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Abstract:
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In the current climate of heightened expectation from consumers, legislative bodies and other stakeholders, there is a need to improve pre-marketing risk assessment. Risk evaluation must be systematically considered throughout the lifecycle of a product. This presentation will discuss two new ideas. The first is the Pre-approval Risk Identification Model (PRIM), which aims to streamline safety evaluation throughout the life-cycle to meet regulatory requirements for good safety assessment which forms the basis for good risk management. The second is the Safety Analysis Plan, presented as a tool for documenting the risk identification processes and analytical framework for regulatory submissions, data analysis and presentation. A case study will be presented.
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