Georgetown University (GU) Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) Abstract Georgetown University (GU) and the FDA share a long history of collaboration that has been fortified by geographical proximity, collective public health interests, common educational and research pursuits, and mutual accords to work together in advancing the discipline of regulatory science. The recent establishment of the GU Program for Regulatory Science and Medicine (PRSM), the NIH Clinical Translational Science Award (CTSA) to GU and Howard University, and the concerted commitments of the GU Medical Center (GUMC), GU Law Center (GULC) and GU School of Continuing Studies (GU SCS) position us to serve as a Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI). We seek a substantive interface with the FDA to provide and receive education, training, professional development, scientific exchange and applied research that will promote collegiality, innovation and outcomes toward more effective and efficient product development and evaluation. We propose a cooperative FDA-GU organization that values teamwork, learners and teachers, and wide-ranging scientific exchange with parallel programs in (1) education, training, professional growth and (2) research and development (harnessing diverse data through information sciences;new approaches to improving the quality of medical product manufacturing). Innovations include (1) joint scholarship and engagement of well-known GU schools devoted to medicine, law and education, (2) a website and person-to-person efforts to inform about educational and training offerings, facilitate exchange of scientific interests, and track progress, and (3) broad-based Interest Groups operating in a problem-solving mode to address the challenges and barriers facing regulatory science. We also plan to reach out to other CERSIs and our academic colleagues to advance the discipline of regulatory science by organizing scientific forums that provide broad exchange of knowledge, research and education.
We propose to augment existing collaborations between Georgetown University (GU) and the FDA to facilitate education, training, professional development, scientific exchange and applied research that will enhance effective and efficient development and evaluation of medical products. Project innovations include problem- oriented Interest Groups, a joint public-access website, and applied research projects employing information sciences to improve detection of adverse events and systematic legal analysis to improve the safety and quality of the supply chain for manufacturing medical products.
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