Home / Events / Interchange / 2019 CDISC Europe Interchange / 2019 CDISC Europe Interchange - Program

Program of events is subject to change.

8 May 2019

Session 1: Opening Plenary & Keynote Address

Joerg Dillert, Oracle, E3C Chair
Pearl I, II & III (Ground Floor)
09:00 – 10:45

Welcome Address

Joerg Dillert, Oracle, E3C Chair

Keynote Presentation

State of the CDISC Union - Bringing Clarity to Data

Doug Peddicord, CDISC Board Chair, and David R. Bobbitt, CDISC President and CEO

Data Standards Governance: Challenges Addressed and Improvements Made

Alana St. Clair, Bess LeRoy and Amy Palmer, CDISC

Session 2: Second Plenary - CDISC 360

David R. Bobbitt, CDISC President and CEO
Pearl I, II & III (Ground Floor)
11:15 – 13:00

Evolution of the CDISC Standards

Peter Van Reusel, CDISC

Automation Using the SHARE 2.0 and ODM 2.0 APIs

Sam Hume, CDISC

Semantic Technology and Linked Data for Clinical Research Standards

Frederik Malfait, Nurocor

Session 3, Track A - SEND

Nick De Donder, Business & Decision Life Sciences
Pearl I (Ground Floor)
14:00 – 15:30

SEND Presentation

Gitte Frausing, Data Standards Decisions ApS

Submitting Tumor.xpt Data to FDA with Confidence

Naira Khatchatrian, Candy Brewer, CRL

Preparing for SEND

Seppe Diels, Roman Radelicki, SGS Life Science

Session 3, Track B: Data Governance

Andrea Rauch, Boehringer Ingelheim
Pearl II (Ground Floor)
14:00 – 15:30

How to Manage Changes to CDISC Standards

Shannon Bellaire Danielsen, Andreas Vigelsø West, Novo Nordisk

CDISC Glossary implementation in the Company

Guido Claes, Janssen Pharmaceutical Companies

Transition a Data Standards Library from a Simple Version to a Metadata Repository: Lessons Learned

Sandra Latorre, Business & Decision Life Sciences

Session 3, Track C: Use Cases

Malathi Hari, Larix
Pearl III (Ground Floor)
14:00 – 15:30

Building the Plane as You Fly: Transitioning to B2E Organizational Approach to Standards

Lauren Shinaberry, AbbVie

Pacemaker Guy: De-Mystifying a Business Use Case for SDTM and Medical Device Domains

Carey Smoak, S-cubed

Associated Persons Domains and Associated Possibilities

Leah van der Meer, Louella Schoemacher, OCS Life Sciences

Session 4, Track A: Submissions

Simon Lundberg, AstraZeneca
Pearl I (Ground Floor)
16:00 – 18:00

Smoother Submissions - What Is Really Involved in the Preparation of an eSubmission Dataset Package?

Kelly Mewes, Shaun Maraj, Roche Products Ltd

Understanding the Technical Conformance Guide

Johannes Ulander, A3 Informatics

First BLA Submission as Small Biotech Company: Fail or Flourish

Nico Van Hecke, Elke Vansnick, Isabelle De Graeve, Ablynx

Roundtable Discussion

Speakers and Invited Guests

Session 4, Track B: Transcending Murphy’s Law

Silvia Faini, LivaNova
Pearl II (Ground Floor)
16:00 – 18:00

Common Questions and Misconceptions (or CDISC Myths and Truths) Creating Clarity

Amy Palmer, CDISC

The << CDISC Stupidario >> (the CDISC Nonsense)

Angelo Tinazzi, Cytel, Inc

The Archeology of Legacy Data Conversions

Jasmine Kestemont, Innovion

Define.xml Review: Failing to Plan is Planning to Fail

Robin Mann, GCE Solutions

Session 4, Track C: End-to-End

Éanna Kiely, ClinBuild
Pearl III (Ground Floor)
16:00 – 18:00

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

Karina Rostgaard Stender, Vicky Poulsen, Novo Nordisk A/S

MDR Requirements for Study Build and Implications for the SHARE Proof-of-Concept

Philippe Verplancke, XClinical GmbH

Towards a Biomedical Concept Library: Creating and Sharing Biomedical Concepts

Kirsten Langendorf, A3 Informatics

Evening Networking Event

19:00 – 22:00
9 May 2019

Session 5, Track A: Foundational

Angelo Tinazzi, Cytel
Pearl II (Ground Floor)
09:00 – 10:30

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

Upgrading Your Library from CDASH v1.1 to CDASH v2.0

Sandra Latorre, Business & Decision Life Sciences

Session 5, Track B: RWE / Observational

Jozef Aerts, XML4Pharma
Pearl III (Ground Floor)
09:00 – 10:30

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

Sujit Khune, Novo Nordisk A/S
Pearl II (Ground Floor)
11:00 – 12:00

Open Rules for CDISC, Web Services, and the SHARE 2.0 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

Stijn Rogiers, SAS
Pearl III (Ground Floor)
11:00 – 12:00

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

Joerg Dillert, Oracle, E3C Chair
Pearl II + III (Ground Floor)
13:00 – 14:00

PMDA Presentation

Dr. Yuki Ando, PMDA

EMA Presentation

Session 8: Regulatory Presentations (cont'd)

Joerg Dillert, Oracle, E3C Chair
Pearl II + III (Ground Floor)
14:30 – 17:00

FDA Presentations

Winning Poster Presentation & Closing Remarks

Pearl II + III (Ground Floor)
17:00 – 17:15