Pharmacovigilance Risk management plans and new risk- benefit analysis tools

The comparative evaluation or weighing of benefits (positive effects) and risks (potential harm) of various medical options for treatment, prophylaxis, prevention or diagnosis. Risk management is a global activity. However, because of differences in indication and healthcare systems, target populations may be different across the world and risk minimisation activities will need to be tailored to the system in place in a particular country or global region.

  • Identify or characterise safety profile
  • Measures to prevent or minimise risks
  • For each of the safety concerns the planned pharmacovigilance activities should be provided
  • Protocols of the studies

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