Meeting
Joint DIA/EFGCP Pharmacovigilance Audit and Inspection Workshop – Opportunities for Patient Safety
| Location: | Canary Wharf, London, UK |
|---|---|
| Date: | 01.10.2010 |
| End Date: | 01.10.2010 |
Description
Objectives • To provide a neutral platform for regulators and industry to jointly review experience from pharmacovigilance audits and inspections across national boundaries • To increase the common understanding of the role of pharmacovigilance inspections and improve future collaboration 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 systemsContact
DIA in Europe
tamara.kohler@diahome.org