#44: The Good Pharmacovigilance Practices in the EU: Global Applications

Overview

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The objective of this tutorial is to provide a platform to address frequently asked questions and recent updates/developments in relation to the EU guidelines on good pharmacovigilance practices taking into account their global application and focusing on the following interest areas:

Overview of the latest developments in the area of pharmacovigilance in the EU including related IT systems
Management and reporting of adverse reactions and signal management
Updates of GVP Module VI
The new EU E2B(R3) ICSR implementation guide
New process for marketing authorization holders regarding the monitoring of medical literature and entry of relevant information into the EudraVigilance database by the EMA
Updates to the EudraVigilance Access Policy.

Who should attend?

This tutorial is designed for professionals who work in the following areas: clinical safety and pharmacovigilance, regulatory affairs, risk management, quality and compliance.

Learning objectives

Describe recent developments on EU Good Pharmacovigilance Practices guidance;
Examine principles for new literature monitoring and the revised EudraVigilance Access Policy;
Discuss FAQs in signal management;
Identify important aspects in preparing risk management plans and conducting postauthorization safety studies;
Describe key principles for pharmacovigilance audits and inspections.