Current Edition

Pharmacovigilance: Why Are So Many Companies Failing their Regulated Audits?

When EU legislation on pharmacovigilance came into force in July 2012, it established the clear legal requirement that marketing authorisation holders must perform audits of their pharmacovigilance systems, including risk-based audits of their
quality systems. So why then are so many life sciences companies struggling with associated audits and inspections? Summarising the 10 aspects of PV covered by the formal requirements, Vanessa Fachada Oliveira, Pharmacovigilance Manager & EU QPPV at Arriello, discusses where companies are falling short and where they need to focus their attention to stay on the right side of inspectors.