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T 47: True Globalization of the PSMF and Why It's a Useful Tool for Non-EU Pharmaceutical Companies





Poster Presenter

      Beverly Gow

      • Senior Director of Projects and Guildford Office Manager
      • Primevigilance Ltd
        United Kingdom

Objectives

Demonstration of how the Pharmacovigilance System Master File is a useful tool for a company to ensure global pharmacovigilance quality and compliance, irrespective of the size, type, and location of the marketing authorisation holder.

Method

Development and ongoing maintenance of 18 Global Marketing Authorisation Holders PSMFs, created by a specialist pharmacovigilance service provider, following the introduction of Good PV Practise (GVP) legislation into the EEA 2012. Reviewing against all company procedures and GVP guidelines. Co-Author: Natalie Smith

Results

The data checklist enabled collection of data across all departments for inclusion into the Pharmacovigilance System Master File. The collated data into a central repository revealed, previously unknown information to key stakeholders within the company. The PSMF provided oversight to senior management within the company and demonstrated where there were potential gaps, areas for improvement and where departments were functioning well with regards to quality and compliance. This pharmacovigilance tool had aided preparation for company regulatory inspections, and ensuring all topics with pharmacovigilance have been addressed appropriately. Since the introduction of the PSMF legislation, we have developed the PSMF tool which has been the subject of a number of successful regulatory audits and inspections.

Conclusion

The Pharmacovigilance System Master File, was demonstrated to be a useful tool for collating information within a company across multiple departments and sites, which would not normally communicate resulting in a central repository. It allows strategic project plans to be developed to ensure continuing improvement and maintenance of a robust pharmacovigilance system. Companies should consider, irrespective of size or location adopting the pharmacovigilance system master file into their companies as a global tool. A complete robust PSMF will enhance the smooth flow of a regulatory audit or inspection, and will instil confidence in an auditor or inspector that the MAH has complete oversight of their pharmacovigilance system. In addition, the PSMF ensures all departments work together to ensure full protection and safety of patients using their products. It aids smooth transition for acquisitions and due diligence and collaboration with partners and vendors. It aids in the understanding of the complex legislation within the EU and stringent requirements concerning safety; example of this include full oversight of a company’s vendors, Qualified Person responsible for pharmacovigilance and National Persons responsible for Pharmacovigilance. Fo r any companies considering submission of a marketing authorisation application in the EEA, the adoption of a global PSMF will ensure a smooth transition into European markets here.