Loading…
Back To Schedule
Thursday, July 1 • 1:30pm - 2:00pm
#434 SC L: Solution Circle: The Burden of Safety Reporting on Sites - What Sponsors of Choice do Differently

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

Tweet Share
Component Type: Session
Level: Intermediate

Safety reporting requirements place heavy burden on sites. Sponsors struggle to keep up with changing global regulations and end up overdistributing, sending duplicate or unnecessary reports. A review of 9 years of safety reports found 86% of safety letters received by sites were uninformative or unnecessary, and over 50% did not meet FDA expectedness and causality criteria. In this session, we discuss the changes implemented by a sponsor to become more favored in safety reporting by sites.

Chair

WCG Clinical Services

Speakers
avatar for Steven Beales

Steven Beales

Senior Vice President, Scientific and Regulatory Review, WIRB-Copernicus Group (WCG)
Steven Beales, WCG’s Senior Vice President of Scientific and Regulatory. An expert in the field of safety reporting technology, Mr. Beales has 25 years of experience in IT, and has spent over 16 years in the pharmaceutical industry. He joined WCG ePharmaSolutions in 2009 and led... Read More →

Thursday July 1, 2021 1:30pm - 2:00pm EDT
TBD Virtual Event Horsham, PA 19044
  22: Solution Circles, Session