Joint DIA / EFGCP Pharmacovigilance Audit and Inspection Workshop

Venue: DE VERE Venues Canary Wharf

Location: London, United Kingdom

Event Date/Time: Oct 01, 2010 End Date/Time: Oct 01, 2010
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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

Other aspects:
• Targeted versus routine inspections
• Feedback from assessments relevant to pharmacovigilance quality system
• Affiliates inspections in the EU and rest of the world
• Inspections of licensing partner, distributors and vendors
• Best practices on how to prepare, conduct, report a pharmacovigilance inspection – mutual experience and recommendations
• Role of performance metrics in pharmacovigilance quality systems