Section outline

  • Lecture:  Pharmacoepidemiology and Drug Safety, Data Systems

    • — The Rules Governing Medicinal Products
    • —  Data Mining and Signal Detection in Spontaneous Reporting Systems
    • —  Drug Development in the Post Vioxx Era - A Paradigm Shift in Pharmacovigilance

    Faculty:  M. Sprafka/Mier Pinco

    Location:  Mission Hall 1407

    • Session Slides:

    • Lecture4 Clinical Development Information Systems - Pinco File
    • UCSF Lecture V2 File
    • Hammad TA, Neyarapally GA, Iyasu S, Staffa JA, Dal Pan G. The Future of Population-Based Postmarket Drug Risk Assessment. A Regulators Perspective. Clin Pharmacol Ther. 94-3-349-5, 2013 File
      Not available unless: Your ID number contains 02
    • Schneeweiss S. A basic study design for expedited safety signal evaluation based on electronic healthcare data. Pharmacoepidemiology and Drug Safety. 19-858–868, 2010 File
      Not available unless: Your ID number contains 02
    • Ray A. Beyond debacle and debate. developing solutions in drug safety. Nat Rev Drug Discov. 8-775-9, 2009 File
      Not available unless: Your ID number contains 02