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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?
- 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.