Role & Responsibilities of Local Safety Unit 23rd – 25th June 2025

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stadmin April 25, 2025 No Comments

Role & Responsibilities of Local Safety Unit 23rd – 25th June 2025

  • This basic pharmacovigilance training session is recommended for active or emerging Local Contact Persons Responsible for Pharmacovigilance (LCPRP) and/or deputy.
  • Training structure includes presentations of following theoretical concepts, interactive sessions and customised case studies.
    • Pharmacovigilance in medicines life cycle
    • Case Management
    • Risk Management Plan (RMP)
    • Safety compliance
      • Key Performance Indicators (KPIs)
      • Non-compliance
      • Pharmacovigilance System Master File (PSMF)
      • Safety Data Exchange Agreement (SDEA)
    • Bussiness Continuity
    • Trainings
    • Suppliers Management
  • Course Lecturer: Pharm. Elena Georgescu – Acquired expertise in 25 years of operational experience in pharmaceutical industry GxP compliance areas.

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