Audit and inspection findings related to:
鈥� Management of individual case safety reports such as assessment of case validity, lack of efficacy, information derived from the Internet
鈥� Record retention and storage, paper versus electronic records
鈥� Pharmacovigilance quality system, structure, documentation, Detailed Description of Pharmacovigilance Systems (DDPS) updates, role of European Qualified Person for Pharmacovigilance (QPPV)
鈥� Reporting of inspection findings, assessment against internal/external references, interpretation of regulatory requirements, consistency across inspections, options for dialogue and escalation
鈥� Management of individual case safety reports such as assessment of case validity, lack of efficacy, information derived from the Internet
鈥� Record retention and storage, paper versus electronic records
鈥� Pharmacovigilance quality system, structure, documentation, Detailed Description of Pharmacovigilance Systems (DDPS) updates, role of European Qualified Person for Pharmacovigilance (QPPV)
鈥� Reporting of inspection findings, assessment against internal/external references, interpretation of regulatory requirements, consistency across inspections, options for dialogue and escalation
