Environment

Pharmacovigilance has become a hot topic due to a combination of factors, which are all intertwined and very current:

Regulatory pressure is building:

• More texts and guidelines regulate Pharmacovigilance activities
• Current and upcoming requirements are geared towards higher expectations for Pharmacovigilance Systems
• An increasing number of countries perform routine Regulatory Authorities Inspections targeting Pharmacovigilance
• The standards for Regulatory Authorities Inspections are on the rise
• Non-compliance may lead to criminal charges

Legal pressure is increasing:

• The number of claims is exploding
• The costs of litigation cases reaches multibillion dollars status

Public interest is growing:

• The public wants more efficient, cheaper and most importantly safe medicines
• One flaw in the system may be sufficient to significantly compromise your reputation

This environment supports the growing need for independent Pharmacovigilance Audits to review the appropriate performance of Pharmacovigilance Systems.

PV Focus possesses expertise in Auditing Pharmacovigilance, together with actual experience of Regulatory Authorities Inspections at a global level.

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PV Focus can propose a variety of audit options allowing you to evaluate Pharmacovigilance Processes.

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