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Enhancing the Regulatory Science of Drug Development: A Workshop

Completed

The National Academies Forum on Drug Discovery, Development, and Translation convened this public workshop to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. The workshop provided an opportunity to explore the concept of regulatory science, examine how it can be used to improve regulatory decision making, and consider alternative mechanisms and institutional frameworks for its development and application.

Description

An ad hoc committee of Drug Forum members will plan and host a public workshop which examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. Individuals from the federal government, pharmaceutical industry, academia, industry, and patient groups will be invited to make presentations and discuss different perspectives on the strengths and weaknesses of the current regulatory science framework. They will also consider strategies for improving regulatory science, which may include: fostering a scientific discipline of regulatory science; promoting closer collaboration between of regulatory and academic researchers; and developing a multi-sectoral infrastructure for regulatory science, which may include regulatory science centers of excellence, innovative federal grant-making mechanisms, and professional development strategies. A summary of the workshop will be prepared in accordance with institutional policy and procedures.

Collaborators

Sponsors

Department of Health and Human Services

Private: For Profit

Private: Non Profit

Staff

Robert Giffin

Lead

Carolyn Shore

Lead

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