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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Document
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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Panel Discussion
Session 2D+E: The Future of TMF (TMF Track)
Chair: Paul Fenton Carter, Montrium, ET3C
Europe Ballroom, Floor -2
TMF Introduction
Paul Fenton Carter, CDISC
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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Poster Session (During Lunch Break)
Chairs: Angelo Tinazzi, Cytel, E3C; and Yen Phan, Elderbrook Solutions, ET3C
Geneva Rooms, Floor -1
Can (prototype) Biomedical Concepts be generated in an automated way?
Jozef Aerts, XML4Pharma
Enhancing oncology data collection and submission: The value of the national cancer institute (NCI) oncology codetable mapping file
Karine Provost, BioTrial
CDISC ARS Overview and Applications of ARD in Practice
Duong Tran, Elderbrook Solutions
Managing SDTM Mapping Challenges in Multi-Study Portfolios: A Guide to Standards and Consistency
Marianne Dutfoy, Cytel
There's a new kid in town: Using Typst for Reviewer's Guide Automation
John McDade, Phastar
What was the Question? The understanding of Questionnaires and the correct implementation for Clinical Reporting in Psychiatric studies.
Roxanne McGuire, MAC Clinical Research
Checking Outside the Box: A Foundation for Submission Success
Julie Ann Hood, Certara
Unlocking Secrets of Seamless eTMF Management: Efficient Quality Control
Cristina Iannaccone, SGS
TMF Meetings: Hosting a Proper British Tea Party
Tajinder Brar, Cencora PharmaLex
Advancing Trial Master File Technology: Trends, Challenges, and Practical Applications in a Quality-Driven Era
Marietta Sarkisian, Flex Databases
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
Artificial Intelligence for Clinical Data Harmonization
Rachna Malik, Global Head, TCS ADD™ Platforms, Tata Consultancy Services
CDISC Standards Implementation: Best Practices and Case Studies in Success
Gilbert Hunter, Certara Pinnacle 21
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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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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Panel Discussion: Culture Change Driving Inspection Success
Vittoria Sparacio, Novartis
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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Panel on Risk Based Approaches in Line with ICH E6 R3
Karen Roy, CDISC / Epista
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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Panel on AI in TMF
Yen Phan, elderbrook solutions
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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Panel Discussion
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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