Tea Babic


Director, Head of PV Audits and Inspections Deputy Head of PV Compliance Global Patient Safety and Pharmacovigilance - Teva Pharmaceuticals



She is a pharmacist with MSc in Clinical Pharmacology. She has 19 years of experience in pharma industry, in QA and PV. Since 2012 she is a PV auditor, and since 2015 she is leading the global team responsible for PV audits, inspection readiness, PSMF maintenance, SOPs.



Tea Babic

Sessions


  • Tuesday - November 22, 2022 - 16:15

    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

      Watch Session


 

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