Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 1: Introduction (2018)

In this series, we will discuss pharmacovigilance and safety reporting in clinical trials. Case studies are presented throughout the series.

Course Syllabus/Topics

  1. Introduction
  2. Audience polling

    • How would you describe yourself?
    • In which of the following types of studies are you involved?
    • Where are you from?
    • Are you currently being funded by a CTSA Hub?
    • Have you ever submitted an unanticipated problem to an IRB?
    • Have you ever reported a serious adverse event to a sponsor?
    • Have you ever reported a serious adverse event to the FDA?
    • What learnings do you hope to take away from today?
  3. SC CTSI Clinical Research Support (CRS)
  4. USC 5 Graduate Programs in Regulatory Sciences
  5. Logistics


Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy |


Eunjoo Pacifici, PharmD, PhD
Chair and Associate Professor of Regulatory and Quality Sciences Associate Director, D. K. Kim International Center for Regulatory Science

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.