S t r e n g t h t h r o u g h C o l l a b o r a t i o n

Transcription

1 THE INTERCHANGE SCHEDULE S t r e n g t h t h r o u g h C o l l a b o r a t i o n MONDAY 4 MAY :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

2 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 LUNCH 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 >>> Tuesday Schedule Continuation Please, See Next Page >>>

3 TUESDAY, 5 MAY :00 15:30 TRACK ONE SESSION 3 De-Identification Session Chair: Dr. Pierre-Yves Lastic, Sanofi European Legislative Framework and Challenges of Study Reports Anonymization Frank Petavy, EMA Responsible De-Identification of Clinical Trial Data Dr. Khaled El Emam, University of Ottawa 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 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, 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 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 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 Translational Standards Strategy for the IMI etriks Project including CDISC Therapeutic Areas 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 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 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 and Gary Walker, Quintiles The BRIDG Model, Incorporating Clinical Genomics Bron Kisler, CDISC Panel Session: Foundational Standards Mark Lambrecht, SAS; Bron Kisler and Wayne Kubick, CDISC

5 WEDNESDAY, 6 MAY 2015 Interchange Conference 09:00 17:00 Exhibition 09:00 10:30 TRACK ONE SESSION 7 CDISC Standard for the Exchange of Non- Clinical Data (SEND) Session Chair: Shannon Labout, CDISC 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 TRACK TWO SESSION 8 User Experiences Session Chair: Joerg Dillert, Oracle Research Concepts A What, Why and How Dave Iberson-Hurst, Assero Limited CDASH from a Statistical Reviewer Perspective Dr. Steve Wilson, FDA Implementing CDISC standard in an Early Phase CRO Successes and Challenges Pascal Guibord, Algorithme Pharma 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 Successful Study Migration Between Two Productive EDC Systems Using CDISC ODM Andreas Koop and Michael Gengler, F. Hoffman-La Roche AG 10:30 11:00 BREAK >>> Wednesday Schedule Continuation Please, See Next Page >>>

6 WEDNESDAY, 6 MAY :00 12:30 TRACK ONE SESSION 9 TRACK TWO SESSION 10 Therapeutic Area Standards and Implementations Session Chair: Bron Kisler, 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 Metadata Repository 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 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 Open Panel Discussion and Q&A Session Andrea Rauch, Boehringer-Ingelheim; Mark Stoll, Merck Serono; Jasmine Kestemont, J&J; Wayne Kubick, CDISC 12:30 14:00 LUNCH >>> Wednesday Schedule Continuation Please, See Next Page >>>

7 WEDNESDAY 6 MAY :00 15:30 SESSION 11 The Coalition for Accelerating Standards and Therapies (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, CDISC and Laura Butte, Critical Path Institute 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 IMI Update Dr. Silva-Lima Beatriz, Innovative Medicines Initiative 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 16:00 19:00 Exhibits Closed

8 THURSDAY 7 MAY :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 :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!

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. Global Diamond Sponsor Ruby Sponsors WiFi Sponsor Emerald Sponsor

11 Interchange Exhibitors:

12 Monday, 4 May :00 17:30 FDA Reviewer Session I N T E R C H A N G E S C H E D U L E A T A G L A N C E 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 17:45 19:15 CDISC Advisory Council Meeting (By Invitation Only Platinum Members) 12:30 14:00 Lunch Tuesday, 5 May :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 :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 :00 12:30 Define-XML Course 14:00 17:30 Dataset-XML Course 09:00 17:30 SEND Implementation Course (2 day course continues on 8 May from 09:00 17:30) 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 :00 17:30 ADaM Implementation Course 12:30 14:00 Lunch