Tea Babic


Director, PV Audits and Inspections - Teva Pharmaceuticals





Tea Babic

Sessions


  • Thursday - September 12, 2024 - 09:00

    PSMF – Pharmacovigilance system master file

    • PSMF summary design, role of QPPV and managing audits
    • Responsibilities of stakeholders
    • Accessibility of PSMF and Transparency and ensuring compliance
    • Challenges in the managing data collection, audit information and documenting changes in logbooks, transferring information to license partners or third parties


 

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