Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 4: Safety Reporting from Other Sources (2018)

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

Ethics & Participant Safety
Regulatory & Quality Sciences
Nancy Pire-Smerkanich, DRSc, MS

Assistant Professor, USC Mann Dept. of Regulatory and Quality Sciences; Associate Director, Regulatory Knowledge and Support

Course Syllabus/Topics

  1. Why is this important?
  2. Other types of Safety Reports
  3. Findings from animal or in-vitro testing
  4. Findings from other studies
  5. Safety information related to drug class
  6. Reports in the public domain
  7. Reports from foreign sources
  8. How does this affect you?
  9. Another additional resources

Acknowledgement

Accompanying text created by Khyati Ashtekar | Graduate Student, Regulatory Science, USC School of Pharmacy | ashtekar@usc.edu