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17th Annual Workshop in Japan for Clinical Data Management

Jan 30 2014 9:30AM - Jan 31 2014 5:00PM | CongresSquare Nakano Central Park South, 4-10-2 Nakano, Nakano, Tokyo 164-0001 Japan

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Overview 

Online registration is now closed.  Onsite registration available.

A fruitful program is being prepared for the 17th Annual Workshop in Japan for Clinical Data Management (CDM), which aims to help Clinical Data Managers improve the quality of clinical research and data management activities.

Clinical data is one of the most important resources in all research projects. It greatly promotes the development of medical treatments. But in order to utilize clinical data more effectively it needs to be efficiently sharable. The question of how to share data has become a key mission of CDM.

During this workshop attendees will discuss the idea that standardization is the key to success, as it enables sharing the data across projects, organizations, and nations. Attendees will also consider the standardization and optimization of the data handling process.

The workshop will give concrete examples from real-life experiences and discuss the difficulties, benefits, challenges, and future goals.

Attendees will get also have opportunities to network with colleagues from around the world and learn about international Clinical Data Management.

We look forward to seeing you in the workshop.


Simultaneous Translation Available

Who Should Attend 

This program will benefit the following individuals:

  • Clinical data managers
  • Clinical research coordinators
  • Biostatisticians
  • Clinical development professionals
  • Information technology professionals
  • QC/QA professionals
  • Regulatory affairs professionals

Hotel & Travel 

Nakano Sunplaza is convenient accommodation adjacent to the venue. To reserve, please visit the following URL or contact the Nakano Sunplaza below:
http://www.expedia.com/Tokyo-Hotels-Nakano-Sunplaza-Hotel.h3567848.Hotel-Information

Nakano Sunplaza
Address: 4-1-1 Nakano, Nakano-ku, Tokyo 164-8512
Telephone: +81-3-3388-1177 / Fax: +81-3-3388-2664
email: hotel@sunplaza.jp
URL: http://www.sunplaza.jp/

Contact Information 

Please contact the DIA Japan office in Tokyo for further information.

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
DIAJapan@diajapan.org
www.diajapan.org

Program Committee 

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Agenda  

Day 1 Thursday, Jan 30, 2014

  • 9:00AM - 9:30AM

    CDM Chatting Session Registration
  • 9:30AM - 11:30AM

    CDM Chatting Session ~ Conducted in Japanese Only

    Speaker(s):

    • Kazuki Furuno
      Data Science Expert Committee, Drug Evaluation Committee, JPMA
      Mochida Pharmaceutical Co., Ltd., Japan
    • Masako Karino
      Mitsubishi Tanabe Pharma Corporation, Japan
    • Takeshi Kawakami, MS
      Japan Clinical Informatics & Innovation, Development Operations
      Pfizer Japan Inc., Japan
    • Kengo Kawasaki
      Associate Director, Data Management, Data Science, Development
      Astellas Pharma Inc., Japan
    • Naoki Tomotsugu
      Project Leader, Head of Planning and Management Office
      Keio University School of Medicine, Japan
    • Hidenobu Yoshida
      Manager
      AbbVie GK, Japan
  • 1:30PM - 1:45PM

    Welcome and Opening Remarks

    Speaker(s):

    • Ko Sekiguchi, MBA
      Senior Vice President and Managing Director, DIA Japan
      DIA Japan, Japan
    • Makoto Yokobori
      President
      SUXAC Inc., Japan
  • 1:45PM - 3:15PM

    Session 1: General Requirements for Standardization


    Session Chair(s):

    • No-image Hideaki Ui, PhD
      Director, Division of Planning & Coordination, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • No-image Makoto Yokobori
      President
      SUXAC Inc., Japan

    “Standardization” is not a purpose but a tool. We always have to have a strong awareness whether it suits its purpose or not. In this session, we would like to discuss the required parts and quality for standardization after outlining the history of data standardization. We want to also consider the standardization of education as it is the most important matter for standardization process.

    Speaker(s):

    • Opportunities, Challenges and Complexities of Sharing Clinical Research Data
      Reza Rostami, MBA, RAC
      Assistant Director, Quality Assurance and Regulatory Compliance
      Duke Clinical Research Institute, United States
    • Relationship of Quality and Standardization
      Hideaki Ui, PhD
      Director, Division of Planning & Coordination, Office of International Programs
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Challenge to Build a Standardized Method for Developing CDM
      Takeshi Kawakami, MS
      Japan Clinical Informatics & Innovation, Development Operations
      Pfizer Japan Inc., Japan
  • 3:45PM - 5:15PM

    Session 2: Step in Standardization in Japan!


    Session Chair(s):

    • Manami Hashimoto
      Oncology Data Management Group, Oncology Biometrics and Data Management Dept.
      Novartis Pharma K.K., Japan
    • Mariko Mizumoto
      Manager, Data Mgt. Group, Clinical Data & Biostatistaics Dept.
      Daiichi Sankyo Co., Ltd., Japan

    Electronic data submission to PMDA was concreted. It will lead to higher requirement for standardization. We would like to share our challenges and current status for standardization, not only data format but also process, focused on seeing submission in Japan. Then let’s discuss the next step!

    Speaker(s):

    • Masato Kobayashi presentation
      Masato Kobayashi, MS
      Senior Manager
      ASTELLAS PHARMA INC, Japan
    • Using Standard Library of Clinical Data Management: Pros and Cons of Standardization
      Yasuharu Shibata
      Manager, Data Management 2, Study Support Clinical Operation Area
      MSD K.K., Japan
    • Data Harmonization across Standards, Platforms and CROs to Meet Regulatory Requirements across the Globe
      Belinda Gardner
      Senior Director, Development Operations
      Pfizer Japan Inc., Japan

Day 2 Friday, Jan 31, 2014

  • 9:00AM - 11:30AM

    Session 3: Data Standards as a Key to Success


    Session Chair(s):

    • No-image Motohide Nishi, MBA
      Director, Asia Pacific Data Sciences & Solutions
      Eli Lilly Japan K.K., Japan
    • Yumi Sugiura
      Clinical Data Quality Manager, Regional Clinical Operation Japan
      Bristol-Myers K.K., Japan

    This session covers the status and landscape of data standards in regulatory authorities and pharmaceutical industry with focus on 1) benefit and challenges from experiences, 2) how to address future industry standards, and 3) opportunities for future innovation. This session will also show you how we are going to improve internal/external decision-making using structured scientific data.

    Speaker(s):

    • FDA Perspective on Electronic Submission of Standardized Study Data: Past, Present & Future
      Ron Fitzmartin, PhD, MBA
      Senior Advisor, Data Standards Program, Office of Strategic Programs, CDER
      FDA, United States
    • Pre-Competitive Collaboration in Clinical Trials - TransCelerate Biopharm Inc.
      Motohide Nishi, MBA
      Director, Asia Pacific Data Sciences & Solutions
      Eli Lilly Japan K.K., Japan
    • Data Standardization and Advancing Regulatory Science
      Yoshiaki Uyama, PhD
      Director, Division of Epidemiology, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 1:00PM - 1:30PM

    CCS (CDM Chatting Session) Report

    Speaker(s):

    • CCS Report
      Hidenobu Yoshida
      Manager
      AbbVie GK, Japan
  • 1:30PM - 3:00PM

    Session 4: Open a New Epoch of the Standardization


    Session Chair(s):

    • Yukiko Nagata
      Manager, Clinical Data Management, Clinical Data Science Dept.
      Takeda Pharmaceutical Company Limited, Japan
    • No-image Kenji Nagaya
      General Manager, CDM and Biostatistics, Pharmaceutical Development Division
      Nippon Kayaku Co., Ltd., Japan

    The “Standardization” of business processes, IT systems, or clinical data is a very useful “tool” in order to create new drugs innovatively in our clinical data management field. In this session, three speakers which have been struggling to open the door to a new era will introduce you their efforts and approaches to manipulate the “tool” freely. And then, we would like to discuss with you how we stand up and effort to this new era, and what we should do to establish.

    Speaker(s):

    • Utilizing a Unified Platform to Bridge Geographical and Departmental Gaps While Expediting an Entire Development Program
      Bill Gluck, PhD, MS
      VP Clinical Knowledge
      DATATRAK, United States
    • “CDISC SHARE” based Standards Development Approach - Through CDISC Asthma Therapeutic Area Standards Development
      Miho Hashio, MPharm
      Biomedical Data Sciences Dept., RD Japan
      GlaxoSmithKline K.K., Japan
    • Experience in Preparing Clinical Data Submissions to the FDA
      Satoru Tsuchiya, MS
      Biostatistics Group, Data Science, Drug Development Div.
      Dainippon Sumitomo Pharma Co., Ltd., Japan
  • 1:30PM - 3:00PM

    Session 5: Challenges in Academic/Research Institutes, for Clinical Data Standardization across the World


    Session Chair(s):

    • Mika Ogasawara
      Senior Manager, Clinical Informatics & Innovation, Development Operations
      Pfizer Japan Inc., Japan
    • Keisuke Utsumi
      Associate Department Manager, Biomedical Data Sciences Department
      GlaxoSmithKline K.K., Japan

    For achieving the “true standardization”, data standardization within/across the medical institutes is essential because they are the upper stream of clinical data. This session will focus on academic/research institutes’ challenge for the standardization. Importance of data collection plan in the study design phase, implementation of EDC system (REDCap), and CDISC implementation will be presented and the possibility of data integration near future will be discussed.

    Speaker(s):

    • Realizing Time and Cost Savings Through Protocol Design Planning Improvements
      Stella Stergiopoulos
      Senior Project Manager
      Tufts Center for the Study of Drug Development, United States
    • Introducing a New Computer System Validated (CSV) Data Capturing System for Investigator-Initiated Researches
      Keiko Ohta
      National Cerebral and Cardiovascular Research Institute, Japan
    • eClinical Solution with CDISC
      Takako Jyouno
      Chief Information Officer
      Foundation For Biomedical Research and Innovation, Japan

Exhibits  

The 17th Annual Workshop in Japan for Clinical Data Management offers interested companies the opportunity to exhibit with a tabletop display.

Fee:
2,300 x 1,400 mm booth space..........¥210,000*
NOTE: *fee includes 5% Japanese Consumption Tax

Booth Rental Fee includes (per 2,300mm x 1,400m booth space):

  • One (1) complimentary full-meeting registration
  • Two (2) complimentary exhibit booth personnel registrations
  • One (1) 1,800 x 600 mm table
  • Two (2) chairs
  • One (1) 5A electrical connection
  • Internet access

No pre-fitted shell-scheme or pipe-and-drape structure is provided.

Additional expenses associated with the exhibit, including special booths, drayage, lights, phone, carpeting, additional electrical connections, etc., will be the responsibility of the exhibitor. Additional Exhibit Booth Personnel will be allowed for ¥12,600 each (limit of 3 per booth space) - please use the Additional Exhibit Booth Personnel Registration Form under Useful Links to register additional staff.

Exhibit Show Dates: January 30-31, 2014

Useful Links:

  • DSG, Inc.
  • EPS Group
  • Makrocare K.K.
  • Medidata Solutions K. K.
  • NTT Data Corporation
  • Pharma Consulting Group Japan K.K.
  • the Uppsala Monitoring Centre

Registration Fees 

Member

Member Academia
¥25000.00
Member Government
¥25000.00
Member Standard
¥48000.00

Non-Member

NonMember Academia
¥25000.00
NonMember Government
¥40000.00
NonMember Standard
¥63000.00
Group Discounts

There are no group discounts for this event.


CANCELLATION POLICY: On or before January 23, 2014
Administrative fee that will be withheld from refund amount:
Industry (Member or Nonmember) = ¥20,000
Government/Academia/Nonprofit (Member or Nonmember) = ¥10,000

Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable.

DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

Register Online
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