Thank you for attending the 2018 Japan Interchange. You will find presentations from the Main Conference below.
Session 1: Opening Plenary & Keynote Address
Opening Remarks
Stephen Pyke, GSK, CDISC Board Chair
Update for Our Community
David R. Bobbitt, CDISC President and CEO
Keynote: Quality Management Systems and CDISC Standards in Clinical Research in Japan
Dr. Takuhiro Yamaguchi, Tohoku University Graduate School of Medicine, Tohoku University Hospital
What's New and What's Next & TA Standards Update
Rhonda Facile, CDISC
Session 2: Second Opening Plenary
CDISC Myths & Truths: Creating Clarity
Dr. Diane Wold and Kit Howard, CDISC
SHARE 2.0 Update
Dr. Sam Hume, CDISC
Challenges and Opportunities: Using CDISC Standards for Observational Studies
Jon Neville, CDISC
Session 3: Perspectives on Submission and Usage of E-Data
Electronic Data Submission in Japan: Current Status and Future
Dr. Yuki Ando, PMDA
Experiences of Receiving and Using Electronic Data: Updates and Some Points to be Considered
Takami Suwa, PMDA
Points to Consider for E-Data Submission: Perspectives from Clinical Pharmacology
Takahiro Tanigawa, Bayer Yakuhin, Ltd.
JCROA Approach to CDISC
Toshihiko Watanabe, Japan CRO Association (JCROA)
Session 4: Use Cases & Updates by Academia & Industry
Investigating Mapping Procedure of Standardized Clinical Information, from the Standardized Structured Medical Record Information eXchange (SS-MIX) to CDISC
Dr. Takahiro Kiuchi, University Hospital Medical Information Network (UMIN) Center
Supporting System for EDC Entry Based on Japanese Standard Storage System
Dr. Hideto Yokoi, Kagawa University Hospital
Generating eCRF in ODM by Direct Data Capture from Electronic Medical Record
Dr. Yasushi Matsumura, Osaka University Graduate School of Medicine
AMED's Contribution to Penetration of CDISC in Academia
Dr. Sae Ochi, Agency for Medical Research and Development (AMED)
Increase Quality and Reduce SDTM Development Time with Test Study Data Simulator
Bhaskar Subramanian, Covance
Building A SHARE-Like Private Tool
Hajime Shimizu, Takeda PRA
Session 5: Presentations by FDA
Data Standards Update
Helena Sviglin, FDA-CDER
CBER Study Data Standards Update
Lisa Lin, FDA-CBER
Session 6: Challenges & Rewards of CDISC Implementation
Challenges of CDISC Implementation and Submission to both PMDA and FDA
Janet Reich, Amgen; and Yumiko Asami, Yutaka Noguchi and Yasuyuki Okuda, Daiichi Sankyo, Co., Ltd.
Challenges for Simultaneous eData Submission to PMDA and FDA
Sho Hibino, Chugai
Legacy Data to CDISC Standards – It’s Not As Hard As It Seems
Kazuhiro Ienaka, Zifo RnD Solutions
Session 7: Updates from CJUG, JPMA & JCROA
CJUG Update
Yoshiteru Chiba, CDISC Japan User Group (CJUG), J3C Vice-Chair
JPMA Results Summary
Keiichi Koizumi, JPMA
eData Submission from Japan CRO’s Perspective
Yuya Ikeda, JCROA, J3C
Session 8: Closing Plenary and Q&A
Data Mapping Using Machine Learning
Ben Bocchicchio, SAS Institute
SDTM Automation Using Computer-Readable SDTM Specs
Kunihito Ebi, Fujitsu Limited