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The IOM Drug Safety Report: Resource Implications (A Workshop)

Completed

This public workshop provided a venue for stakeholders to explore challenges associated with ensuring a culture of safety and quality in drug review and evaluation. The workshop followed a 2007 IOM report, The Future of Drug Safety: Promoting and Protecting the Health of the Public and evaluated the human and financial resources required to implement key recommendations that were made in this report. The workshop was hosted by the National Academies Forum on Drug Discovery, Development and Translation.

The workshop was held on March 12, 2007. Please visit our event page for additional information and meeting materials for the workshop.

Description

The Institute of Medicine recently released a report, The Future of Drug Safety: Promoting and Protecting the Health of the Public. This report included recommendations for changes in the structure and process of drug review and monitoring at the FDA. The Forum on Drug Discovery, Development, and Translation (the Forum) plans to inform its future meetings through a public workshop that will feature invited presentations and discussions to explore the types and magnitudes of resources that may be required to implement the key recommendations of the report. The one-day workshop, which will be planned and conducted by an ad hoc committee and will include a wide range of speakers with expertise in public finance, information technology, safety science, federal budget analysis, economics, FDA operations, and program management and evaluation.

The Forum provides a convening mechanism for interested parties from the academic, industrial, consumer, and federal research perspectives to meet and discuss issues of mutual interest in a neutral setting. The purpose is to foster dialogue and discussion across sectors and institutions, and to illuminate issues, not resolve them. As part of its charge, the Forum uses workshops to better inform its members.

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