Topic outline

General

Lesson 1: Background and general principles of Pharmacovigilance and its legislative framework (focus EU)

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Learning outcomes of this lesson:


Lesson 2: Pharmacovigilance Measures and the European EudraVigilance

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Learning outcomes of this lesson:

  • 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


Lesson 3: Principles of risk management in the European Union

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Learning outcomes of this lesson:


Lesson 4: Safety Communication including Direct Health Care Professional Communication (DHPC)

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Assessment

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