Risk Management, RMPs, and REMS

Program Management Oversight of Risk Management Operations

When do I need program management oversight of risk management operations?

In anticipation of regulatory approval for a Risk Evaluation and Mitigation Strategy (REMS), companies should be prepared to immediately implement and manage daily operations of the program.

What is program management oversight of risk management operations?

Coordination of activities across multiple departments/disciplines, and possibly multiple external vendors, requires diligent oversight to ensure compliance with the REMS requirements. The complexity of the risk management approach impacts the complexity of implementation, operation, management, and assessment, which in turn defines the scope and nature of the coordination activities.

What makes the ParagonRx approach to program management oversight of risk management operations unique?

ParagonRx is uniquely qualified to coordinate your REMS operations, regardless of their complexity. Our extensive experience includes:
  • Design, management, and/or assessment of >100 risk management programs
  • Ability to rapidly access the supplemental resources of inVentiv Health, if needed
  • Coordinating activities across multiple departments/disciplines and external vendors
  • Providing strategic and tactical guidance to the risk management team
  • Systematic mapping of all processes
  • Supporting pre-launch preparations
  • Managing implementation readiness
  • Ongoing operational support
  • Conducting post-launch implementation audits