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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