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Work Package 7 – Quality Management Systems

Work Package 7 was created to increase existing knowledge on quality management systems for pharmacovigilance staff at National Competent Authorities (NCAs) through its provision of a training programme. WP7 delivered a toolkit which can be used for the further development of quality management systems (QMS) in pharmacovigilance (PV). The toolkit is a diverse collection of case studies, good practices, templates and guidance for NCAs to aid the understanding of quality management and the establishment and operation of their PV quality systems.

Quality Management Systems toolkit:

Introduction to Quality Management Systems E-learning Module

Compliance and Performance: Management and Indicators Document

Document and Records Management Document

Exchange of Information between PV Assessors and PV Inspectors Best Practice Guidance and E-learning Module

Pharmacovigilance Quality Manual Template

Quality Planning and Quality Objectives Guidance Document and E-learning Module

Quality Standards of Pharmacovigilance Assessment Document

Resource Management Best Practice Guidance and E-learning Module

Stakeholder Feedback and Customer Satisfaction Document

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