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