“CDISC Standards are the Global Language for Sharing Data”

Location: Eurosites George V | 28, Avenue George V | 75008 | Paris, France

THE INTERCHANGE SCHEDULE

MONDAY

7 April 2014

08:30 – 17:00 SDTM -Theory & Application Course

(Day 1 of a 2-Day Training)

08:30 – 17:00 ODM Implementation Course

TUESDAY

8 April 2014

08:30 – 17:00 SDTM -Theory & Application Course

(Day 2 of a 2-Day Training)

08:30 – 12:00

Controlled Terminology Implementation Course

10:00 – 12:00

**NEW** Dataset-XML Course

13:30 – 17:00

**NEW** Define XML Course

WEDNESDAY

9 April 2014

Interchange Conference

08:00 – 17:00

07:30 – 17:00

Ø Exhibition Open

Ø Conference

Registration

09:00 – 11:00

Ø SESSION 1

Ø Opening Plenary

Ø Session Chair: Peter Van Reusel, Chairman of CDISC E3C

Welcome Address – Peter Van Reusel, Chairman of CDISC E3C

State of CDISC Union – Rebecca Kush, President & CEO, CDISC

State of CDISC Standards – Wayne Kubick, CTO, CDISC

Data Sharing – Frank Rockhold, GlaxoSmithKline

TransCelerate Overview – Pete Milligan, GlaxoSmithKline

11:00 – 11:30 BREAK

11:30 – 13:00

Ø SESSION 2

Ø Regulatory Views on CDISC Standards

Ø Session Chair: Rebecca Kush, President & CEO, CDISC and David

Hardison, Chair-Elect, CDISC Board

Overview of CDISC Implementation at PMDA – Yuki Ando,

Pharmaceuticals & Medical Devices Agency (PMDA) Japan eStudy Data and FDA: Where Are We?

Mary Ann Slack, U.S. FDA New Regulatory Guidance from FDA

Ron Fitzmartin, U.S. FDA

13:00 – 14:30 LUNCH

>>> Wednesday Schedule Continuation … Please, See Next Page >>>

WEDNESDAY, 9 April 2014

14:30 – 16:00

Parallel Track 1 – SESSION 3

Ø Adoption and Evolution of CDISC Standards Ø Session Chair: Mark Lambrecht, SAS

Parallel Track 2 – SESSION 4

Ø Standards in Use Ø Session Chair: Paul Houston, CDISC Europe

Foundation

The Evolution of CDISC Standards and Therapeutic Area Highlights Tina Apers, Business and Decision Life Sciences

CDISC LAB Model from a Central Lab Perspective Karen Elrod, Covance Laboratory Services

CDISC Standards Adoption: Winning Strategies for Medical Device Companies Ale Gicqueau, Clinovo

Capturing Rater-Specific Data: Is a New Domain in Order?

Anne Bush, Theorem Clinical Research

Implementation of CDISC-based Global Standards at Sanofi Group Marie-Rose Van-Keer and Véronique Long, Sanofi

Using CDISC Standards to Efficiently Produce Clinical Safety Information for Independent Data Monitoring Committees (DMCs-DSMBs) Jonathan Seltzer, ACI Clinical (Formally Applied Clinical

Intelligence, LLC)

16:00 – 16:30 BREAK

>>> Wednesday Schedule Continuation … Please, See Next Page >>>

WEDNESDAY, 9 April 2014

16:30 – 18:00

Parallel Track 1 – SESSION 5

Ø Therapeutic Area Standards Ø Session Chair: Rhonda Facile, CDISC

Parallel Track 2 – SESSION 6

Ø CDISC XML Ø Session Chair: Philippe Verplancke, XClinical

Overview Presentations on CFAST Rhonda Facile, CDISC

Ron Fitzmartin, FDA

Semantic Extension to CDISC ODM: An Archetype Approach for Interoperability between Clinical Care and Clinical Research Theodoros N. Arvanitis, Institute of Digital Healthcare,

WMG, University of Warwick, Coventry

Panel Discussion John Owen, Johnson & Johnson; Prodhomme Marc-

Antoine, Business & Decision Life Sciences; Angelo Tinazzi,

Cytel Inc.; Ron Fitzmartin, FDA

Breaking free from XPT files with CDISC Dataset-XML Kevin Burges, Formedix

A new transport standard for electronic submissions in XML: Dataset-XML Jozef Aerts, CDISC XML Technology Team / FH Joanneum

Graz

19:00 – 22:00 NETWORKING EVENT

THURSDAY, 10 April 2014

Interchange Conference

09:00 – 10:30

Parallel Track 1 - SESSION 7

Ø Metadata Governance Ø Session Chair: Andrea Rauch, Boehringer

Ingelheim

Parallel Track 2 - SESSION 8

Ø New Ways of Using CDISC Ø Session Chair: Ola Strandberg, UMC

Successfully Embracing Changes to CDISC Standards Dr. Elke Sennewald, Theorem Clinical Research GmbH

Update on the Collaboration Between CDISC and WHO-ICTRP: Registration of all Clinical Trials as a Scientific and Ethical Responsibility Ghassan Karam, World Health Organization

Is your Library a Success: A Solution to Manage and Measure Conformance to your Standards across Partners and Projects Lauren Shinaberry, Business and Decision Life Sciences

SDTM in Business Intelligence Mike Collinson, Oracle

Design of Metadata Libraries for Report Generation (TFL) – Increasing Productivity Gopinath Viswanathan & Giri Balasubramanian, Kinship

Technologies Private Limited (A Unit of PRA International)

Integrating the Recent FDA Guidance and CDISC Initiatives to Significantly Reduce Timelines and Costs in Safety Monitoring while Improving Subject Safety and Overall Study Quality Rafaël Smets, SGS Life Sciences Services

10:30 – 11:00 BREAK

>>> Thursday Schedule Continuation … Please, See Next Page >>>

THURSDAY, 10 April 2014

11:00 – 12:30

Parallel Track 1- SESSION 9

Ø Metadata Automation Ø Session Chair: Joerg Dillert, Oracle

Parallel Track 2 - SESSION 10

Ø ADaM Ø Session Chair: Daniel Graham, AstraZeneca

How to Model CDISC SHARE to Drive Validation Max Kanevsky, OpenCDISC

A Systematic Review of ADaM IG Interpretation Angelo Tinazzi, Cytel Inc.

Lessons on the Metadata Approach Dave Iberson-Hurst, Assero Limited

Implementation of CDISC ADaM in the Pharmacokinetics Department Joanna Magielse, SGS Life Science Services

Representing CDISC Foundational Standards in RDF Josephine Gough, Hoffmann-La Roche; Geoff Low,

Medidata; and Frederik Malfait, IMOS Consulting

Open Source Repository in the Cloud Hanming Tu, Accenture

12:30 – 14:00 LUNCH

>>> Thursday Schedule Continuation … Please, See Next Page >>>

THURSDAY

10 April 2014

14:00 – 15:30

Ø SESSION 11

Ø SHARE and the

Future of CDISC Standards

Ø Session Chair: Wayne Kubick, CTO, CDISC

Introduction: SHARE and the CDISC Technical Roadmap

Wayne Kubick, CTO, CDISC

The Industry Perspective of CDISC SHARE Simon Bishop, GlaxoSmithKline

Controlled Terminologies and SHARE Erin Muhlbradt, National Cancer Institute Enterprise Vocabulary

Services

Demonstration: The Many Faces of SHARE

Julie Smiley, SOA Software and Wayne Kubick, CDISC

15:30 – 16:00 BREAK

16:00 – 17:30

Ø SESSION 12

Ø CLOSING

PLENARY (Q&A Session)

Ø Session Chair: Pierre-Yves Lastic, Sanofi

Opening Remarks – Dipak Kalra, University College London

EMA Update – Fergus Sweeney, European Medicines Agency

Q&A Session with Distinguished Panel – Wayne Kubick,

CDISC; Fergus Sweeney, EMA; Mary Ann Slack and Ron

Fitzmartin, FDA; Yuki Ando, PMDA, Japan; Pete Milligan, GSK; and

Dipak Kalra, University College London Closing Remarks - Peter Van Reusel, E3C Chairman

T h a n k y o u f o r j o i n i n g u s & s u p p o r t i n g t h e C D I S C m i s s i o n !

FRIDAY

11 April 2014

08:30 – 16:30 ADaM Implementation Course

08:30 – 16:30

CDASH Implementation Course

08:30 – 12:00

**NEW** Define-XML Course

SAVE THE DATE!

CDISC International Interchange 2014

Bethesda, MD

10 – 14 November 2014

Conference and Education

www.cdisc.org/interchange

Bethesda North Marriot Hotel & Conference Center

501 MARINELLI Road

North Bethesda, MD 20852

CDISC Asia-Pacific and Japan

Interchange

Tokyo, Japan

28 July – 01 August 2014

Conference and Education

www.cdisc.org/interchange

Tokyo, Japan

INTERCHANGE SPONSORS

Diamond Sponsor:

Ruby Sponsors:

WiFi is Kindly Sponsored by:

SCHEDULE AT A GLANCE

Monday, 7 Apri l 2014 08:30 – 17:00 SDTM -Theory & Application Course (Day 2 of a 2-Day Training) – 2 concurrent courses in Berlin

Room and Bruxelles Room

08:30 – 17:00 ODM Implementation Course – Namur Room

Tuesday, 8 April 2014 08:30 – 17:00 SDTM -Theory & Application Course (Day 2 of a 2-Day Training) – 2 concurrent courses in Berlin

Room and Bruxelles Room

08:30 – 12:00 Controlled Terminology Implementation Course – Namur Room

10:00 – 12:00 **NEW** Dataset-XML Course – Amsterdam Room

13:30 – 17:00 **NEW** Define Xml Course – Namur Room

Wednesday, 9 Apri l 2014 08:00 – 17:00 Exhibition Open – Reception Area

7:30 – 17:00 Conference Registration – Location Entrance

09:00 – 18:00 Conference Sessions – Session 1, 2, 3 & 5 in Auditorium Room – And session 4 & 6 in Milan Room

19:00 – 22:00 Networking Event - Room Name

Thursday, 10 Apri l 2014 09:00 – 17:30 Conference Sessions – Session 7, 9, 11 & 12 in Auditorium Room – And session 8 & 10 in Milan Room

Fr iday, 11 Apri l 2014 08:30 – 16:30 ADaM Implementation Course – Berlin Room

08:30 – 16:30 CDASH Implementation Course – Namur Room

08:30 – 12:00 **NEW** Define-XML Course – Bruxelles Room