CDISC International Interchange Program Embracing a Changing Landscape Standards to Connect Research and Patient Care

Transcription

1 CDISC International Interchange Program Embracing a Changing Landscape Standards to Connect Research and Patient Care B e t h e s d a N o r t h M a r r i o t t H o t e l a n d C o n f e r e n c e C e n t e r N o r t h B e t h e s d a, M D

2 T H E I N T E R C H A N G E S C H E D U L E MONDAY 10 Nov :00 17:00 BRIDG Deep Dive Implementation Course 09:00 17:00 ODM Implementation Course 09:00 17:00 SDTM -Theory & Application Course (Day 1 of a 2-Day Training) 09:00 17:00 SEND Implementation (Day 1 of a 2-Day Training) 08:30 17:00 CFAST Program Orientation (By invitation only Open to CDISC fellows and new team members) TUESDAY 11 Nov :00 17:00 SDTM -Theory & Application Course (Day 2 of a 2-Day Training) 09:00 12:00 Dataset-XML Course 09:00 12:00 Controlled Terminology Course 13:00 17:00 Define-XML Course 13:00 17:00 CDISC Healthcare Link Course 16:00 18:00 (CDISC Platinum Member CAC Representatives Only - By Invitation) 18:00 20:00 Exhibition Booth Setup 18:00 20:00 Conference Registration

3 WEDNESDAY 12 Nov 2014 Interchange Conference 08:00 17:00 07:30 17:00 Exhibits Open Conference Registration 08:30 10:00 Session 1 Opening Plenary: Embracing a Changing Landscape Session Chair: Pierre-Yves Lastic, Sanofi Keynote Speaker General Peter Chiarelli, One Mind for Research Keynote Speaker Dr. Eileen Navarro Almario, FDA State of CDISC Union Dr. Rebecca Kush, President, CDISC 10:00 10:30 BREAK 10:30 12:15 Session 2 Second Opening Plenary Session Chair: David Hardison, ConvergeHEALTH by Deloitte Dr. Martha Brumfield, Critical Path Institute Dr. Mayumi Shikano, PMDA - Japan Dr. Ron Fitzmartin, FDA Wayne Kubick, CTO 12:15 13:30 LUNCH Adoption of CDISC Standards Dr. Kenneth Getz, Tufts University School of Medicine 12:00 13:30 EXHIBITS

4 WEDNESDAY, 12 Nov :30 15:00 Session 3 (Track 1): New Approaches to Research Chair: Wayne Kubick, CDISC Session 4 (Track 2): Everything You Wanted to Know about SDTM Chair: Dan Godoy, MedImmune Real World Experience Dr. David Hardison, ConvergeHEALTH by Deloitte Everything You Always Wanted to Know About Leading an SDS Sub-team but Were Afraid to Ask And Then be Volunteered Stetson Line, Amgen De-identification Methods for Clinical Trials Data: Meeting Privacy Obligations for Clinical Trials Transparency Initiatives Khaled El Emam, Privacy Analytics Associated Persons Domains Who, What, Where, When, Why, How? Michael Stackhouse, Theorem Clinical Research Smart Clinical Program Design Information Model Dr. Laslo Vasco, AstraZeneca SDTM Based Clinical Data Repository to Meet Reporting and Analysis Across Clinical Development Robert O Connor, Infinity Pharmaceuticals, Inc. 15:00 15:30 BREAK

5 WEDNESDAY, 12 Nov 2014 SESSION 5 (Track 1): CDISC Implementation Stories 15:30 17:30 SESSION 6 (Track 2): CDISC Related PhUSE Projects Standards Governance Chair: Dr. Dave Jordan, Abbvie; and Dr. Rebecca Kush, CDISC Speakers will each present a diagram depicting their use of CDISC standards within their organizations. Chair: Landen Bain, CDISC PhUSE Standard Scripts for Analysis and Reporting Frank Senk, AstraZeneca Delivering Statistical Results as an RDF Data Cube Marcelina Hungria, DIcore Group, LLC Panel Discussion Panelists to be announced. Creating RDF from CDASH Mitra Rocca, FDA A Sponsor and CRO: Governing and Implementing Standards as Partners Gary Walker, Quintiles; and Scott Bahlavooni, Biogen Idec 18:00 19:30 Evening Event: Please join us for this networking reception and meet experts and colleagues from the industry.

6 THURSDAY, 13 NOV 2014 Interchange Conference 08:30 10:00 08:00 09:00 Conference Registration SESSION 7 (Track 1): CDISC Standards from the Start Chair: Dr. Rebecca Kush and Rhonda Facile, CDISC Speakers in this session will share their experience using CDISC standards from the start and panel discussion will follow. SESSION 8 (Track 2): Considerations in Creating ADaM Datasets from SDTM Datasets Chair: Nate Freimark, Theorem Clinical Research Implementation of CDISC ADaM in the Pharmacokinetics Department Joanna Magielse, SGS Life Sciences Checking for SDTM and ADaM Compliance: The Need for Human Involvement Kristine Kelly, Fred Wood, Sandra Minjoe and Jerry Salyers, Accenture Life Sciences Best Practices for CDISC ADaM Validation Checks: Past, Present and Future Shelley Dunn, d-wise Standards Around Questionnaire Data from Collection to SDTM and ADaM Karin LaPann, PRA Health Sciences 10:00 10:30 BREAK

7 THURSDAY, 13 NOV :30 12:00 SESSION 9 (Track 1): Implementation of Therapeutic Area Standards Chair: Bron Kisler, CDISC Speakers in this session will present their experiences implementing CDISC Therapeutic Area Standards, including Oncology and Multiple Sclerosis SESSION 10 (Track 2): CDISC for Safety Monitoring Devices and Epidemiology Chair: Kit Howard, CDISC Integrating CDISC Initiatives to Reduce Safety Monitoring Timelines While Improving Subject Safety and Overall Study Quality Rafael Smets, SGS Life Sciences Device Studies: A Case Study Janice Englund, Theorem Clinical Research 12:00 13:30 13:00 13:30 Lunch Network with Exhibitors Trial Development of Clinical and Epidemiological Research Data Repository System Using the CDISC ODM Takahiro Kiuchi, Yoshiteru Chiba, and Hirono Ishikawa, UMIN Center (The University of Tokyo Hospital) A Statistician s View on CDASH Ben Vali, FDA

8 Thursday 14 Nov 2014 Interchange Conference 13:30 15:30 SESSION 11: Embracing Change for Patients Chair: Sam Hume, CDISC CFAST Approaches to Standards Development for Therapeutic Areas Dr. Ron Fitzmartin, FDA; Rhonda Facile, CDISC; John Owen, Johnson & Johnson; Jon Neville, C-Path; and Diane Wold, GSK Panel Discussion 15:30 16:00 BREAK 16:00 17:30 SESSION 12: Closing Keynote and Panel Chair: Dr. Rebecca Kush and Wayne Kubick, CDISC esource Checklists for Breast Cancer: The ispy Study Dr. Laura Esserman, University of California, San Francisco Opening Remarks for Regulatory Panel Discussion Dr. Steve Wilson, FDA Panel Discussion - Regulators Invited FRIDAY 14 Nov :00 12:00 SDTM for Medical Devices 09:00 17:00 CDASH Implementation Course 09:00 17:00 ADaM Implementation Course

9 SAVE THE DATE! CDISC European Interchange in Basel, Switzerland 4 8 May 2015 Conference, Training and Workshops Call for Abstracts Open until 5 January CDISC Japan Interchange in Tokyo, Japan June 2015 Conference, Training and Workshops