MONDAY 4 MAY :00 12:00 Controlled Terminology Course. 09:00 17:00 CDASH Implementation Course. 09:00 17:00 FDA Reviewer Session

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1 THE INTERCHANGE SCHEDULE MONDAY 4 MAY :00 12:00 Controlled Terminology Course 09:00 17:00 CDASH Implementation Course 09:00 17:00 FDA Reviewer Session 13:00 17:00 Healthcare Link Course 09:00 17:00 ODM Implementation Course

2 TUESDAY 5 MAY 2015 Interchange Conference 08:00 17:00 Exhibition Opens 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 Regulatory Plenary 12:30 14:00 LUNCH Session Chair: Peter Van Reusel, Chairman of CDISC E3C Welcome Address Peter Van Reusel, Chairman, CDISC E3C KEYNOTE To be announced State of CDISC Union Rebecca Kush, President, CDISC Real World Evidence David Hardison, Chair-Elect of the CDISC Board of Directors, ConvergeHEALTH by Deloitte CDISC Technical Roadmap Wayne Kubick, CTO, CDISC Session Chair: Rebecca Kush, President, CDISC IMI Update Dipak Kalra, University College London European Medicines Agency Update Speaker Invited, EMA FDA Process for Validation Study Data in Conformance with CDISC Standards Virginia Hussong, FDA Our Way to CDISC Submissions An Update 12 Months Later Yuki Ando Pharmaceuticals & Medical Devices Agency of Japan >> Tuesday Schedule Continuation Please, See Next Page >>>

3 TUESDAY, 5 MAY :00 15:30 TRACK ONE SESSION 3 De-Identification Session Chair: Pierre-Yves Lastic, Sanofi PhUSE De-Identification Working Group: Providing De-Identification Standards to CDISC Data Models Jean-Marc Ferran, PhUSE, Qualiance Managing the Unexpected Consequences of De- Identifying CDISC-Compliant Data David Handelsman, d-wise Experiences with De-Identification - The DataSphere project Pierre-Yves Lastic, Sanofi TRACK TWO SESSION 4 Foundational Standards 1 Session Chair: Daniel Graham, AstraZeneca ADaM Standards: What's New? Gavin Winpenny, Business & Decision Life Sciences Journey from ADaM-Like to Full ADaM Rebecca Tootell and Daniel Graham, AstraZeneca Associated Persons Domains: Who, What, When, Where, Why, How Alyssa Wittle, Theorem Clinical Research Handling Non-Standardized Questionnaires Ann-Sophie Bekx, Business & Decision Life Sciences 15:30 16:00 BREAK >>> Tuesday Schedule Continuation Please, See Next Page >>>

4 TUESDAY, 5 MAY :00 18:00 TRACK ONE SESSION 5 TRACK TWO SESSION 6 Strategic, Partner, Future Session Chair: Paul Houston, CDISC CDISC Standards May Harm Your Health - Unless You SHARE Them (CDISC 2020) Jozef Aerts, University of Applied Sciences FH Joanneum Update on CDISC Related PhUSE Projects Stephen Bamford, PhUSE and Business & Decision Life Sciences Standards Translational Strategy for Development of Knowledge Management Services: The Case of The etriks Project and Therapeutic Paul Houston & Dorina Bratfalean, CDISC CDISC - CT registration: What We Are Doing Together Now - Paul Houston, CDISC What is IDMP? And Any Relevance to CDISC? Anders Helmø Larsen, SAS Institute Clinical Endpoint Education Simone Suriano, Ethical Standards Requirements for the Next Generation of eclinical Software James Streeter, Oracle Open Panel Discussion and Q&A Session 19:00 22:00 NETWORKING EVENT Foundational Standards 2 Session Chair: Mark Lambrecht, SAS Adapting CDISC to Adaptive Design Angelo Tinazzi, Cytel Inc. Accommodating Evolving Standards in Business Intelligence and Cross Study Analysis Mike Collinson, Oracle CDASH: A Model to Support Data Management, Traceability and Standards Development Shannon Labout, CDISC How the CDISC Protocol Standard is Used Speaker to be announced. Panel Session: Foundational Standards Mark Lambrecht, SAS

5 WEDNESDAY, 6 MAY 2015 Interchange Conference 09:00 10:30 TRACK ONE SESSION 7 SEND Session Chair: Wayne Kubick and Shannon Labout, CDISC TRACK TWO SESSION 8 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 Standardization of Pre-Clinical Data and Metadata Using SEND Sylvain MERIAU and Stephane AUGER, Danone Research SEND Implementation Roman Radelicki, SGS Life Science Services The Challenges Faced When Implementing SEND For Multisite Studies Gitte Frausing, Data Standards Decisions Successful Study Migration Between Two Productive EDC Systems Using CDISC ODM Andreas Koop, Michael Gengler, Michael Walter, F. Hoffman-La Roche AG CDISC Your Collaboration - Benefits of Using CDISC Standards in a Cross-Sponsor, Cross Geography Oncology Regulatory Submission Musa Nsereko, Incyte Corporation CDASH from a Statistical Reviewer Perspective Steve Wilson, FDA Research Concepts A What, Why and How Dave Iberson-Hurst, Assero Limited Implementing CDISC standard in an Early Phase CRO Successes and Challenges Pascal Guibord, Algorithme Pharma Inc. 10:30 11:00 BREAK >>> Wednesday Schedule Continuation Please, See Next Page >>>

6 WEDNESDAY, 6 MAY :00 12:30 TRACK ONE SESSION 9 TA Development and User Guides Session Chair: Bron Kisler, CDISC Implementation of Oncology Specific SDTM Domains Jacintha Eben, SGS Life Science Service TRACK TWO SESSION 10 MDR from The Pharma Perspective Session Chair: Andrea Rauch, Boehringer- Ingelheim Metadata-Driven Automation Based on Semantic Technology Within a Major Pharmaceutical Company Robin Koeger, F. Hoffman-La Roche Differential Analysis of the CFAST Asthma User Guide and SDTM Standards Performed at AstraZeneca Michael Hörnestam, AstraZeneca Ingredients for a Successful Metadata Repository Implementation: Sponsor and Vendor Perspectives Susanne Pangritz and Barry Cohen, Bayer Healthcare and Accenture Management and Usage of Metadata For The Real World Application of the Implementation Creation of SDTM and ADaM Datasets Guide for Medical Devices Aurelien Guillouche and Laurent Le Renard, Novartis Terek Peterson, Theorem Clinical Research Oncology Here is SHARE With RCs - What Else Does Your MDR Need? Wayne Kubick, CDISC Open Panel Discussion and Q&A Session Andrea Rauch, Boehringer-Ingelheim and others to be announced. 12:30 14:00 LUNCH >>> Wednesday Schedule Continuation Please, See Next Page >>>

7 WEDNESDAY 6 MAY :00 15:30 SESSION 11 CFAST 15:30 16:00 BREAK 16:00 17:15 SESSION 12 CLOSING PLENARY (Q&A Session) Session Chair: Rhonda Facile, CDISC CFAST Program Status, Metrics and Plans for 2015 Rhonda Facile and Laura Butte, CDISC and Critical Path Institute Harmonizing Data in Diabetes Clinical Trials - The Journey & Anticipated Impact for Clinicians and Patients Rachael Zirkel and Amy Palmer, Eli Lilly & Company and CDISC The Use of Therapeutic Area Data Standards for the Advancement of Regulatory Science: Drug Development Tools (DDTs) Jon Neville and Bess LeRoy, Critical Path Institute Striving Towards a Seamless Adoption of Current and Future CDISC Therapeutic Area Standards Within a Major Pharmaceutical Company Jonathan Chainey, F. Hoffmann-La Roche Panel Discussion: Connection to IMI Projects Panelists to be announced. Session Chair: Peter Van Reusel, Chairman of CDISC E3C Cost Benefits of End-to-End Data and Metadata Standardization for Clinical Research Gerald NEVEU and Stephane AUGER, Danone Research Panel Discussion: What's Next on Our Way to 2020 FDA, EMA, PMDA, and CDISC Closing Remarks Peter Van Reusel, Chairman of CDISC E3C

8 THURSDAY 7 MAY :00 12:00 Define-XML Course 13:00 17:00 Dataset-XML Course 09:00 17:00 SEND Implementation Course 09:00 17:00 SDTM Implementation Course 09:00 17:00 SDTM for Medical Devices Course FRIDAY 8 MAY :00 17:00 ADaM Implementation Course 09:00 17:00 SEND Implementation Course 09:00 17:00 SDTM Implementation Course 09:00 17:00 SDTM-Medical Devices Course Thank You for Joining Us and Supporting the CDISC Mission!

9 SAVE THE DATE! CDISC Japan Interchange Tokyo, Japan June 2015 Conference, Training and Workshops CDISC International Interchange Chicago, IL 9 13 November 2015 Conference, Training and Workshops

10 Europe Interchange Sponsors. Diamond Sponsor Breakfast Sponsor