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Regulatory Science and Innovation Programme for Europe (ReScIPE): A proposed model
Author(s) -
Hines Philip A.,
Guy Richard H.,
Brand Angela,
Humphreys Anthony J.,
PapalucaAmati Marisa
Publication year - 2020
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1111/bcp.14099
Subject(s) - regulatory science , agency (philosophy) , stakeholder , business , product (mathematics) , quality (philosophy) , regulatory agency , science policy , knowledge management , computer science , political science , medicine , public relations , sociology , public administration , social science , philosophy , geometry , mathematics , epistemology , pathology
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 challenges. A model is proposed to realise these objectives in Europe, comprising a synergistic relationship between the European Medicines Agency, the European Medicines Regulatory Network and academic research centres to establish a novel regulatory science and innovation platform.