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.

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

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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.