Topic outline
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Lesson 1: Background and general principles of Pharmacovigilance and its legislative framework (focus EU)
Learning outcomes of this lesson: 
- Outline the principles of pharmacovigilance
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Explain the major steps in pharmacovigilance signal management
- List the key stakeholders in pharmacovigilance and their roles
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Learning outcomes of this lesson: 
- 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
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Receive a grade Receive a passing grade
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Pharmacovigilance - Risk management
After completing the course, you will be able to:
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Outline the principles of pharmacovigilance
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Explain the major steps in pharmacovigilance signal management
- List the key stakeholders in pharmacovigilance and their roles
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Compare Post Authorisation Safety Studies (PASS) and Post Authorisation Efficacy Studies (PAES)
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Outline the organisation of public hearings
- Explain the concept and structure of EudraVigilance
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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
