Pharmacovigilance audit failures. What’s still going wrong?
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?
This guide summarizes the 10 aspects of PV covered by the formal requirements, where companies are falling short and where they need to focus their attention to stay on the right side of inspectors.