Risk Management

  • Provide strategic input into risk management and risk minimization approaches
  • Partner, support, and advise in your discussions with Regulatory Agencies, in the EU and the US
  • Produce regulatory acceptable risk management documents

Additional Risk minimization activities including:

  • Patient and healthcare professional communication programs
  • Risk Evaluation and Mitigation Strategies (REMS)

Additional Pharmacovigilance Activities (APVA)

  • Elements to Assure Safe Use (ETASU)
  • Monitoring the effectiveness of risk minimization activities
  • Off-label use monitoring