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Overview

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

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.