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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

      Who should attend?

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

      Learning objectives

      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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