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

Tutorial name:
#45: The Good Pharmacovigilance Practices in the EU: Global Applications

Day & Time:
June 14, 9:00AM - 5:00PM

Room Number:

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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

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:
• 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 .

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