
15:05 - 16:20
Session 8: Novelty in Clinical Trials and CDISC Standards
Chair: Hidetoshi Misawa, Pfizer
15:05 - 15:30
DDF: The Art of the Possible Becomes a Reality
Barrie Nelson and Frederik Malfait, Nurocor
15:30 - 15:55
TBA
TBA
15:55 - 16:20
Integrating Digital Data Flow with Generative AI for Enhanced Clinical Trial Automation
Kunihito Ebi and Daisuke Seyama, Fujitsu Limited
16:20 - 17:00
Session 9: Closing Plenary
Dr. Hideto Yokoi, Kagawa University Hospital
16:20 - 16:50
Closing Keynote Presentation
Satoru Tsuchiya, Sumitomo Pharma
16:50 - 17:00
Closing Remarks
Akira Soma, J3C Chair