Regulatory Science and Innovation Programme for Europe (ReScIPE)

A proposed model

Philip A. Hines, Richard H. Guy, Angela Brand, Anthony J. Humphreys, Marisa Papaluca-Amati

Research output: Contribution to journalArticle

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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.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalBritish Journal Of Clinical Pharmacology
Early online date19 Aug 2019
DOIs
Publication statusE-pub ahead of print - 19 Aug 2019

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Regulatory Science and Innovation Programme for Europe (ReScIPE) : A proposed model. / Hines, Philip A.; Guy, Richard H.; Brand, Angela; Humphreys, Anthony J.; Papaluca-Amati, Marisa.

In: British Journal Of Clinical Pharmacology, 19.08.2019, p. 1-6.

Research output: Contribution to journalArticle

Hines, Philip A. ; Guy, Richard H. ; Brand, Angela ; Humphreys, Anthony J. ; Papaluca-Amati, Marisa. / Regulatory Science and Innovation Programme for Europe (ReScIPE) : A proposed model. In: British Journal Of Clinical Pharmacology. 2019 ; pp. 1-6.
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