Thank you for attending the 2017 Japan Interchange. You will find presentations from the Main Conference below.
Session 1: Opening Plenary & Keynote
Keynote: Regulatory Science Research on Therapeutic Area Standards for the Development of Drugs in Japan
Dr. Takashi Moritoyo, Director and Project Professor, Department of Clinical Research Governance, University of Tokyo Hospital
CDISC Standards in 2017 and Forward
Rhonda Facile, CDISC VP, Standards Development; Dr. Diane Wold, CDISC Sr. Director, Standards Development and Modeling
Session 2: Second Opening Plenary
SHARE 2.0
Dr. Lauren Becnel, CDISC VP, Strategy and Innovation
Update on CDISC Education in Japan
Kit Howard, CDISC Director, Education
CDASH and SDTM: Why Do We Need Both Standards?
Kit Howard, CDISC Director, Education
Session 3: PMDA Update
Current Status of Electronic Data Submission in PMDA
Dr. Yuki Ando, PMDA
Experiences Receiving and Using Electronic Data in PMDA
Chikako Ishige, PMDA
Implementation of Therapeutic Area Standards in Japan
Hiroshi Sakaguchi, PMDA
Session 4: Update from Japanese Academia and Use Cases for CDISC Standards & Technology
Reports on the Application of the CDISC Standards in NHO Nagoya Medical Center
Dr. Toshiki Saito, National Hospital Organization, Nagoya Medical Center
The Experience of PMDA Pilot Project for Utilization of Electronic Data in an Academic Setting
Dr. Takuhiro Yamaguchi, Tohoku University
Significance and Problem of the CDISC Introduction in Academic Research Organization
Shizuko Takahara, Kanazawa University
Define2Validate - An Implementation of Dataset-XML Validator with R
Dr. Masafumi Okada, University Hospital Medical Information Network (UMIN) Center
Current Status Update on the WHODrug B3/C3 Formats and CDISC SDTM Compliance
Damon Fahimi, Uppsala Monitoring Centre
Introducing Metadata Repository Implementation Practices
Kunihito Ebi, Fujitsu
Good Data Validation Practice
Sergiy Sirichenko, Pinnacle 21
Session 5: Updates from the FDA and Q&A with Global Regulatory Agencies
FDA-CDER Presentation
Dr. Ron Fitzmartin, FDA-CDER
Q&A with FDA, PMDA and CDISC Representatives
Session 6: Best Practice in Regulatory Submissions
Experiences in Electronic Study Data Submission
Takuma Oda, Janssen Pharmaceuticals
Experience and Challenges in Simultaneous Electronic Data Submission to PMDA and FDA
Mayumi Kominami, Novartis
Lessons Learned from e-Data Submission
Hiroshi Haneji, Sanofi
Session 7: Updates from CJUG, JPMA and JCROA
Update from the CDISC Japan User Group (CJUG)
Kazuhiro Ienaka, CJUG
JPMA Results Summary
Naoto Awaji, JPMA, J3C
eData Submission from Japan CRO’s Perspective
Yuya Ikeda, JCROA, J3C
Creation of Trial Summary Domain Data of SDTM Based on ClinicalTrials.gov Data in XML Format Using SAS
Anna Tsutsui, AstraZeneca K.K.
Challenges in Creating Japanese Translation of CDISC ADaM IG v.1.0 in Adherence to CDISC Operating Procedure 007
Yumiko Asami, Daiichi Sankyo, CJUG ADaM Team; Hisae Watanabe, Ono Pharmaceutical, CJUG ADaM Team; Kota Ono, Hokkaido University, CJUG ADaM Team; Masataka Sano, Chiba Institute of Technology, CJUG ADaM Team
Session 8: Special Regulatory Topics
How to Increase the Efficiency of Preparing ClinicalTrials.gov
Annie Xu, PAREXEL International
A Challenge for CDISC Implementation – CDISC Data Readiness for Multiple Regulatory Submissions
Miho Hashio, GlaxoSmithKline K.K.