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The day was mostly in Italian, except for the presentations provided by the two guests, Peter, Florence and Marian . See here below the agenda.

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 day (all slides in English):

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Benvenuti e Aggiornamento attività CDISC Italian User Network e dal mondo CDISC

Silvia Faini / Angelo Tinazzi (CDISC E3C IBiG)

Enabling traceability using the CDISC Dataset-XML Standard.

Jozef Aerts (XML4Pharma)

What's the Use of the Controlled Terminology?

Thierry Lambert (ADCLIN)

A Governed Platform for collaboration, change management and
versioning

Alberto Romanelli (SAS)

ADaM Traceability with Multiple Imputations

Silvia Faini (Cytel Inc)

ADaM Traceability in a Respiratory Trial

Paola Vaghi (Chiesi)

CDISC Key initiatives for 2023 and beyond

Peter Van Reusel (CDISC)

Introduction to ISS/ISE

Florence Le Maulf (Cytel)

ISS/ISE and CDISC Angelo Tinazzi (Cytel)

The value of Real-World Evidence in Clinical Trials

Stefano Patarnello e Marta Cicchetti (Gemelli Digital Medicine/Healthcare and SAS)

E9(R1) Estimand Framework & CDISC

Marian Mitroiu (Biogen)

APIs through SAS, Endless possibilities

Davide Marinucci (Alira Health)

A successful journey through FDA review - Sharing experience in a Vaccine Submission

Gabriele Filippo Di Domenico (GSK)

China submission preparation: lost in translation

Rebecca Moretti e Glauco Cappellini (Chiesi)

Clinical Studies Visualization & Analysis

Marta Cicchetti (SAS

Doing good BIMO and News from the Data Submission Regulatory World

Angelo Tinazzi (Cytel Inc)

Final Q&A, Chiusura

Silvia Faini / Angelo Tinazzi (CDISC E3C IBiG)

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