Section outline

  • Discussion Seminar: Case Study: Safety Issues, Adverse Event Reporting, Signal Detection
    Brief overview of reporting requirements for FDA, EMEA; Types of reporting classifications; MEDRA; Case studies of safety issues, adverse event reporting; signal detection.

    Faculty: Pamela Munster

    Location:      Mission Hall 1106

    • Session Slides:

    • Phase I designs TICR 5-6-15 File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading:

    • Detailed guidance on the collection, verification. URL
    • Detailed guidance on the European database URL

    • Assignment:  Case Study Assignment: Due June 3, 2015. Email to Marlene.grenon@ucsf.edu and to Dr. Chin