Details zu Anfahrt unter der Agenda im Dokument: 27th German CDISC UN Agenda_2018-08-17.pdf

Details zum Meeting am Vorabend und Unterkunft: CDISC Ludwigshafen Hotelauswahl und Vorabend.pdf


Presentations:

27th DACH CDISC UN Meeting Presentations.zip

Agenda - 27th German CDISC User Network Meeting

(Version 2018-08-17)

Date:

25. September   2018


Location:

AbbVie Deutschland Gmbh & Co. KG

Knollstrasse 50

67061 Ludwigshafen

Bau 71 / Raum 301
 

Kontakt: Anja Kreis
 anja.kreis[at]abbvie.com

Admin: Martina Berroth
  martina.berroth[at]abbvie.com

Time

Topic

Who

9:30

Registration

All

10:00


Welcome and introduction to AbbVie


Anja Kreis

Kurt Hellstern

10:10


10:40

ISS – Integrated Analysis (integration where, how – experiences gained within a project)


ISS – Metadata Handling in Define.xml


Petra Rein


Judith Köppert


11:10

Break


11:30

Discussion: Define.xml Process

Sabine Erbslöh, Susanne Bracht

12:30

Lunch and Get-Together


13:30



14:15

Use of MDR/SHARE

(set-up, integration with SHARE, how is it used, benefits, user feedback)


An update on CDISC SHARE and how to use it


Michael Walter, Anja Kreis



Frederick Malfait

15:00

Break


15:30

Update to the FDA Technical Conformance Guide


Discussion: Collection of Protocol Deviations (eCRF, external File, Derived) which deviations belong where (SDTM/ADaM)


Converting original results using UCUM webservices


Other topics to come along

Marion Friebel


Dennis May


Nicola Tambascia


All

16:15

CDISC User Group Discussion

• Annotated CRF Working Group update

• Going Live with the new GUN Wiki

• Break-out sessions to be planned for the next Meeting?

• CDISC News / Regulatory Updates

• Topics of interest

• Next meeting / Meeting / Closing remarks

All

Markus Stoll

Markus Stoll

17:00

Meeting end