Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: Workshop Summary


Note: Proceedings contain the opinion of the presenters, but do NOT reflect the conclusions of the Health and Medicine Division or the National Academies. Learn more about the differences between Reports and Proceedings.

The field of endeavors known as "regulatory science" has grown out of the need to link and integrate knowledge within and among basic science research, clinical medicine, and other specific scientific disciplines whose focus, aggregation, and ultimate implementation could inform biomedical product development and regulatory decision making. On October 20–21, 2015, the Forum on Drug Discovery, Development, and Translation held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory sciences, opportunities to address barriers to the discipline's success, and avenues for fostering collaboration across sectors. The workshop, co-sponsored by the Burroughs Wellcome Fund, also held panels that explored key needs for strengthening the discipline of regulatory science, including considering what are the core components of regulatory science infrastructure to foster innovation in medical product development. To focus the workshop discussions, the planning committee adopted the theme of innovation in regulatory science through integration of information. This report is a summary of the workshop. 

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