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 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.

journal_name

Br J Clin Pharmacol

authors

Hines PA,Guy RH,Brand A,Humphreys AJ,Papaluca-Amati M

doi

10.1111/bcp.14099

subject

Has Abstract

pub_date

2020-12-01 00:00:00

pages

2530-2534

issue

12

eissn

0306-5251

issn

1365-2125

journal_volume

86

pub_type

杂志文章
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