About this course

After completing the 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
Duration: 8 hours


Start date: 4/11/21

Course files