Development and Application of a Universal Benefit-risk Assessment Framework for Medicines

Time

Mon, Jun 25 11:00AM
M 08

Title

Development and Application of a Universal Benefit-risk Assessment Framework for Medicines

Abstract Summary

An instrument was developed to explore current BR assessment practices and future plans of major regulatory agencies and pharmaceutical companies. To identify potential barriers, strengths and future challenges following the instrument development, 14 agencies and 24 companies were recruited. From the findings, no agencies or companies currently use a full quantitative system. The ideal framework is likely an overarching framework of a semi-quantitative nature, with the flexibility to incorporate existing assessment methodologies, and capable of optimizing communication. The scope of the framework should cover both agencies and companies, and be applied across the entire life cycle of a product. Common barriers to implementation include resource limitation, the lack of expertise, and the lack of a scientifically validated and accepted framework. Through engaging the stakeholders from agencies and companies, these outcomes confirm the sentiments and the direction for developing a common benefit-risk framework.

Poster Presenter

James Leong
PhD, MPharm,
Head of Education, Centre of Regulatory Excellence, Graduate Medical School ,
Duke NUS
Singapore

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