CDISC Japan Interchange “Unlocking the Power of Global Standards for
Industry, Academia, Regulatory Agencies & Patients”
30 May - 03 June 2016
University of Tokyo
Ito International Research Center
Tokyo, Japan
INTERCHANGE SCHEDULE CDISC Authorized Education Courses
Location: CAC Croit Corporation 24-1 Hakozaki-cho, Nihonbashi, Chuo-ku, Tokyo 103-0015
MONDAY, 30 May 2016
09:00 - 17:00 ODM Implementation Instructor: Yoshiteru Chiba, UMIN Center
09:00 - 17:00 SDTM Theory and Application (Day 1 of a 2-Day Course) Instructor: Hiromi Yamamoto, Eli Lilly
13:00 - 17:00 ADaM Primer Instructor: Seiko Yamazaki, CMIC
TUESDAY, 31 May 2016 09:00 - 17:00 SDTM Theory and Application (Day 2 of a 2-Day Course) Instructor: Hiromi Yamamoto, Eli Lilly
09:00 - 17:00 ADaM Theory and Application Instructor: Seiko Yamazaki, CMIC
09:00 - 17:00 Define-XML Instructor: Kunihito Ebi, Fujitsu
WEDNESDAY, 01 June 2016 09:00 - 17:00 CDASH Implementation Instructor: Satoshi Ueno, University of Tsukuba
13:00 - 17:00 Controlled Terminology Instructor: Bron Kisler, CDISC VP, Strategic Alliances & Development
CDISC Symposium
WEDNESDAY, 01 June 2016 13:00 - 18:00 Smarter Research through CDISC Standards for Therapeutic Areas Instructors: Dr. Rebecca Kush, CDISC President & CEO Barrie Nelson, CDISC VP, Standards, Terminology & Technical Services Amy Palmer, CDISC Senior Project Manager, Standards Development Location: Tetsumon Memorial Hall, University of Tokyo, 14th Floor of the Faculty of Medicine Experimental Research Building, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033
SAVE THE DATE! CDISC International
Interchange 2016 26-30 September 2016
Bethesda, Maryland
CDISC Europe
Interchange 2017 24-28 April London, UK
CDISC Interchange Conference
THURSDAY, 02 June 2016 09:00 - 10:00 Exhibition Booth Set-Up
10:00 - 20:00 Exhibition Open
08:30 - 17:00 Conference Registration
09:00 - 10:30 Session 1: Opening Plenary & Keynote Session Chair: Hidetoshi Misawa, J3C Chair
Opening Remarks Hidetoshi Misawa, J3C Chair, and Dr. Rebecca Kush, CDISC President & CEO Keynote Presentation: The AMED Mission: The Impact of Sharing Medical Data Dr. Makoto Suematsu, President, Japan Agency for Medical Research and Development State of the CDISC Union Dr. Rebecca Kush, CDISC President & CEO
10:30 - 11:00 Coffee Break
11:00 - 12:15 Session 2: Update from CDISC Operations Session Chair: Toshiki Saito, J3C
2016 Plans for CDISC Standards and Terminology 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 Update on CDISC Education in Japan Shannon Labout, CDISC VP, Education CDISC Authorized Education Instructors Graduation Ceremony Shannon Labout, CDISC VP, Education
12:15 - 13:45 Lunch Break
13:45 - 15:15 Session 3: Update from the Japan Pharmaceuticals and Medical Devices Agency Session Chair: Satoru Tsuchiya, J3C
PMDA Update Dr. Yuki Ando, PMDA Implementation of CDISC Therapeutic Area Standards in Japan Ken Sakushima, PMDA CDISC Standard for Exchange of Non-Clinical Data (SEND) Yukiko Hoshino, PMDA Q&A with PMDA Representatives
15:15 - 15:45 Coffee Break
15:45 - 17:25 Session 4: Use Cases for CDISC Standards & Technology Session Chair: Takuhiro Yamaguchi, J3C
An Overview of the New CDASH Model and Implementation Guide v2.0 Shannon Labout, CDISC VP, Education A Business Case for Using CDASH Arvind Sri Krishna Mani, Zifo Technologies CDISC SEND Update Lou Ann Kramer, Instem SHARE API 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
18:00 - 20:00 NETWORKING RECEPTION
FRIDAY, 03 June 2016
10:00 - 16:00 Exhibition Open
08:30 - 12:10 Conference Registration
09:00 - 10:20 Session 5: Updates from Global Regulatory Agencies Session Chair: Toshiki Saito, J3C
FDA-CDER Presentation Dr. Stephen Wilson, Director, Division of Biometrics III, FDA-CDER
FDA-CDER Presentation Dr. Ron Fitzmartin, Sr. Advisor, Office of Strategic Programs, FDA-CDER
Q&A with FDA, PMDA and CDISC Representatives
10:20 - 10:50 Coffee Break
10:50 - 12:10 Session 6: CDISC Standards Across the Globe Session Chair: Shiro Hinotsu, J3C
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
University Hospital Medical Information Network (UMIN) Center 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 WHODrug B3 and C3 Formats When Creating the SDTM Dataset Damon Fahimi, Uppsala Monitoring Centre
12:10 - 13:40 Lunch Break
13:40 - 15:20 Session 7: Updates from the CDISC Japan Users Group Session Chair: Kaoru Matsumi, J3C
CJUG CDASH Update Hiroshi Yamaguchi, CJUG CDASH Team CJUG SDTM Update Yoshiteru Chiba, CJUG SDTM Team CJUG ADaM Update Youhei Takanami, CJUG ADaM
CJUG SEND Update Yoshinori Fujimura, CJUG SEND Team
JPMA Results Summary Yumiko Asami, JPMA eData Submission from Japan CRO’s Perspective Yuya Ikeda, JCROA, J3C
15:20 - 15:50 Coffee Break
15:50 - 17:20 Session 8: Special Regulatory Topics Session Chair: Satoru Tsuchiya, J3C
Validation at the Time of Application, and Notes on Data and Structure Yuki Ogasawara, Fujitsu
What is High Quality Study Metadata? Sergiy Sirichenko, Pinnacle 21
Special Q&A with PMDA and CDISC Panelists:
Dr. Yuki Ando, Senior Scientist for Biostatistics, PMDA Dr. Rebecca Kush, CDISC President & CEO Dr. David Hardison, Chair, CDISC Board of Directors, Deloitte Dr. Pierre-Yves Lastic, Past-Chair, CDISC Board of Directors, Sanofi Bron Kisler, CDISC VP, Strategic Alliances & Development Barrie Nelson, CDISC VP, Standards, Terminology and Technical Services Amy Palmer, CDISC Senior Project Manager, Standards Development
17:20 - 17:25 Closing Remarks Hidetoshi Misawa, J3C Chair
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