2020 Europe Interchange Presentations

Thank you for attending the Virtual 2020 Europe Interchange. You will find a link to each of the presentation slides from the event below.

Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.

Session 1: Opening Plenary and Welcome Address


Opening Remarks & Welcome Address 
Joerg Dillert, E3C Chair


Keynote Presentation: IMI PIONEER - Prostate cancer diagnosis and treatment enhancement through the power of big data in Europe 
Prof. James N'Dow, University of Aberdeen

Session 2: Medical Devices

CDISC Standards for Medical Devices: Historical Perspective and Current Status (Paper)
Carey Smoak, S-Cubed

When Medical Devices Unleash SDTM Power (Paper)
Roxane Debrus, Terumo Europe NV and Silvia Faini, LivaNova

SDTM and Activity Trackers: Early Experiences and Challenges 
Martin Gram and Gianluca Mortari, Novo Nordisk

Session 3: CDISC Foundational

Deconstructing SDTM - Finding the Hidden Gems 
Johannes Ulander, S-Cubed

Efficacy ADaM datasets applicable to all solid tumor studies 
Letizia Nidiaci, Rossi C., Scartoni S., Menarini Ricerche S.p.A.

Building a Team for Legacy Data Conversion 
Lieke Gijsbers, OCS Life Sciences and Jasmine Kestemont, Innovion

Session 4: Submission Experience

NMPA Submission (Data Submission in China) 
Sujit Khune and Marianne Caramés, Novo Nordisk

Re-mastering the Define-XML and its Brother, the "Reviewer Guide" 
Angelo Tinazzi, Cytel Inc

Journey to PMDA Submission (From Legacy Data to SDTM 3.2) 
Charlotte Dhont and Oana Pasalau-Cioaba, UCB

Session 5: Metadata

Lean Protocol: The Case for Standards Driven Digital Protocols 
Frederik Malfait, Nurocor

A Perfect Summer: Working Towards Better Terminology 
Dave Iberson-Hurst, Assero

Beyond Biomedical Concepts: How Study Management Concepts Fill the Gaps 
Dr. Philippe Verplancke, XClinical GmbH

Session 6: CDISC Foundational, Cont'd

Development and Implementation of the LOINC-SDTM Mapping Table 
Ward Puttemans, UCB and Erin Muhlbradt, NIH

What's Up with LOINC and UCUM? From EHR Records to LB Dataset in Just a Few Minutes (Paper)
Jozef Aerts, XML4Pharma

Use case for multiple enrollments 
Wafaa Jebert, ichnos sciences

Session 7: First Day Closing Remarks

Updates from the CDISC Board to the Community 
Jonathan Zung, CDISC Board Chair

Session 8: Regulatory Session, Part I

Use of CDISC SDTM in Large-scale IPD Meta-Analyses
Dr. Christina Reith, Nuffield Department of Population Health, University of Oxford

Big Data Task Force 
Sofia Zastavnik, HMA/EMA

Regulatory Presentation
Dr. Yuki Ando, PMDA

Session 9: TAUG

Let Food be thy Medicine and Medicine be thy Food 
Fatima Kassim and Louella Schoemacher, OCS Life Sciences

SDTM: Let's read outside the Bible 
Sandra Latorre, Business & Decision Life Sciences

Application of CDISC Data Standards in Cardiovascular Data 
Shilpakala Vasudevan, Ephicacy

Session 10: Tech-Enabled Standards

CDISC Library Try-out: From Implementation to Evaluation of the API (Paper)
Roman Radelicki, SGS Life Sciences

Creating and Maintaining Open Source: Why and How? 
Katja Glass, Katja Glass Consulting

CDISC 360 Metadata-Driven Data Transformation Engine for Automation and Transparency (Paper)
Gregory Steffens, AbbVie

A vision of the invisible a new SDTM Validation Tool 
Anamaria Calai, Cmed Clinical Services

Session 11: RWD

The IMI EHDEN Project - Cultivating real world data across Europe 
Maxim Moinat, The Hyve; Nigel Hughes, Janssen

Janssen Autism Knowledge Engine (JAKE) System in Autism Spectrum Disorder (Paper)
Sarah Bonneux, Janssen

Mapping EHR Data to EDC - A Case Study
Suchitra Ramaswamy, Zifo Rnd Solutions

Session 12: Regulatory Session, Part II

The Regulatory Framework behind the sdTCG
Helena Sviglin, FDA-CDER

Helpful Tips for Review-Ready NDA/BLA Submissions to FDA CDER
Dr. Matilde Kam, FDA-CDER

FDA-CDER Presentation
Dr. Alan Shapiro, FDA-CDER

Session 13: Closing Plenary

State of the CDISC Union 
David R. Bobbitt, President and CEO

Closing Remarks
Peter Van Reusel, CDISC