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Sunday, June 18 • 9:00am - 5:00pm
#43: The Good Pharmacovigilance Practices in the EU: Global Applications

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Component Type: Tutorial
CE: CME 6.50; IACET 6.50; RN 6.50

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 Polic

    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

  • Speakers
    avatar for Saad Shakir

    Saad Shakir

    Director, Drug Safety Research Unit
    Saad Shakir is Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is an academic Unit associated with the University of Portsmouth. Here he leads a research team with an active programme for monitoring and studying the safety of medicines. He has worked and... Read More →

    Kristina Strutt

    Senior Vice President, Global Patient Safety, Ipsen Biopharm Limited
    Kristina studied medicine at Cambridge and London Universities in the UK. She has 28 years Clinical Development and Drug Safety pharma experience in the UK, Switzerland and Germany. She lectures in pharmacovigilance on various courses in the UK, and is an examiner for the Faculty... Read More →

    Sunday June 18, 2017 9:00am - 5:00pm CDT
    S405b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
      Short Course, Tutorial |   06: Safety-PV, Tutorial
    • format json
    • Credit Type CME, IACET, RN
    • Tags Tutorial