CDISC Asia-Pacific/Japan Interchange CDISC Standards: Transcending Geographic Lines for the Betterment of Clinical Research
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1 CDISC Asia-Pacific/Japan Interchange CDISC Standards: Transcending Geographic Lines for the Betterment of Clinical Research 28 July - 01 August 2014 AP Tokyo Yaesu-Dori KPP Yaesu Building Tokyo, Japan
2 INTERCHANGE SCHEDULE CDISC Authorized Education Courses* MONDAY, 28 July :00-17:00 SDTM Theory & Application Course (Day 1 of a 2 day course) Instructor: Shannon Labout, CDISC TUESDAY, 29 July :00-17:00 SDTM Theory & Application Course (Day 2 of a 2 day course) Instructor: Shannon Labout, CDISC 09:00-12:00 Controlled Terminology Course Instructor: Bron Kisler, CDISC 13:00-17:00 Define-XML Course Instructor: Sally Cassells, Next Step Clinical Systems WEDNESDAY, 30 July :00-17:00 CDASH Implementation Course Instructor: Shannon Labout, CDISC 09:00-17:00 ADaM Implementation Course Instructor: Monika Kawohl, Accovion GmbH *Please note: CDISC Education courses will be held at: CAC Exicare, 24-1 Hakozaki-cho, Nihonbashi, Chuo-ku, Tokyo Learn CDISC from CDISC
3 CDISC Interchange Conference THURSDAY, 31 July :30-17:00 Conference Registration CDISC is the global language for clinical research data. 09:00-09:30 Exhibition Booth Set-Up 09:30-17:30 Exhibition Open 09:00-10:30 Session 1: Opening Plenary & Keynote Session Chair: Dr. Ken Toyoda, J3C Chair Opening Remarks Dr. Ken Toyoda (J3C Chair) and Partha Chakraborty (AP3C Chair) Keynote Presentation: The Role of ARO and NIH in Japan Dr. Yoichi Nakanishi, Chair of ARO Council and Director of Center for Clinical and Translational Research at Kyushu University Hospital State of the CDISC Union: CFAST; CDISC Goals & Strategy Dr. Rebecca Kush, CDISC President & CEO Complying with Privacy & Data Protection Laws when Preparing Clinical Trial Data for Sharing & Publishing Dr. Pierre-Yves Lastic, CDISC BoD Chair & Sanofi Chief Privacy Officer 10:30-11:00 Coffee Break 11:00-12:00 Session 2: Second Opening Plenary Session Chair: Takako Nozaki, J3C The State of CDISC Standards Wayne Kubick, CDISC Chief Technical Officer Leveraging CDISC Standards in the FDA Review Process: The FDA transmart Pilot Experience Dr. David Hardison, CDISC BoD Chair-Elect & ConvergeHEALTH by Deloitte CDISC Activities in Europe Bron Kisler, CDISC VP of Strategic Initiatives 13:00-14:30 Session 3: CFAST & CDISC SHARE Session Chair: Yuya Ikeda, J3C CFAST Overview, Governance & Collaborations Dr. Rebecca Kush, CDISC President & CEO CFAST at Year 1.5: Overview, Status & Lessons Learned Rhonda Facile, CDISC Senior Director, Standards & Development CDISC Shared Health and Clinical Research Electronic Library (SHARE) Wayne Kubick, CDISC Chief Technical Officer
4 14:30-15:00 Coffee Break 15:00-17:20 Session 4: CDISC in Japan Session Chairs: Yoshiteru Chiba (J3C) and Koji Iwamoto (J3C) CDISC Progress in Japan Dr. Ken Toyoda, J3C Chair Basic Policy & Future Plans for Electronic Data Submission in Japan Yasunori Yoshida, Director of Office of Review Management, PMDA eclinical Future with CDISC Takako Jyouno, Translational Research Informatics Center Challenges & Opportunities in edata Submission from Japan Pharmaceutical Industry s Perspective Naoto Awaji, JPMA Data Science Subcommittee, Chugai Clinical Research Center Progress Status of CRO Support: Differences in Interpretation of CDISC Standards among Pharmaceutical Companies in Japan Yuya Ikeda, CDISC Group Sub-leader, Stat-DM Working Group, JCROA Pilot Project for Advanced Review with Electronic Data at PMDA 17:45-19:45 NETWORKING RECEPTION FRIDAY, 01 August 2014 Yuki Ando, Senior Scientist for Biostatistics, PMDA 08:30-13:00 Conference Registration 10:00-15:30 Exhibition Open 09:00-10:15 Session 5: Regulatory Submission Session Chair: Satoru Tsuchiya, J3C Recent FDA Guidance and Experiences with CDISC Dr. Ron Fitzmartin, Senior Advisor, Data Standards Program, FDA-CDER Panel Discussion about edata Submission Dr. Ron Fitzmartin (FDA-CDER), Yuki Ando (PMDA) & CDISC 10:15-10:45 Coffee Break The CDISC Vision: Informing Patient Care and Safety through Higher Quality Medical Research
5 10:45-12:00 Session 6A: CDISC in the Asia-Pacific Region Session Chairs: Dr. Kiyoteru Takenouchi (AP3C Past-Chair and CDISC BoD Member) and Partha Chakraborty (AP3C Chair) Asia-Pacific CDISC Coordinating Committee Introduction Partha Chakraborty, AP3C Chair Clinical Data Standard Plan from Chinese Regulatory Perspective Simon Wang, Roche CDISC China Coordinating Committee (C3C) Updates Dr. Zibao Zhang, PPD CDISC Progress in South Korea from a South Korean Regulatory Perspective 13:00-15:20 Session 6B: CDISC in the Asia-Pacific Region (cont d) Dr. Yu Bin Lee, Ministry of Food and Drug Safety, South Korea Session Chairs: Dr. Kiyoteru Takenouchi (AP3C Past-Chair and CDISC BoD Member) and Partha Chakraborty (AP3C Chair) Impact of Recent Regulations: Perspectives from the Trial Sites Dr. Sauren Das, Excel Life Sciences Implementation Challenges for Standards in Statistical Programming Gaurab Chakraborty, Theorem Clinical Research Global Panel on CDISC Progress & Adoption around the Asia-Pacific Region Regulatory Representatives & AP3C Members 15:20-15:25 Closing Remarks SAVE THE DATE CDISC International CDISC Europe Interchange 2014 Interchange November May 2015 Bethesda, Maryland Basel, Switzerland
6 CONFERENCE AT-A-GLANCE MONDAY, 28 July :00-17:00 SDTM Theory & Application Course TUESDAY, 29 July 2014 Room 2A-4 09:00-17:00 SDTM Theory & Application Course (Cont d) Room 2A-4 09:00-12:00 Controlled Terminology Course Rooms 2A-2 & 2A-3 13:00-17:00 Define-XML Course Rooms 2A-2 & 2A-3 WEDNESDAY, 30 July :00-17:00 CDASH Implementation Course Rooms 2A-2 & 2A-3 09:00-17:00 ADaM Implementation Course Room 2A-4 THURSDAY, 31 July :30-17:00 Conference Registration Rooms K & L (11F) 09:30-17:30 Exhibition Open Room M (11F) 09:00-10:30 Session 1: Opening Plenary & Keynote Rooms K & L (11F) 10:30-11:00 Coffee Break Room M (11F) 11:00-12:00 Session 2: Second Opening Plenary Rooms K & L (11F) 13:00-14:30 Session 3: CFAST & CDISC SHARE Rooms K & L (11F) 14:30-15:00 Coffee Break Room M (11F) 15:00-17:20 Session 4: CDISC in Japan Rooms K & L (11F) 17:45-19:45 NETWORKING RECEPTION Rooms F & G (12F) FRIDAY, 01 August :30-13:00 Conference Registration Rooms K & L (11F) 10:00-15:30 Exhibition Open Room M (11F) 09:00-10:15 Session 5: Regulatory Submission Rooms K & L (11F) 10:15-10:45 Coffee Break Room M (11F) 10:45-12:00 Session 6A: CDISC in the Asia-Pacific Region Rooms K & L (11F) 13:00-15:20 Session 6B: CDISC in the Asia-Pacific Region (Cont d) Rooms K & L (11F) 15:20-15:25 Closing Remarks Rooms K & L (11F)
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