Improving Preclinical and Clinical Regulatory Submissions Through Enhanced ECG Interval and Arrhythmia Assessment

 

THURS, MAR 1, 2018 // 11:00am-12:00pm EST (UTC -5)

 

During this webinar, sponsored by VivaQuant, experts will review advances in ECG safety assessment including reductions in interval measurement variability, reductions in confidence limits in concentration effect models, and accurate reporting of up to 20 common arrhythmias

The clinical perspective will be delivered by Dr. Jay W. Mason. He will discuss reductions in interval measurement variability and confidence limits in concentration effect models and review the implications for clinical TQT studies and Phase I (IQ-CSRC) studies supporting TQT waivers, supporting why tighter confidence limits and more accurate measurements matter.

Following, Mike Gralinski, CEO of CorDynamics, will offer a preclinical perspective on the potential of incorporating a detailed assessment of arrhythmias for every cardiovascular study, and share his thoughts on how and when this additional information should be leveraged. He will discuss the value of knowledge versus liability of disclosure, the potential value of pre-study arrhythmia screening, and the idea of incorporating baseline/control arrhythmia assessment.



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Presenter
Jay W. Mason, MD

University of Utah
View Biography
Presenter
Michael Gralinski, Ph.D.
CEO and Co-Founder
CorDynamics
View Biography
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