Section outline

  • Lecture:  Pharmacoepidemiology and Drug Safety

    • Drug safety monitoring (pharamacovigilance) - review of regulatory data systems:
      • FAERS/Spontaneous Reports
      • FDA Sentinel
      • Clinical trial safety data
    • Safety signals - evaluation across pre-clinical to post-market settings
    • Definitions
    • International Perspective (EMA - PASS studies)
    • Case Study - Vioxx and cardiovascular disease

    Faculty:  Michael Sprafka

    Location:  Mission Hall 2107

    • Session Slides:

    • Lecture 4 Sprafka Pharmacovigilance and Regulatory Considerations 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