Copenhagen, Denmark

14th June 2018

SDTM Revisited

 

Summary:

This year was the first time ever a PhUSE Single Day Event has been hosted by LEO Pharma. The theme for the event was SDTM Revisited – tying into the Future Forward theme for the PhUSE EU Connect 2018 – that SDTM is to stay with the industry for a foreseeable part of the future.

The main event was a novelty for a Single Day Event, at least in Denmark: a panel discussion on the history, best practices, challenges, and future plans for the development of SDTM among five companies. During the discussion there were a couple of remarkable points: that creation of SDTM is tied to capable individuals, and not particular departments; and somebody even suggested aligning SDTM interpretations across the industry.
It was demonstrated that Controlled Terminology standards are extremely complex, and that relatively subtle changes can have a huge impact on clinical trials utilising versions of those standards.


The Danish organising team would like to extend its gratitude to PhUSE for supporting and organising the event. It is not difficult to shine with such a great and professional backbone making everything happen.


 

Presentations:

Welcome – Jørgen Mangor Iversen,
 LEO Pharma & Pia Hjulskov Kristensen, H. Lundbeck 

SDTM at Lundbeck – Dennis Jørgensen & Aik Hoe Seah, H. Lundbeck

SDTM at LEO – Mette Marie Andersen,
 LEO Pharma 

Is it Possible to Make a Global Submission; And What are the Top Five Challenges in Complying with CDISC Standards? – Marianne Carames, Trine Danø Klingberg & Mikkel Traun, Novo Nordisk 

Panel Discussion: How Implementation of SDTM has Changed Over Time – Mikkel Traun, Novo Nordisk

Lessons Learned from Two Different FDA Filings – Carey Smoak,S-CUBED

Where Did My Terminology Go? – Johannes Ulander, S-CUBED

The Ferring Data Model (FDM) – Omar Hamidi, Ferring

Pinnacle 21 Enterprise Edition – Malathi Hari,
 Larix

PhUSE Update – Yvonne Moores, PhUSE Strategy & Innovation Director

 

View the event brochure.

 

Sponsors:

 

If you are interested in sponsoring this event, click here.

 

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