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2nd DIA Clinical Operation & Monitoring Workshop in Japan

Feb 28 2014 12:00AM - Feb 28 2014 5:30PM | KFC Hall 1-6-1 Yokoami Sumida-ku Tokyo 130-0015 Japan

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The 2nd DIA Clinical Operation and Monitoring Workshop, focused on the theme “Operational Excellence – Think Globally, Act Locally”, will be a great opportunity for industry and regulatory professionals and academia to have open discussion.

One of the recent hot topics in the field of operation and monitoring is the “Risk-based Approach to Monitoring”. This concept, which originated in the United States, seems straightforward at first, but actually raises key questions related to the essence of clinical trial quality. This workshop will address what kind of impact this concept can make to global clinical development and how it could be implemented in the clinical trial environment in Japan.

The workshop will also focus on effective information technology (IT) utilization and productivity improvement, which are other key factors of operational excellence. In addition, there will be a chatting session to allow attendees to network and discuss various themes.

We hope you will use this workshop as a chance to gain a greater understanding of current and future potential and discuss key issues with professionals in the same field to find the best solutions for operational excellence.

Please note that dress code is business casual to make the atmosphere of the workshop ideal for open discussion.

Who Should Attend 

This program will benefit the following individuals:
  • Clinical research associate, site monitor
  • Study manager, study leader
  • Clinical development professional
  • Clinical research coordinator
  • Clinical data manager
  • Clinical development related IT professional
  • QC/QA professional
  • Regulatory affairs professional

Contact Information 

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

Tel: +81-3-5575-2130
Fax: +81-3-3583-1200

Program Committee 

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Day 1 Thursday, Feb 27, 2014

  • 9:00AM - 9:30AM

    Monitoring Chatting Session (MCS)
  • 9:30AM - 11:30AM

    Monitoring Chatting Session ~ (Japanese Language only)


    • Midori Fujikawa
      Leader, Clinical Research Coordination Dept.
      Chugai Pharmaceutical Co., Ltd., Japan
    • Norio Shimazaki
      Site Manager, Regional Clinical Operation
      Bristol-Myers K.K., Japan
    • Kazumasa Sugao
      Group Manager, Clinical Research Department II, Development Division
      Mitsubishi Tanabe Pharma Corporation, Japan
  • 1:00PM - 1:15PM

    Welcome and Opening Remarks


    • Ko Sekiguchi, MBA
      Senior Vice President and Managing Director, DIA Japan
      DIA Japan, Japan
    • Eri Sekine
      Head of Oncology Biometrics and DM Department, Oncology Development
      Novartis Pharma K.K., Japan
  • 1:15PM - 2:15PM

    The Center of “Excellence” - New Model for Clinical Study in Japan in the Risk-based Monitoring Era

    Session Chair(s):

    • Suzuko Oikawa
      Director, Clinical Research
      Bristol-Myers K.K., Japan
    • Kyoji Tamanoi
      Senior Clinical Trial Manager, Clinical Operations
      ICON Japan K.K., Japan

    To continue improvement in clinical study operation it seems very important to understand the basic concept of Risk-based Monitoring when we pursue Operational Excellence. At this Keynote Session we will go back to the very basic point of ‘What is the risk?’ and ‘What kind of framework is required to manage the quality based on the risk?’. Then the concept of Risk-based Monitoring will be shared.


    • Risk-based Quality Management
      Hiroe Tsubaki, DrSc, PhD
      Vice Director-General
      The Institute of Statistical Mathematics, Japan
    • Risk-Based Monitoring: From PMDA Point of View
      Seiko Miyazaki, PhD
      Director, Office of Conformity Audit
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 3:45PM - 5:15PM

    Session 2: Progress of IT technology used in Site Monitoring Activity

    Session Chair(s):

    • No-image Hiroshi Kosaku
      IPD Company President
      CMIC HOLDINGS Co., Ltd., Japan
    • Keiichi Inaizumi
      Study Manager, Japan Development & Clinical Alliance Management
      Pfizer Japan Inc., Japan

    IT technology used in site monitoring activity has been progressing every year. Not only the allocation system of the investigational product (e.g. IVRS) and EDC (Electronic Data Capture), which are used by sponsors and in clinical sites, but also the ePRO (Electronic Patient Reported Outcomes) into which patients input data directly are increasingly introduced in clinical studies. Site monitoring activity has been changing along with this progress of IT technology. Moreover, the government is proposing further use of IT technology in the ‘clinical research and clinical trial activation five year plan 2012’ initiative. The efficiency improvement of clinical trials using IT technology is also promoted. The near-futuristic measures, which integrate the patient’s information among the clinical sites and transfer the data in a patient’s medical record into EDC, have already started. In accordance with these changes the new approaches for efficiency improvement of clinical trials at clinical sites have also begun to be taken according to the 5-year plan. In this session we are introducing the progress of IT technology used in site monitoring activity and the approaches. This will be a great opportunity for you to learn and discuss how it will change the field’s future.


    • Outline and Challenges of ePRO
      Motohide Nishi, MBA
      Director, Asia Pacific Data Sciences & Solutions
      Eli Lilly Japan K.K., Japan
    • Think Different: Future Monitoring Activities Enabled by IT Technology
      Osamu Komiyama
      Senior Manager, Statistical Research & Consulting Group, Clinical Statistics
      Pfizer Japan Inc., Japan
    • The Initiative of Applying Advanced IT Technology to Clinical Studies by National Hospital Organization
      Suminobu Ito, MD, PhD
      Director, Clinical Research Center
      National Hospital Organization Headquarters, Japan
    • Progress of IT Technology for Clinical Trials and Problems found by GCP Inspection
      Mitsune Yamaguchi, PhD
      Manager, Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Day 2 Friday, Feb 28, 2014

  • 9:00AM - 11:30AM

    Session 3: Discussion on Risk-based Monitoring Approach from a Clinical Operations Perspective

    Session Chair(s):

    • Mitsuo Hayashi, MSc
      Director, Site Monitoring, Clinical Operation Area, Japan Development
      MSD K.K., Japan
    • Satoshi Saeki
      Senior Manager
      Astellas Pharma Inc., Japan

    The last few years have seen a dramatic change in the environment surrounding clinical development, with IT advances such as EDC, IWRS and ePRO enabling sponsors to monitor the status and progress of clinical trials both remotely and in a timely manner. These changes have led Europe and the US to build on the Risk-based Quality Management approach and propose Risk-based Monitoring, a new concept designed to protect subjects and maintain clinical trial data integrity more efficiently. This concept is prompting a fundamental revision of the traditionally held views on monitoring. In Japan, where discussions for introducing Risk-based Monitoring have just begun, the specifics of how to adapt Risk-based Monitoring to current practices are still to be defined. In this session, the key success factors for the implementation of Risk-based Monitoring will be presented from the viewpoint of a non- Japanese CRO, and the specific activities undertaken by both domestic and foreign pharmaceutical companies in Japan to successfully implement Risk-based Monitoring will be described. In addition, representatives from PMDA and a study site will also join the panel discussion and directions of Risk-based Monitoring, which we should seek for in Japan, will be discussed from respective positions.


    • FDA Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring
      Ann Meeker-O'Connell, MS
      Senior Director, QA Clinical Strategy Team Lead
      Janssen Pharmaceuticals, Inc., United States
    • Key Factors for the Success of Risk-based Monitoring
      Kyle Given
      Medidata Solutions Worldwide, United States
    • Initiatives taken by Japanese company to adapt Risk-based Monitoring
      Yuta Yamaga
      Mitsubishi Tanabe Pharma Corporation, Japan
    • Initiatives taken by Foreign Affiliated Company to adapt Risk-based Monitoring
      Keiji Funayama, PhD
      Field Operation Group, Oncology Global Development, Oncology Development Dept
      Novartis Pharma K.K., Japan
    • Efforts to Adapt Risk-based Monitoring in a Clinical Trial Site
      Yuji Kumagai, MD, PhD
      Director, Clinical Trial Center
      Kitasato University East Hospital, Japan
    • Mari Shirotani
      Office of Safety I
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
  • 1:00PM - 2:30PM

    Session 4: Improvement of Process and Productivity

    Session Chair(s):

    • Toshiko Ishibashi, PhD, RN
      Clinical Research Coordinator
      St. Luke's International Hospital, Japan
    • Mikiro Kobayashi
      Associate Manager, MDC-J Oncology, Development & Medical Affairs Div
      GlaxoSmithKline K.K., Japan

    In keen global competition of drug development, Japan has been required to lower the cost and increase the speed of clinical trials while maintaining the quality of clinical operations. Due to these circumstances various actions aimed at improvement of productivity are underway in sponsors and clinical trial sites. On the other hand, unnecessary data collection and procedures are often seen and these inhibit the productivity in the sites. At last year’s meeting the “Lean Six Sigma” procedure was introduced and discussed to resolve CRF related issues and to lead to improvement activities of clinical trials. During this session we will go one step further from the topics of last year and introduce the efforts to promote patients’ enrolment in a site, the activities to improve productivity, and efforts to reduce queries of CRF in a pharmaceutical company. Concrete efforts using the procedure of Lean Six Sigma in collaboration with a sponsor and a clinical trial site will be also introduced. In addition, Toshio Miyata, who previously worked on revising GCP ministerial ordinance/notification at the Ministry of Health, Labour and Welfare, Pharmaceutical and Food Safety Bureau Evaluation and Licensing Division, will point out current wasteful processes in clinical trials.


    • What is the True Quality of Clinical Trials? Eliminate “Japanese ALCOA”!
      Toshio Miyata, MD
      Executive Director
      Health and Global Policy Institute, Japan
    • Lean Six Sigma in Drug Development
      Hirotaka Inoue
      Head, Leading Changes Office, Japan Development & Medical Affairs
      GlaxoSmithKline K.K., Japan
    • Proposal from medical institutions for CRC/CRA to conduct clinical operations effectively using Lean Six Sigma
      Naoto Awaji, MSc
      Group Manager, Data Science Group, Biometrics Dept.
      Chugai Clinical Research Center Co., Ltd., Japan
    • Rie Nakamura
      Oncology Global Monitoring Operation
      Novartis Pharma K.K., Japan
    • Effort for Eliminating Wasted Data and Queries
      Kanako Chida
      Oncology Data Management, Oncology Biometrics and Data Management
      Novartis Pharma K.K., Japan
    • Improvement of Productivity at Study Site - Effort for Implementation of Subject Entry
      Toshiko Ishibashi, PhD, RN
      Clinical Research Coordinator
      St. Luke's International Hospital, Japan
  • 4:00PM - 5:30PM

    Summary Discussion


    • Midori Fujikawa
      Leader, Clinical Research Coordination Dept.
      Chugai Pharmaceutical Co., Ltd., Japan
    • Norio Shimazaki
      Site Manager, Regional Clinical Operation
      Bristol-Myers K.K., Japan
    • Kazumasa Sugao
      Group Manager, Clinical Research Department II, Development Division
      Mitsubishi Tanabe Pharma Corporation, Japan


The 2nd DIA Clinical Operation & Monitoring Workship in Japan offers interested companies the opportunity to exhibit with a tabletop display.

2,300 x 1,700 mm booth space..........¥210,000*
NOTE: *fee includes 5% Japanese Consumption Tax

Booth Rental Fee includes (per 2,300mm x 1,700m 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 ¥12,600 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: February 27-28, 2014

Useful Links:

  • Fujitsu Limited
  • Information Mediary Corporation
  • Japan Medical Association Center for Clinical Trials
  • Makrocare K.K.
  • Medidata Solutions K. K.

Registration Fees 


Member Academia
Member Government
Member Standard


NonMember Academia
NonMember Government
NonMember Standard
Group Discounts

There are no group discounts for this event.

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.

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