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

Perspectiva general

The objective of this short course 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

Back to DIA 2017

Objetivos de aprendizaje

At the conclusion of this course, 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 - is something missing here?
Describe key principles for pharmacovigilance audits and inspections

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

Perspectiva general

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Objetivos de aprendizaje

Be informed and stay engaged.