Regulatory Science Symposium: Pharmacovigilance and Safety Reporting 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.

Ethics & Participant Safety
Regulatory & Quality Sciences
Regulatory Science Symposium: Pharmacovigilance and Safety Reporting Session 6: Safety Reporting in Industry-Sponsored Trials and Case Studies - Part 2 (2018)

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

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