Clinical trial sponsors are facing a variety of considerations related to patient safety, investigational product supply chain interruptions, and trial data quality and integrity when considering restarting previously paused or disrupted clinical trials due to the COVID-19 pandemic. How widespread is the impact of COVID-19 on clinical trials? What are the primary legal issues a sponsor should consider in deciding when and how to restart a trial? This webinar will review FDA’s and the European Union’s guidances on the issue, which provide a degree of regulatory flexibility for clinical trials conducted during the COVID-19 pandemic. Speakers will then discuss how industry and FDA are responding to real-world implications of restarting clinical trials disrupted by COVID-19. Covered issues will include remote source data verification, alternatives to onsite inspections of clinical trial sites, and best practices for ensuring integrity in the clinical trial despite COVID-19 modifications.
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Scott L. Cunningham, Partner, Covington & Burling LLP
Louisa M. Daniels, Vice President and Assistant General Counsel, Pfizer, Inc.
John A. Murphy III, Vice President & Deputy General Counsel, BIO
Cynthia Schnedar, Executive Vice President, Greenleaf Health, Inc., and Member, FDLI Board of Directors
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