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.
Sessions
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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
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