2019-03-06 / 28. CDISC DACH User Network Meeting / Berlin

Parexel International GmbH

Am Bahnhof Westend 11

D-14059 Berlin

-> Building 11

March 6th 2019

Start: 9:30 a.m.

End: approx. 5 p.m.

Details about the Meeting Location, Team Dinner, Tipps for Travel and Accomodation and the Agenda topics: Agenda 28th DACH UN Meeting

Time	Topic		Who
9:30	Registration
10:00	01	Welcome and introduction to Parexel NoLineFeedNoLineFeedNoLineFeedNoLineFeedNoLineFeedNoLineFeedNoLineFeed	Jens Fischer Kurt Hellstern
10:10 10:55	02	CDISC Proof of Concept: Evolving our standards towards end to end automation Discussion	Peter Van Reusel NoLineFeedNoLin
11:10	Break
11:30	03	End-to-End in my Company Don’t we all pursue a step by step approach? How far are we on this way? Experience exchange	All - Petra, Michael, Chantal, Torsten, (Anja), (Markus) (Bitte max auf 1 oder 2 Slides)
12:30	Lunch and Get-Together
13:30 14.30	04	An update on CDISC SHARE and how to use it Medical Informatics Initiative (MII): Core Data Set as Basis for Recruitment for Clinical Trials in Germany‘s University Hospitals	Frederik Malfait Christian Gulden (i.A. TMF)
15:00	Break
15:30	05	~~CDISC Primer~~ (Agreed to be rescheduled in the meeting due to time constraints) Working Group Homepage: https://www.phusewiki.org/wiki/index.php?title=CDISC_Implementation_Primer CDISC related PhUSE working groups	~~Beate Hientzsch~~ Hasan Kantarci
16.00	06	Regulatory Updates /FDA Technical Conformance Guide	Marion Friebel
16.15	07	CDISC User Group Discussion Overview SDTM IG 3.3 Updates Annotated CRF Working Group update Feedback: How is the GUN Wiki doing? Topics of interest Next meeting / Meeting / Closing remarks	All – Petra Markus Stoll Markus Stoll
17:00	Meeting end