DIA
Drug Information Association Logo

18th Annual Workshop in Japan for Clinical Data Management

Jan 29 2015 9:30AM - Jan 30 2015 5:15PM | KFC Hall 1-6-1 Yokoami Sumida-ku Tokyo 130-0015 Japan

« Back to Listing

Overview 

The Big Data era is here.  The importance and value of gathering and storing data effectively and efficiently cannot be underestimated in the success of a business and its ability to grow and innovate.   This is particularly true in the health care market, not only for corporations but also for the regulatory bodies where the framework of collecting research and analysis based on clinical data can contribute significantly to improved medical care and scientific findings.
 
The 18th  Annual Workshop in Japan for Clinical Data Management (CDM) will be held in Tokyo, January, 2015, with a theme of “Focus on Cool Data” with educational content designed for all levels of professionals, from beginner to expert.

Just what is “Cool” data?  It is the rethinking of the nature of data and data management activities in preparing for an e-submission while applying risk-based approaches, actual experience, current and future benefits and challenges and how they align with our ultimate goal.
 
The objective of this workshop is to help you improve the quality of your clinical research and data management activities by providing attendees with critical information about international clinical data management through educational sessions and networking opportunities among industry, government, and academia involved with global Clinical Data Management.

Hotel & Travel 

Attendees should make airline and hotel reservations as early as possible. Dai-ichi Hotel Ryogoku is a convenient accomodation adjacent to the venue. To reserve, please contact the Dai-ichi Hotel Ryogoku below.
Address: 1-6-1 Yokoami, Sumida-ku, Tokyo 130-0015, Japan
Telephone: +81-(0)3-5611-5211 / Fax: +81-(0)3-5611-5212
email: daiichi-hotel@dh-ryogoku.com
URL: http://www.dh-ryogoku.com/english/index.html

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 

Previous Next

Agenda  

Day 1 Thursday, Jan 29, 2015

  • 9:30AM - 11:30AM (Tokyo Standard Time)

    CDM Chatting Session

    Speaker(s):

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

    Welcome and Opening Remarks
  • 1:45PM - 3:30PM (Tokyo Standard Time)

    Session 1 : Which Data Should Be Collected in Clinical Trials?


    Session Chair(s):

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

    Speaker(s):

    • Tetsuo Nakabayashi, MD, PhD
      Senior Scientist for Medical Science
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
    • Yoji Nagai, MD, PhD
      Deputy Director, Translational Research Informatics Center
      Foundation for Biomedical Research & Innovation, Japan
  • 4:00PM - 5:30PM (Tokyo Standard Time)

    Session 2 : What Is the Advantage of Having an ARO?


    Session Chair(s):

    • Yukiko Nagata
      Manager, Clinical Data Management, Clinical Data Science Dept.
      Takeda Pharmaceutical Company Limited, Japan
    • Kyoko Minamoto
      Clinical Research Support Center
      The University of Tokyo Hospital, Japan

    Speaker(s):

    • Reza Rostami, MBA, RAC
      Assistant Director, Quality Assurance and Regulatory Compliance
      Duke Clinical Research Institute, United States
    • Haruko Yamamoto, MD, PhD
      Director, Dept of Advanced Medical Technology Development
      National Cerebral and Cardiovascular Center, Japan
    • Hiroshi Ohtsu, MS
      Assistant Professor, Lead. Center for the dev. & research of Cancer Medicine
      Juntendo University, Japan

Day 2 Friday, Jan 30, 2015

  • 9:00AM - 10:30AM (Tokyo Standard Time)

    Session 3 : Risk-based Monitoring


    Session Chair(s):

    • Yumi Sugiura
      Clinical Data Quality Manager, Regional Clinical Operation Japan
      Bristol-Myers K.K., Japan
    • Mariko Mizumoto
      Manager, Data Mgt. Group, Clinical Data & Biostatistaics Dept.
      Daiichi Sankyo Co., Ltd., Japan

    Speaker(s):

    • Andrew Lawton
      Global Head, Clinical Data Management
      Boehringer Ingelheim Ltd., United Kingdom
    • Junichi Nikaido
      Field Operation 5, Japan International Clinical Research Operation Dept
      Novartis Pharma K.K., Japan
  • 11:00AM - 12:20PM (Tokyo Standard Time)

    Session 4 : Next Generation Data Management


    Session Chair(s):

    • Manami Hashimoto
      Oncology Data Management Group, Oncology Biometrics and Data Management Dept.
      Novartis Pharma K.K., Japan
    • No-image Motohide Nishi
      Eli Lilly Japan K.K., Japan

    Speaker(s):

    • Anita Walden
      Sr Informacist, Biomedical Informatics
      Duke Translational Medicine Institute, United States
    • Rob Nichols, MS
      General Manager Europe, VP Global Corporate Development
      DATATRAK, United Kingdom
    • Narreh Sevan Ghazarians
      Project Manager
      Transperfect Translations, United States
    • Wei Li
      Biostatistician
      National Center For Cardiovascular Diseases, China
  • 1:35PM - 1:55PM (Tokyo Standard Time)

    CDM Chatting Session Report
  • 1:55PM - 3:15PM (Tokyo Standard Time)

    Session 5 : Can We Maximize the Potential of Post Marketing Surveillance?


    Session Chair(s):

    • No-image Motohide Nishi
      Eli Lilly Japan K.K., Japan
    • Manami Hashimoto
      Oncology Data Management Group, Oncology Biometrics and Data Management Dept.
      Novartis Pharma K.K., Japan

    Speaker(s):

    • Shinichi Hotta
      Japan Clinical Informatics & Innovation, Development Operations
      Pfizer Japan Inc., Japan
    • Masanori Taketsuna
      Research Scientist, Statistical Science, Science & RA Medicines & Development
      Eli Lilly Japan K.K., Japan
    • Masako Karino
      Group Manager, Pharmacovigilande Dept,Pharmacovigilance & Quality Assurance Div.
      Mitsubishi Tanabe Pharma Corporation, Japan
  • 3:45PM - 5:15PM (Tokyo Standard Time)

    Session 6 : Toward Electronic Submission of Study Data for New Drug Applications


    Session Chair(s):

    • Motohiro Hoshino
      Inspector, Office of Conformity Audit
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • No-image Kenji Nagaya
      General Manager, CDM and Biostatistics, Pharmaceutical Development Division
      Nippon Kayaku Co., Ltd., Japan

    Speaker(s):

    • Yuki Ando
      Senior Scientist for Biostatistics
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Yoshiteru Chiba
      ChibaPlanningOffice Co., Ltd., Japan
    • Yasuharu Shibata
      Manager, Data Management 2, Study Support Clinical Operation Area
      MSD K.K., Japan
    • Yumiko Asami
      Statistical Manager
      Daiichi Sankyo Co., Ltd., Japan

Exhibits  

The 18th 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..........¥216,000
*NOTE: *fee includes 8% 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 450 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 ¥12,960 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 29-30, 2015

Useful Links:

  • Medidata Solutions K. K.
  • PAREXEL International
  • Pharma Consulting Group Japan K.K.
  • the Uppsala Monitoring Centre

Registration Fees 

Member

Member Academia
¥19000.00
Member Government
¥25000.00
Member Industry ~ Early bird pricing ends 1/8/15
¥42000.00
Member Industry ~ Early bird pricing ends 1/8/15 (As of 01/09/2015)
¥48000.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥19000.00
NonMember Government
¥40000.00
NonMember Standard
¥63000.00
Register Online
« Back to Listing Back To Top