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12th International Conference and Exhibition on Pharmacovigilance & Drug Safety

Rome, UK

Essam Ghanem

Essam Ghanem

Celyad Biopharmaceutical, Belgium

Title: Driven strategy for effective monitoring pharmacovigilance quality system – key points


Biography: Essam Ghanem


Risk mitigation during medicinal products life cycle requires harmonization of pharmacovigilance activities handled by the involved stakeholders regarding their engagement strategy to ensure compliance. Pharmacovigilance system compliance necessitates the presence of effective quality system management. Real world data indicates that compliance rate needs to be optimized via incorporated standardized parameters and well identified compliance metrics. This presentation will provide an overview of the needed strategy for building up and monitoring of the quality system of pharmacovigilance. Such driven strategy for pharmacovigilance quality management will improves compliance rate and minimize authorities’ inspections critics.