Event Calendar

Data Management / EDC / 21 CFR 11

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2019 Agenda


Saturday, September 28, 3:45-4:30                                          

Where Did My Data Go and Who Does it Concern, Anyway? Using Results from Pharmaceutical Clinical Research Trials Beyond the NDA

The presentation will demonstrate how pharmaceutical organizations use results obtained from Phase I – III clinical trials other than for the purposes of obtaining NDA and product monograph publishing.  Several industry-initiated, medical and commercial programs will be reviewed during the presentation. The examples of such programs will include medical education programs, advisory board meetings, medical ambassador programs, speaker tours, detail aids, patient focus groups, and educational initiatives. Furthermore, the presentation will discuss how the pharmaceutical industry interacts with healthcare workers, key opinion leaders (KOLs) and patients. Clinical research professionals who attend the presentation will also be able to learn and understand how their expertise can be used beyond clinical operations. 729
Presenter: Sonja Elsaid, MSc, CCRP, Medical Affairs Consultant, MaRS

Ms. Elsaid will demonstrate how pharmaceutical organizations use results obtained from Phase I – III clinical trials other than for the purposes of obtaining NDA and product monograph publishing.  Several industry-initiated, medical and commercial programs will be reviewed during the presentation. The examples of such programs will include medical education programs, advisory board meetings, medical ambassador programs, speaker tours, detail aids, patient focus groups, and educational initiatives. Furthermore, Ms. Elsaid will discuss how the pharmaceutical industry interacts with healthcare workers, key opinion leaders (KOLs) and patients. Clinical research professionals who attend the presentation will also be able to learn and understand how their expertise can be used beyond clinical operations. 729

Presenter: Sonja Elsaid, MSc, CCRP, Medical Affairs Consultant, MaRS

Track: Data Management / EDC / 21 CFR 11


Saturday, September 28, 4:35-5:20                                          

Succeeding with CTMS

Integrating clinical research data collected through divergent software applications can be a challenge. Knowing how and when to use clinical trial management software/systems (CTMS) and how to integrate data from other e-clinical systems can help ensure successful trial execution.  This presentation will highlight what you can expect from a modern CTMS including successful integration ideas and techniques. 731

Presenter: Jan Nielsen, BS, PMP, Senior Project Manager & Community Manager CTMS, BSI Business Systems Integration AG

Track: Data Management / EDC / 21CFR 11