Risk Management, RMPs, and REMS

Risk Management Strategy

What is a risk management strategy?

Not all products require risk minimization controls beyond labeling. Knowing which ones do and determining the most appropriate risk management strategy to implement requires careful analysis and planning to ensure that the benefits of the product outweigh the risks without undue internal and external stakeholder burden. All new and updated marketing authorizations in the EU, and selected countries outside the EU, require an RMP as a condition of marketing approval. For many products, routine pharmacovigilance activities and risk minimization measures are adequate to prevent or minimize risks. For other products, additional pharmacovigilance activities and risk minimization measures are required but must be justified and approved by regulators to ensure a positive risk-benefit balance for the target population.

How can ParagonRx help?

ParagonRx supports clients in developing a global risk management strategy that defines broad principles of how the risks can be minimized regardless of the end market. That global strategy is then adapted to the regulations and clinical practices of local markets through the customization of regulatory documents and risk minimization tools.

What makes the ParagonRx approach to a risk management strategy unique?

ParagonRx offers uniquely customized support:

  • A strategic approach to minimize patient risks while supporting appropriate product access for patients and commercial success for marketing authorization applicants
  • Systematic methods that reinforce the confidence of regulators
  • Evidence-based analyses that are defensible
  • Proactive contingency planning
  • Unparalleled expertise built on the experience of developing risk management strategies or documentation for more than 100 products