22 February 2019, Milan
What's new at 360 degree
The 6th Italian CDISC User Network Annual Meeting was held in Milan Friday 22nd February 2019 at the SAS office. In collaboration with IBiG, the Italian Association of Biostatisticians, and sponsored by SAS and Cytel, the event was a success in terms of numbers with about 80 attendees (a record for our event!) and topics discussed "What’s new at 360 degrees". Silvia Faini (LivaNova) and Angelo Tinazzi (Cytel), who are active part of the Italian CDISC UN as well as members of the CDISC European Committee, chaired the event.
The day was mostly in Italian, except for the presentations given by the CDISC CSO Peter Van Reusel, who illustrated the new ambitious "CDISC 360" project aimed at improving the use of the CDISC standards in the coming years, and by Stijn Rogiers (SAS) who gave a good summary of the issues related to the governance of the CDISC standards.
Several Pharmaceutical companies and CROs contributed with presentations related to the innovations introduced in the various CDISC standards in the last 18 months: CDASH 2.0 (C. Rossi - Menarini), SDTM Ig 3.3 (F. Montanaro - Latis), ADaM Ig 1.2 (P. Vaghi - Chiesi Farmaceutici), Define-XML 2.1 (S. Faini - LivaNova). Use cases were also covered by G. Varriale and M. Cea (SAS) presenting some examples of the application of forecasting, data mining and AI techniques in clinical trials, while G. Di Domenico and S. Lombardi (GSK Vaccines) shared their experience of applying CDISC standards to eDiary data, from data collection to data-analysis. An interesting Cytel project regarding the use of TAUGs was presented by A. Tinazzi, with the promise of future updates on the development and benefits (a poster with more complete information is expected for the next European CDISC Interchange).
The day was full of information and ideas for both CDISC newcomers and for the more experienced participants. With the next European CDISC Interchange taking place on 8 and 9 May in Amsterdam, CDISC offered 5 discounted tickets to the members of the Italian CDISC UN. Thanks to their work some of these tickets have been assigned to the speakers of the day.
Until the next event, the Italian CDISC UN continues to be active with the regular calls, the LinkedIn group and the CDISC wiki page, where further information on the activities of the Italian CDISC UN, together with the presentations of the dayAGENDA (in Italian but slides are in English)
- Benvenuti+Intro [SAS e CDISC E3C] 00.CDISC-ITA-UN-2019-Intro.pdf
- CDISC 360 Project Introduction [Peter Van Reusel, CDISC CSO] 01.CDISC 360 0.97.pdf
- CDASH 2.0 [Cristina Rossi, Menarini] 02.CDASH 2.0 What, why and how - Cristina Rossi Menarini Ricerche.pdf
- SDTM Ig 3.3 [Fabio Montanaro, Latis] 03.Montanaro - SDTM-Ig-3.3.pdf
- Clinical Trial - AI Value Cases [Massimiliano Cea, SAS] 04.SAS_AI_ValueCases_CDISC.pdf
- ADaM 1.2 e altro da ADaM Team [Paola Vaghi, Chiesi] 05.ADaM_Paola Vaghi.pdf
- Define 2.1 / ARM / e altri PhUSE WG sul tema [Silvia Faini, Livanova] 06_Define-XMLv2-1_ItalianCDISCUN_20190222_Faini_LivaNova_Final.pdf
- Standards Management & Study Metadata Management [Stijn Rogiers, SAS] 07.Best Practices in Data Standards Governance_Stijn Rogiers (SAS)_22Feb2019.pdf
- Use Case: Real Case in Vaccine sull'implementazione dei dati da e-diary in CDISC format [Gabriele Filippo Di Domenico and Stefano Lombardi, GSK] 08.e-Diary&CDISC_final.pdf
- Therapeutic Area User Guide Update [Angelo Tinazzi, Cytel] 09.CDISC-ITA-UN-2019-TAUGs.pdf
- Novità Mondo Regolatorio, Final Q&A e Chiusura [CDISC E3C] 10.CDISC-ITA-UN-2019-Regulatory-QA.pdf
Pictures from the event