Thank you for attending the 2019 Europe Interchange in Amsterdam. You will find presentations from the Main Conference below.
Session 1: Opening Plenary & Keynote Address
Welcome
Joerg Dillert, Oracle, E3C Chair
Welcome Address from the CDISC Board Chair
Dr. Douglas Peddicord, Association of Clinical Research Organizations, CDISC Board Chair
Keynote Presentation: Towards the Internet of FAIR Data
Dr. Luiz Olavo Bonino, Leiden University Medical Centre
State of the CDISC Union - Bringing Clarity to Data
David R. Bobbitt, CDISC President and CEO
CDISC Standards Update
Bess LeRoy, CDISC
Session 2: Second Plenary - CDISC 360
Evolution of the CDISC Standards
Peter Van Reusel, CDISC
CDISC 360 Automation Using the CDISC Library and ODM 2.0 APIs
Dr. Sam Hume, CDISC
Semantic Technology and Linked Data for Clinical Research Standards
Frederik Malfait, Nurocor Inc.
Session 3, Track A: SEND
Preparing for SEND
Seppe Diels, SGS Life Science
Submitting Tumor.xpt Data Set from Legacy Application to FDA with Confidence
Naira Khatchatrian, CRL
Updates from the CDISC SEND Team
Gitte Frausing, Data Standards Decisions ApS
Session 3, Track B: Data Governance
How to Manage Changes to CDISC Standards
Shannon Bellaire Danielsen and Mikkel Traun, Novo Nordisk
Transition a Data Standards Library from a Simple Version to a Metadata Repository: Lessons Learned
Sandra Latorre, Business & Decision Life Sciences
CDISC Glossary Implementation in the Company
Guido Claes, Janssen Pharmaceutical Companies
Session 3, Track C: Use Cases
Building the Plane As You Fly: Transitioning from Functional Area Driven Standards to a Beginning-to-End (B2E) Organizational Approach
Lauren Shinaberry, AbbVie
Pacemaker Guy: De-Mystifying a Business Use Case for SDTM and Medical Device Domains (Paper)
Carey Smoak, S-cubed
Associated Persons Domains and Associated Possibilities
Leah van der Meer, Louella Schoemacher, OCS Life Sciences
Session 4, Track A: Submissions
Smoother Submissions - What Is Really Involved in the Preparation of an eSubmission Dataset Package?
Kelly Mewes and Artur Krupa, Roche Products Ltd
First BLA Submission as Small Biotech Company: Fail or Flourish
Nico Van Hecke and Elke Vansnick, Ablynx
Understanding the Technical Conformance Guide
Johannes Ulander, A3 Informatics
Session 4, Track B: Transcending Murphy’s Law
The Archeology of Legacy Data Conversions
Jasmine Kestemont, Innovion
The << CDISC Stupidario >> (the CDISC Nonsense)
Angelo Tinazzi, Cytel, Inc
Define.xml Review: Failing to Plan is Planning to Fail
Frank Senk and Robin Mann, GCE Solutions
CDISC Myths and Truths: Creating Clarity
Amy Palmer and Alana St. Clair, CDISC
Session 4, Track C: End-to-End
Our Journey: Innovative Approach to Planning and Designing Trials in Database
Djenan Ganic, Christina Nowack, intilaris LifeSciences and Bayer AG
One Model to Rule Them All
Mikkel Traun, Rasmus Stenholt and Vicky Poulsen, Novo Nordisk A/S
MDR Requirements for Study Build and Implications for the CDISC 360 Project
Philippe Verplancke, XClinical GmbH
Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts
Kirsten Langendorf, A3 Informatics
Session 5, Track A: Foundational
Upgrading Your Library from CDASH v1.1 to CDASH v2.0
Sandra Latorre, Business & Decision Life Sciences
Handling Multiple Enrollments and Screenings Subjects in SDTM: Are We There Yet?
Éanna Kiely, Syneos/ClinBuild
Analysis Result Metadata: Which Details to Include and What Is Missing
Rob Wartenhorst, GSK Vaccines
Session 5, Track B: RWE / Observational
Novel SDTM Implementation to Maximise Benefits of Sharing Legacy Data
Kalynn Kennon, Sam Strudwick, Infectious Diseases Data Observatory (IDDO), University of Oxford
CDISC Standards - A Bridge between EHR and EDC Systems
Prathima Surabhi, Nicolas Griffon, Christel Daniel, Karen Fanouillere, Laurent Luttenauer, Mats Sundgren, Nadir Ammour, AstraZeneca
Considerations for Using CDISC Standards in Observational Studies
Bess LeRoy, Jon Neville, CDISC
Session 6, Track A: Rules
Open Rules for CDISC, Web Services, and the CDISC Library API (Formerly CDISC SHARE API)
Jozef Aerts, XML4Pharma
Raising the Bar for Data Standardization: How to Ensure Your Submission Data Supports Automated Review Process at FDA and PMDA?
Sergiy Sirichenko, Max Kanevsky, Pinnacle 21
Session 6, Track B: RWE / Observational
Real-World Data: From Observational Research to Clinical Trials
Sonia Araujo, IQVIA
Necessity of Observational Research CDISC Standard for RWD and Public Health Research
Satoshi Ueno, National Institute of Public Health
Session 7: Regulatory Presentations
PMDA Update
Dr. Yuki Ando, PMDA
EMA Introduction; Big Data - Challenges and Opportunities, Moving Forward with Recommendations from the HMA-EMA Joint Big Data Taskforce
Dr. Alison Cave, European Medicines Agency
Session 8: Regulatory Presentations (cont'd)
FDA Electronic Submissions Update and Real World Data at FDA
Dr. Gideon Scott Gordon, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA
FDA Study Data Technical Conformance Guide (sdTCG) v4.3 (Study Data Technical Conformance Guide Technical Specification Document)
Helena Sviglin, Office of Strategic Programs, Center for Drug Evaluation and Research, FDA
Perspectives in the Use of Study Data for Regulatory Reviews (Video)
Dr. Lilliam Rosario, Dr. Matthew Whittaker, Dr. Alan Shapiro, Helena Sviglin, and Dr. Weiya Zhang, Office of Computational Science, Center for Drug Evaluation and Research, FDA