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Risk Management

Assessing the measures applicable to certain risks is mandatory in every PV system. iVigee is experienced with balanced risk management, defining product safety, and addressing gaps with further studies and risk minimization measures.

Design, Piloting and Testing of Risk Management Systems

We can design a pilot risk management programme for you, measure its effectiveness at a reduced scale, and ultimately expand the measures efficiently.

Risk Minimisation Tools

Which combination of tools are best for your organization? Combining different risk minimisation tools can be a powerful action.

Measurement of Risk Minimisation Effectiveness

Proper evaluations of the effectiveness of risk minimisation measures provide a valuable data source to be shared in audits or inspections.

Implementation of Risk Minimisation Plans

Challenges with implementing your Risk Minimisation Plans? Our tools help with the chronology and follow-up of risk minimisation plan execution. Our RMP expertise is designed to assist your organization at both the central and local country affiliate level with RMP implementation.

Worldwide Peer review of RMPs and/or REMS

Reviews of your documentation before or even during their implementation help mitigate compliance issues. 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 countries with similar regulatory requirements.

Signal and Risk Management

Signal management is the fundamental component of pharmacovigilance and a designated critical process.

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Risk Management

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