MDIC presents an informative series of online teleconference workshops featuring emerging trends in medical technology regulatory science, MDIC projects and subject matter experts sharing perspectives, progress and opportunities.

Initial Telecon Hosted by:

MDIC Computational Modeling & Simulation (CM&S) Project

Thursday, December 4th, 2014, 3:00pm – 4:00pm EST

Agenda

5 minutes | Overview

Dawn Bardot, MDIC CM&S Project Manager

20 minutes | Mock Submissions to FDA/CDRH: History and Lessons Learned

Kyle Myers, Director, Division of Imaging, Diagnostics and Software Reliability, OSEL, FDA & MDIC CM&S PI

20 minutes | Bayesian Incorporation of Virtual Patients to Inform Clinical Trials

Tarek Haddad, Sr. Principal Statistician, Cardiac Rhythm Management R&D, Medtronic & MDIC CM&S Clinical Trials Informed by Simulation and Bench Working Group Chair