Thank you for attending the 2018 Europe Interchange in Berlin. You will find presentations from the Main Conference below.
Session 1: Opening Plenary & Keynote Address
Welcome Address
Stephen Pyke, GlaxoSmithKline (GSK) and CDISC Board Chair
Keynote Presentation - Using Electronic Health Records for Real World Trials: Our Experience from the Salford Lung Study
Dr. Martin Gibson, NorthWest EHealth
State of CDISC Union
David Bobbitt, CDISC
CDISC Standards Update
Rhonda Facile, CDISC
Session 2: Second Opening Plenary - Regulatory Presentations
PMDA Update: Current Situation and Future
Dr. Yuki Ando, PMDA
A Regulatory Perspective on Future Big Data Challeges
Dr. Alison Cave, EMA
Data Standards Update
Dr. Ron Fitzmartin, FDA
CBER Study Data Standards Update
Lisa Lin, FDA
Session 3, Track A: Global Submission Experience
Is It Possible to Make a Global CDISC Submission?
Marianne Carames, Novo Nordisk A/S
Challenges of Submitting Electronic Study Data to Two Authorities: PMDA & FDA
Ina Assfalg, Boehringer Ingelheim
Analysis Results Metadata for PMDA submission: Business Case Presentation
Roxane Debrus, Business & Decision Life Sciences
Session 3, Track B: eSource
Into the Fire, CDISC & FHIR
Dave Iberson-Hurst, Assero Limited & A3 Informatics
eSource to SDTM: The Trade-offs and Pay-offs
Donald Benoot and Swapna Pothula, SGS Life Sciences
Implemented Clinical Data Sending Function in Open Source Type EHR/EMR
Professor Takahiro Kiuchi and Yoshiteru Chiba, UMIN
Session 3, Track C: Newcomers Session: A CDISC Overview
Who/Where: A CDISC History
John Owen, CDISC
Why: The Purpose and Benefits of Standards
Dr. Sam Hume, CDISC
How: COPs, Tools and Processes
Amy Palmer, CDISC
Session 4, Track A: ADaM
Workshop: The Unveiled Secrets of ADaM
Angelo Tinazzi, Cytel and Silvia Faini, CROS-NT
ADaM Mapping - Opportunities for Metadata Driven Automation
Elena Glathe, Bayer AG
ADaM 2018: What's New and What's Coming
Monika Kawohl, HMS Analytical Software
Introducing The ADaM Implementation Guide v1.2
Terek Peterson, Covance
Session 4, Track B: Machine Learning
Machine Learning Applications for Clinical Data Scientists
Mike Collinson, Oracle
How Machine Learning can be Empowered by Using Data Standards in Digital Biomarker Space
Farhan Hameed, Pfizer
Data Mapping Using Machine Learning
Nathan Asselstine, SAS
CDISC Standards in the Age of Artificial Intelligence
Jozef Aerts, University of Applied Sciences FH Joanneum
Session 4, Track C: Newcomers Session: Connected CDISC Standards
CDASH & SDTM / SEND
Sujit Khune, Novo Nordisk, E3C member
CT & QRS
Dr. Erin Muhlbradt, NCI-EVS
ADaM
Silvia Faini, CROS NT, E3C member
ODM, Define and More XML
Dr. Sam Hume, CDISC
Session 5, Track A: What's New
ODMv2 and the CDISC Data Exchange Standards: The Big Picture
Dr. Sam Hume, CDISC
QRS (Questionnaires, Ratings and Scales) Domain Mappings and Updates
Éanna Kiely, Syneos Health™
CDASH v2.0
Peter Van Reusel, CDISC
SDTMIG v3.3: New Domains - New Benefits
Nick De Donder, Business & Decision Life Sciences
Session 5, Track B: Process Implementation and Optimization
Cost Benefit Analysis of Using Standards
Jasmine Kestemont, Innovion
Harmonization of Independent Read Data with 3rd Party Vendors and Alignment with CRO
Monitha Mohan Haril Kumar, Merck KGaA
A Statistics-Based Tool to Inform Risk-Based Monitoring Approaches
Silvia Faini and Lisa Comarella, CROS NT
A CRO’s Perspective on Successful Partnering to Deliver SDTM/SEND Contributions
Helen Owen, LGC Group
Session 5, Track C: Newcomers Session: TAs, SHARE, LAB & Regulatory
Therapeutic Area User Guide Overview
Bess LeRoy, CDISC
CDISC SHARE
Dr. Lauren Becnel, CDISC
LAB & LOINC
Dr. Erin Muhlbradt, NCI-EVS
Global Regulatory Report
Amy Palmer, CDISC
Session 6, Track A: Define XML
Live Define-XML - Real Life Experiences
Katja Glass, Bayer AG
Value Level Metadata (VLM) - Not a Challenge Anymore
Malathi Hari, Larix A/S
Define-XML – What You See Isn’t Always What You Get
Will Greenway, Quanticate
Session 6, Track B: Utilizing CDISC
Clinical Data Sharing and Semantic Linking with RDF and W3C Standards
Paul Houston, CDISC
Impact of CDISC Standard Implementations in IMI Clinical and Translational Research Data
Dr. Dorina Bratfalean, CDISC
Where Did My Terminology Go?
Johannes Ulander, S-Cubed
Session 6, Track C: Newcomers Session - CDISC in Academia
Data Collection and Registry Standard Aiming for Easy-to-Use RWD
Satoshi Ueno, National Center of Neurology and Psychiatry (NCNP)
Portal of Medical Data Models to Foster Best Practice Sharing in Clinical Research and Re-use of EHR Data
Dr. Martin Dugas, University of Münster
Observational Trial in Academic Setting: Current Initiatives and Challenges
Dr. Kavita Gaadhe, Clinical Research Unit, Charite
Session 7: Challenges and Doing Better
Top 5 Challenges at Novo Nordisk Complying with CDISC Standards
Sujit Khune and Anja Lundgreen, Novo Nordisk
Leveraging the Value of Clinical Data by Establishing an Integrated Metadata Repository
Michael Walter, F. Hofmann La Roche
SDTM: It is Not all Black and White
Swapna Pothula, SGS Life Sciences
Session 8: Closing Plenary & Keynote Presentation
Keynote Presentation: Disruption Leads to Innovation
Chris Decker, d-Wise and CDISC Board Member
Closing Remarks
Joerg Dillert, Chair, CDISC E3C
Poster Session
Bluegrass Biggs, BiggsB, "A Path Forward - Lessons Learned Validating CDISC Conversions"
Djenan Ganic, intilaris LifeSciences GmbH, "CDISC Study/Protocol Design provision drives early clinical study setup"
Judith Goud, Nurocor, "CDASH IG v2.0 Implementation Considerations"
David Roulstone, Pinnacle 21, "Define.xml: what you should and should not be documenting in your define files"
Cathal Gallagher, d-Wise, "Updates From The EMA Technical Anonymization Group & Policy 0070"
Assia Bouhadouza, Sanofi, "Management of multiple results in non-extensible codelist variables"
Bob Van den Poel, Janssen Research and Development, "Implementing the CDISC SEND Data Standard at Janssen Research & Development"
Carey Smoak, S-cubed, "A Critique of the Use of the Medical Device SDTM Domains in Therapeutic Area User Guides"
Farhan Hameed, Pfizer, "An Ontologically-driven Approach to Implement Data Standards for Machine Learning for Wearable Devices"
Éanna Kiely, Syneos Health, "CDASH, ODM and Web Technologies"
Angelo Tinazzi, Cytel Inc., "Mind the gap: Pinnacle 21 Community version vs Pinnacle 21 Enterprise version"
Dr. Jozef Aerts, University of Applied Sciences FH Joanneum, "A Protocol Annotation Tool"
Dr. Jozef Aerts, University of Applied Sciences FH Joanneum, "The SDTM-IG in a machine-readable Form"
Michael Walther, Hofmann La Roche/Roche Diagnostics GmbH, "Leveraging the value of clinical data by establishing an integrated Metadata Repository"
Morten Hasselstrøm Jensen, Novo Nordisk A/S, "Please automate creation of analysis results metadata!"