The 2nd JCG Meeting (January 28, 2004)1 The 2 nd Japan CDISC Group (JCG) Meeting 28 January 2004 Yoshio Tsukada JCG Leader

The 2nd JCG Meeting (January 28, 2004)2 Overview of JCG CDISC History in Japan CDISC History in Japan JCG Membership & Structure JCG Membership & Structure Expectations on CDISC in Japan Expectations on CDISC in Japan Current and Future Activity Current and Future Activity

The 2nd JCG Meeting (January 28, 2004)3 CDISC History in Japan Jan 2002First introduction in Japan Jan 2002First introduction in Japan May 2002CDISC Japan Meeting May 2002CDISC Japan Meeting Nov 2002J3C formed Nov 2002J3C formed Jan 2003JCG Kick-off Meeting Jan 2003JCG Kick-off Meeting Apr st JCG Meeting Apr st JCG Meeting May 2003Activities started May 2003Activities started Jan nd JCG Meeting Jan nd JCG Meeting

The 2nd JCG Meeting (January 28, 2004)4 JCG Membership & Structure Membership Two types of JCG Membership Contribute as a Corporate Sponsor/member Company Contribute as a Corporate Sponsor/member Company Contribute as an Individual Volunteer Contribute as an Individual Volunteer Devotes his/her time to CDISC activities in Japan for the time being, and recommend to be a Corporate sponsor/member in the near future

The 2nd JCG Meeting (January 28, 2004)5 Membership

The 2nd JCG Meeting (January 28, 2004)6 65 Individuals from 40 Companies Individual Company As of January 1, 2004

The 2nd JCG Meeting (January 28, 2004)7 Structure of JCG European CDISC Group

The 2nd JCG Meeting (January 28, 2004)8 J3C Japan CDISC Coordinating Committee Mineko Fujimoto (Schering) Rieko Ichihara (Pfizer) Hiroaki Matsuda (Boehringer-Ingelheim) Motohide Nishi (Yamanouchi) Nobuaki Sakashita (Parexel) Kiyoteru Takenouchi (Dendrite) Kazue Tomita (Eli Lilly) Masahiro Yokokawa (Parexel) Yoshio Tsukada (Aventis)

The 2nd JCG Meeting (January 28, 2004)9 Size of TF and Modeling Teams in JCG 46 (including team leader)

The 2nd JCG Meeting (January 28, 2004)10 Expectations on CDISC in Japan Facilitate ‘business’ processes among Investigators, Pharmaceutical companies, CROs, Clinical Laboratories, Technology vendors Facilitate ‘business’ processes among Investigators, Pharmaceutical companies, CROs, Clinical Laboratories, Technology vendors Increase efficiencies of performing clinical trials Increase efficiencies of performing clinical trials Facilitate reviews of regulatory submissions Facilitate reviews of regulatory submissions Provide means for long-term archive of electronic clinical trial data and digital signatures Provide means for long-term archive of electronic clinical trial data and digital signatures Support to utilize Foreign clinical data in Japan Support to utilize Foreign clinical data in Japan Support to provide Japanese clinical data to US/EU Support to provide Japanese clinical data to US/EU Fix the foundations for Multi-national/regional clinical trials including Japan Fix the foundations for Multi-national/regional clinical trials including Japan

The 2nd JCG Meeting (January 28, 2004)11 Support and facilitate CDISC implementation in Japan Support and facilitate CDISC implementation in Japan Contribute to the establishment of CDISC Standards included Japanese local requirements Contribute to the establishment of CDISC Standards included Japanese local requirements JCG Mission

The 2nd JCG Meeting (January 28, 2004)12 Current Activity (till 2003) Introduction and Learning CDISC in Japan Education & Membership Education & Membership PR/Communications PR/Communications Modeling Teams Modeling Teams  ODM (Operational Data Model)  LAB (Laboratory Data Model)  SDS (Submission Data Standards)  ADaM (Analysis Data Model) JCG Update

The 2nd JCG Meeting (January 28, 2004)13 Future Activity (2004 onward) Support and facilitate CDISC Implementation in Japan Increase Awareness Increase Awareness Share information in JCG Share information in JCG Organize Training Courses Organize Training Courses Influence Regulatory Authority Influence Regulatory Authority Facilitate CDISC Standards into daily business Facilitate CDISC Standards into daily business

The 2nd JCG Meeting (January 28, 2004)14 JCG: Past and Future Introduction phase Learning phase Implementation phase

The 2nd JCG Meeting (January 28, 2004)15 Nobuaki Sakashita (Education & Membership) Kiyoteru Takenouchi (PR/Coms) Mineko Fujimoto (Modeling) Yoshio Tsukada JCG Contacts

The 2nd JCG Meeting (January 28, 2004)16 Think Globally Act Locally Thank you! Japan CDISC Group