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.

Services Offered:

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

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Countries covered
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Local ICSRs processing timeline compliance
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Product aRMM implementations supported

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Apr 22, 2020

Local Person for Pharmacovigilance (LPPV) Strategy Considerations in the EU

To ensure the safety of their products Marketing Authorization Holders (MAHs) must…

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Jul 21, 2021

Integration of Pharmacovigilance Systems Under a Mutual Operating Guide

Pharmacovigilance (PV) activities are fundamental to both patient safety and regulatory compliance,…

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Feb 25, 2022

Requirements for Nomination of a PV Contact Person at National Level in European Union

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders…