2025 CDISC + TMF Europe Interchange Program
Program is preliminary and subject to change.
9:00 - 10:30
Session 1: Opening Plenary
Chair: Nick De Donder, De Donder Life Sciences, E3C Co-Chair
International Ballroom, Floor -2
9:00 - 9:10
CDISC Welcome
Nick De Donder, De Donder Life Sciences; Karen Roy, CDISC
9:10 - 9:50
Keynote Presentation
Dimitrios Athanasiou, European Medicines Agency, World Duchenne Organization
9:50 - 10:30
CDISC360i and State of the Standards
Chris Decker, CDISC President and CEO; Peter Van Reusel, CDISC Chief Technology Officer; Paul Carter, Chair, Trial Master File (TMF) Reference Model Steering Committee
10:30 - 11:00
Morning Break
11:00 - 12:30
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
11:00 - 11:20
ICH M11
Nick Halsey, EMA
11:20 - 11:40
EU Initiatives
Jesper Kjaer, Novo Nordisk
11:40 - 12:00
EMA Update
Eftychia-Eirini Psarelli, EMA
12:00 - 12:30
Panel Discussion
- Nick Halsey, EMA
- Jesper Kjaer, Novo Nordisk
- Eftychia-Eirini Psarelli, EMA
11:00 - 12:30
Session 2D+E: The Future of TMF (TMF Track)
Chair: Paul Carter, Montrium, ET3C
Europe Ballroom, Floor -2
11:00 - 11:15
TMF Introduction
Paul Carter, CDISC
11:15 - 12:00
ICH E6 R3 and the TMF
Torsten Stemmler, Head of GCP Inspections, BfArM
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 & Poster Session
Chairs: Angelo Tinazzi, Cytel, E3C; and Yen Phan, Elderbrook Solutions, ET3C
International & Geneva Foyers, Floors -1 & -2 (Poster Session in Geneva Rooms, Floor -1)
Implementation of Clinical Data Interchange Standards Consortium (CDISC) Standards to Real-World Data: Challenges and Strategies in the Setting of Observational Studies
Lucia Simoni, IQVIA
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
Jing Zhang, 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
13:30 - 15:30
Session 3A: Digital Data Flow
Chair: Stijn Rogiers, argenx, E3C
Zurich
13:30 - 14:00
ICH M11, TransCelerate, CDISC & HL7 Vulcan: Making the Electronic Protocol a Reality
Peter Van Reusel, CDISC
14:00 - 14:30
Protocol to Study Live in 15 Mins. AI, USDM and BCs in Action
Johannes Ulander, 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
Chair: Elsa Lozachmeur, Viatris Innovation
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 Pharma Clinical Research
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
Session Sponsor
Chair: Sujit Khune, Novo Nordisk, E3C
New York
13:30 - 14:00
Demonstration by Tata Consultancy Services
Mayank Bhatia, Tata Consultancy Services
14:00 - 14:30
CDISC Standards Implementation: Best Practices and Case Studies in Success
Gilbert Hunter, Certara Pinnacle 21
14:30 - 15:00
CDISC 360i Demonstration
15:00 - 15:30
CDISC COSA Demonstration
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
TMF Presentation
Presenter Invited
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, Regeneron
15:00 - 15:30
Panel Discussion: Culture Change Driving Inspection Success
Vittoria Sparacio, Novartis; Torsten Stemmler, BFarm; Panelists Invited
15:30 - 16:00
Afternoon Break
16:00 - 17:30
Session 4A: CDISC 360i
Nick De Donder, De Donder Life Sciences
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
Karen Roy, CDISC / Epista
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