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CSRC and BioTel Research Present: Remote Cardiac Safety Monitoring for Clinical Trials – Pandemic and Beyond

Friday, Oct 16, 2020

The Cardiovascular Safety Research Consortium (CSRC) has brought together industry experts along with representatives from FDA — from both Centers of Drug and Device Evaluation —  in order to explore some best practices for remote cardiac monitoring.

This Cardiac Safety Research Consortium webinar will be moderated by CSRC Executive Director, Jonathan Seltzer, MD, FACC and is sponsored by BioTel Research. The agenda features regulatory and industry experts:

  • Use of Remote Captured Data to Assess Cardiac Safety – Fred Senatore, MD, PhD, FACC, Medical Officer/Clinical Team Leader, Division of Cardiology & Nephrology, CDER, FDA
  • Cardiac Monitoring Medical Device Landscape— LT Stephen Browning, BS, Assistant Division Director – Blood Pressure and Flow Devices, Division of Cardiac Electrophysiology, Diagnostics and Monitoring, CDRH, FDA
  • Practical Aspects of Remote Cardiac Safety Monitoring—Polina Voloshko, MD Chief Medical Officer, BioTel Research
  • Case Study:  Remote Physiologic Parameters during the COVID-19 Pandemic—Ken Stein, MD, Senior Vice President, Chief Medical Officer for Rhythm Management and Global Health Policy, Boston Scientific
  • Regulatory Landscape for Clinical Outcome Assessment— Elektra Papadopoulos, MD, MPH, Acting Director, Division of Clinical Outcome Assessment, Office of New Drugs, CDER, FDA
  • Considerations for Remote Capture of Clinical Outcome Assessments – Ken Faulkner, PhD, Vice President, eCOA Scientific Services, ERT