Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model.

ABSTRACT: Regulatory science underpins the objective evaluation of medicinal products. It is therefore imperative that regulatory science and expertise remain at the cutting edge so that innovations of ever-increasing complexity are translated safely and swiftly into effective, high-quality therapies. We undertook a comprehensive examination of the evolution of science and technology impacting on medicinal product evaluation over the next 5-10 years and this horizon-scanning activity was complemented by extensive stakeholder interviews, resulting in a number of significant recommendations. Highlighted in particular was the need for expertise and regulatory science research to fill knowledge gaps in both more fundamental, longer-term research, with respect to technological and product-specific challe

SUBMITTER: Hines PA 

PROVIDER: S-EPMC7688530 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature