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Anmeldung/Registrierung:

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Für Event “CDISC DEUN Usergroup Meeting”

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Meeting Agenda (KLick to download PDF version)

View file
name30th German CDISC UN Agenda

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20230314.pdf
height

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150


Date:                    14 March 2023

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65843 Sulzbach(Taunus) 

Kontakt: katrin.besch@mainanalytics.deCurrent Agenda - Last update 2023-02-07besch[at]mainanalytics.de

                                                                                                                                                                                                                                                                          

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

              *  Dagmar Kottig-Roth

, GF

              *  PR, AE CE, EG, EC, VS, FT, FA, TS, QS, SC, SE
                  plus Model SDTM v1.8 to v2.0



Steffen Müller

Volunteer?

Dagmar Kottig-Roth

Jens Fooken


Dagmar Kottig-Roth

Judith

Köpperth

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   Expected updates

 o  DM / DC

All


Monika Kawohl + All

t.b.d.



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   Tool Presentation

 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

Volunteer(s)?

Stefanie Sturm


Markus

Volunteer?

Stoll




Christina Paul (verschoben)

Jozef Aerts

Volunteer?

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

 LB domain History

Volunteer?

Volunteer?

Volunteer?

Volunteer?

    ·  Submission of Programs to authorities

Monika Kawohl and all







Dagmar Kottig-Roth

Nicola Tambascia

Volunteer?

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




Summary:



other Meeting detailsPresentations...

Anfahrt:

Mit dem Auto:

Sag Google Maps oder Deinem Navi:

Otto-Volger Straße 3c, 65843 Sulzbach (Taunus)

Oder nutze diesen Link (Google-Maps): https://goo.gl/maps/aNaP9v94VMausUJh6

Parken

Bitte suchen Sie sich einen öffentlichen Parkplatz. Möglichkeiten finden Sie in den Straßen

  • Otto-Volger-Straße
  • Oberliederbacher Weg
  • Im Haindell
  • Am Limespark

Anreise mit Bahn:

Nächster Halt – Sulzbach(Taunus) Bahnhof, von dort Fussweg ca. 900m (12-15 Minuten)

Image Removed

  

Hotelempfehlungen

Sulzbach

Dorint

https://hotel-frankfurt-sulzbach.dorint.com/de/   

Landhotel Sulzbacher Hof

https://www.sulzbacher-hof.de/   

Bad Soden

H+ Hotel

https://www.h-hotels.com/de/hplus/hotels/hplus-hotel-bad-soden/hotel  

Hotel Rheinischer Hof

http://rheinischer-hof.com/de/  

Milbor Hotel

http://milbor-hotel-bad-soden.de/de/

Vorabend Event/Abendessen:

ab ca. 18.30 ??? t.b.updated

Anmeldung/Registrierung:

Per Email unter:  katrin.besch@mainanalytics.de

20230314_GCUG_01-01_Definev2-1-news_SMueller.pdf

20230314_GCUG_01-02_FDA-TCG-v5-0_JFooken.pdf

20230314_GCUG_01-03_Whats_New_IGv3.4_DKottig-Roth.pdf

20230314_GCUG_01-04_SDTM_IG_3_4_WhatsNew_JKoeppert.pdf

20230314_GCUG_02-01_CDISC-Requirements-FDA-PMDA_MKawohl.pdf

20230314_GCUG_02-03_Multiple enrollments_JKoeppert.pdf

20230314_GCUG_03-02_CDISC Hackathon-Admiral-Insights_AWeber_20230315_updt.pdf

20230314_GCUG_03-03_CORE_SSturm.pdf

20230314_GCUG_03-06_CDISC_Library_API_JAerts.pdf

20230314_GCUG_04-03_LB_History_DKottig-Roth.pdf

20230314_GCUG_04-04_Submission of Programs to authorities_NTambascia.pdfFür Event “CDISC DEUN Usergroup Meeting”