Section outline

  • After completing this course, you will be able to:
    • Outline the principles of pharmacovigilance
    • Explain the major steps in pharmacovigilance signal management
    • List the key stakeholders in pharmacovigilance and their roles
    • Compare Post Authorisation Safety Studies (PASS) and Post Authorisation Efficacy Studies (PAES)
    • Outline the organisation of public hearings
    • Explain the concept and structure of EudraVigilance
    • Outline the principles of risk management for medicinal products in the European Union (EU) including the risk management plan
    • Explain the EU specific measures for additional monitoring
    • Outline the concept of safety communication
    • Relate the ‘Direct to health care professionals communication’ to the overall principles of safety communication
     

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