Good Pharmacovigilance Practices (GVP) provide the principal EU regulatory guidance for performing pharmacovigilance activities under the EU legislative framework.
Why a pharmacovigilance professional uses it
The GVP modules explain how the EU pharmacovigilance framework is implemented across areas including pharmacovigilance systems and quality systems, the PSMF, inspections, audits, risk management, ICSR management, PSURs, PASS, signal management, additional monitoring, safety communication and risk-minimisation measures.
Regulatory status
GVP is guidance. It should be interpreted together with applicable EU legislation, including Directive 2001/83/EC, Regulation (EC) No 726/2004 and relevant implementing measures. QPPV.com distinguishes the legal requirement from the GVP explanation of how that requirement is operationalised.