Pharmacovigilance Risk Management:

Risk management in pharmacovigilance is undertaken to promote safe use of medicines and safeguard health of patients. It is a set of activities performed for identification of risk, risk assessment, and risk minimization and prevention. Risk management has the following stages: identification and characterization of the safety profile of the medicinal product; planning of pharmacovigilance activities to characterize risks and identify new risks; planning and implementation of risk minimization and mitigation and assessment of the effectiveness of these activities; and document postapproval obligations that have been imposed as a condition of the marketing authorization.

  • • Risk Management for Outsourcing
  • • Risk Identification
  • • Risk Impact Mitigation through Risk Management
  • • Risk Management Plan

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Pharmacovigilance Risk Management: Conference Speakers

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