Thank you for attending the 2017 Europe Interchange in London. You will find presentations from the Main Conference below.
Session 1: Opening Plenary
Opening Keynote: Raising the Standard for Global Collaboration in Emerging Infection
Laura Merson, IDDO
State of the CDISC Union
Dr. Nicole Harmon, CDISC
Future of CDISC
David Bobbitt, CDISC
The State of CDISC Standards
Barrie Nelson, CDISC
Session 2: Second Plenary
Real Life Experience on Data Review of Drug Submission in Japan
Dr. Yuki Ando, PMDA
EMA Update
Frank Pétavy, EMA
FDA Update
Dr. Ron Fitzmartin, FDA
Session 3: Achieving Submission Quality
Good Data Validation Practice
Sergiy Sirichenko and Max Kanevsky, Pinnacle21
Technical Rejection of Submissions for Non-Conformance to Study Data Standards
Dr. Ron Fitzmartin, CDISC
Validation of ADaM Datasets based on CDISC ADaMIG 1.1 Pinnacle21 Community Conformance Findings and Explanations
Jeroen Den Herder, SGS
An FDA Submission Experience Using the CDISC Standards
Angelo Tinazzi, Cytel
Session 4: CDISC in the Open World
Visualizing and Validating Metadata Traceability within the CDISC Standards (TRACE XML)
Sam Hume, CDISC
eSource: The e2C Project
Geoff Low, Medidata Solutions
Standard Curation Process in IMI Translational Research
Dorina Bratfalean, CDISC EU Foundation
eTRIKS Data Harmonization Service Platform: Putting Standards into Action
Ibrahim Emam, Imperial College
Session 5: Standards in Practice
Clinical Study Oversight: Different Approaches and Starter Pack
Jasmine Kestemont, Innovion
Practical Benefits of EC: Building a Comprehensive Exposure Story
Donald Benoot, SGS
Extension Studies - CDISC Submission Challenges and Scenarios
Sachin Bharadia, Zifo RnD Solutions
Submitting QRS (Questionnaires, Ratings and Scales) Controlled Terminology to CDISC
Èanna Kiely, inVentiv Health Clinical
Session 6: Additional Use Cases of CDISC Standards
Mobile Health: Applying CDISC Standards for Cross Study Clinical Research in Parkinson's Disease with Patient Engagement and Mobile Surveys
Wei Gu, University of Luxembourg
Big Data Analytics in Support of Clinical Trial Operations - The Fallacy Behind Risk Based Monitoring
Jon Roth, Biorasi LLC
Current and Future Requirements Linked to Sharing Patient Level Data
Sophie Buyle, Business & Decision Life Sciences
Session 7: Therapeutic Area User Guides
Implementation of Therapeutic Area Standards in Japan
Hiroshi Sakaguchi, PMDA
Status Update of the Vaccines Reactogenicity Therapeutic Area User Guide Development
Deborah Paletta, Business & Decision Life Science
Device Domains: Examples of Their Use in Clinical Trials
Oksana Voevutska, Chiltern
Mapping of Gastrointestinal Tolerance Data to SDTM
Lieke Gijsbers, OCS Consulting
Session 8: From Protocol to Submission
Protocol Terminology - Advancing on The Holy Grail of CDISC Standards
Melissa Cook, Independent
CDISC XML Technology End-to-End Bench to Bedside
Sally Cassells, Next Step Clinical Systems
Session 9: Implementation Use Cases
Why End to End Standards Need to Begin with Statistics
Susan J. Kenny, PhD, Maximum Likelihood, Inc.
Create Your Own SDTM Mapping Framework
Martin Houben, OCS Consulting
Analysis Result Metadata… Are We There Yet?
Carla Santillan, Chiltern
Session 10: Visualize Your Data
Big Data vs Smart Data in Clinical Trials
Mike Collinson, Oracle
Solving Standards Governance Pain Points with MDR Visualizations
Ken Stoltzfus, Accenture
Bringing SDTM Alive for Monitoring and Review
Philip Bartle, PPD
Session 11: Moving Forward
The CDISC Moonshot. Can We Do It?
Jozef Aerts, Univ.Appl.Sci. FH Joanneum
SHARE 2.0
Lauren Becnel, CDISC
SDTM, Graph Databases and Biomedical Concepts
Johannes Ulander, S-Cubed
Session 12: Closing Plenary
Keynote - Data Standardization: (How) Important for Tomorrow's Knowledge Generation?
Hans-Georg Eichler, EMA