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

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
JournalBritish Journal of Clinical Pharmacology
DOIs
Publication statusAccepted/In press - 01-01-2019

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All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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