Advancing the Discipline of Regulatory Science for Medical Product Development An Update on Progress and a Forward-Looking Agenda: Workshop Summary (2016) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-4
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defines regulatory science as "the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public health impact, or performance of FDA-regulated products."2 Substantial efforts have been devoted to defining regulatory science and communicating its value and role across the scientific and regulatory ecosystems. Investments are also being made in technology infrastructure, regulatory systems, and workforce development to support and advance this burgeoning discipline.
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On October 20–21, 2015, the Forum held a public workshop to facilitate dialogue among stakeholders about the current state and scope of regulatory science, 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, held discussion 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.
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Subject-matter experts will be invited to discuss key needs for further es tablishing and strengthening the discipline, and to explore priorities and potential opportunities for collaboration to address those needs. The workshop will include consideration of the core components of the regulatory science infrastructure that include the workforce, process, and systems in the public and private sec tors needed to foster innovation in medical product development and evaluation methodologies, with attention to the entire product development life cycle.
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The four case studies were as follows: o Identification and Development of Meaningful Biomarkers o Integrating Clinical Trial Data o Next-Generation Surveillance o Innovative Modeling for Integrating Data • Chapter 4 describes needs for regulatory science infrastructure and workforce. • Chapter 5 summarizes challenges, opportunities, and key focus areas for advancing regulatory science offered by individual work shop participants.
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