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- Benvenuti+Intro CDISC E3C Silvia Faini, Livanova Inc. A_Intro_ITA_CDISC_and_global_SF_AT_20201007-Final.pdf
- Deconstructing SDTM Johannes Ulander , S-Cubed 2020-02-28-CDISC-ITUN-Johannes-Ulander.pdf
- Re-mastering the define-xml and its brother the Reviewer Guide, Angelo Tinazzi, Cytel Inc. CDISC-ITA-2020-Europe-re-mastering the define.xml and its brothers-Tinazzi.pdf
- Efficiently leveraging your RWD investment across the product life cycle, Stijn Rogiers, SAS CDISC Italian User Network 2020_Stijn Rogiers_RWE_Final.pdf
- Validation Rules and Validation Tools, Silvia Faini, Livanova 4_ItalianCDISC2020_ValidationRules_ValidationTools_Faini_LivaNova16-9updated.pdf
- CDISC SEND Data Standardization and Exploration, Marco Pergher, Aptuit 5_CDISC SEND oct2020 SIMEF v5.pdf
- News from the Regulatory World, Angelo Tinazzi, Cytel Inc. CDISC-ITA-2020-Novità Mondo Regolatorio-Tinazzi.pdf
- Efficacy ADaM datasets applicable to all solid tumor studies, Letizia Nidiaci, Menarini 6_CDISC-2020-Efficacy ADaM datasets Final_Milano.pdf
- Protocol Deviations and Quality in Vaccines Trials, Angela Gambioli, GSK PROTOCOL DEVIATIONS AND QUALITY IN VACCINES TRIALS_Gambioli_sep.pdf
- Updates on Handling Multiple Enrollments and Screenings Subjects in SDTM, Éanna Kiely, ClinBuild Updates on Handling Multiple Enrollments and Screenings Subjects in SDTM - ClinBuild - Eanna Kiely - V1.0.pdf
The day was also completed by a pre workshop on "define-xml and submission ready documents" with 26 attendee. See here Q&A received during the workshop IBIG-CDISC-define-xml and submission-ready-documents-Q&A_20200928.pdf.
A collection of pictures of our virtual speakers:
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