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Pharmacovigilance - Risk management
 
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
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Dieser Kurs ist entgeltpflichtig. Bitte bezahlen Sie das Teilnahmeentgelt, um in den Kurs eingeschrieben zu werden.

Entgelt: EUR 10,00

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