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

SPONSORS & EXHIBITORS

Global Ruby Sponsor:

Exhibitors: