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Post Approval - Risk Management


To meet client requirements, BCI can develop post-approval strategies and provide pharmacovigilance planning services, including development of safety specifications and risk minimization plans. Our services include:

  • Risk identification and assessment
  • Risk communication
  • Interventions to reduce risk
  • Evaluation of intervention effectiveness
  • Modification of interventions when needed
  • Development, implementation and evaluation of risk minimization action plans (RiskMAPs)