Program of events is subject to change.

2023 Europe Interchange Program

All times in Europe Central Time

Session 1: Opening Plenary

9:00 - 10:30
Nick De Donder, Business & Decision Life Sciences
Vandsalen
9:00 - 9:10
CDISC Welcome
9:10 - 9:25
State of the CDISC Union
Dave Evans, CDISC President and CEO
9:25 - 9:55
State of CDISC Standards
9:55 - 10:30
Keynote Presentation
Speaker Invited

10:30 - 11:00
Morning Break

Session 2: Regulatory Topics

11:00 - 13:00
Sujit Khune, Novo Nordisk A/S
Vandsalen
11:00 - 11:30
PMDA Presentation
Dr. Yuki Ando, PMDA
11:30 - 12:00
FDA Presentation
Helena Sviglin, FDA
12:00 - 12:30
EMA Presentation
Eftychia-Eirini Psarelli, EMA
12:30 - 13:00
Regulatory Panel Session
EMA, FDA, PMDA, DKMA, NHA Representatives Invited

13:00 - 14:00
Lunch

Session 3: Track A- CDISC Foundational

14:00 - 15:30
Éanna Kiely, Alexion
Vandsalen
14:00 - 14:30
Special Handlings Required for Questionnaires, Ratings, and Scales
Jintao Shi, Boehringer Ingelheim
14:30 - 15:00
Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE
Monika Kawohl, mainanalytics GmbH
15:00 - 15:30
Everything you want to know about CTUG, CT Relationships and other Controlled Terminology topics
Ward Puttemans, SolCur; Erin Muhlbradt, NCI-EVS; Anna Pron-Zwick, AstraZeneca

Session 3: Track B- Biomedical Concepts

14:00 - 15:30
Simon Lundberg, AstraZeneca
Blomstersalen
14:00 - 14:30
The Development of CDISC Biomedical Concepts: Update and Next Steps
Jon Neville, CDISC
14:30 - 15:00
Creating CORE Rules from Biomedical Concepts
Johannes Ulander, data4knowledge ApS
15:00 - 15:30
Extending Biomedical Concepts to Analysis
Kirsten Langendorf, data4knowledge ApS

Session 3: Track C- Governance

14:00 - 15:30
Silvia Faini, Cytel
Arkaden 8
14:00 - 14:30
To EC or not to EC, that is the Question
Caroline Francis, AstraZeneca
14:30 - 15:00
The Joy (and Pain) of Implementing a Higher SDTM and SDTM IG Version ‐ A Sponsor Story
Kathleen Hectors, Janssen
15:00 - 15:30
SDTM and define.xml automation made easy
Vicky Poulsen, Novo Nordisk A/S

Afternoon Break

15:30 - 16:00

Session 4: Track A- Real World Data

16:00 - 18:00
Stijn Rogiers, argenX
Vandsalen
16:00 - 16:30
Leveraging on Real World Evidence (RWE) to Address Pitfalls in the Design and Conduct of Clinical Trials in Africa: Strategies for Optimizing Patient Recruitment and Retention.
Obiageli Onwusaka, Kena George, ClinFocus Inc
16:30 - 17:00
Heterogeneity in Data Sources: How to Deal with it?
Thierry Escudier, Manuel Neukum, EvidentIQ
17:00 - 17:30
Creation of SDTM Datasets for a Real World Study Using Electronic Medical Records
Norman Stein, John McCrae, Sylwia Migas, NorthWest EHealth
17:30 - 18:00
Panel Discussion
Global Regulatory Representatives Invited

Session 4: Track B- Optimization Use Cases

16:00 - 18:00
Johannes Ulander, data4knowledge
Blomstersalen
16:00 - 16:30
Can We Do It Better? Real-Time Validation of SDTM Mapping Is Superior to Double Programming
Daniel Rolo, Bioforum
16:30 - 17:00
All you Wanted to Know About Blood Pressure but Were Afraid to ask?
Nicolas DE SAINT JORRE, Marius CONJEAUD, Quanticsoft
17:00 - 17:30
Displaying the ODM‐XML as a CRF Rendition Using a Style Sheet
Jørgen Iversen, LEO Pharma A/S
17:30 - 18:00
A Language‐Orientated Approach to CDISC Metadata‐Driven Automation
Stuart Malcolm, Veramed

Session 4: Track C- Secondary Use of CDISC

16:00 - 18:00
William Stevens, Oxford University
Arkaden 8
16:00 - 16:30
Clinical Data Reuse: Opportunities and Challenges
Siddhant Prabhu, Parag Limaye, Ateeq Rehman, Deloitte
16:30 - 17:00
Automatic defining ADaM for new clinical studies using Machine Learning
Thomas Rye Olsen, Sune Darkner, Henning P. Föh, Rasmus Stenholt, University of Copenhagen, Department of Computer Science
17:00 - 17:30
CDISC Paediatric User Guide: a Successful Academic Collaboration to Improve Paediatric Data Standards
Rebecca Leary, Newcastle University; and John Owen, CDISC
17:30 - 18:00
Challenges and Opportunities for CDISC at the Intersection of Observational and Intervention Research: the ECRAID‐Base Experience with CDISC Implementation.
Ankur Krishnan, Lauren Maxwell, Steve Canham, Frank Leus, Lisanne Vincent, Ellen van Deuren, Roxanne Schaaks, Heidelberg Institute of Global Health

Evening Networking Event

19:00 - 21:00

Session 5: Track A- Core Rules Development

9:00 - 10:30
Nick De Donder, Business & Decision Life Sciences
Vandsalen
9:00 - 9:30
CORE Update
Peter Van Reusel, CDISC
9:30 - 10:00
Challenges of Creating CORE Rules
Amy Palmer, CDISC
10:00 - 10:30
Developing and Implementing CDISC CORE: a Data Manager's Testimonial
Els Janssens, Marisa Wyckmans, SGS Health Science

Session 5: Track B- Analysis Results Standard

9:00 - 10:30
Angelo Tinazzi, Cytel
Blomstersalen
9:00 - 9:30
CDISC Analysis Results Logical Model: Background and Overview
Bess LeRoy, Bhavin Busa, CDISC
9:30 - 10:00
Coming together ‐ a Journey in the Harmonisation and Modernisation of Clinical Analysis Standards
Warwick Benger, Edwin van Stein, Saqwindar Singh, GlaxoSmithKline
10:00 - 10:30
Analysis Results Standards Guidelines and Implementation Using R Shiny
Smriti Anand, Pfizer; Jayashree Vedanayagam, Princeps Technologies Inc.

Session 5: Track C- CDISC Foundational

9:00 - 10:30
Éanna Kiely, Alexion
Arkaden 8
9:00 - 9:30
Infant safety Data (Associated Persons data) collection in HIV study
Kai Zhao, MSD
9:30 - 10:00
DHT Data Standard Subteam: A Path to Data Standardization of DHTs
Zahra Karimaddini, John Franchino, Michael Wise, Roche; Amy Palmer and Kit Howard, CDISC
10:00 - 10:30
Lessons learned with the SENDIG‐DART FDA Fit‐For‐Use pilot
Gitte Frausing, Data Standards Decisions Aps

Morning Break

10:30 - 11:00

Session 6: Track A- CORE Implementation

11:00 - 13:00
Peter Van Reusel, CDISC CSO
Vandsalen
11:00 - 11:30
Technical Update
Sam Hume, CDISC
11:30 - 12:00
Tales from the Journey of a CORE Developer
Jozef Aerts, XML4Pharma
12:00 - 12:30
How we Achieved Real Time Validation by Integrating CORE into our Django (Python) Clinical Trial Platform
Madeleine De Forest‐Brown, Amiel Kollek, Lindus Health
12:30 - 13:00
How the new CDISC Open Rules Engine (CORE) can Improve the Speed and Quality of Dataset Deliverables in Clinical Trials
Kevin Burges and James Conway, Formedix

Session 6: Track B- Updates Towards Regulatory

11:00 - 13:00
Eftychia-Eirini Psarelli, EMA
Blomstersalen
11:00 - 11:30
International Council on Harmonization (ICH) Progress Towards and Internationally Harmonized Clinical Electronic Structured Harmonized Protocol (CESharP)
Vada Perkins, Bayer Pharmaceuticals; Ron Fitzmartin, FDA; Nick Halsey, EMA; Janice Maniwang, FDA
11:30 - 12:00
FDA‐CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chris Connelly, CDISC
12:00 - 12:30
Adapting and Evolving with OVRR Requirements
Sarah McLaughlin, Carol Baker, Karen Conway, Erin Gnas, Jenn Mastri, Merck
12:30 - 13:00
Raising Awareness for Additional FDA Data Standards Submission Recommendations
Angelo Tinazzi, Cytel

Lunch

13:00 - 14:00

Session 7: Track A- Digital Data Flow

14:00 - 16:00
Stijn Rogiers, argenX
Vandsalen
14:00 - 14:30
CDISCs Activities on DDF, Benefits for the Community and Looking Ahead
Dave Iberson-Hurst, data4knowledge ApS
14:30 - 14:45
Protocol Optimization with DDF
Siddharth Shah, ZS Associates
14:45 - 15:00
Using DDF to Drive Clinical Data Automation
Suman Kumar, Deloitte
15:00 - 15:15
Automating the Digital Data Flow with a Standards Foundation
Raj Indupuri, eClinical Solutions
15:15 - 15:30
Automating Study Set-up with a Digital Data Flow
Bron Kisler, Nurocor
15:30 - 16:00
Panel Discussion

Session 7: Track B- Submission Experience

14:00 - 16:00
Simon Lundberg, AstraZeneca
Blomstersalen
14:00 - 14:30
Balancing Quality and Efficiency ‐ a Novo Nordisk Submission Example
Adrian Czaban, Novo Nordisk A/S
14:30 - 15:00
Ensuring that a Define‐XML is Submission Ready
Caro Sluijter, OCS Life Sciences
15:00 - 15:30
The Journey of a 100 Million Records Submission
Sandeep Muttanna, Vicky Poulsen, Novo Nordisk A/S
15:30 - 16:00
Panel Discussion

Session 7: Track C- Governance

14:00 - 16:00
Silvia Faini, Cytel
Arkaden 8
14:00 - 14:30
Automate harmonization of study metadata for integrated define.xml
Nynne Louise Berthou Storm, Novo Nordisk A/S
14:30 - 15:00
Standardisation in a fast growing environment; MDR, EDC and other abbreviations.
Louella Schoemacher, OCS Life Sciences; Jasmine Kestemont, Innovion
15:00 - 15:30
E2E clinical development standards - taking us beyond the silos
Graham Downing, UCB BioSciences GmbH
15:30 - 16:00
Panel Discussion

Closing Remarks

16:00 - 16:30