It was early March 2020, after the world was hit by the Covid-19 pandemic, that those of us on the CDISC Eu committee together with the CDISC team had to decide to switch our upcoming CDISC Eu 2020 event from face-to-face to virtual. This was done in less than two months with a very successful outcome, despite the regret of not seeing all our colleagues and friends from all over Europe.

After three years and three successful virtual CDISC Eu events, we are ready to kick off a new CDISC Eu Interchange — this time face-to-face and in Copenhagen, one of my favorite European cities.

Cytel is again present and supporting the event in various ways:

Both Silvia Faini and I, as part of the CDISC Eu committee, will chair two streams, the “Governance” and the “Analysis Results Standard” respectively.

Our team will also be contributing two posters: “From Artifact to Metadata: A Divergent Approach to Automation through Standardization” where Nicolas Rouille will discuss the Cytel approach to standardization and automation through use of metadata; and “(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness” where Silvia and I will share our experience with data integration in support of ISS/ISE. Both will continue the conversations we had at PHUSE 2022 last November (for the full papers, see here and here).

I will also give, with my presentation in the “Updates Towards Regulatory” stream, an overview of what I consider hidden gems — a set of additional overlooked FDA data standard guidance (if you want to have a preview, look at my two previous blogs here and here). Nevertheless, Cytel is also one of the sponsors of the event.

Lastly, don’t hesitate to step into the poster area during the planned breaks and discuss our solutions and ideas!

But what we will see in Copenhagen? Well, I do think the agenda put in place by our colleagues from the CDISC Eu committee and our friends from CDISC has no equal, definitively, it is the “back to the future” agenda.

More than any previous event, this year’s agenda has really made a switch and consolidated topics such as Biomedical Concepts, Digital Data Flow, Automation, Analysis Results Standard, Open-source Industry Initiatives such as CORE and COSA, practical experience with Real World Data including dealing with SDTM, Data Standards Governance, and MDR. New CDISC initiatives will also be presented such as the Trial Master File standard. We will have the evergreen streams around the use of foundational standards and submission experience but will also get an update from representatives from the FDA, EMA, and PMDA.

I look forward to meeting all of you in person!

Don’t miss Cytel’s key sessions at CDISC Eu 2023:

Session 3: Track C- Governance

Date/Time: April 26 | 14:00 – 15:30

Session Chair: Silvia Faini, Cytel

Room: Arkaden 8

Session 5: Track A- Analysis Results Standard

Date/Time: April 27 | 9:00 – 10:30

Session Chair: Angelo Tinazzi, Cytel

Room: Vandsalen

Session 5: Track C- Governance, Part II

Date/Time: April 27 | 9:00 – 10:30

Session Chair: Silvia Faini, Cytel

Room: Arkaden 8

Session 6: Track A- Updates Towards Regulatory

Session: Raising Awareness for Additional FDA Data Standards Submission Recommendations

Cytel Speaker: Angelo Tinazzi

Date/Time: April 27 | 12:00 – 12:30

Room: Vandsalen

Cytel Posters at CDISC Eu 2023:

From Artifact to Metadata: A Divergent Approach to Automation through Standardization, Nicolas Rouille

(Re)Integration Dilemma: Integrated Summaries of Safety and Effectiveness, Angelo Tinazzi and Silvia Faini

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