2025 CDISC + TMF Europe Interchange Program
Program is preliminary and subject to change.
9:00 - 10:30
Session 1: Opening Plenary
Nick De Donder, CDISC
International Ballroom
9:00 - 9:10
CDISC Welcome
Chris Decker, CDISC President and CEO
9:10 - 9:50
Keynote Presentation
Dimitrios Athanasiou, European Medicines Agency, World Duchenne Organization
9:50 - 10:30
CDISC Updates
CDISC Speakers To Be Confirmed
10:30 - 11:00
Morning Break
11:00 - 12:30
Session 2: Track A, B, C - Regulatory Presentations
Sujit Khune, Novo Nordisk
International Ballroom
11:00 - 12:30
Presenters Invited from EMA, FDA, and PMDA
11:00 - 12:30
Session 2D+E: The Future of TMF (TMF Track)
Paul Carter, Montrium
Europe Ballroom
11:00 - 11:15
TMF Introduction
Paul Carter, CDISC
11:15 - 12:00
ICH E6 R3 and the TMF
Speaker Invited
12:00 - 12:30
TMF RM V4
TMF RM V4 Project Management Team - Gill Gittens (Transperfect), Lisa Mulcahy (Mulcahy Consulting), and Donna Dorozinsky (Just In Time GCP)
12:30 - 13:30
Lunch
13:30 - 15:30
Session 3A: Digital Data Flow
Stijn Rogiers, argenx
Zurich
13:30 - 14:00
USDM / ICH M11
Peter Van Reusel, CDISC
14:00 - 14:30
Protocol to Study Live in 15 Mins. AI, USDM and BCs in Action
Kirsten Langendorf, data4knowledge ApS
14:30 - 15:00
Bringing the USDM Model to the Catwalk
Julie Jacobsen Bryndum and Anja Lundgreen, Novo Nordisk A/S
15:00 -15:30
Navigating Post-Go-Live Changes in Automated Clinical Study Builds: Optimizing USDM / M11 for EDC and Beyond
Joerg Dillert, Oracle
13:30 - 15:30
Session 3B: Artificial Intelligence
Wafaa Jebert, Merck
Londres
13:30 - 14:00
Leveraging AI to Simplify SDTM Standards and Streamline Clinical Data Management
Ward Puttemans and Bram Seigers, argenx / SolCur
14:00 - 14:30
Let Robots Sort It Out: Smarter CDISC Open Rules with AI
Roman Radelicki, SGS Health Science
14:30 - 15:00
The Role of Data Standardization in AI-Driven Clinical Research
Angelica Prado and Adrian Czaban, Novo Nordisk A/S
15:00 - 15:30
AI for Standards Library Search
Ayomide Fasemire, AstraZeneca
13:30 - 15:30
Session 3C: Innovation Showcase
Sujit Khune, Novo Nordisk
New York
13:30 - 15:30
Presentations to be Confirmed
13:30 - 15:30
Session 3D: Technology in TMF Management (TMF Track)
Anne-Nöelle Charles, GSK
Munich & Paris
13:30 - 14:00
How to Leverage Next-Generation Tools Today to Optimize TMF Processing and Enhance Efficiency
Aaron Grant and Carol Radwanski, Just in Time GCP
14:00 - 14:30
TMF Technology Trends: Insights from eTMF Data
Jim Horstmann, Veeva Systems
14:30 - 15:00
Exploring the Role of TMF Metrics and KPIs in Trial Innovation - Is There a Purpose Beyond Inspection Readiness?
Franciska Darmer, LS Darmer Advisory
15:00 - 15:30
The Requirements of the 2023 EMA Guideline on Clinical Systems and the CSV Tab of the CDISC TMF RM
Lisa Mulcahy, Mulcahy Consulting
13:30 - 15:30
Session 3E: TMF Culture and Engagement (TMF Track)
Joanne Malia, Regeneron
Copenhague & Lisbonne
13:30 - 14:00
The Danish TMF Network
Karla Navera-Andersen, Ascendis Pharma A/S
14:00 - 14:30
Panel Discussion: Building a Unified TMF Culture Strategy: Engaging End Users, Clinical Functional Areas, and Collaborating Clinical Partners
Lies Orbie, argenx
Panelists:
- Melissa De Swaef, argenx
14:30 - 15:00
Elevate Your TMF Inspection Readiness with a Focused Preparation Program
Hobson Lopes and Ramya Iyer, Regeneron
15:00 - 15:30
Panel Discussion: Culture Change Driving Inspection Success
Vittoria Sparacio, Novartis; Panelists Invited
15:30 - 16:00
Afternoon Break
16:00 - 17:30
Session 4A: CDISC 360i
Nick De Donder, CDISC
Zurich
16:00 - 16:30
CDISC 360i Update and Next Steps
CDISC Speaker To Be Confirmed
16:30 - 17:00
Enhanced Biomedical Concepts: A Design Perspective in OpenStudyBuilder Supporting CDISC 360i
Mikkel Traun and Nicolas de Saint-Jorre, Novo Nordisk A/S
17:00 - 17:30
CDISC 360i, and the Worm that Turned
Jeremy Teoh and Warwick Benger, GSK
16:00 - 17:30
Session 4B: CDISC Foundational
Angelo Tinazzi, Cytel
Londres
16:00 - 16:30
Unraveling the Complex Web of Data Relationships
Emma Törner and Parag Wani, AstraZeneca
16:30 - 17:00
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.
17:00 - 17:30
CDISC Protocol Deviation Sub-Team SDTMIG 4.0 Updates and Open Topics
Éanna Kiely, Alexion, AstraZeneca Rare Disease
16:00 - 17:30
Session 4C: Academia
Kalynn Kennon, IDDO
New York
16:00 - 16:30
Pioneering Efforts to Expand CDISC Standards in Japanese Academic Research
Megumi Kitayama, Wakayama Medical University
16:30 - 17:00
The Importance of CDISC Standards when Retaining, Archiving, and Preserving Clinical Trial Records and Data
Matthew Addis, Arkivum
17:00 - 17:30
Mapping REDCap Data into SDTM: A Case Study of Healthy Volunteer Research Data
Susan Mutter, PROMETRIKA, LLC
16:00 - 17:30
Session 4D: Risk Based Approaches (TMF Track)
James E. Martin, Syneos Health
Munich & Paris
16:00 - 16:30
What Does a Risk Based Approach Really Mean? Summary of the TMF RM Risk Initiative
Joanne Malia, CDISC / Regeneron
16:30 - 17:00
TMF Risk Management: Developing A Plan for Mitigating Risk Identified by the CDISC Risk Tool
Marion Mays, CDISC / Jerion Consulting Group
17:00 - 17:30
Panel on Risk Based Approaches in Line with ICH E6 R3
Panelists Invited
16:00 - 17:30
Session 4E: Fundamentals of TMF (TMF Track)
Vittoria Sparacio, Novartis
Copenhague & Lisbonne
16:00 - 16:30
TMF as a Foundation for Success: Streamlining Operations and Ensuring Data Integrity
Laurel-Ann Schrader, TransPerfect
16:30 - 17:00
The “5 Identities” of a TMF Reference Model
Claudia Panitz, Boehringer Ingelheim
17:00 - 17:30
TMF Completeness - A Major Component of Inspection Ready TMF
Sagar Sutar, Emmes Group
19:00 - 22:00
Interchange Evening Networking Event
Must be registered for the Main Conference and selected "Evening Event" during the registration process to attend.
Uptown Geneva
9:00 - 10:30
Session 5A: CDISC Open Rules
Johannes Ulander, data4knowledge
Zurich
9:00 - 9:30
Utilizing CDISC CORE Validation Tools: Validating Clinical Submission Domains from SAS
Daniel Christen, SAS Institute AG
9:30 - 10:00
From Silos to Synergy: Uniting Forces for a Successful CDISC Open Rules Implementation
Els Janssens and Marisa Wyckmans, SGS Health Science
10:00 - 10:30
FDA Business Rules and CDISC Open Rules, the Road to Adoption
Nick De Donder, CDISC; and Jozef Aerts, XML4Pharma
9:00 - 10:30
Session 5B: Analysis Results Standard
Simon Lundberg, AstraZeneca
Londres
9:00 - 9:30
ARS/eTFL Portal Presentation
Bess LeRoy, CDISC
9:30 - 10:00
Analysis Results Standard for Test-Driven Development
Yann Féat, mainanalytics GmbH
10:00 - 10:30
ARS Implementation Journey & Benefits
Mayank Bhatia, Tata Consultancy Services
9:00 - 10:30
Session 5C: Real World Data
Stijn Rogiers, argenx
New York
9:00 - 9:30
Bridging the Standards: Standardized Mapping and Lineage
Berber Snoeijer, ClinLine; and Jules van der Zalm, OCS Consulting
9:30 - 10:00
The Curious Case of External Controlled Arms (ECA): Practical Solutions for External and RWD Integration
Gautham Selvaraj and Angelo Tinazzi, Cytel, Inc.
10:00 - 10:30
International Patient Summary for Research (IPS+R): New Priority Data Category in the EHDS
Catherine Chronaki, HL7 Europe
9:00 - 10:30
Session 5D: TMF Interoperability (TMF Track)
Lisa Mulcahy, Mulcahy Consulting
Munich & Paris
9:00 - 9:30
Redefining TMF Excellence: Embedding Quality by Design through QMS Integration
Donatella Ballerini, Montrium
9:30 - 10:00
Linking TMF and RIM for Submissions under EU-CTR
Martina Duevel, Bayer
9:30 - 10:00
Panel Discussion: TMF Interoperability from Concept to Reality?
Anne-Nöelle Charles, GSK
Panelists:
- Anne-Nöelle Charles, GSK
- Jay Smith, TransPerfect
9:00 - 10:30
Session 5E: TMF Management (TMF Track)
Irina Sargsyan, Enovalife
Copenhague & Lisbonne
9:00 - 9:30
TMF Management of Transition ("Rescue") Studies: Navigating Challenges and Strategies
Georgiana Brahy, Parexel
9:30 - 10:00
TMF Acquisition Preparation: Building Success Brick by Brick
Jason Weinstein, Regeneron
10:00 - 10:30
Key Considerations for Biometrics CROs Not Managing the TMF - The Journey So Far
Caroline Terrill, Cytel
10:30 - 11:00
Morning Break
11:00 - 12:30
Session 6A: Regulatory Submissions
Eftychia-Eirini Psarelli, EMA
Zurich
11:00 - 11:30
Collaborating on Standards: An Approach to Harmonizing Vaccine Regulatory Submissions
Médéric Celle, Sanofi; and Estella Sani, GSK
11:30 - 12:00
CDISC-Compliant ISS Submission: A Use Case
Lieke Gijsbers, OCS Life Sciences
12:00 - 12:30
Implementation of RTOR Standards at AstraZeneca
Robert Zollinger, AstraZeneca
11:00 - 12:30
Session 6B: Standards in Action
Silvia Faini, Cytel
Londres
11:00 - 11:30
RECIST and iRECIST Comparison
Katarzyna Wojewodzka, Rho Inc.
11:30 - 12:00
Best Practices for Efficient CDISC-Compliant PK NCA
Mitchikou Tseng, OCS Life Sciences
12:00 - 12:30
Fitting Multi-Omics Data into SDTM
Adrian Czaban and Vicky Poulsen, Novo Nordisk A/S
11:00 - 12:30
Session 6C: ADaM
Elsa Lozachmeur, Viatris Innovation
New York
11:00 - 11:30
Estimands in ADaM: Overcoming Challenges of Multiple Estimands and Intercurrent Events
Dennis Kusian and Dr. Marius Klotz, Metronomia Clinical Research GmbH
11:30 - 12:00
Rethinking ADaM Specs: Efficient Creation of High-Quality ADaM Datasets and Metadata Without Predefined Specifications
Jeroen Den Herder and Wouter Milis, SGS Health Science
12:00 - 12:30
Enhancing PK Data Standardization: Insights from ADaM IG for Non-Compartmental Analysis
Rathika Muthu, Zifo RnD Solutions
11:00 - 12:30
Session 6D: AI in TMF Management (TMF Track)
Yen Phan, elderbrook solutions
Munich & Paris
11:00 - 11:30
The Big TMF Battle: AI Versus the Geek
Jacki Petty and Rob Jones, Cencora Pharmalex
11:30 - 12:00
How to Quiet the TMF Noise Using AI
Traci Wendler, Genmab
12:00 - 12:30
Exceeding TMF Auto-Classification Accuracy Benchmarks using Generative AI
Nataraj Dasgupta, Consultant
11:00 - 12:30
Session 6E: Partnerships in TMF Management (TMF Track)
Martin Hausten, Boehringer Ingelheim
Copenhague & Lisbonne
11:00 - 11:30
Beyond the TMF Plan and TMF Index: Harmonizing Sponsor and CRO Expectations in Outsourced TMF Management
Katie Hoover, Vital GxP Consulting
11:30 - 12:00
Next-Gen Security: Customizing Access Profiles for Peak Performance
Sofie Webers and Cristina Iannaccone, SGS Health Science
12:00 - 12:30
argenx eTMF Migration Factory - Enable Clinical Teams to Focus on Core Business Activities
John Blunden, NNIT & argenx
12:30 - 13:30
Lunch
13:30 - 15:30
Session 7, Track A & B: AC/BC - Highway to Automation
Els Janssens, SGS Health Science
Zurich & Londres
13:30 - 14:00
BC Presentation Update
Bess LeRoy, CDISC
14:00 - 14:30
AI-Powered Discovery of Biomedical Concepts
Amiel Kollek, Lindus Health
14:30 - 15:00
Biomedical Concept / Analysis Concept Use Case - Protocol, Collection, Analysis, Mapping
Speaker to be Confirmed
15:00 - 15:30
Analysis Concepts Presentation
Speaker to be Confirmed
13:30 - 15:30
Session 7C: Applied Standards Governance
Éanna Kiely, Alexion
New York
13:30 - 14:00
Library Navigator: A Novel Approach to Standard Library Presentation in Clinical Trials Using Define.xml
Catherine Laugel, Merck KGaA
14:00 - 14:30
User-Centric Data Standards Browser - From Concept to Reality
Katarzyna Konarzewska and Igor Klaver, GSK
14:30 - 15:00
Turbocharging Operational Efficiency with 100% Standardization
Vicky Poulsen and Sinna Lisa Vange, Novo Nordisk
15:00 - 15:30
Governing the Ungovernable: Can A CRO Effectively Govern Its Standards?
Angelo Tinazzi, Cytel, Inc.
13:30 - 15:30
Session 7D+E: The Future of TMF (TMF Track)
Jamie Toth, BeiGene
Europe Ballroom
13:30 - 14:00
An Update on the ISF RM
Jamie Toth, CDISC / BeiGene
14:00 - 14:30
Presentation of the CDISC TMF Reference Model Roadmap
Paul Carter, CDISC / Montrium
14:30 - 15:00
Digital Data Flow, ICH M11 Current State and Aligning TMF Standards Development
Nick Hargaden, CDISC / Moderna
15:00 - 15:30
Panel Discussion: TMF Oversight in the Digital Era
Aaron Grant, CDISC / Just in Time GCP
Panelists:
- Nick Hargaden, Moderna
- Heather Childs, PPD
- Jim Horstmann, Veeva
15:30 - 16:00
Afternoon Break
16:00 - 16:50
Session 8: Closing Plenary
Sujit Khune, Novo Nordisk
International Ballroom
16:00 - 16:40
Closing Keynote Presentation
Dr. Vaseeharan Sathiyamoorthy, World Health Organization
16:40 - 16:50
Closing Remarks