2023 Europe Interchange Presentation Archive
The 2023 CDISC Europe Interchange has ended. We look forward to seeing you in Berlin next year!
2023 Europe Interchange Program
Session 1: Opening Plenary and Keynote Presentation
Nick De Donder, Business & Decision Life Sciences
Vandsalen
CDISC Welcome
Nick De Donder, Business & Decision Life Sciences
Presentation Files
Document
State of the CDISC Union
Dave Evans, CDISC President and CEO
Presentation Files
Document
State of CDISC Standards
Bess LeRoy, CDISC
Presentation Files
Keynote Presentation: How to Make the Big Data Dream Come True
Dr. Anja Schiel, Team Leader, International HTA (iHTA), Norwegian Medicines Agency (NoMA)
Presentation Files
Session 2: Regulatory Topics
Sujit Khune, Novo Nordisk A/S
Vandsalen
PMDA Presentation
Dr. Yuki Ando, PMDA
Presentation Files
FDA’s Study Data Policy Framework and How CDISC Properties Are Evaluated for Inclusion
Helena Sviglin, FDA-CDER
Presentation Files
Data Submission and Evidence Generation in Europe - an EMA Update
Eftychia-Eirini Psarelli, EMA
Presentation Files
Regulatory Panel Session
Lunch
Poster Session
Session 3: Track A- CDISC Foundational
Éanna Kiely, Alexion
Vandsalen
Special Handlings Required for Questionnaires, Ratings, and Scales
Jintao Shi, Boehringer Ingelheim
Presentation Files
Proposal for New ADaM Paired Variables: PARQUAL/PARTYPE
Monika Kawohl, mainanalytics GmbH; Elizabeth Dennis, EMB Statistical Solutions, LLC; Paul Slagle, IQVIA
Presentation Files
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
Presentation Files
Session 3: Track B- Biomedical Concepts
Simon Lundberg, AstraZeneca
Ballonsalen + Blomstersalen
The Development of CDISC Biomedical Concepts: Update and Next Steps
Jon Neville, Bess LeRoy CDISC
Presentation Files
Creating CORE Rules from Biomedical Concepts
Johannes Ulander, data4knowledge ApS
Presentation Files
Document
Extending Biomedical Concepts to Analysis
Kirsten Langendorf, data4knowledge ApS
Presentation Files
Session 3: Track C- Governance
Silvia Faini, Cytel
Arkaden 8
To EC or not to EC, that is the Question
Caroline Francis, AstraZeneca
Presentation Files
The Joy (and Pain) of Implementing a Higher SDTM and SDTM IG Version ‐ A Sponsor Story
Kathleen Hectors, Janssen
Presentation Files
SDTM and define.xml Automation Made Easy
Vicky Poulsen, Hanne van Kints Novo Nordisk A/S
Presentation Files
Session 4: Track A- Real World Data
Stijn Rogiers, argenX
Vandsalen
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
Presentation Files
Document
Heterogeneity in Data Sources: How to Deal with it?
Thierry Escudier, Manuel Neukum, EvidentIQ
Presentation Files
Creation of SDTM Datasets for a Real World Study Using Electronic Medical Records
Norman Stein, John McCrae, NorthWest EHealth
Presentation Files
Document
Panel Discussion
Session 4: Track B- Optimization Use Cases
Johannes Ulander, data4knowledge
Ballonsalen + Blomstersalen
Can We Do It Better? Real-Time Validation of SDTM Mapping Is Superior to Double Programming
Daniel Rolo, Bioforum
Presentation Files
All you Wanted to Know About Blood Pressure but Were Afraid to ask?
Nicolas De Saint Jorre, Novo Nordisk; Marius Conjeaud, Neo4j
Presentation Files
Displaying the ODM‐XML as a CRF Rendition Using a Style Sheet
Jørgen Iversen, LEO Pharma A/S
Presentation Files
A Language‐Orientated Approach to CDISC Metadata‐Driven Automation
Stuart Malcolm, Veramed
Presentation Files
Session 4: Track C- Secondary Use of CDISC
Dr. Jozef Aerts, XML4Pharma
Arkaden 8
Clinical Data Reuse: Opportunities and Challenges
Siddhant Prabhu, Parag Limaye, Ateeq Rehman, Deloitte
Presentation Files
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
Presentation Files
CDISC Paediatric User Guide: a Successful Academic Collaboration to Improve Paediatric Data Standards
Rebecca Leary, Newcastle University; and John Owen, CDISC
Presentation Files
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
Presentation Files
Session 5: Track A- Analysis Results Standard
Angelo Tinazzi, Cytel
Vandsalen
CDISC Analysis Results Logical Model: Background and Overview
Bhavin Busa, Richard Marshall, CDISC
Presentation Files
Coming together ‐ a Journey in the Harmonisation and Modernisation of Clinical Analysis Standards
Warwick Benger, Edwin van Stein, Saqwindar Singh, GlaxoSmithKline
Presentation Files
Document
Analysis Results Standards Guidelines and Implementation Using R Shiny
Smriti Anand, Pfizer; Jayashree Vedanayagam, Princeps Technologies Inc.
Presentation Files
Session 5: Track B- Core Rules Development
Nick De Donder, Business & Decision Life Sciences
Ballonsalen + Blomstersalen
CDISC Conformance Rules and the CORE Engine: Progress and Roadmap
Peter Van Reusel, CDISC
Presentation Files
Challenges of Creating CORE Rules
Amy Palmer, CDISC
Presentation Files
Developing and Implementing CDISC CORE: a Data Manager's Testimonial
Els Janssens, SGS Health Science
Presentation Files
Session 5: Track C- Governance, Part II
Silvia Faini, Cytel
Arkaden 8
Automate Harmonization of Study Metadata for Integrated define.xml
Nynne Louise Berthou Storm and Matthew Phelps, Novo Nordisk A/S
Presentation Files
Standardisation in a Fast Growing Environment; MDR, EDC and Other Abbreviations
Louella Schoemacher, OCS Life Sciences; Jasmine Kestemont, Innovion
Presentation Files
E2E clinical Development Standards - Taking us Beyond the Silos
Graham Downing, UCB BioSciences GmbH; Janneke van Blijswijk, ZS Associates
Presentation Files
Session 6: Track A- Updates Towards Regulatory
Eftychia-Eirini Psarelli, EMA
Vandsalen
International Council on Harmonization (ICH) Progress Towards and Internationally Harmonized Clinical Electronic Structured Harmonized Protocol (CESharP)
Panagiotis Telonis, EMA; Jimita Parekh, Medable Inc.
Presentation Files
FDA‐CTP and CDISC Project to Develop Tobacco Related Standards to Achieve Efficiencies for All Stakeholders
Chris Connolly, CDISC; Chrissie Cai, FDA-CTP
Raising Awareness for Additional FDA Data Standards Submission Recommendations
Angelo Tinazzi, Cytel
Presentation Files
Document
Adapting and Evolving with OVRR Requirements
Sarah McLaughlin and Jenn Mastri, MSD
Presentation Files
Session 6: Track B- CORE Implementation
Peter Van Reusel, CDISC CSO
Ballonsalen + Blomstersalen
How to Extend and Run CORE
Sam Hume, CDISC
Presentation Files
Tales from the Journey of a CORE Developer
Jozef Aerts, XML4Pharma
Presentation Files
How we Achieved Real Time Validation by Integrating CORE into our Django (Python) Clinical Trial Platform
Madeleine De Forest‐Brown, Amiel Kollek, Lindus Health
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
Presentation Files
Leveraging CORE for Real Time Validation – No More Endless Iterations
Eyal Wultz, Bioforum
Presentation Files
Panel Discussion
Session 6: Track C- Submission Experience
Simon Lundberg, AstraZeneca
Arkaden 8
Balancing Quality and Efficiency - a Novo Nordisk Submission Example
Adrian Czaban, Novo Nordisk A/S
Presentation Files
Ensuring That a Define-XML is Submission Ready
Caro Sluijter, OCS Life Sciences
Presentation Files
The Journey of a 100 Million Records Submission
Sandeep Muttanna, Vicky Poulson, Novo Nordisk A/S
Presentation Files
Document
Lunch
Poster Session
Session 7: Track A- Regulatory Topics, Part II
Eftychia-Eirini Psarelli, EMA
Vandsalen
PDUFAVII Updates: Data and Statistical Considerations when Submitting Analysis Data for DHT-Derived Endpoints
Dr. Matilde Kam, Division Director, Division of Analytics and Informatics (DAI), Office of Biostatistics (OB), OTS/ CDER, US Food and Drug Administration (FDA)
Presentation Files
Document
Advancing Premarket Safety Analytics
Dr. Y. Veronica Pei, MD, MPH, MEd; Lieutenant Commander, U.S. Public Health Service; Associate Director of Biomedical Informatics, Office of New Drugs (OND), CDER, US Food and Drug Administration (FDA)
Presentation Files
Document
Session 7: Track B- Digital Data Flow
Stijn Rogiers, argenX
Ballonsalen + Blomstersalen
CDISCs Activities on DDF, Benefits for the Community and Looking Ahead
Dave Iberson-Hurst, CDISC
Presentation Files
Protocol Optimization with DDF
Siddarth Shah, ZS Associates
Presentation Files
Using DDF to Drive Clinical Data Automation
Suman Kumar, Deloitte
Presentation Files
Automating the Digital Data Flow with a Standards Foundation
Jason Konn, eClinical Solutions
Presentation Files
Panel Discussion
Session 7: Track C- CDISC Foundational, Part II
Éanna Kiely, Alexion
Arkaden 8
Infant Safety Data (Associated Persons data) Collection in HIV Study
Kai Zhao, MSD
Presentation Files
DHT Data Standard Subteam: A Path to Data Standardization of DHTs
Zahra Karimaddini, Roche
Presentation Files
Document
Lessons Learned with the SENDIG-DART FDA Fit-For-Use Pilot
Gitte Frausing, Data Standards Decisions Aps
Presentation Files
Document
Session 8: Closing Plenary
Sujit Khune, Novo Nordisk A/S; CDISC E3C Co-Chair
Vandsalen
TMF Presentation
Karen Roy and Paul Fenton; TMF Reference Model
Presentation Files
Closing Remarks
Sujit Khune, Novo Nordisk A/S; CDISC E3C Co-Chair
Presentation Files
Document