Copenhagen, Denmark

6th June 2019

PhUSE are pleased to announce that this is the 10th Single Day Event in Copenhagen.


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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.



ADaM Revisited



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

Novo Nordisk Park

DK-2760 Måløv


Please click here to view the venue on a map.



Time Presentation Speaker(s)
08:45–09:30 Registration & Welcome Refreshments
09:30–09:40 Welcome Pia Hjulskov Kristensen,
H. Lundbeck
Mikkel Traun,
Novo Nordisk
09:40–10:10 SEND at Novo Nordisk Pia Jellinggaard and Gitte Koch Ullmann,
Novo Nordisk
10:10–10:40 ADaM at Lundbeck Karin Fleischer Steffensen,
H. Lundbeck
10:40–11:00 Coffee Break
11:00–11:30 ADaM at Bayer – Metadata and Automation Elena Glathe,
11:30–12:00 One Model to Rule Them All...and in the Trial Bind Them Karina Rostgaard Stender and Vicky Poulsen,
Novo Nordisk
12:00–12:30 ADSL: Friend or Foe? Jørgen Mangor Iversen,
LEO Pharma
12:30–13:30 Lunch Break
13:30–14:00 Treatment Allocation in ADaM Ari Knoph,
Novo Nordisk
14:00–14:30 Open Source for Pharma – Solutions, Challenges and Visions Katja Glass,
Katja Glass Consulting
14:30–15:00 Define Compare: A Web-based Tool for Comparing Study Metadata Andrew Ndikom,
Clinical Metadata
15:00–15:45 Coffee Break & Poster Session
15:45–16:15 Pair Comparison and Ranking Subjects: The Combined Assessment of Function and Survival (CAFS) Case Study

Konstantinos Lymperis,

16:15–16:45 Three Agencies Tackle Data Sharing: Synergies and Differences Jean-Marc Ferran,
16:45–17:00 PhUSE Updates

Yvonne Moores,
GCE Solutions
(PhUSE Special Projects Director)

17:00–17:15 Closing Remarks Pia Hjulskov Kristensen,
H. Lundbeck
Mikkel Traun,
Novo Nordisk
17:15–18:00 Networking & Refreshments


SDE Chairs:

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.






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