T HE I NT ERCHA N GE SCHED UL E
“Strength through Collaboration ”
MONDAY
4 MAY 2015
09:00 – 17:30
FDA Reviewer Session
09:00 – 12:30
Controlled Terminology Course
09:00 – 17:30
CDASH Implementation Course
14:00 – 17:30
Healthcare Link Course
09:00 – 17:30
ODM Implementation Course
12:30 – 14:00
LUNCH
TUESDAY
5 MAY 2015
Interchange Conference
09:00 – 17:00
 Exhibition
Open
08:00 – 17:00
 Conference
Registration
09:00 – 10:30
SESSION 1
 Opening
Plenary
10:30 – 11:00
BREAK
11:00 – 12:30
SESSION 2
 Second Plenary
12:30 – 14:00
 Session Chair: Peter Van Reusel, Chairman of CDISC E3C
Welcome Address – Peter Van Reusel, Chairman, CDISC E3C
KEYNOTE: Ophthalmic Technology Development Update:
The Intersection between Man and Machine – Dr. Joseph
Rappon, Alcon, Inc.
State of CDISC Union – Dr. Rebecca Kush, President, CDISC
Real World Evidence – Dr. David Hardison, Chair-Elect of
the CDISC Board of Directors, ConvergeHEALTH by Deloitte
The State of CDISC Standards – Wayne Kubick, CTO, CDISC
 Session Chair: Dr. Rebecca Kush, President, CDISC
Maximising the Reuse of Health Data for Research:
Sustaining the Outcomes of EHR4CR – Dr. Dipak Kalra,
University College London
EMA Update – Dr. Fergus Sweeney, European Medicines
Agency
FDA Process for Validation of Study Data in Conformance
with CDISC Standards – Dr. Ron Fitzmartin, FDA
Our Way to CDISC Submissions – An Update 12 Months
Later
Yuki Ando – Pharmaceuticals & Medical Devices Agency of
Japan
LUNCH
>>> Tuesday Schedule Continuation … Please, See Next Page >>>
TUESDAY, 5 MAY 2015
14:00 – 15:30
TRACK ONE – SESSION 3
TRACK TWO – SESSION 4
 De-Identification
Session Chair: Dr. Pierre-Yves Lastic, Sanofi
 Foundational Standards 1
Session Chair: Daniel Graham, AstraZeneca
European Legislative Framework and Challenges
of Study Reports Anonymization
Frank Petavy, EMA
ADaM Standards: What's New?
Gavin Winpenny, Business & Decision Life Sciences
Responsible De-Identification of Clinical Trial Data Journey from ADaM-Like to Full ADaM
Dr. Khaled El Emam, University of Ottawa
Rebecca Tootell, AstraZeneca
PhUSE De-Identification Working Group:
Providing De-Identification Standards to CDISC
Data Models
Jean-Marc Ferran, PhUSE, Qualiance
Associated Persons Domains: Who, What, When,
Where, Why, How
Alyssa Wittle, Theorem Clinical Research
Managing the Unexpected Consequences of DeIdentifying CDISC-Compliant Data
David Handelsman, d-Wise
Handling Non-Standardized Questionnaires
Ann-Sophie Bekx, Business & Decision Life Sciences
Panel Discussion
Frank Petavy, EMA; Dr. Khaled El Emam, University
of Ottawa; Jean-Marc Ferran, PhUSE, Qualiance;
David Handelsman, d-Wise; and Dr. Pierre-Yves
Lastic, Sanofi
BREAK
15:30 – 16:00
>>> Tuesday Schedule Continuation … Please, See Next Page >>>
TUESDAY, 5 MAY 2015
16:00 – 18:00
TRACK ONE – SESSION 5
TRACK TWO – SESSION 6
 Strategic, Partner, Future
Session Chair: Paul Houston, CDISC
 Foundational Standards 2
Session Chair: Mark Lambrecht, SAS
CDISC Standards May Harm Your Health - Unless
You SHARE Them (CDISC 2020)
Jozef Aerts, University of Applied Sciences FH
Joanneum
Adapting CDISC to Adaptive Design
Angelo Tinazzi, Cytel Inc.
Update on CDISC Related PhUSE Projects
Stephen Bamford, PhUSE and Business & Decision
Life Sciences
Accommodating Evolving Standards in Business
Intelligence and Cross Study Analysis
Mike Collinson, Oracle
Translational Standards Strategy for the IMI
eTRIKS Project including CDISC Therapeutic Areas
Paul Houston & Dorina Bratfalean, CDISC
CDASH: A Model to Support Data Management,
Traceability and Standards Development
Shannon Labout, CDISC and Gary Walker, Quintiles
CDISC - CT registration: What We Are Doing
Together Now Paul Houston, CDISC
The BRIDG Model, Incorporating Clinical Genomics
Bron Kisler, CDISC
What is IDMP? And Any Relevance to CDISC?
Anders Helmø Larsen, SAS Institute
Panel Session: Foundational Standards
Mark Lambrecht, SAS; Bron Kisler and Wayne Kubick,
CDISC
Clinical Endpoint Adjudication - How CDISC Can
Improve Quality Simone Suriano, Ethical
Standards Requirements for the Next Generation
of eClinical Software
James Streeter, Oracle
Open Panel Discussion and Q&A Session
19:30 – 22:30
NETWORKING EVENT
WEDNESDAY, 6 MAY 2015
Interchange Conference
09:00 – 17:00 Exhibition
09:00 – 10:30
TRACK ONE – SESSION 7
TRACK TWO – SESSION 8
 CDISC Standard for the Exchange of NonClinical Data (SEND)
Session Chair: Shannon Labout, CDISC
 User Experiences
Session Chair: Joerg Dillert, Oracle
Is SEND The Next Wave…? Focus on Adoption of
SEND Standard and Experience From a Pilot
Kirsten Walther Langendorf, SAS Institute
Research Concepts – A What, Why and How
Dave Iberson-Hurst, Assero Limited
Standardization of Pre-Clinical Data and Metadata CDASH from a Statistical Reviewer Perspective
Using SEND
Dr. Steve Wilson, FDA
Sylvain Meriau and Stephane Auger, Danone
Research
SEND Implementation
Roman Radelicki, SGS Life Science Services
Implementing CDISC standard in an Early Phase
CRO – Successes and Challenges
Pascal Guibord, Algorithme Pharma
The Challenges Faced When Implementing SEND
For Multisite Studies
Gitte Frausing, Data Standards Decisions
CDISC Your Collaboration - Benefits of Using CDISC
Standards in a Cross-Sponsor, Cross Geography
Oncology Regulatory Submission
Musa Nsereko, Incyte Corporation and Alberto
Montironi, Novartis
10:30 – 11:00
Successful Study Migration Between Two
Productive EDC Systems Using CDISC ODM
Andreas Koop and Michael Gengler, F. Hoffman-La
Roche AG
BREAK
>>> Wednesday Schedule Continuation … Please, See Next Page >>>
WEDNESDAY, 6 MAY 2015
11:00 – 12:30
TRACK ONE – SESSION 9
TRACK TWO – SESSION 10
 Therapeutic Area Standards and
Implementations
Session Chair: Bron Kisler, CDISC
 Metadata Repository from the Pharma
Perspective
Session Chair: Andrea Rauch, BoehringerIngelheim
Metadata-Driven Automation Based on Semantic
Technology within a Major Pharmaceutical
Company
Robin Koeger, F. Hoffman-La Roche
Ingredients for a Successful Metadata Repository
Implementation: Sponsor and Vendor Perspectives
Susanne Pangritz, Bayer Healthcare and Barry
Cohen, Accenture
Management and Usage of Metadata for the
Creation of SDTM and ADaM Datasets
Aurelien Guillouche and Laurent Le Renard, Novartis
Oncology
Management and Usage of Metadata for the
Creation of SDTM
Christine Meissner, Boehringer Ingelheim
Here is SHARE With RCs - What Else Does Your
MDR Need?
Julie Evans, CDISC
Standards: The Human Side
Trisha Simpson, UCB
Implementation of Oncology Specific SDTM
Domains
Jacintha Eben, SGS Life Science Services
Differential Analysis of the CFAST Asthma User
Guide and SDTM Standards Performed at
AstraZeneca
Michael Hörnestam, AstraZeneca
Real World Application of the Implementation
Guide for Medical Devices
Terek Peterson, Theorem Clinical Research
Harmonizing Data in Diabetes Clinical Trials - The
Journey & Anticipated Impact for Clinicians and
Patients Rachael Zirkel, Eli Lilly & Company and
Amy Palmer, CDISC
12:30 – 14:00
Open Panel Discussion and Q&A Session
Andrea Rauch, Boehringer-Ingelheim; Mark Stoll,
Merck Serono; Jasmine Kestemont, J&J; Wayne
Kubick, CDISC
LUNCH
>>> Wednesday Schedule Continuation … Please, See Next Page >>>
WEDNESDAY
6 MAY 2015
14:00 – 15:30
15:30 – 16:00
16:00 – 17:15
16:00 – 19:00
 Session Chair: Rhonda Facile, CDISC
SESSION 11
CFAST Program Status, Metrics and Plans for 2015
Rhonda Facile, CDISC and Laura Butte, Critical Path Institute
 The Coalition
The Use of Therapeutic Area Data Standards for the
for
Advancement of Regulatory Science: Drug Development
Accelerating
Tools (DDTs)
Standards
Jon Neville and Bess LeRoy, Critical Path Institute
and
Striving Towards a Seamless Adoption of Current and
Therapies
(CFAST)
Future CDISC Therapeutic Area Standards within a Major
Pharmaceutical Company
Jonathan Chainey, F. Hoffmann-La Roche
IMI Update
Dr. Silva-Lima Beatriz, Innovative Medicines Initiative
BREAK
 Session Chair: Peter Van Reusel, Chairman of CDISC E3C
SESSION 12
Cost Benefits of End-to-End Data and Metadata
Standardization for Clinical Research
 Closing
Gerald Neveu and Stephane Auger, Danone Research
Plenary
Panel Discussion: What's Next on Our Way to 2020?
(Q&A
FDA, EMA, PMDA, and CDISC
Session)
Closing Remarks
Peter Van Reusel, Chairman of CDISC E3C
Exhibits Closed
THURSDAY
7 MAY 2015
09:00 – 12:30
Define-XML Course
14:00 – 17:30
Dataset-XML Course
09:00 – 17:30
SEND Implementation Course
09:00 – 17:30
SDTM Theory and Application Course
12:30 – 14:00
LUNCH
FRIDAY
8 MAY 2015
09:00 – 17:30
ADaM Implementation Course
09:00 – 17:30
SEND Implementation Course
09:00 – 17:30
SDTM Theory and Application Course
12:30 – 14:00
LUNCH
Thank You for Joining Us and Supporting the CDISC Mission!
SAVE THE DATE!
CDISC Japan Interchange
Tokyo, Japan
22 – 26 June 2015
Conference, Training and Workshops
www.cdisc.org/interchange
CDISC International Interchange
Chicago, IL
9 – 13 November 2015
Conference, Training and Workshops
www.cdisc.org/interchange
Europe Interchange Sponsors
……………………………………………………………………………………………………………………………………………….
Global Diamond Sponsor
Ruby Sponsors
WiFi Sponsor
Emerald Sponsor
Interchange Exhibitors:
INTERCHANGE SCHEDULE AT A GLANCE
Monday, 4 May 2015
09:00 – 17:30
FDA Reviewer Session
09:00 – 12:30
Controlled Terminology Course
09:00 – 17:30
CDASH Implementation Course
14:00 – 17:30
Healthcare Link Course
09:00 – 17:30
17:45 – 19:15
12:30 – 14:00
ODM Implementation Course
CDISC Advisory Council Meeting (By Invitation Only – Platinum Members)
Lunch
Tuesday, 5 May 2015
08:00 – 17:00
Conference Registration
09:00 – 17:00
Exhibit Opens
09:00 – 18:00
Main Conference Sessions
12:30 – 14:00
Lunch
19:30 – 22:30
Networking Event
Wednesday, 6 May 2015
08:00 – 17:00
Conference Registration
09:00 – 17:00
Exhibit Opens
09:00 – 17:15
Main Conference Sessions
12:30 – 14:00
Lunch
16:00 – 19:00
Exhibits Closed
Thursday, 7 May 2015
09:00 – 12:30
14:00 – 17:30
09:00 – 17:30
09:00 – 17:30
Define-XML Course
Dataset-XML Course
SEND Implementation Course (2 day course – continues on 8 May from 09:00 – 17:30)
SDTM Theory and Application Course (2 day course – continues on 8 May from 09:00 – 17:30)
12:30 – 14:00
Lunch
Friday, 8 May 2015
09:00 – 17:30
12:30 – 14:00
ADaM Implementation Course
Lunch