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

Authors :
Hines, Philip A.
Guy, Richard H.
Brand, Angela
Humphreys, Anthony J.
Papaluca‐Amati, Marisa
Source :
British Journal of Clinical Pharmacology; Dec2020, Vol. 86 Issue 12, p2530-2534, 5p
Publication Year :
2020

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 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. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
03065251
Volume :
86
Issue :
12
Database :
Complementary Index
Journal :
British Journal of Clinical Pharmacology
Publication Type :
Academic Journal
Accession number :
147223374
Full Text :
https://doi.org/10.1111/bcp.14099