27 Ottobre 2017, Milan

The implementation of the CDISC-ADaM standards

About 45 people from various Italian Pharmaceutical Companies and CROs attended the 5th “Italian CDISC User Group Network” on October, 27th, 2017 at the University of Milano-Bicocca and in collaboration with BIAS, the Biometrics Italian Association. 5 students from the local statistical faculty also attended the event.

The meeting was fully dedicated to the use and implementation of the CDISC-ADaM standards.

Coordinated by Silvia Faini of CROS-NT and Angelo Tinazzi of Cytel Inc., both members of the European CIDSC Committee (E3C), the event started first with a summary made by Angelo of the main characteristics of the CDISC foundational standards (with focus to submission requirements) and current CDISC initiatives, while Silvia introduced ADaM and its principles, introduction completed by her colleague Antonio Valenti from CROS-NT who gave some tips and tricks to avoid bad interpretation of the ADaM standards.

The morning session was completed by Alessia Sacco from Valos with a presentation on how her company is creating define.xml using Pinnacle21 community version and SAS.

In the afternoon Valerio Romolini and Gabriele Filippo Di Domenico from GSK Vaccines and Angelo Tinazzi presented some practical implementation of ADaM in two distinct therapeutic area, respectively Vaccines and Oncology.

Although it was not intended to be an ADaM training, with the final open discussion Silvia and Angelo went through the main ADaM principles by using real examples making sure the key messages were well understood by the audience.

The Italian CDISC user network, in addition to the annual face to face event, try to run regular teleconferences (i.e. at least quarterly); for this reason the participants were also invited to bring idea and topics to discuss for the next events. Some of the most recent topics discussed by other European Network, such as the German, the French and the UK, were also quickly introduced as an example.

We would like to thanks SSFA for the logistics support and Cytel for sponsoring the event to celebrate their 30 years of activity.

AGENDA (in Italian but slides are in English)

 

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