Thank you for joining us at the 2016 CDISC Japan Interchange. Presentation slides from the conference are available below. We look forward to seeing you again at future CDISC events!
Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.
Session 1: Opening Plenary & Keynote
State of the CDISC Union
Dr. Rebecca Kush, CDISC President & CEO
Session 2: Update from CDISC Operations
Barrie Nelson, CDISC VP, Standards, Terminology and Technical Services
CFAST: Developing Standards for Therapeutic Areas and the Use of SHARE in These Processes
Amy Palmer, CDISC Senior Project Manager, Standards Development
CDISC Education in Japan
Shannon Labout, CDISC VP, Education
Session 3: Update from the Japan Pharmaceuticals and Medical Devices Agency
PMDA Update
Dr. Yuki Ando, PMDA
Implementation of CDISC Therapeutic Area Standards in Japan
Ken Sakushima, PMDA
Perspectives on Electronic Non-Clinical Data Submission in Japan
Yukiko Hoshino, PMDA
Session 4: Use Cases for CDISC Standards & Technology
An Overview of the New CDASH Model and Implementation Guide v2.0
Shannon Labout, CDISC VP, Education
CDISC SEND Update
Lou Ann Kramer, Instem
Using SHARE API for TAUG-enabled Studies
Kunihito Ebi, Fujitsu
Understanding the Potential of SHARE: A Visual Business Case and Technical Use Case
Peter Van Reusel, Business & Decision Life Sciences
Translation of CDISC Standards in Japanese
Yoshiteru Chiba, J3C
Session 5: Updates from Global Regulatory Agencies
Standardized Data for Regulator Review - An Update
Dr. Stephen Wilson, Director, Division of Biometrics III, FDA-CDER
Update on the Requirement for Standardized Submissions
Dr. Ron Fitzmartin, Sr. Advisor, Office of Strategic Programs, FDA-CDE
Session 6: CDISC Standards Across the Globe
Mobile Health, Real World Evidence, Genomics... How Does CDISC Fit In?
Dr. Pierre-Yves Lastic, Past-Chair, CDISC Board of Directors, Sanofi
Practical Implementation of CDISC Therapeutic Area Standards
Priya Govindaswamy, Chiltern
Clinical Data Capture from EHRs: Summary of Experiences at UMIN
Dr. Masafumi Okada, UMIN
Integrated Design of eCRFs and SDTM Datasets with ODM.xml and Define.xml
Dr. Philippe Verplancke, xClinical GmbH
How to Use the New WHO Drug B3 and C3 Formats When Creating the SDTM Dataset
Damon Fahimi, Uppsala Monitoring Centre
Session 7: Updates from the CDISC Japan Users Group
CJUG CDASH Update
Hiroshi Yamaguchi, CJUG CDASH Team
CJUG SDTM Update
Yoshiteru Chiba, CJUG SDTM Team
CJUG ADaM Update
Youhei Takanami, CJUG ADaM Team
CJUG SEND Update
Yoshinori Fujimura, CJUG SEND Team
Update of JPMA Activities on eSubmission
Yumiko Asami, JPMA
Survey on Support on Status on Issues of CDISC Implementation in 2016 vs Last Three Years
Yuya Ikeda, JCROA, J3C
Session 8: Special Regulatory Topics
Submitting Study Data via PMDA Gateway
Kunihito Ebi, Fujitsu
What Is High Quality Study Metadata?
Sergiy Sirichenko, Pinnacle 21