2001 Past Meetings and Presentations - 2001

7-9 May - Educational course on Clinical Data Management for PERI in Vancouver, Canada, presented by Kaye Fendt (CDISC Director on the Board).

10 May - The first official meeting of the Clinical Trial Special Interest Group (CT-SIG) Minneapolis, MN. Seven representatives from CDISC attended, representing LAB and ODM teams and the Board of Directors.

15 May - VFA Germany (Association of German Pharma Companies), meeting at Aventis, Frankfurt, Germany; Udo Siegmann (Parexel) presented on CDISC.

17 May - "The Future of Clinical Data Management" presented by Udo Siegmann (Parexel) for the Nordic Clinical Data Management (NCDM) Meetings, Star Hotel, Malmoe, Sweden.

19-23 May - Poster Session by the CDISC Education Committee at the annual conference for the Society for Clinical Trials,

21-23 May - The second DIA Workshop on "Data Standards for Clinical Development", chaired by Wayne Kubick and Rebecca Kush, 22-23 May 2001 in Washington, D.C. at the Washington Marriott. This Workshop was preceded by an associated Workshop "21CFR11 and the FDA Guidance for Computerized Systems Used in Clinical Trials", chaired by Paul Bleicher, on 21-22 May. (See www.diahome.org) CDISC presentations were made in both of these workshops. In addition, there was a luncheon on 22 May to discuss DIA-CDISC ongoing relationships, and the CDISC Industry Advisory Board met that evening to discuss the CDISC Strategic Plan.

6 June - The New Jersey Chapter of the American Statistical Association Spring Symposium on "International Harmonization and Electronic Submission" in Piscataway, NJ. Speakers included Robert O'Neill (CDER, FDA), Weichung Joe Shih (UMDNJ-School of Public Health), Richard Simon (Biometrics, NCI), Steve Wilson (CDER, FDA), and Michael Walega (Biometrics, Covance). Presentations included CDISC.

11-13 June - The Marcus Evans Second Annual Internet Solutions for Clinical Trials Conference (www.marcusevans.com/SearchE/searchset.html) in Washington, D.C. featured a CDISC presentation by Rebecca Kush (CDISC President).

25-26 June - The RAPS Electronic Submissions Meeting, San Diego, CA included a presentation on the CDISC SDS initiatives by Laurence Wallmann (Quintiles Transnational) and one on ADaM by Dave Christiansen (CDISC Director on the Board).

27-29 June - A Pharma R&D Directions Europe 2001 incorporating e-R&D Conference, was held in Barcelona. ECPI (European Centre for Pharmaceutical. Axel Rolle (Novartis) included CDISC in his presentation at this conference.

2-3 July - Presentation on CDISC at the IIR European Clinical Data Management meeting in London by Kaye Fendt (CDISC Director on the Board).

8-12 July - For the 37^th DIA Annual Meeting 2001 in Denver, CO (Denver Convention Complex), CDISC had a session, chaired by Rebecca Kush, in the Clinical Track on 10 July from 1:30-3:00 entitled "Industry Standards for Clinical Data Interchange to Streamline the Clinical Trial Process". Presenters included Axel Rolle (Novartis), Udo Siegmann (Parexel), Wayne Kubick (Lincoln Technologies), Richard Tresley, M.D. (Merck), and Steve Wilson (FDA). Rick Ferris (PHT) provided an educational seminar on XSL the morning of 10 July and that evening was the "Clinical Data Connectathon" during a reception jointly sponsored by numerous CDISC Corporate Sponsors and Members. Details on this activity are on the CDISC website.

13 September - Udo Siegmann, Leader of the CDISC European Contact Group, presented to VFA (R&D Pharma Germany) in Berlin, Germany.

24-27 September - Society for Clinical Data Management postponed their Annual Conference to 3-5 February 2002. There will be a presentation and a tutorial on CDISC at this conference.

30 September - 2 October - DIA Clinical Laboratories Meeting was held in Evian, France. The event was chaired by David Cocker and the chair of the DM session was Graham Bunn. Speakers on a CDISC session included Sally Cassells (PHT), who presented on "Standardizing Transmissions from Central Labs" and Graham Bunn, who presented on a Clinical Application Platform that uses CDISC standards to transfer data seamlessly from lab to DM system.

1-5 October - There was another week of HL7 Working Group Meetings in Salt Lake City, UT, along with representatives from each of the CDISC Working Teams. These included CDISC team meetings, CT-SIG meetings and strategic meetings among FDA, CDISC and HL7 Board representatives. Notes from these meetings are available for anyone interested.

15-16 October - Presentation made by Udo Siegmann (PAREXEL), European Contact Group Leader, at the Applied Clinical Trials Electronic Trial Management Conference in London, UK.

16-17 October - CDISC Board of Directors Meeting, Chicago, IL

22-23 October - Udo Siegmann (PAREXEL) made a CDISC presentation at the eyeforpharma e-Marketing and Sales Conference in Amsterdam.

22-23 October - Informatics Advisory Council 2^nd Annual Meeting, Menlo Park, CA, Sun Microsystems Campus - Presentation on CDISC and potential for collaboration with other standards groups, Kaye Fendt.

29-31 October - DIA European Clinical Data Management Meeting 'The Information Exchange', Paris, France, included a CDISC Session with presentations by Udo Siegman (PAREXEL), Wayne Kubick (Lincoln Technologies) and Judy Sromovsky (Merck). Again, Rick Ferris provided an educational seminar on XSL. On the evening of 30 October, a European Clinical Data Connectathon, which was hosted by multiple CDISC sponsors and included ~10 participating companies, was quite successful. We are indebted to Pierre Yves (Sanofi-Synthelabo IAB representative to CDISC), who facilitated this event in his home locale.

29-30 October - A CDISC presentation "Improving Data Quality and Accelerating R&D through the Clinical Data Interchange Standards Consortium" was presented by Rebecca Kush at the International Quality and Productivity Center (IQPC) Conference on Web-based Clinical Trials in Boston, MA.

5-7 November - PhRMA's Biostatistics and Data Management Steering Committee (BDMSC) held a Workshop in Bethesda, MD. Jason Burke presented on XML in the Emerging Technology Session for this workshop. 

19 November - Department of Health and Human Services Food and Drug Administration held a Public Meeting on 'Electronic Interchange Standard for Digital ECG and Similar Data'; CDISC was represented by Scott Getzin (Eli Lilly and Geoff Gordon (Lincoln Technologies) at this event.

21 November - Joris Cauquil (Pierre-Fabre) and Pierre Yves Lastic (Sanofi-Synthelabo) presented CDISC at the Annual Meeting of the Data Management Biomedical (DMB - French Data Management Association) in Paris.

22 November - Joris Cauquil (Pierre-Fabre) and Pierre Yves Lastic (Sanofi-Synthelabo) presented CDISC to the Annual Meeting of SFdS Biopharmacie et Sante (French
Statistical Association for people involved in health and biology) in Paris.

3-5 December - The DIA ePharma Meeting was postponed indefinitely.

10 December - Teleconference for the ACDM International Collaboration Sub-Committee, which includes participants from Australia - discussions on CDISC and ways to collaborate with ACDM; CDISC representatives: Udo Siegmann (PAREXEL), Joris Caquil (Pierre-Fabre), Elaine Job (Aventis Pharmaceuticals) and Rebecca Kush.