CRED Understanding Clinical Development 2024

09/10/2024

An introduction to PV post marketing

MAH responsibilities EU/EEA

UK

Regulation (EC) No 726/2004 (REG) and Directive 2001/83/EC (Dir)

The Human Medicines Regulations 2012, as amended and the Commission Implementing Regulation (CIR) (EU) No 520/2012

A PV system is defined as a system used by an organization to fulfil its legal tasks and responsibilities in relation to PV. It is designed to monitor the safety of authorized medicinal products and detect any changes to their risk-benefit balance A set of measures to facilitate the performance of PV in the EU and UK is provided by the Good Pharmacovigilance Practice (GvP) Guidelines

The Organisation for Professionals in Regulatory Affairs

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No GVP Module I

PV systems and their Quality systems

II

PV system master file

III PV inspections IV PV audits

V Risk management system VI Collection, management and

submission of reports of suspected ADRs to medicinal products

VII Periodic safety update reports VIII Post-authorization safety studies

IX Signal management X Additional monitoring XV Safety communication XVI Risk minimization measures, selection of tools and effectiveness indicators

The Organisation for Professionals in Regulatory Affairs

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