Home / 2018 CDISC Europe Interchange

2018 CDISC Europe Interchange

Program subject to change without notice.

Wednesday, April 25, 2018

Session 1: Opening Plenary

Chair: Joerg Dillert, Chair, CDISC E3C
09:00 - 10:30

Welcome Address

Stephen Pyke, CDISC Board Chair

Keynote - Using Electronic Health Records for Real World Trials: Our Experience from the Salford Lung Study

Martin Gibson, NorthWest EHealth

Martin Gibson is Chief Executive of Northwest EHealth, Director of the NIHR Clinical Research for Greater Manchester. He is a consultant physician specialising in diabetes and lipid disorders at Salford Royal NHS Foundation Trust. Martin is an active clinical trialist and has had a long-term interest in the use of electronic clinical data systems to improve healthcare and facilitate research.

State of CDISC Union

David Bobbitt, CDISC

CDISC Standards Update

Shannon Labout, CDISC

Session 2: Second Plenary - Regulatory Updates

Chair: Dr. Nicole Harmon, CDISC
11:00 - 12:30

EMA - Frank Petavy

FDA - Dr. Ron Fitzmartin

FDA - Dr. Lisa Lin

PMDA - Dr. Yuki Ando

Session 3, Track A: Global Submission Experience

Chair: Sujit Khune, Novo Nordisk
14:00 - 15:30

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

How CDISC is Challenged by FDA & PMDA


Session 3, Track B: eSource

Chair: Jozef Aerts, University of Applied Sciences FH Joanneum
14:00 - 15:30

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 Overview

Chair: Shannon Labout, CDISC
14:00 - 15:30
Rhonda Facile and Dr. Sam Hume, CDISC

Who/Where - A CDISC History

Why: Purpose and Benefits

How: COPs, Tools and Processes

Session 4, Track A: ADaM

Chair: Simon Lundberg, AstraZeneca
16:00 - 18:00

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

Chair: Stijn Rogiers, SAS
16:00 - 18:00

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 - Connected CDISC Standards

Chair: Peter van Reusel, CDISC European Liaison
16:00 - 18:00


Sujit Khune, Novo Nordisk, E3C member


Eanna Kiely, Syneos Health, E3C member


Silvia Faini, CROS NT, E3C member

ODM, Define and more XML

Dr. Sam Hume, CDISC
Thursday, April 26, 2018

Session 5, Track A: What's New

Chair: Eanna Kiely, Syneos Health
09:00 - 10:30

ODMv2 and the CDISC Transport Standards: The Big Picture

Dr. Sam Hume, CDISC

QRS (Questionnaires, Ratings and Scales) Domain Mappings and Updates

Éanna Kiely, Syneos Health

CDASH v2.0

Shannon Labout, CDISC

SDTMIG v3.3: New Domains - New Benefits

Nick De Donder, Business & Decision Life Sciences

Session 5, Track B: Process Implementation and Optimization

Chair: Andrea Rauch, Boehringer-Ingelheim
09:00 - 10:30

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 and Natalia Smeljanski, Merck KGaA

A Statistics-Based Tool to Inform Risk-Based Monitoring Approaches

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 - Drug Submission Requirements

Chair: Dr. Sam Hume, CDISC
09:00 - 10:30
Rhonda Facile and Dr. Sam Hume, CDISC

TAUG overview
Drug Submmision Requirements

Session 6, Track A: Define XML

Chair: Silvia Faini, CROS NT
11:00 - 12:30

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

Chair: Dr. Nicole Harmon, CDISC
11:00 - 12:30

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

Dorina Bratfalean, CDISC

Where Did my Terminology Go?

Johannes Ulander, S-Cubed

Session 6, Track C: Newcomers - CDISC in Academia

Chair: Jozef Aerts, University of Applied Sciences FH Joanneum
11:00 - 12:30

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

Martin Dugas, University of Münster

Session 7: Challenges and Doing Better

Chair: Angelo Tinazzi, Cytel
14:00 - 15:30

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, Hofmann La Roche

SDTM: It is Not all Black and White

Swapna Pothula, SGS Life Sciences

Session 8: Closing Plenary

Moderator: Peter van Reusel, CDISC European Liaison
16:00 - 17:15

Closing Panel Discussion

Regulatory Authorities, CDISC and European Coordinating Committee

Closing Remarks

Joerg Dillert, Chair, CDISC E3C