Risk Management, RMPs, and REMS

Risk Management Plan Design

What is a Risk Management Plan?

A Risk Management Plan (RMP) or European Union (EU) RMP is a detailed description of activities and interventions designed to identify, characterize, and minimize risks relating to medicinal products, collectively referred to as a risk management system. It also includes an assessment of the effectiveness of those activities and interventions. An RMP is required for all new and updated marketing authorizations in the EU and may be required in selected countries outside the EU.

After deciding to pursue a new or updated marketing authorization in the EU or applicable countries outside the EU, careful analysis, planning, and a strategic approach to program design are critical to define a strategy for the RMP. Key decisions include whether routine pharmacovigilance activities and/or risk minimization measures will suffice to ensure a positive risk-benefit balance for the target population without undue burden on internal and external stakeholders or if additional activities and/or measures may be required.

Purposefully identifying the appropriate level of risk detection and minimization is critical to:

  • Appropriate RMP design
  • Effective contingency planning
  • The likelihood of acceptance by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee for Medicinal Products for Human Use (CHMP), or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh), and, ultimately, EMA

What makes the ParagonRx approach to designing an RMP unique?

ParagonRx offers uniquely customized support:

  • Systematic benefit-risk assessment
  • Evidence-based methods that align with EMA’s current thinking and ICH-Q9 methodologies (e.g., ethnographic research, care process mapping, failure mode and effects analysis [RxFMEA®])
  • Proactive contingency planning
  • Unparalleled expertise in design of risk management programs

Our staff has a unique combination of regulatory insight, deep pharmaceutical experience across the product lifecycle, care management, risk management, pharmacovigilance, pharmacy, and clinical expertise. We are highly experienced in creating regulatory documents of varying levels of complexity.