Overview

This tutorial will provide an overview of the recent updates to the Good Pharmacovigilance Practice Module VI based on several case studies. It will give an overview of the operational aspects and business processes based on the legal provisions that place a shared responsibility on MAHs, NCAs and the European Medicines Agency as regards the follow-up of individual cases and the duplicate management but will also address processes related to the nullification and amendment of ICSRs. Finally, frequently asked questions will be addressed in relation to the preparation for the simplified reporting of suspected adverse reactions and the access to Eudravigilance.

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Who should attend?

This tutorial is designed for Qualified Persons Responsible for Pharmacovigilance (QPPVs) and pharmacovigilance experts including ICSR data entry and processing specialists.

Learning objectives

Discuss recent updates to GVP Module VI based on several case studies/li>
Describe the follow-up process and duplicate management process based on the shared responsibilities between MAHs, NCAs and the EMA
Understand how to prepare for simplified adverse reaction reporting and access to EudraVigilance

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SC02: Hot Topics in Pharmacovigilance

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.