As a result of the increased focus on Drug Safety, internal Audits of Pharmacovigilance Systems have now become a requirement. Those who have experienced Regulatory Inspections will be aware that there is now an expectation that companies maintain a comprehensive internal Auditing program for their Pharmacovigilance Systems. Furthermore, the EMEA Position Paper on Compliance (CPMP/PhVWP/1618/01) specifically refers to internal Audits to monitor the effectiveness of the Pharmacovigilance System.

PV Focus brings valuable global experience of both Audits and Regulatory Inspections (FDA, MHRA and other agencies). PV Focus has developed its own approach to Auditing Pharmacovigilance Systems to cover all relevant regulatory requirements and regulations for Pharmacovigilance and Clinical Drug Safety processes. PV Focus can also support the preparation of Regulatory Inspections through the conduct of Mock inspections for Pharmacovigilance and Clinical Safety.

PV Focus also has experience of Clinical Quality Assurance and can offer Audit and Mock Inspection services for GCP processes, as well as consulting in setting up the Audit Function.

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SUN.eVeille Safety is a service of regulatory review developed in partnership with SUNNIKAN Consulting. SUN.eVeille Safety covers all regulatory requirements and regulations applicable to the management of Pharmacovigilance and Clinical Drug Safety.

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