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Time | Topic | Who |
9:30 | Registration | All |
10:00 | Welcome and introduction to mainanalytics | Beate Hientzsch Markus Stoll |
10:10 | Focus Session · FDA CDISC Standards “requirements” in 2023 o Define-XML v2.1 - What’s New o Technical Conformance Guide – Updates? o SDTM-IG v3.3 / v3.4 - What’s New * SV * LB/MB/IS * GF * PR, AE CE, EG, EC, VS, FT, FA, TS, QS, SC, SE | Steffen Müller Jens Fooken Dagmar Kottig-Roth Dagmar Kottig-Roth Dagmar Kottig-Roth Judith Köppert |
11:15 | Break | |
11:30 | Continue CDISC Standards discussion… · FDA vs PMDA - Discussion · CDISC Outlook 2023 - Expected updates/News o ADaM MSG insights o DM / DC | All All Nicola Tambascia Judith Köppert |
12:30 | Lunch and Get-Together | |
13:30 14:15 14:30 | CDISC COSA Initiative · COSA Introduction o CDISC Hackathon: "admiral" - Insights o CDISC Rules Engine (CORE) DEUN UG TOI-Initiative - Tools of Interest Presentations · Status + Outlook 2023 CDISC Library for Dummies – First Steps · Data Standard Browser · API Remote Access – How To | Markus Stoll Andrea Weber Stefanie Sturm Markus Stoll Christina Paul Jozef AertzAerts |
15:00 | Break | |
15:30 | CDISC - Hidden Details · COVID-TAUG o SDTM o ADaM Component · CT Relationships · Dictionaries in define.xml o Define CT · LB domain History · Submission of Programs to authorities | Monika Kawohl and all Dagmar Kottig-Roth Nicola Tambascia |
16.00 | CDISC User Group Discussion · Poll - Usergroup Steering Committee · Topics of interest · Next meeting / Meeting / Closing remarks | Markus Stoll and all |
17:15 | Meeting end |
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