2023-03-14 / 30. CDISC DACH User Network Meeting / Sulzbach(Taunus)

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
                  plus Model SDTM v1.8 to v2.0

Steffen Müller

Jens Fooken

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

Monika Kawohl + All

Nicola Tambascia

Judith Köppert

12:30

Lunch and Get-Together

13:30

14:15

14:30

Markus Stoll

Andrea Weber

Stefanie Sturm

Markus Stoll

Christina Paul (verschoben)

Jozef Aerts

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