Regulatory Science Innovation Centers (CERSIs)
Regulatory science, Regulatory invention, Regulatory research, Regulatory education, public health collaboration, regulatory decision making.
Regulatory science is an emerging discipline that supports evidence-based regulatory decisions for medical products by using innovative tools, standards and scientific approaches. To strengthen research capacity in this area, the United States Food and Drug Administration (FDA) initiated the Centers of Excellence in Regulatory Science and Innovation (CERSI) program in collaboration with academic institutions. The CERSI model encourages cross-disciplinary research, knowledge exchange, and training to address regulatory challenges in drug development, medical devices, biologics and advanced therapies. This review highlights the concept of regulatory science, the evolution of the CERSI network, and the impact of CERSI activities on scientific advancement, education, and public health. The methodology used for evaluation is based on horizon scanning and stakeholder interactions reported in regulatory documents. The outcomes indicate that CERSIs have promoted innovation, developed trained professionals, and contributed to regulatory guidance. The paper also discusses the potential implementation of CERSI-like models in India to build regulatory capacity.
Registration ID: IJVRA_701911 Published ID: IJVRA2603486
"Regulatory Science Innovation Centers (CERSIs) ", IJVRA - International Journal of Versatile Research and Analysis (www.IJVRA.org), ISSN:2984-8903, Vol.4, Issue 3, page no.710-720, March-2026, Available :https://ijpub.org/ijvra/papers/IJVRA2603486.pdf
Paper Reg. ID: IJVRA_701911
Published Paper Id: IJVRA2603486
Research Area: Pharmacy All
Country: Dharashiv , Maharashtra , India
ISSN: 2984-8903 | IMPACT FACTOR: 9.12 Calculated By Google Scholar | ESTD YEAR: 2023
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