Pharmacovigilance and Safety Reporting Boot Camp Session 6: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 2 (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. Exercise-2: Clinical Trial Adverse Event for a drug approved for a different indication
    The case study talks about a prescription drug that has been approved for a different indication for which a rare serious adverse reaction (SAR) is reported. In this case, what changes can be expected by the FDA?
  2. Exercise-3: Medical Device Trial Report
    The case study discusses how fast Medical Device Reporting (MDR) has to be done for an investigational device in case of serious injury to the subject/s.

Acknowledgement

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


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.