Pharmacovigilance services

Pharmacovigilance services
Product Description

Services of EU QPPV, Local QPPVPharmacovilgilance System Set up and Review servicesICSR managementOn-going monitoring and signal managementLiterature surveillance servicesRisk managementReporting – Product Safety Update Reports (PSURs) – Periodic Benefit-Risk Evaluation Reports (PBRERs) – Development Safety Update Reports (DSURs) – Periodic Adverse Drug Experience Reports (PADERs) – Risk Management Reports (RMPs)Safety Data Exchange AgreementsPharmacovigilance Quality System, audits and inspections – Pharmacovigilance System Master File (PSMF) – Standard Operating Procedures (SOPs) – Internal and third party audits, mock-up inspections, CAPA writingTraining

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Inpharmatis

  • LV
  • 2018
    On CPHI since
View company profile
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Inpharmatis

  • LV
  • 2018
    On CPHI since
View company profile

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