CDISC Italian User Network TC 07 Febbraio 2018

CDISC Italian User Network TC 07 Febbraio 2018 Angelo Tinazzi (Cytel) Silvia Faini (CROS NT) © CDISC 2015 2

Upcoming webinars • CDISC Public Webinar Series - CDISC Newcomers Webinar THU, 8 FEB 2018 10: 00 AM - 11: 30 AM CET • CDISC Public Webinar Series - Standards Updates and Additions - CDAD TAUG v 1. 0 - THU, 8 FEB 2018 10: 00 AM 11: 30 AM CST • CDISC Tech Webinar - Getting Started with CDISC SHARE API v 1. 0 - TUE, 13 FEB 2018 10: 00 AM - 11: 30 AM CST • CDISC Members-Only Mini-Training Series - Standards Governance Challenges - THU, 8 MAR 2018 10: 00 AM - 11: 30 AM CET © CDISC 2015

Public Trainings - Berlino 23 -24 e 27 Aprile Link • Lunedì 23 Aprile § § § Controlled Terminology - 09: 00 | 12: 30 SDTM Theory & Application - 09: 00 | 17: 00 SHARE Hands-on Workshop - 09: 00 | 12: 30 SEND Implementation - 09: 00 | 17: 00 CDISC Standards from the Start Workshop - 13: 00 | 17: 00 ADa. M Primer - 13: 30 | 17: 30 • Martedì 24 Aprile § ADa. M Theory and Application - 09: 00 | 17: 00 § ODM Implementation - 09: 00 | 17: 00 • Venerdì 27 Aprile § CDASH Implementation - 09: 00 | 17: 00 § Define-XML - 09: 00 | 17: 00 © CDISC 2015

Public Trainings - Milano 14 -18 Maggio • Presso la sede milanese di Liva. Nova • Corsi ADa. M in Italiano tenuti da Angelo Tinazzi https: //www. cdisc. org/events/education/publiccourses/2018/05/public-courses-milan-italy • 2 -day SDTM Theory and Application - 14 -15 May 2018; 09: 00 -17: 00 • 1 -day CDASH Implementation - 16 May 2018; 09: 0017: 00 • 1/2 -day ADa. M Primer - 16 May 2018; 13: 00 -17: 00 • 1 -day ADa. M Theory and Application - 17 May 2018; 09: 00 -17: 00 • 1 -day Define-XML - 18 May 2018; 09: 00 -17: 00 © CDISC 2015

European CDISC Interchange 1/3 • Berlino 25 -26 Aprile • Programma provvisorio https: //www. cdisc. org/2018 -europe-interchange-preliminary-program • Per registrarsi https: //www. cdisc. org/events/interchanges/2018 europe-interchange/landing Non-members Gold members Platinum members Early bird (entro 8 Marzo) $1270 $1005 $785 Full ticket $1490 $1220 $920 © CDISC 2015

European CDISC Interchange 2/3 • Ci saranno 3 sessioni in parallelo: track C totalmente dedicato ai «CDISC newcomers» • Update dalle agenzie regolatorie • Probabile update della collaborazione con Ph. USE • I temi degli altri stream: § § § § § Global Submission Experience What’s new ADa. M Define Process optimization Utilizing CDISC Challenges and Doing Better e. Source Machine Learning © CDISC 2015

European CDISC Interchange 3/3 • Case study relativi alle sottomissioni (2 bigpharma) • Esperienze e suggerimenti su Define. XML: valuelevel metadata e stylesheet • Aggiornamento su CDASH, SDTM, ADAM e ODM • Workshop ADa. M • Partenership CRO/Pharma: presentazioni da entrambi i punti di vista © CDISC 2015