2025 CDISC + TMF Europe Interchange Presentation Archive
The 2025 CDISC+TMF Interchange has now concluded. Thank you to those who participated! We look forward to seeing you next year in Milan!
Session 1: Opening Plenary
Chair: Nick De Donder, De Donder Life Sciences, E3C Co-Chair
International Ballroom, Floor -2
CDISC Welcome
Nick De Donder, De Donder Life Sciences; Karen Roy, CDISC
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Keynote Presentation: Standardization and Interoperability in Rare Diseases, the Journey from Efficiency to Equity, the Duchenne Experience
Dimitrios Athanasiou, World Duchenne Organization, PCWP Member European Medicines Agency
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CDISC360i and State of the Standards
Chris Decker, CDISC President and CEO; Peter Van Reusel, CDISC Chief Standards Officer; Paul Fenton Carter, Chair, Trial Master File (TMF) Reference Model Steering Committee
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Session 2: Track A, B, C - The European Landscape of Clinical Research and Health Care
Chair: Sujit Khune, Novo Nordisk, E3C Co-Chair
International Ballroom, Floor -2
EMA Update
Eftychia-Eirini Psarelli, EMA
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Clinical Electronic Structured Harmonised Protocols – How is ICH M11 Supporting Trial Design and Reporting?
Nick Halsey, EMA
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Exploring Efforts in Europe to Integrate Clinical Research with Clinical Care
Jesper Kjaer, Novo Nordisk
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Session 2D+E: The Future of TMF (TMF Track)
Chair: Paul Fenton Carter, Montrium, ET3C
Europe Ballroom, Floor -2
ICH E6 R3 and the TMF
Torsten Stemmler, Head of GCP Inspections, BfArM
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TMF RM V4
TMF RM V4 Project Management Team - Gill Gittens (Transperfect), Lisa Mulcahy (Mulcahy Consulting), and Donna Dorozinsky (Just In Time GCP)
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Session 3A: Digital Data Flow
Chair: Stijn Rogiers, argenx, E3C
Zurich, Floor -2
ICH M11, TransCelerate, CDISC & HL7 Vulcan: Making the Electronic Protocol a Reality
Dave Iberson-Hurst, CDISC
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Protocol to Study Live in 15 Mins. AI, USDM and BCs in Action
Johannes Ulander, data4knowledge ApS
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Bringing the USDM Model to the Catwalk
Julie Jacobsen Bryndum and Anja Lundgreen, Novo Nordisk A/S
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Navigating Post-Go-Live Changes in Automated Clinical Study Builds: Optimizing USDM / M11 for EDC and Beyond
Joerg Dillert and Michelle Ajayi, Oracle
Session 3B: Artificial Intelligence
Chair: Elsa Lozachmeur, Viatris Innovation
Londres, Floor -2
Leveraging AI to Simplify SDTM Standards and Streamline Clinical Data Management
Ward Puttemans and Bram Seigers, argenx / SolCur
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Let Robots Sort It Out: Smarter CDISC Open Rules with AI
Roman Radelicki, SGS Pharma Clinical Research
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The Role of Data Standardization in AI-Driven Clinical Research
Angelica Prado and Adrian Czaban, Novo Nordisk A/S
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AI for Standards Library Search
Ayomide Fasemire, AstraZeneca
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Session 3C: Innovation Showcase
Chair: Sujit Khune, Novo Nordisk, E3C
New York, Floor -2
Dataset-JSON Viewer: When Machine-Readable Becomes Human-Viewable
Dmitry Kolosov, Independent
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Session 3D: Technology in TMF Management (TMF Track)
Chair: Anne-Nöelle Charles, GSK
Munich & Paris, Floor -2
How to Leverage Next-Generation Tools Today to Optimize TMF Processing and Enhance Efficiency
Aaron Grant and Carol Radwanski, Just in Time GCP
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TMF Technology Trends: Insights from eTMF Data
Jim Horstmann, Veeva Systems
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Media Department
Exploring the Role of TMF Metrics and KPIs in Trial Innovation - Is There a Purpose Beyond Inspection Readiness?
Rob Jones, Cencora PharmaLex
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The Requirements of the 2023 EMA Guideline on Clinical Systems and the CSV Tab of the CDISC TMF RM
Lisa Mulcahy, Mulcahy Consulting
Session 3E: TMF Culture and Engagement (TMF Track)
Chair: Joanne Malia, Regeneron
Copenhague & Lisbonne, Floor -2
The Danish TMF Network
Karla Navera-Andersen, Ascendis Pharma A/S
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Panel Discussion: Building a Unified TMF Culture Strategy: Engaging End Users, Clinical Functional Areas, and Collaborating Clinical Partners
Lies Orbie, argenx
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Elevate Your TMF Inspection Readiness with a Focused Preparation Program
Hobson Lopes, Regeneron
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Session 4A: CDISC 360i
Chair: Nick De Donder, De Donder Life Sciences
Zurich, Floor -2
Breaking Down Silos with CDISC 360i: A Technical Roadmap
Julie Smiley, CDISC Vice President, Data Science
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Enhanced Biomedical Concepts: A Design Perspective in OpenStudyBuilder Supporting CDISC 360i
Mikkel Traun and Nicolas de Saint-Jorre, Novo Nordisk A/S
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CDISC 360i, and the Worm that Turned
Jeremy Teoh and Warwick Benger, GSK
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Session 4B: CDISC Foundational
Chair: Angelo Tinazzi, Cytel
Londres, Floor -2
Unraveling the Complex Web of Data Relationships
Emma Törner and Parag Wani, AstraZeneca
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Enhancing Clinical Data Quality and Consistency with Value Level Metadata for Non-CRF Data Collection
Zahra Karimaddini and Igor Steiner, F. Hoffmann-La Roche Ltd.
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CDISC Protocol Deviation Sub-Team SDTMIG 4.0 Updates and Open Topics
Éanna Kiely, Alexion, AstraZeneca Rare Disease
Session 4C: Academia
Chair: Kalynn Kennon, IDDO
New York, Floor -2
Pioneering Efforts to Expand CDISC Standards in Japanese Academic Research
Megumi Kitayama, Wakayama Medical University
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The Importance of CDISC Standards when Retaining, Archiving, and Preserving Clinical Trial Records and Data
Matthew Addis, Arkivum
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Mapping REDCap Data into SDTM: A Case Study of Healthy Volunteer Research Data
Susan Mutter, PROMETRIKA, LLC
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Session 4D: Risk Based Approaches (TMF Track)
Chair: James E. Martin, Syneos Health
Munich & Paris, Floor -2
What Does a Risk Based Approach Really Mean? Summary of the TMF RM Risk Initiative
Joanne Malia, CDISC / Regeneron
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TMF Risk Management: Developing A Plan for Mitigating Risk Identified by the CDISC Risk Tool
Marion Mays, CDISC / Jerion Consulting Group; Sarah Hitching, Hedian
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Session 4E: Fundamentals of TMF (TMF Track)
Chair: Vittoria Sparacio, Novartis
Copenhague & Lisbonne, Floor -2
TMF as a Foundation for Success: Streamlining Operations and Ensuring Data Integrity
Laurel-Ann Schrader, TransPerfect
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The “5 Identities” of a TMF Reference Model
Claudia Panitz, Boehringer Ingelheim
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TMF Completeness - A Major Component of Inspection Ready TMF
Sagar Sutar, Emmes Group
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Session 5A: CDISC Open Rules
Chair: Johannes Ulander, data4knowledge
Zurich, Floor -2
Utilizing CDISC CORE Validation Tools: Validating Clinical Submission Domains from SAS
Daniel Christen, SAS Institute AG
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From Silos to Synergy: Uniting Forces for a Successful CDISC Open Rules Implementation
Els Janssens and Marisa Wyckmans, SGS Pharma Clinical Research
FDA Business Rules and CDISC Open Rules, the Road to Adoption
Nick De Donder, CDISC; and Jozef Aerts, XML4Pharma
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Session 5B: Analysis Results Standard
Chair: Simon Lundberg, AstraZeneca
Londres, Floor -2
ARS/eTFL Portal Presentation
Bess LeRoy, CDISC
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Analysis Results Standard for Test-Driven Development
Yann Féat, mainanalytics GmbH
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ARS Implementation Journey & Benefits
Mayank Bhatia, Tata Consultancy Services
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Session 5C: Real World Data
Chair: Stijn Rogiers, argenx
New York, Floor -2
Bridging the Standards: Standardized Mapping and Lineage
Berber Snoeijer, ClinLine; and Jules van der Zalm, OCS Consulting
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The Curious Case of External Controlled Arms (ECA): Practical Solutions for External and RWD Integration
Gautham Selvaraj and Angelo Tinazzi, Cytel, Inc.
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International Patient Summary for Research (IPS+R): New Priority Data Category in the EHDS
Catherine Chronaki, HL7 Europe
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Session 5D: TMF Interoperability (TMF Track)
Chair: Lisa Mulcahy, Mulcahy Consulting
Munich & Paris, Floor -2
Redefining TMF Excellence: Embedding Quality by Design through QMS Integration
Donatella Ballerini, Montrium
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Linking TMF and RIM for Submissions under EU-CTR
Martina Duevel, Bayer
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Panel Discussion: TMF Interoperability from Concept to Reality?
Anne-Nöelle Charles, GSK
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Session 5E: TMF Management (TMF Track)
Chair: Martin Hausten, Boehringer Ingelheim
Copenhague & Lisbonne, Floor -2
TMF Management of Transition ("Rescue") Studies: Navigating Challenges and Strategies
Georgiana Brahy, Parexel
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TMF Acquisition Preparation: Building Success Brick by Brick
Jason Weinstein, Regeneron
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Key Considerations for Biometrics CROs Not Managing the TMF - The Journey So Far
Caroline Terrill, Cytel
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Session 6A: Regulatory Submissions
Chair: Eftychia-Eirini Psarelli, EMA
Zurich, Floor -2
Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions
Médéric Celle, Sanofi; and Estella Sani, GSK
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CDISC-Compliant ISS Submission: A Use Case
Lieke Gijsbers, OCS Life Sciences
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Implementation of RTOR Standards at AstraZeneca
Robert Zollinger, AstraZeneca
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Session 6B: Standards in Action
Chair: Silvia Faini, Cytel
Londres, Floor -2
AstraZeneca Standard Output Library (AZSOL): Driving Excellence in Standardization and Automation for Tables, Figures, and Listings (TFLs)
Magdalena Soin and Birgit Weinkauf, AstraZeneca
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Best Practices for Efficient CDISC-Compliant PK NCA
Mitchikou Tseng, OCS Life Sciences
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Fitting Multi-Omics Data into SDTM
Adrian Czaban and Vicky Poulsen, Novo Nordisk A/S
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Session 6C: ADaM
Chair: Wafaa Jebert, Merck
New York, Floor -2
Estimands in ADaM: Overcoming Challenges of Multiple Estimands and Intercurrent Events
Dennis Kusian and Dr. Marius Klotz, Metronomia Clinical Research GmbH
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Rethinking ADaM Specs: Efficient Creation of High-Quality ADaM Datasets and Metadata Without Predefined Specifications
Jeroen Den Herder and Wouter Milis, SGS Pharma Clinical Research
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Enhancing PK Data Standardization: Insights from ADaM IG for Non-Compartmental Analysis
Kirana Prabeer Palangadath, Zifo RnD Solutions
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Session 6D: AI in TMF Management (TMF Track)
Chair: Yen Phan, elderbrook solutions
Munich & Paris, Floor -2
The Big TMF Battle: AI Versus the Geek
Jacki Petty and Rob Jones, Cencora Pharmalex
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How to Quiet the TMF Noise Using AI
Traci Wendler, Genmab
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Session 6E: Partnerships in TMF Management (TMF Track)
Chair: Irina Sargsyan, Enovalife
Copenhague & Lisbonne, Floor -2
Beyond the TMF Plan and TMF Index: Harmonizing Sponsor and CRO Expectations in Outsourced TMF Management
Katie Hoover, Vital GxP Consulting
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Next-Gen Security: Customizing Access Profiles for Peak Performance
Sofie Webers and Cristina Iannaccone, SGS Pharma Clinical Research
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argenx eTMF Migration Factory - Enable Clinical Teams to Focus on Core Business Activities
John Blunden, NNIT & Francesco Fiorentini, argenx
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Session 7, Track A & B: AC/BC - Highway to Automation
Chair: Els Janssens, SGS Pharma Clinical Research
Zurich & Londres, Floor -2
Enhancing Clinical Research Efficiency: Leveraging CDISC Biomedical Concepts for Automation
Bess LeRoy, CDISC
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AI-Powered Discovery of Biomedical Concepts
Amiel Kollek, Lindus Health
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Analysis Concepts definition – Initial Perspectives from the CDISC Working Group
Kirsten Langendorf, data4knowledge ApS
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Data Concepts from Protocol to CSR, Use Cases and Progress
Warwick Benger and Igor Klaver, GSK
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Session 7C: Applied Standards Governance
Chair: Éanna Kiely, Alexion
New York, Floor -2
Library Navigator: A Novel Approach to Standard Library Presentation in Clinical Trials Using Define.xml
Catherine Laugel, Merck KGaA
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Turbocharging Operational Efficiency with 100% Standardization
Vicky Poulsen and Sinna Lisa Vange, Novo Nordisk
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Governing the Ungovernable: Can A CRO Effectively Govern Its Standards?
Angelo Tinazzi, Cytel, Inc.
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User-Centric Data Standards Browser - From Concept to Reality
Katarzyna Konarzewska and Igor Klaver, GSK
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Session 7D+E: The Future of TMF (TMF Track)
Chair: Jamie Toth, BeiGene
Europe Ballroom, Floor -2
An Update on the ISF RM
Jamie Toth, CDISC / BeiGene
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Presentation of the CDISC TMF Reference Model Roadmap
Paul Fenton Carter, CDISC / Montrium
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Digital Data Flow, ICH M11 Current State and Aligning TMF Standards Development
Nick Hargaden, CDISC / Moderna; Dave Iberson-Hurst, data4knowledge
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Panel Discussion: TMF Oversight in the Digital Era
Aaron Grant, CDISC / Just in Time GCP
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Session 8: Closing Plenary
Chair: Sujit Khune, Novo Nordisk, E3C Co-Chair
International Ballroom, Floor -2
Closing Keynote Presentation: Improving the Clinical Trial Environment: A New Framework from WHO
Dr. Vaseeharan Sathiyamoorthy, World Health Organization
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Closing Remarks
Sujit Khune, Novo Nordisk A/S, E3C; Jamie Toth, BeOne Medicines, ET3C
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