6th June 2019
PhUSE are pleased to announce that this is the 10th Single Day Event in Copenhagen.
Please note: Novo Nordisk requires any Health Care Provider (HCP) or Health Care Official (HCO) to make themselves known via email after registering for the event, in accordance with their business ethics procedures.
All PhUSE Single Day Events are FREE to members, to become a member click here. Registrations per company are limited to 20% of maximum attendance.
Whereas last year’s theme was ‘SDTM Revisited’, this year's theme will be ‘ADaM Revisited’.
There are still many challenges in using the CDISC foundational standards. The Copenhagen SDE 2019 will focus on experiences in applying the ADaM standards. There will also be a presentation on CDISC SEND. Other subjects are also welcome.
This year, there will also be an opportunity to present posters during the breaks. The Copenhagen SDE is renowned for the great ambience and socialising during the breaks, so this is an excellent opportunity to present a topic and discuss with industry colleagues.
The focus will be on learnings, best practices and strategies in applying the base CDISC standards in global submissions in compliance with many implementation guides and individual regulatory technical conformance guides.
Novo Nordisk Park
Please click here to view the venue on a map.
||Registration & Welcome Refreshments
||Pia Hjulskov Kristensen,
||SEND at Novo Nordisk
||Pia Jellinggaard and Gitte Koch Ullmann,
||ADaM at Lundbeck
||Karin Fleischer Steffensen,
||ADaM at Bayer – Metadata and Automation
||One Model to Rule Them All...and in the Trial Bind Them
||Karina Rostgaard Stender and Vicky Poulsen,
||ADSL: Friend or Foe?
||Jørgen Mangor Iversen,
||Treatment Allocation in ADaM
||Open Source for Pharma – Solutions, Challenges and Visions
Katja Glass Consulting
||Define Compare: A Web-based Tool for Comparing Study Metadata
||Coffee Break & Poster Session
||Pair Comparison and Ranking Subjects: The Combined Assessment of Function and Survival (CAFS) Case Study
||Three Agencies Tackle Data Sharing: Synergies and Differences
(PhUSE Special Projects Director)
||Pia Hjulskov Kristensen,
||Networking & Refreshments
Mikkel Traun, Novo Nordisk
Pia Hjulskov Kristensen, H. Lundbeck
If you have any questions, or require any information, please contact one of the SDE Chairs.
If you are interested in sponsoring this event, click here.
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