Presentations from the 2008 European CDISC Interchange Meeting
April 23-24, 2008
Copenhagen, Denmark

Day 1: Wednesday, 23 April 2008
Day 2: Thursday, 24 April 2008

The presentations are listed according to the original programme schedule for the 2008 EU Interchange. You may simply click on the titles below to link to the posted .pdf of the presentation.

Please Note: Two substitutions were made to the presentations after the publication of the original programme. In Session 3 Track 2, Dave Smith presented in the place of Nathalie Stassen; and in Session 7 Track 2, Valdo Amera presented ePRO Integration & CDISC Certification of an ePRO Technology Provider, in the place of Anthony Costello’s presentation on Implementing CDASH-based design libraries for faster standards adoption.

Day 1

Session 1: Opening
Chair: Tim M. Jaeger, Chairman of the European CDISC Coordinating Committee

• Welcome to Copenhagen and the world of CDISC (slides were not presented)
  Tim M. Jaeger, Chairman of the European CDISC Coordinating
  Committee & Ed Helton, Chairman of CDISC Board of Directors
• CDISC worldwide
  Rebecca Kush, CDISC President
• CDISC technical update
  Dave Iberson-Hurst, CDISC VP Technical Strategy
  

Session 2: Track 1
Scope of Implementation - Today and Tomorrow
Chair: Dave Iberson-Hurst, CDISC VP Technical Strategy

• Data-Element, analysis model and metadata registry
  Mark Regennass, Wega
• Metadata repository use in an End to End, CDISC standards based
  Clinical data lifecycle
  Barry Cohen, Octagon Research
• Pharmacogenomics Data: transmission and submission
  Joyce Hernandez, Merck & Phil Pochon, Covance
  

Session 2: Track 2
CDISC Scope Extended
Chair: Ann-Sofie Bergstrom, European CDISC Coordinating Committee

• CDISC/SEND renewed efforts in 2007: Update on standards
  for exchange of nonclinical datasets for FDA submissions
  with emphasis on operational uses
  Gitte Frausing, Novo Nordisk
• NonLinear Mixed Effects Consortium: The role of CDISC
  Standards in the future of clinical modeling and simulation
  Steen Hvass Ingwersen, Novo Nordisk
• Monitoring risks in clinical trials for medical devices: The
  point of view of national competent authorities
  Daniela Luzi, National Research Council, Italy
  

Session 3: Track 1
CDISC It! From Protocol to CRF
Chair: Graham Bunn, European CDISC Coordinating Committee

• Protocol Model v1.0 - Project Update
  Lisa Chatterjee, CDISC Protocol Team Leader, Digital Infuzion
• ‘2h protocol’ - Trial planning & protocol generator system for
  explanatory development
  Ivan Miluska, Novartis
• CDASH - Standard CRFs - An idea whose time has come
  Rhonda Facile, CDISC Director of CDASH Project

Session 3: Track 2
Tools, Tools, Tools!
Chair: Barry Burnstead, European CDISC Coordinating Committee

• Challenges of modelling interdependent study schedule instructions
  Ed Seguine, Medidata
• ODM can foster EDC
  Xavier Gobert, Flexcipio
• Enabling the End to End eClinical process using ODM-based tools
  Andrew Newbigging, Medidata
• Bridging the gap between ODM and SDTM: Tools for creating
  SDTM datasets from ODM data
  Jozef Aerts, XML4Pharma
• Technology Suppliers Perspective: The journey to CDISC ODM Certification
  Simon Hawken, eRT
• Integrated clinical architecture
  Dave Smith, SAS

Key Note Presentation
Introduction
Tim M. Jaeger, Chairman of the European CDISC Coordinating Committee

• The resurgence of clinical research in public health: clinical
  data management and the future of health care
  Sir John Bell, University of Oxford and Office for Strategic
  Coordination of Health Research

Session 4:
CDISC at the FDA: SDTM & ADaM Pilot
Chair: Herbert Noack, European CDISC Coordinating Committee

• The CDISC SDTM/ADaM Pilot Project - Results and Learnings
  Cathy Barrows, GlaxoSmithKline
• Re-modelling the CDISC SDTM/ADaM Pilot Analysis Datasets
  in the New ADaM Style
  Susan Kenny, Inspire
• Loading SDTM data into the JANUS data warehouse: an
  experience report from a recent submission
  Greg Ridge, Carol Vaughn & Pierre-Yves Lastic, Sanofi-Aventis

Day 2

Session 5: Track 1
CDISC It! Legacy conversion and SDTM & ADaM Implementation
Chair: Niels Both, European CDISC Coordinating Committee

• Case Study: Analysis and metrics of End-to-End legacy data
  Conversion into SDTM, ADaM, and Define.XML
  Robert Stemplinger, ICON
• Implementing SDTM in a small sponsor environment
  Alex Helman, Sepracor
• Clinical trial data conversion into CDISC SDTM and ADaM
  Standards- first experience from an FDA submission project
  Berthold Traub, Nycomed

Session 5: Track 2
eHealth & Clinical Research & Safety Monitoring
Chair: Pierre-Yves Lastic, European CDISC Coordinating Committee

• Experiences from the trenches of eClinical to healthcare integration
  Landen Bain, CDISC Liaison to Healthcare
• Electronic healthcare record systems and clinical research at G. Pompidou Hospital
  Chistel Daniel, INSERM
• Secondary use of electronic health record systems in the area of clinical research
  Miguel Valenzuela, Roche

Session 6: Track 1
CDISC It! SDTM, ADaM & Define.XML Implementation for Reporting and Submission
Chair: Herbert Noack, European CDISC Coordinating Committee

• Creation of CDISC compliant regulatory submissions
  Spenser Groves, Ipsen
• Systematic approach to develop SDTM and ADaM company standards
  Elke Sennewald, Kendle
• Use of ADaM specifications in the submission of analysis datasets to the FDA
  Zoe Williams, LEO Pharma

Session 6: Track 2
Tools, Tools, Tools!
Chair: Udo Siegmann, European CDISC Coordinating Committee

• CDISC-Gateway™ Panacea for CDISC Standards
  Sunil Agarwal, Cognizant
• A mapping tool for supporting data migration to CDISC models (slides not available)
  Ronald Steinhau, Entimo
• Data migration/submission utility tools
  Ivan Li, Ipsen
• Effect of data standards on AE reporting and signal detection
  Robert Weber, Lincoln Technologies
• Applied benefits of implementing CDISC standards with SAS
  Dave Smith, SAS
• Using ODM to optimise study set up and EDC system build within a multi-vendor environment
  Mark Wheeldon, Formedix
• SAP to submissions output using CDISC metadata
  Joel Hoffman, Waban Software

Session 7: Track 1
CDISC It! SDTM, ADaM & Define.XML Implementation for Reporting and Submission
Chair: Barry Burnstead, European CDISC Coordinating Committee

• Adoption of the SDTM from data capture to statistical analysis - A case study in cardiology
  Rolf Meinert, Datamap
• Using CDISC data models to generate standard safety analysis and reporting
  David Handelsman, SAS Institute
• Define.XML: Implementation experiences and user expectations
  Monika Kawohl, Accovion

Session 7: Track 2
CDISC It! From Protocol to CRF
Chair: Wolfgang Summa, European CDISC Coordinating Committee

• ePRO Integration & CDISC Certification of an ePRO Technology Provider
  Valdo Amera
• A plug-in for an outlining editor to CRF planning in ODM
  Johannes Huesing, KKS University Heidelberg
• Experience with SDTM value level metadata and steps
  towards CDASH in an investigator-oriented EDC environment
  Philippe Verplancke, XClinical

Session 8:
Closing Session
Chair: Tim M. Jaeger, Chairman of the European CDISC Coordinating Committee

• European CDISC User Networks
  Ann-Sofie Bergstrom, European CDISC Coordinating Committee
• EU/EMEA collaboration with CDISC
  Pierre-Yves Lastic, European CDISC Coordinating Committee
• Closing Address (slides were not presented)
  Tim M. Jaeger, Chairman of the European CDISC Coordinating Committee