• Benefit-Risk Assessments
  • Risk Management Plans

Our pharmacovigilance experts lead or support the Client’s risk management planning in the pre-approval and post-market settings. This includes the development of risk minimisation programmes with an implementation scheme, specific tools, and evaluation strategy. Our team also converts EU-RMPs into Canadian RMPs, ensuring that all Canadian-specific requirements are addressed.

Our pharmacovigilance experts lead or support the Client’s risk management planning in the pre-approval and post-market settings.
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For organizations that are legislatively mandated to perform post-market benefit risk assessments, Certus PV performs overall appraisals of the benefit and risk of the product as used in clinical practice. Based on the evaluation of the cumulative safety data and the risk-benefit analysis, we can propose changes and/or actions for further discussion with the regulatory authority.