ParagonRx® | Minimize Risk and Optimize Use

Key Topics

Audit and inspection findings related to:

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