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Description
IND safety reporting is a core function of clinical trials. Study sites and sponsors are responsible for reporting adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), suspected unexpected serious adverse reactions (SUSARs), unanticipated problems (UPs), and unanticipated adverse device effects (UADEs) according to detailed instructions of FDA guidances. This webinar describes what is reported, to whom, and according to what timelines. It explains the criteria for determining causality and discusses the actions that sponsors must take when identifying significant risks to study populations.
Audience
Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), Contract Research Organizations (CROs), Faculty, Investigators, Sponsors, Students
Meet the Presenter
Barbara Hendrickson, MD – University of Chicago
Dr. Barbara Hendrickson is on faculty at the University of Chicago and a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is a physician with subspecialty training in pediatrics and infectious diseases and has extensive experience with clinical trial safety planning, monitoring and data assessment.
