Based on a Cardiac Safety Research Consortium Think Tank held in October 2017 on “Detection, Assessment, and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development, this publication discusses emerging cardio-oncology nuances and the latest regulatory thinking on ways to manage risks.
New Blog: "Ask the IRB Experts"Visit Blog
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In a recent webinar, Steven Beales, Senior VP, Scientific and Regulatory at WCG, facilitated a conversation with FDA leaders, discussing overreporting SUSARs and the impact on patient safety.
A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule
WCG’s SafetyVigilance® Online Safety Event Solution Delivers Quality and Efficiency to Unify Enterprise Trial Management and Meet Regional Guidelines and Regulations