2024 CDISC + TMF Europe Interchange Presentation Archive
Session 1: Opening Plenary and Keynote Presentation
Nick De Donder, Business & Decision Life Sciences; Karen Roy, CDISC
Europa 5 + 6
CDISC + TMF Welcome
Nick De Donder, Business & Decision Life Sciences; Karen Roy, CDISC
Presentation Media
Document
CDISC Vision: Rebuilding our Foundation and Transforming the Standards Paradigm
Chris Decker, CDISC President and CEO
Presentation Media
CDISC Three Year Roadmap: Focus on the First Step to Realize the Long-Term Vision
Peter Van Reusel, CDISC
Presentation Media
Will ICH M11 be the Catalyst to the Digital Transformation in Pharma R&D?
Rob DiCicco, VP, Portfolio Management; TransCelerate Biopharma
Presentation Media
Document
Session 2A: Foundational Standards
Kalynn Kennon, IDDO
Europa 5
Tobacco Implementation Guide (TIG) v1.0: A New Standard for Regulatory Submission
Christine Connolly, CDISC; Chrissie Cai, FDA-CTP
Presentation Media
Getting Started with the New CDISC Analysis Results Standard
Bess LeRoy, CDISC
Presentation Media
Document
Using SDTM to Standardize and Store Antimicrobial Resistance Surveillance Data
Yanina Borzykh, IDDO
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Document
Session 2B: AI in Standards
Stijn Rogers, argenx
Europa 6
Leveraging Large Language Models for Regulatory Intelligence
Soundarya Palanisamy, SAS; Dario Fabiani, DedaGroup Business Solutions
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Document
AI Powered Mapping of Trial Outcomes to CDISC Standards: Unlocking the Potential of Past Data
Ece Kavalci & Oskar Wroz, Lindus Health
Presentation Media
AI agents as Co-Scientists: Pioneering the Next Frontier in Pharma with Advanced Clinical Data Insights
Sam Khalil, Novo Nordisk A/S
Presentation Media
Session 2C: Navigating Submission Pathways
Simon Lundberg, AstraZeneca
Berlin 1-3
Understand PFDD Guidance Series and Impact on Data Submission
Jintao Shi, Boehringer Ingelheim
Presentation Media
10 Years of FDA Study Data Technical Conformance Guide: Have You Missed any FDA Data Submissions Requirements?
Angelo Tinazzi, Cytel
Presentation Media
Efficient Construction of ADaM and Safety Output, Following the New FDA ST&F Guide
Mikael Staf and Katarina Hedman, AstraZeneca
Presentation Media
Session 2D: TMF Inspections (TMF Track)
Karen Roy, CDISC
Zoo 4 + 5
TMF Introduction
Karen Roy, CDISC; Jamie Toth, BeiGene; Paul Fenton, Montrium
Back to the TMF: Managing Your Documents Across Time and Space
Dr. Torsten Stemmler, Federal Institute for Drugs and Medical Devices (BfArM)
Presentation Media
Inspection Panel – Audience-Led Questions
Lunch & Poster Session
Europa 2 - 4
Poster: Welcome to the {iddoverse}: An R Package for Converting IDDO-SDTM data to Analysis Datasets
Rhys Peploe, IDDO
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Document
Poster: Elevate Your Game: Leveling Up SDTM Validation With the Magic of Data Managers
Jennifer Manzi and Julie Ann Hood, Pinnacle21
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Poster: A Risk-Based Approach to Long Term Data Integrity of Clinical Data and the role of CDISC Standards
Matthew Addis, Arkivum
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Document
Poster: APIs through SAS, Endless Possibilities
Davide Marinucci, Alira Health
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Poster: CDASH Implementation Roadmap at AstraZeneca
Joanna Kuźmicz, AstraZeneca
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Poster: Bridging the Gap: TMF Culture and Engagement in a Diverse Workforce
Michal Fryza, KCR
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Document
Poster: Origin-ise your ADaM: A Metadata Assignment Flowchart
Lucy Watson & Saqwindar Singh, GSK
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Poster: Data Standards Conformance Checks for Vaccine Trials
Estella Sani, GSK
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Poster: Introduction to OpenStudyBuilder COSA Project
Katja Glaβ, Katja Glaβ Consulting
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Document
Poster: Setting your CRO up for Success, Become More Friend than Foe
Rob Jones, Phlexglobal
Presentation Media
Poster: Use Case - A Custom Domain for Induced Pain, Going from Source to SDTM to ADaM
Caro Sluijter, OCS Consulting
Presentation Media
Document
Poster: Comparing the Pros and Cons Between two Different Approaches for Generating Harmonized SDTM data
Tanjua Yadav & Kasper Dideriksen, Novo Nordisk
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Document
Poster: Data Quality Considerations when Providing Large Volumes of Consolidated Clinical Trial Data for Secondary Use
Siddhant Prabhu, Novo Nordisk
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Poster: Explore the Evolution of Controlled Terminology Standards: A Case Study Perspective
Christine Mathiesen, Priyanka Prabhakar, Kasper Dideriksen; Novo Nordisk
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Poster: We Have a Big Metadata Problem
Dr. Sam Hume, CDISC
Presentation Media
Poster: Automation of SDTM Data Derivation with R
Ben Barnaby-Pass, Phastar
Presentation Media
Document
Session 3A: Digital Health Technologies
Stijn Rogers, argenx
Europa 5
The Impact of Digital Health Technologies on Records and Retention
Jamie Toth, BeiGene
Presentation Media
Digital Health Technologies (DHTs): A Path to Data Standardization
Christine Connolly, CDISC
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Considerations for Driving High Quality DHT Datasets and Aligning with CDISC Standards
Kate Lyden, VivoSense; Vanessa Sarrechia, argenx
Session 3B: End-to-End Implementation
Johannes Ulander, data4knowledge
Europa 6
GSK's Journey Towards an MDR
Igor Klaver, GSK
Presentation Media
Discover the Remarkable end-to-end Strategy Behind Merck KGaA New Standard Library
Wafaa Jabert, Merck
Presentation Media
Using a Standards Library to Support end-to-end CDISC Automation
Stuart Malcolm, Veramed
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Session 3C: CDISC CORE Update & Workshop
Nick De Donder, Business & Decision Life Sciences
Berlin 1-3
CDISC Conformance Rules and the CDISC Open Rules Engine. Continuing the Road to Adoption
Nick De Donder, Business & Decision Life Sciences
Presentation Media
Document
CORE Workshop
Nick De Donder, Business & Decision Life Sciences; Els Janssens, SGS Health Science; Jozef Aerts, XML4Pharma
Session 3D: Partnerships in TMF Management (TMF Track)
Dawn Niccum, inSeption Group
Zoo 4
There is Something Rotten in the Realm of the TMF: Why the eTMF does not Deliver to its Promise, a Polemic
Dr. Max Horneck, elderbrook solutions GmbH
Presentation Media
Buried Treasure: Bringing the Hidden Value of TMF Metrics to the Light
Joanne Malia, Regeneron; Janice Cassamajor, Cencora Pharmalex
We are the (TMF) Champions
Jason Weinstein, Regeneron; Jacki Petty, Cencora Pharmalex
Presentation Media
Panel
Session 3E: TMF Culture and Engagement (TMF Track)
Anne-Noëlle Charles, GSK
Zoo 5
Characteristics of the 5 Generations of People and Considerations for TMF Management
Lisa Mulcahy, Mulcahy Consulting LLC
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Improving Your TMF Culture: Winning Heart and Minds
Chris Jones, Novartis
Presentation Media
Document
TMF Education and Culture Panel
Session 4: Regulatory
Sujit Khune, Novo Nordisk A/S
Europa 5 + 6
FDA Presentation on Technical Conformance Guide (TCG)
Helena Sviglin, FDA
Presentation Media
PMDA Presentation
Dr. Yuki Ando, PMDA
Presentation Media
Supporting Submission and Standardisation of Data - an EMA Update
Eftychia-Eirini Psarelli, EMA
Presentation Media
Session 4D: The Impact of Regulations (TMF Track)
Vittoria Sparacio, Novartis
Zoo 4
How Have the Regulations Influenced Risk Based TMF Strategies?
Sarah Hitching, Hedian Records Management
Presentation Media
EU CTR- Regulatory or EC/IRB Submissions- How to File?
Martina Duevel, Bayer
Presentation Media
The EU CTR and its Impact on TMF
Karla Navera-Andersen, Ascendis Pharma A/S
Presentation Media
Session 4E: Technology in TMF Management (TMF Track)
Martin Hausten, Boehringer Ingelheim
Zoo 5
Content Classification and Review- Not a One Trick Pony
Gary Shorter, IQVIA
Presentation Media
TMF Interoperability: The Critical Importance of Standard Integration of Clinical Trial Management Data to Promote eTMF Health and Completeness
Jay Smith, TransPerfect
Presentation Media
Document
A Risk Based Approach to eTMF Data Integrity Across the Whole Trial Lifecycle
Matthew Addis, Arkivum; Jim Markley, Just In Time GCP
Presentation Media
Document
Session 5A: CORE Implementation
Nick De Donder, Business & Decision Life Sciences
Europa 5
Adopt and Adapt CDISC CORE: A Sponsor's Reflections
Addie Nina Olsen and Vicky Poulsen, Novo Nordisk A/S
Presentation Media
Our Road to Adopting CORE: An Implementation Journey in SDTM Dataset Validation
Els Janssens, SGS Health Science
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Implementing CDISC CORE in a Cloud Native, Regulated Environment Supporting Rare Disease Submissions
Sandeep Juneja, argenx; Emmy Pahmer, OCS Life Sciences
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Document
Session 5B: COSA
Éanna Kiely, Alexion
Europa 6
Open-Source Practicalities and the Legal Side
Katja Glass, Katja Glass Consulting
Presentation Media
Document
Lifting the Language Barrier: Choosing not to Choose
John McDade, Phastar
Presentation Media
How to Build a Global, Reusable, Shareable Metadata Flow with a Customer-Centric Focus
Anja Lundgreen & Martin Gram, Novo Nordisk A/S
Presentation Media
Session 5C: Analysis Results Standards Workshop
Kalynn Kennon, IDDO
Berlin 1-3
Analysis Results Stands Hands-on Workshop
Bess LeRoy and Richard Marshall, CDISC
Session 5D: Risk Based Approaches (TMF Track)
Joanne Malia, Regeneron
Zoo 4
TMF Completeness Check- The GSK Risk Based Approach to Inspection Readiness
Anne-Noelle Charles, GSK
Presentation Media
TMF Quality Reviews Using Risk Based Approaches - Up-taking an ISO/ANSI Method
Dr. Katharina Weisrock, Boehringer Ingelheim Pharma GmbH & CO KG
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A Risk Based Approach for Determining how to Manage the TMF for Different Types of Studies
Rebecca Reel, Biogen; Rebecca Halbur, Moderna
Presentation Media
Session 5E: TMF Essentials (TMF Track)
Yen Phan, elderbrook solutions Gmbh
Zoo 5
TMF Reference Model to Improve TMF Management
Jackie Morrill, LMK/TransPerfect
Presentation Media
The Benefit of Adopting the TMF Reference Model
Morten Nielsen, Epista
Presentation Media
Increasing Quality of the TMF Through Risk Based QC
Dawn Niccum, inSeption Group; Carol Radwanski, Just In Time GCP
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Document
Session 6A: Digital Data Flow
Stijn Rogers, argenx
Europa 5
ICH M11 Clinical electronic Structure Harmonized Protocol (CeSHarP) and CDISC: Making the Electronic Protocol a Reality
Peter Van Reusel, CDISC
Presentation Media
The TransCelerate / CDISC Digital Data Flow Project: Practical Electronic Study Designs
Dave Iberson-Hurst, CDISC
Presentation Media
DDF: The Art of the Possible Becomes a Reality
Frederik Malfait; Nurocor
Presentation Media
Session 6B: Pivoting JSON
Silvia Faini, Cytel
Europa 6
Key Takeaways from the Dataset JSON Pilot
Dr. Sam Hume, CDISC
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The Need for Speed: Why Dataset JSON is so Important
Dr. Jozef Aerts, XML4Pharma
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ARD Generator : A SAS Tool for Metadata Driven Analysis Using the Analysis Standard Result
Karl Wallendszus, Oxford Population Health
Presentation Media
Session 6C: Submission Experience
Eftychia-Eirini Psarelli, EMA
Berlin 1-3
Preparing an E-Submission Ready ISS- Lost in the Jungle?
Stefanie Sturm, mainanalytics GmbH
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Document
Navigating Data Package Submission in the Chinese Regulatory Landscape
Rebecca Moretti & Emanuele Rocco Calabrò, Chiesi Farmaceutici S.p.A
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How to Use WHODrug for Compliance with CM Domain in the CDISC SDTM Standard
Marilina Castellano, Uppsala Monitoring Centre
Session 6D: TMF Management Through Metrics (TMF Track)
James Martin, Syneos Health
Zoo 4
Enhancing Meta-Analysis Through TMF Methodologies
Yen Phan, University of Oxford
Presentation Media
TMF Health Management Through Fit for Purpose Tools Beyond Completeness-Timeliness-Quality
Susan Homminga and Anne-Noelle Charles, GSK
Presentation Media
Metrification of Your TMF Plan
Oli Cram, Ennov
Presentation Media
Session 6E: Enhancing Quality (TMF Track)
Irina Sargsyan, Business & Decision Life Sciences
Zoo 5
Elevate the Inspection Readiness of your TMF Through an Agile Methodology
Donatella Ballerini & Paul Fenton, Montrium
Presentation Media
The Challenges of Investigator Site Files and why the Investigator Site File Reference Model Initiative is Needed!
Dr. Konrad Janik, Accelerated Enrollment Solutions; Dawn Niccum, inSeption Group; Matt Lowery, CRBD Plus; Jamie Toth, Beigene
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How to Migrate Study Data (and How Not to!)- A Case Study Review
Frederik Soerensen and Pawel Rucki, Base Life Science
Presentation Media
Document
Lunch
Europa 2 - 4
Session 7A: Digital Data Flow
Sujit Khune, Novo Nordisk A/S
Europa 5
Development of Unified Studies Definition Model (USDM) Through Translation of the Human-Readable Protocols
Jasmine Kestemont, Innovion; Stijn Rogiers, argenx
Ripping up the Protocol: Pairing up USDM and ICH M11 to Inform Real-Time Study Builds
Zaid Al-Jubouri, Lindus Health
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Demonstrating e2e Study Data Automation Using Extended USDM Model
Kirsten Walther Langendorf, Johannes Ulander, Dave Iberson-Hurst; data4knowledge;
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From OpenStudyBuilder to the Digital Data Flow- USDM Format
Maurizio Mazzei & Nicolas De Saint Jorre, Neo4J
Presentation Media
Document
Panel Discussion
Session 7B: ADaM
Angelo Tinazzi, Cytel
Europa 6
Advancing Clinical Trial Analysis: Bridging Gaps in Hierarchical Composite Endpoints Implementation
Christoffer Bäckberg, AstraZeneca
Presentation Media
Estimands Implementation Using Data Standards
Cedric Davister, Merck KGaA; Alexandra Cochinaire, Johnson and Johnson
Presentation Media
Setup of ADAE and ADTTE for Exposure Adjusted Incidence Rate Reporting in an Integrated Summary of Safety (ISS) Submission
Mitchikou Tseng, OCS Consulting
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Visualizing ADaM: A Practical Guide Through Examples
Silvia Faini & Angelo Tinazzi, Cytel
Presentation Media
Session 7C: Implementation Challenges
Wafaa Jabert, Merck
Berlin 1-3
Challenges in Implementing SDTM and ADaM in Oncology Platform Trials
Carla Santillan, Fortrea
Presentation Media
Adjudication of Events and Findings
Jennifer Mastri and Diana Litvan, MSD
Presentation Media
Submitting Laboratory Data in Multiple Standard Units
Éanna Kiely, Alexion/AZ
Presentation Media
Navigating the Labyrinth of Controlled Terminology: Challenges and Opportunities in Integrating and Managing Diverse Terminologies for Broad Use of Metadata
Kasper Dideriksen & Martin Gram, Novo Nordisk A/S
Session 7 D&E: Data-Driven TMF (TMF Track)
Paul Fenton, Montrium
Zoo 4+5
Interactive Session: AI and eTMF - Where are we at Today and Where are we Going?
Towards a More Data Driven TMF: Integration of the TMF Reference Model with Digital Data Flow, ICH M11, and Other CDISC Standards
Nick Hargaden, Moderna; Paul Fenton, Montrium
Presentation Media
Exploring the Benefits and Barriers of TMF Reference Model Exchange Mechanism - Panel
Session 8: Closing Plenary
Sujit Khune, Novo Nordisk A/S; Jamie Toth, BeiGene
Europa 5 + 6
Closing Remarks
Sujit Khune, Novo Nordisk A/S; Jamie Toth, BeiGene; Chris Decker, CDISC
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