Basel, September 2, 2008

1. 3rd German CDISC User Group Meeting Basel, September 2, 2008

2. 3rd German CDISC User Group Meeting Herzlich willkommen in Basel!

3. 3rd German CDISC User Group MeetingSome words about Basel • Third most populous city with 166,209 inhabitants (2008) • 731,000 inhabitants in the metropolitan area • Oldest university of the Swiss Confederation (1460) • Basel was called "Basilia" in Latin, and this name is documented from the year 374 AD • In 1225–1226 the Bridge over the Rhine was constructed lesser Basel (Kleinbasel) founded as a beachhead to protect the bridge • In 1356 the Basel earthquake destroyed much of the city • In 1501 Basel joined the Swiss Confederation as 11th canton

4. F. Hoffmann-La Roche AG Shaped by “family values” for over 110 years Adele and Fritz Hoffmann-La Roche

5. Roche Basel then … 1896 1945

6. … and tomorrow Roche Basel today

7. RocheAppliedScience RocheMolecularDiagnostics Genentech RocheProfessionalDiagnostics VentanaMedicalSystems Chugai RocheDiabetesCare Roche Group Structure Pharmaceuticals Diagnostics RochePharma

8. Basel headquarters One of Roche’s largest centers Group and divisional management, Corporate Executive Committee functions Global management of R&D, production and marketing More than 7,500 employees Pharma research: metabolic disorders, diseases of the central nervous system Pharma production: around 20 medicines are manufactured in Basel Pharma packaging and logistics centre in Kaiseraugst

9. 3rd German CDISC User Group MeetingAgenda - Morning

10. 3rd German CDISC User Group MeetingAgenda - Afternoon

11. CDISC User Group Organization Bylaws Chair and Executive Committee Work Streams Update on CDISC User Group Portals Updates from Other CDISC User Groups

12. Global CDISC User NetworkGeneral objectives • Support CDISC • Test models • Propose implementation approaches • Propose new domains • Provide a network to address domain specific issues • Promote/distribute standards • Support CDISC activities • Support User Community • Provide more direct links to CDISC Organization • Contact Network • Discussion Forum • Expansion of community (i.e., other Networks) • More involvement • Support for implementation • Documentation of issues/resolutions • Access to documentation (regardless of implementation level at individual company)

13. Charter Bylaws 1 Bylaws 2 Bylaws 3 BylawsDefinition • Bylaw is a rule governing the internal management of an organization, such as a business corporation. • In a business situation, bylaws are drafted under the authority of its Charter or Articles of Incorporation. The bylaws contain the most fundamental principles and rules regarding the nature of the organization. They widely vary from organization to organization, but generally cover topics such as how directors are elected, how meetings of directors (and in the case of a business, shareholders) are conducted, and what officers the organization will have and a description of their duties. • Unless otherwise provided by law, the organization does not formally exist until bylaws have been adopted. CDISC GlobalUser Network(CGUN) CDISC RegionalUser Network 1 (CRUN 1) CDISC RegionalUser Network 2(CRUN 2) CDISC RegionalUser Network 3(CRUN 3)

14. German CDISC User Group BylawsArticle 1 - Name • The name of the organization shall be the German CDISC User Group, hereto after referred to as “the User Group.”

15. German CDISC User Group Bylaws Article 2 – Purpose and Objectives • Purpose - The User Group is an independent, grassroots community of CDISC Users, committed to the open exchange of knowledge and information on the implementation of CDISC standards with local users from german-speaking European countries. Other interested parties are welcome to participate as well. • Objectives – The objectives of theUser Group are to: • Provide a venue for presentations and discussions about the CDISC standards • Provide a forum for participants to share knowledge and cooperatively address CDISC standards implementation issues • Elevate the level of familiarity of CDISC among participants and within participating organizations • Act as a liaison to the national and regional CDISC organizations • Provide a cooperative voice for pharmaceutical and biotechnology companies, universities and institutions, and service providers from german-speaking European countries for discussion of standards and related regulations

16. German CDISC User Group Bylaws Article 3 – Membership • Participation in the User Group shall be open to all who share in its purpose.

17. German CDISC User Group Bylaws Article 4 – Committees • Members for the Executive Committee will be elected by the German CDISC User Group participants in a general meeting and by a simple majority and will serve for a term of approximately 2 years. The Executive Committee shall consist of a minimum of 3 people. • The Executive Committee shall manage the business of the User Group. The Executive Committee may eliminate committees and may establish new committees as necessary to carry out the objectives of the User Group. The responsibilities of the Executive Committee are; • Plan and run general meetings • Communicate with membership • Communicate with CDISC and other organizations • Maintain Bylaws document • Form and/or participate on subcommittees or work streams • Any other business of the User Group as required

18. German CDISC User Group Bylaws Article 4 – Committees (cont.) • The Executive Committee will elect a Chair who will serve a term of approximately 2 years by a simple majority. Candidates for the Executive Committee Chair should have an active record of service in the User Group and should usually have served on the Executive Committee. • The Executive Committee may charter permanent or ad hoc committees or work streams as necessary to carry out the objectives of the User Group. The Executive Committee will solicit participation on these committees or work streams from the general membership. An Executive Committee member will lead each committee or work stream. • The Executive Committee and other committees or work streams shall generally make decisions regarding User Group business based on consensus. In the event that a committee or work stream chooses to take a vote on a matter, all present at the meeting shall have the right to one vote and decisions will be made by a simple majority.

19. German CDISC User Group Bylaws Article 5 – Meetings • Executive Committee Meetings – Teleconferences shall be held on a bi-monthly basis, or as deemed necessary by the Executive Committee. Members shall be notified of the time and place of the Meeting with 7 day minimum notice. • General User Group Meetings – approximately two to three meetings shall be held over the course of each year at a place and time determined by the Executive Committee or its designee. Members shall be notified of the time and place of the Meeting with 3 months minimum notice and a draft agenda shall be submitted with 28 day minimum notice. • Other committees or work streams shall meet as deemed necessary. All meetings and teleconferences of the User Group shall be open to all.

20. German CDISC User Group Bylaws Article 6 – Voting • All present at a Meeting shall have the right to one vote, except as otherwise specifically provided in the Bylaws. • Decisions will be made by simple majority of the participants present if unanimous consensus cannot be reached. There is, however, an exception for amendments to the Bylaws (see Article 8).

21. German CDISC User Group Bylaws Article 7 – Dues • The User Group shall not charge dues for membership. Voluntary contributions such as providing meeting facilities, teleconference services, or refreshments are welcomed.

22. German CDISC User Group BylawsArticle 8 – Amendments • Amendments to the Bylaws may be proposed by any participant of the User Group. The Bylaws must be amended by at least ten participants and constituting two-thirds affirmative vote of those present. • Notice of proposed changes to the Bylaws must be announced by the Executive Committee to the General Membership at least 28 days prior to each vote. • Amended Bylaws will be effective immediately upon approval, unless otherwise requested in the proposed change or recommended by the Executive Committee.

23. German CDISC User Group BylawsArticle 9 – Dissolution • Dissolution of the User Group will occur by a general meeting and has to be agreed by a two-thirds affirmative vote of those present. • TASK: Bylaws to be agreed by German CDISC User Group

24. German CDISC User GroupElection of Chair and Executive Committee Proposal: • Chair: • Daniel Rehn, F. Hoffmann-La Roche AG • Executive Committee: • Jozef Aerts, XML4Pharma GmbH • Kurt Hellstern, Hands-On GmbH • Monika Kawohl, Accovion GmbH • Elke Sennewald, Kendle • Sebastian Claudius Semler, TMF e.V. • TASK: Chair and Executive Committee to be elected by German CDISC User Group to serve a term until (and including) first user group meeting in 2010

25. German CDISC User GroupEstablishment of Work Streams Proposed work streams: • ODM, led by Jozef Aerts, XML4Pharma GmbH • SDTM (incl. CDASH and controlled terminology), led by Kurt Hellstern, Hands-On GmbH • ADaM, led by Elke Sennewald, Kendle • define.xml / eSubmission, led by Monika Kawohl, Accovion GmbH Work stream tasks: • Information exchange • Best practices (discuss, prepare, present) • Implementation issues • Requests for new requirements • Discussion of work stream goals and meeting schedule (TCs) • TASK: Proposed work streams to be agreed by German CDISC User Group

26. German CDISC User Group PortalCurrent http://groups.yahoo.com/group/german_cdisc_ug/

27. German CDISC User Group PortalFuture http://cdiscportal.digitalinfuzion.com/Global%20User%20Networks/Europe/German%20Language/default.aspx/

28. Regional CDISC User GroupsContact Network • Regional CDISC User Group Portals • News / Announcements • Shared documents • Discussions • Surveys • Member lists with profiles • German CDISC User Group Meetings • CDISC News • Case Studies and Best Practices • Work Streams

29. Other CDISC User GroupsUpdate US User Groups European User Groups English CDISC User Group Chicago Nordic CDISC User Group Seattle Boston Area Washington, D.C. Area Atlantic (NY, NJ, PA) German CDISC User Group Bay Area Delaware Area French CDISC User Group Research Triangle Park Italian CDISC User Group

30. English CDISC User Group Overview on CDISC models Trial Design Model implementations TC recordings (LiveMeeting) User discussionswhat was done, what were the lessons learnt Review of real SDTM focused implementations Achieving system integration How have companies handled terminology (e.g. company terminology versus CDISC terminology) How have companies handled bought-in applications contributing to CDISC implementation (developing a business case, choosing a vendor, working with the vendor to implement the application, vendor support, measuring benefits) Delaware Area CDASH introduction and practical implementation tutorials SDTM mapping tutorials Introduction to the CDISC Analysis Data Model (ADaM) Implementation Guide Overview/Update of the Oncology SDS subteam, and the proposed Tumor Identification and Tumor Results (measurements) domains Overview of SDTM v3.1.2 feedback Contribution to CDISC Controlled Terminology Terminology gap analysis spreadsheet CDISC NewsSelected regional user group updates

31. Research Triangle Park CDISC roadmap and overview on CDISC models ADaM Overview, Case Study and Discussion New SAS tools Discussion on the implementation of SDTM Discussion on tools for CDISC implementation Posting of relevant job openings Washington, D.C. Area CDISC roadmap and overview on CDISC models Integrated CDISC Safety Data Pilot PDUFA IV IT Plan overview by FDA CDISC NewsSelected regional user group updates

32. Other CDISC User GroupsFurther information

33. CDISC News General news BRIDG – M. Regenass, Wega Informatik AG ADaM – E. Sennewald, Kendle

34. CDISC NewsUpcoming webcasts The CDISC-HL7 Protocol Representation Standard:Monday, September 8, 2008 11am-12:30pm Eastern Time USAThis webcast will explore the benefits and value of a protocol representation standard and will provide an update on the progress that has been made through a joint CDISC and HL7 project. There will be an introduction of the history of the structured protocol, followed by a presentation on the Trial Design Model, which is used in both the protocol standard and the CDISC standard for regulatory submission of case report form data Study Data Tabulation Model (SDTM), and a presentation on the Biomedical Research Integrated Domain Group (BRIDG) model, into which the protocol standard is harmonized along with other standards for protocol-driven research. Two implementations will be reviewed – one on the use of structured standard eligibility criteria (enhanced to be specific to a therapeutic area) for identifying potential study subjects and one on facilitating study start-up from protocol through CRF generation through the use of the Protocol Representation Standard and the CDISC Operational Data Model (ODM).

35. CDISC Newsv-Learning • CDISC is now offering training courses and conference proceedings in a virtual learning format. • The virtual learning format - a computer based, web delivered - allows for students to learn at their own pace on their own schedule • The sessions are available online for use on the student’s own desktop • Users gain access to interactive CDISC topics and courses • The course content is the same material which is taught in an instructor-led classroom • Sessions contain audio and video demonstrations, self study workshops and solutions • V-Learning modules currently available: • CDISC Submission Readiness • Intro to CDISCNew! • Intro to BRIDGNew! • CDISC 2008 European Interchange conferenceNew!

36. PhUSE 2008 Conference “Working in a Global Environment” 12 - 15 October 2008The Midland Hotel26 Brabyne Brow, Stockport Manchester SK6 5DT Preliminary Program Focus on Clinical Programming, Data Management and Statistics CDISC stream and panel discussion http://www.phuse.eu/Conference-2008.aspx CDISC 2008 International Interchange 26 - 31 October 2008Marriott Crystal Gateway1700 Jefferson Davis HighwayArlington, VA 22202 Preliminary Program Training courses Workshops Main conference with parallel tracks http://www.cdisc.org/events/index.html CDISC NewsUpcoming events

37. CDISC Case Studies ODM-based CRF print-outs and SAS export – M. Walter, Roche Diagnostics GmbH CDISC-based eSubmission – M. Kawohl, Accovion GmbH

38. CDISC User Group Work Streams ODM – Michael Walter, Roche Diagnostics GmbH (a.i.) SDTM – K. Hellstern, Hands-On GmbH ADaM – E. Sennewald, Kendle Define.xml – M. Kawohl, Accovion GmbH

39. CDISC User Group Work StreamsGoals • Sharing of expertise and knowledge • Sharing of useful tools (e.g. Stylesheets, ODM vendor extensions, SAS macros) • Joint mock eSubmission • Test new CDISC models and provide joint feedback • Identification of implementation examples • Case studies • Best practices document • Identification of implementation issues • Discussion of implementation issues and proposal of joint solutions / implementation approaches • Case studies, FAQs • New requirements • Requirements document (e.g. stylesheet improvements, new SDTM domains) • Goals 2009 • What do we want to achieve? • Meeting schedules of work streams

40. 3rd German CDISC User Group MeetingAgenda - Afternoon

41. CDISC User Group Discussion Work stream summaries Best practices Topics of interest Next meeting / Meeting locations Q&A

42. Herzlichen Dank! • Bis zum nächsten Mal und… • weitere Teilnehmer sind immer willkommen! • Kontakte: • Chair/Coordinator: Daniel Rehn (daniel.rehn@roche.com) • ODM Work stream: Jozef Aerts (jozef.aerts@xml4pharma.com) • SDTM Work stream: Kurt Hellstern (kurt.hellstern@hands-on.ch) • ADaM Work stream: Elke Sennewald (sennewald.elke@kendle.com) • Define.xml Work stream: Monika Kawohl (monika.kawohl@accovion.com) • Organization/Interfaces: Sebastian Semler (sebastian.semler@tmf-ev.de)