Risk Management
Risk Management System
Our team is ready to propose the risk management system design, and select an appropriate set of pharmacovigilance activities and risk minimization tools tailored to your product.
Risk Minimization Measures
iVigee may offer our experience with the set-up of the system for the implementation of risk minimization measures from global planning to local approval, implementation, dissemination and tracking.
Risk Minimization Effectiveness
We are ready to provide regular assessments of the effectiveness of implemented risk minimization tools and suggest their adjustments or updates to achieve the optimal risk-benefit balance of the product.
Worldwide Peer review of RMPs and/or REMS
We offer to review your risk management plans and strategies before their submission to the competent authorities and optimize the risk management strategy for the concrete product. This service is focused on multi-national enterprises, given that risk management plans and risk evaluation and mitigation strategies designed for a geographic area can be implemented in various countries.
