LPPVs & Local PV Services
Pharmacovigilance requires achieving local coverage and meeting diverse local regulatory requirements. In this context, Marketing Authorization Holders must ensure a proper local pharmacovigilance function across different countries. We help MAHs establish local PV systems and provide them with Local Persons for Pharmacovigilance (LPPVs, Local QPPVs, LSRs) for continious local PV management accross Europe (EU/EEA), Russia & CIS, and MENA.
In each covered country we provide local PV services under the our Unified Governance Model, consolidating country-level operations into a seamless, integrated regional system. This allows us to provide our clients with a single interface for oversight and compliance monitoring as well as deliver a consistent service and outputs globally.
Provision of Local Persons for Pharmacovigilance (LPPV / Local QPPV / LSR) and Deputies
Creation and maintenance of local PV systems, including local PSMF, local SOPs, etc.
Assurance of 24/7 availability where required
Local literature screening for pharmacovigilance
Handling of safety reports – intake, processing, reporting, tracking
Submission of domestic and foreign ICSRs to local Competent Authorities where required
Local implementation of aRMMs (Educational Materials, DHPC communications)
Local PV legislation monitoring with constant updates to the customer
PV training for customer’s local affiliate or distributor staff
Submission of aggregate safety reports (PSURs) and Risk Management Plans (RMPs) where required
Handling of requests and inspections from local Competent Authorities