16th Annual Workshop in Japan for Clinical Data Management: SMART CDM

Overview

Limited Onsite Registration still available.

As the international meeting for professionals, we encourage all levels, from beginners to experts, to participate this annual meeting, and we hope to provide a more sophisticated program than ever before. Changes in ‘Information’ and ‘Technology’ are fast-growing, complex, global, and massive. Recently, however, we can hear the word ‘smart’ regarding these changes – because people don’t hope to be swayed by them, they hope to take advantage of them. We think that the environment surrounding the CDM is similar to this. Therefore the theme was determined as “SMART CDM” because we would like to consider with you how we can foster smart CDM. This workshop is expected to form sessions on the following topics.

Standardization, Safety, Speedy, Strategy, Simplification
Management, Metrics, Metadata, Multinational
Assurance, Asia, Adaptive design, Accuracy
Risk based approach, Regulation, Reliability, Relationship
Technology, Teamwork, Terminology, Translate

Objectives of this workshop are to improve the quality of clinical research and data management activities. This annual workshop will provide information to attendees about the international clinical data management and attendees will get opportunities to network with colleagues in global Clinical Data Management.

Simultaneous Translation Available

Who Should Attend

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

Hotel & Travel

There are a limited number of rooms at the Hotel Grand Palace at the reduced rates shown below. Room availability at this rate is guaranteed only until January 6, 2013 or until the room block is filled.
Attendees should make their airline and room reservations as soon as possible.
Single ¥ 18,050/night / Twin ¥ 21,525/night
1-1-1 Iidabashi, Chiyoda-ku, Tokyo 102-0072, Japan
Tel: +81-(0)3-3264-3078
Fax: +81-(0)3-3230-6822
toru-ishikawa@grandpalace.co.jp
http://www.grandpalace.co.jp/english/index.html
To reserve your room, please contact the Hotel Grand Palace above and mention the DIA Workshop or click here for the Hotel Reservation Form.

Contact Information

DIA Japan, Nisso 22 Building, 7F, 1-11-10 Azabudai, Minato-ku,
Tokyo 106-0041 Japan
Tel: +81-3-5575-2130
Fax: +81-3-3583-1200
diajapan@diajapan.org

Tabletop Exhibit Opportunity

Program Committee

Previous Next

Program Committee 1-3 of 10

Yukiko Nagata

Manager, Clinical Data Management, Clinical Data Science Dept.
Takeda Pharmaceutical Company Limited, Japan

Makoto Yokobori

President
SUXAC Inc., Japan

Manami Hashimoto

Oncology Data Management Group, Oncology Biometrics and Data Management Dept.
Novartis Pharma K.K., Japan

Program Committee 4-6 of 10

Kenji Nagaya

General Manager, Clinical Data Management and Biostatistics
NIPPON KAYAKU Co., LTD., Japan

Ken Katayama

Chief Clinical Researcher, Clinical Development I, Clinical Development Dept. II
Kowa Company Ltd., Japan

Mariko Mizumoto

Manager, Data Mgt. Group, Clinical Data & Biostatistaics Dept.
Daiichi Sankyo Co., Ltd., Japan

Program Committee 7-9 of 10

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

Hideaki Ui

Principal Inspector, Office of Conformity Audit
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Program Committee 10-10 of 10

Keisuke Utsumi

Section Manager, eDM Section, Biomedical Data Sciences Department
GlaxoSmithKline K.K., Japan

Agenda

Day 1 Thursday, February 07, 2013

9:30AM - 11:30AM
CCS(CDM Chatting Session) - Conducted in Japanese only
Speaker(s):
- Kazuki Furuno
  Manager, Clinical Development Planning & Management
  Mochida Pharmaceutical Co., Ltd., Japan
- Masako Karino, PharmD
  Group Manager, Post-Marketing Study Data Management & Biostatistics Group
  Mitsubishi Tanabe Pharma Corporation, Japan
- Takeshi Kawakami
  Japan Clinical Informatics & Innovation, Development Operations
  Pfizer Japan Inc., Japan
- Junji Kobayashi
  Biostatistics & Data Management Group
  Santen Pharmaceutical Co., Ltd., Japan
- Hidenobu Yoshida
  Japan Data & Statistical Sciences Group Manager
  Abbott Japan Co., Ltd., Japan
1:00PM - 1:10PM
Welcome and Opening Remarks
Speaker(s):
- Makoto Yokobori
  President
  SUXAC Inc., Japan
1:10PM - 3:10PM
Session 1: Journey to SMART CDM

Session Chair(s):
- Manami Hashimoto
  Oncology Data Management Group, Oncology Biometrics and Data Management Dept.
  Novartis Pharma K.K., Japan
- Keisuke Utsumi
  Section Manager, eDM Section, Biomedical Data Sciences Department
  GlaxoSmithKline K.K., Japan
Do you have a picture for “SMART CDM”? Changes in the world are very fast. Especially ‘Information’ and ‘Technology’ are growing to be complex, globalize, and mass. CDM is expected to be simple and cool (= SMART!). In this session, we would like to discuss what is “SMART CDM” from standardization, technology, process, communication, and so on. Shall we enjoy “SMART CDM”!

Speaker(s):
- Reconsideration of Clinical Data Management
  Hiroshi Ohtsu, MS
  Project Assistant Professor, Department of Clinical Trial Data Management,
  The University of Tokyo, Japan
- Win the Global Clinical Data Management Battlefield -SMART Way!
  Divya K Bhati, MBA,MSc,PMP
  Research Scholar
  Institute of Health Management Research (IIHMR), India
- Different Departments, Different Needs – is there really ONE Standard Management Possible?
  Claus Lindenau, PhD
  Managing Director
  ClinFusion, Germany
- Standards for Clinical Research: What Data Managers Should Know
  Anita Walden
  Sr Informacist, Biomedical Informatics
  Duke Translational Medicine Institute, United States
3:40PM - 5:45PM
Session 2: Approaches for Global Studies – Asian Challenges

Session Chair(s):
- Mariko Mizumoto
  Manager, Data Mgt. Group, Clinical Data & Biostatistaics Dept.
  Daiichi Sankyo Co., Ltd., Japan
- Yukiko Nagata
  Manager, Clinical Data Management, Clinical Data Science Dept.
  Takeda Pharmaceutical Company Limited, Japan
Session 2: Approaches for Global Studies – Asian Challenges

Speaker(s):
- Implementation of CDISC standards and Clinical Data in English language – Endeavors by Mid-size Japanese Pharma –
  Junji Kobayashi
  Biostatistics & Data Management Group
  Santen Pharmaceutical Co., Ltd., Japan
- Reducing Data Management Challenges in Asian Studies
  Sourav Gupta
  Head-Strategy, DDi
  MakroCare, India
- Aim at Data Management as a Global Member
  Miyako Tanada
  Group Manager, Oncology Data Management Group
  Novartis Pharma K.K., Japan
- Our Experience of Executing a Multi-national Study Using Data Management Resource in Japan
  Yu Jincho, JD,MSc
  Clinical Data Scientist
  GlaxoSmithKline K.K., Japan

Day 2 Friday, February 08, 2013

9:00AM - 10:30AM
Session 3: Looking at SMART IT

Session Chair(s):
- Noriko Kawamura
  Group Manager, Data Management Group, Drug Development Div.
  Dainippon Sumitomo Pharma Co., Ltd., Japan
- Kenji Nagaya
  General Manager, Clinical Data Management and Biostatistics
  NIPPON KAYAKU Co., LTD., Japan
Session 3: Looking at SMART IT

Speaker(s):
- Do you Really use your Smart IT System Thoughtfully?
  Hiroaki Yasui, MBA
  Associate Director of Japan Operation
  Perceptive Informatics, Japan
- Single Source Data Collection and the Evolving Role of Data Managers of the Future
  Reza Rostami, MBA,RAC
  Assistant Director, Quality Assurance and Regulatory Compliance
  Duke Clinical Research Institute, United States
- Reusing data from Electronic Health Records in Clinical Trials
  Alan Yeomans, MSc
  Quality Manager
  Pharma Consulting Group AB, Sweden
11:00AM - 12:30PM
Session 4: Finding the Right Path: for SMART Data Integration and Interoperability

Session Chair(s):
- Junko Kondo
  Onshore Liaison, Business Process Outsourcing
  Accenture Japan, Japan
- Motohide Nishi, MBA
  Director, Asia Pacific Data Sciences & Solutions
  Eli Lilly Japan K.K., Japan
Session 4: Finding the Right Path: for SMART Data Integration and Interoperability

Speaker(s):
- Using Metadata Repository to Improve Clinical Data Integration
  Srinivasan Anandakumar
  Associate Director, Projects
  Cognizant Technology Solutions Corporation, United States
- Standardization of Clinical Study Databases: on the Value of Metadata Driven Data Modeling
  Charlotte Mauron, MSc
  Senior Manager
  F. Hoffmann-La Roche, Switzerland
- Subra Subramanian, MBA
  Director, Product Strategy
  Oracle Health Sciences, United States
1:30PM - 3:45PM
Session 5: Face the "Risk Based Approach"

Session Chair(s):
- Yumi Sugiura
  Clinical Data Quality Manager, Regional Clinical Operation Japan
  Bristol-Myers K.K., Japan
- Makoto Yokobori
  President
  SUXAC Inc., Japan
Session 5: Face the "Risk Based Approach"

Speaker(s):
- Optimizing data validation
  Andrew Newbigging
  Senior Vice President, Development
  Medidata Solutions Worldwide, United Kingdom
- TCS Solution for SMART CDM
  Devraj Goulikar
  Head, Platform Solutions Life Science
  TATA Consultancy Services, India
- The FDA Guidance of Risk-based Approach to Monitoring as Viewed by CDM
  William Gluck, PhD,MS
  Vice President, DCCS
  DATATRAK International, United States
- Multivariate Bayesian Logistic Regression for Clinical Safety Data
  William DuMouchel, PhD
  Chief Statistician
  Oracle Health Sciences, United States
4:15PM - 4:35PM
CCS (CDM Chatting Session) Report
Speaker(s):
- CCS (CDM Chatting Session) Report
  Kazuki Furuno
  Manager, Clinical Development Planning & Management
  Mochida Pharmaceutical Co., Ltd., Japan
4:35PM - 6:00PM
Session 6: Let’s Discuss what the Integrity is!

Session Chair(s):
- Kenji Nagaya
  General Manager, Clinical Data Management and Biostatistics
  NIPPON KAYAKU Co., LTD., Japan
- Hideaki Ui
  Principal Inspector, Office of Conformity Audit
  Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Keisuke Utsumi
  Section Manager, eDM Section, Biomedical Data Sciences Department
  GlaxoSmithKline K.K., Japan
Speaker(s):
- Let's Discuss What the Integrity Is! - From Regulator’s Point of View
  Hideaki Ui
  Principal Inspector, Office of Conformity Audit
  Pharmaceuticals and Medical Devices Agency (PMDA), Japan
- Let's Discuss what the Integrity is! - From CDM's Point of View
  Makoto Yokobori
  President
  SUXAC Inc., Japan

Exhibits

The 16th Annual Workshop in Japan for Clinical Data Management: SMART CDM offers interested companies the opportunity to exhibit with a tabletop display.

Fee:
2,300 x 1,200 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: February 7-8, 2013

Useful Links:

Application & Contract for Exhibit Space
Exhibit Personnel Registration Form
ADDITIONAL Exhibit Booth Personnel Registration Form (limit 3 per booth space; cancellations receive NO refund)

Exhibiting Companies 1-12 of 12

ASKLEP Inc.
Bracket Global
Cognizant Japan K.K.
DSG, Inc.
Makrocare K.K.
Medidata Solutions K. K.
NTT Data Corporation
Oracle Corporation Japan
PAREXEL International Inc.
Pharma Consulting Group Japan K.K.
the Uppsala Monitoring Centre
TIBCO Software Japan Inc.

Registration Fees

Member

Charitable Nonprofit/Academia Member: ¥25000.00
Member Government: ¥25000.00
Member Standard: ¥48000.00

Non-Member

Charitable Nonprofit/Academia Nonmember: ¥40000.00
NonMember Government: ¥40000.00
NonMember Standard: ¥63000.00

Group Discounts

There are no Group Discounts for this event.

CANCELLATION POLICY: On or before November 12, 2012
Administrative fee that will be withheld from refund amount:
Industry (Member or Nonmember) = ¥21,400
Government/Academia/Nonprofit (Member or Nonmember) = ¥10,700
Tutorials Only (Member or Nonmember) = ¥6,000

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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