Thank you for joining us at the 2014 CDISC International Interchange. Presentation slides from the conference are available below. We look forward to seeing you again at future CDISC events!
Note: Presentations are subject to copyright and may not be used without written consent of CDISC or its affiliates.
Session 1: Opening Plenary & Keynote
CDISC Brief
General Peter Chiarelli, One Mind
Dr. Eileen Navarro Almario, FDA
Dr. Rebecca Kush
Session 2: Second Opening Plenary
Dr. Martha Brumfield, Critical Path Institute
Dr. Mayumi Shikano, Pharmaceutical and Medical Devices Agency (PMDA)
Dr. Ron Fitzmartin, FDA
Session 3: New Approaches to Research
Dr. David Hardison, ConvergeHEALTH by Deloitte
Dr. Khaled El Emam, Privacy Analytics
Laszlo Vasko, AstraZeneca
Session 4: Everything You Wanted to Know about SDTM
Stetson Line, Amgen
Alyssa Wittle, Theorem Clinical Research
Session 5: CDISC Implementation Stories
Dr. Ron Fitzmartin, Senior Advisor, Office of Strategic Programs at the Center for Drug Evaluation and Research, FDA
Dr. Ron Fitzmartin (CDER-FDA), Yuki Ando (PMDA), and CDISC Representatives
Dr. David C. Jordan, TransCelerate Clinical Data Standards Workstream Leader
Session 6: CDISC Related PhUSE Projects - Standards Governance
Frank Senk, AstraZeneca
Marcelina Hungria, Dlcore Group, LLC
Mitra Rocca, FDA
Gary Walker, Quintiles, and Scott Bahlavooni, Biogen Idec
Session 7: CDISC Standards from the Start
Rhonda Facile, CDISC and Dr. Rebecca Kush, CDISC
Session 8: Considerations in Creating ADaM Datasets from SDTM Datasets
Dr. Joanna Magielse, SGS Life Sciences
Kristin Kelly, Fred Wood, Sandra Minjoe and Jerry Salyers, Accenture Life Sciences
Shelley Dunn, d-Wise
Karin LaPann, PRA Health Sciences; and Nancy Brucken, inVentiv Health Clinical, LLC
Session 9: Implementation of Therapeutic Area Standards
Jacintha Eben, SGS Life Science Services
Kevin Lee, Accenture
Susan Zhao, Medivation Inc
Enrique Aviles, Critical Path Institute
Session 10: CDISC for Safety Monitoring, Devices and Epidemiology
Integrating CDISC Initiatives to Reduce Safety Monitoring Timelines While Improving Subject Safety and Overall Study Quality
Rafael Smets, SGS Life Sciences
Janice Englund, Theorem Clinical Research
Yoshiteru Chiba, UMIN Center ( The University of Tokyo Hospital)
Session 11: CDISC
Recent FDA Guidance and CDISC Activities
Dr. Ron Fitzmartin, FDA
CFAST at Year 2: Overview & Lessons Learned
Rhonda Facile, CDISC, and John Owen, Jonson &Johnson
CFAST: Innovative Approaches to Standards Development
Jon Neville, Critical Path Institute, and Dr. Diane Wold, GSK
Session 12: Closing Keynote and Panel
Dr. Laura Esserman, University of California, San Francisco