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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.

SUBMITTER: Hines PA

PROVIDER: S-EPMC7688530 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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

Hines Philip A PA Guy Richard H RH Brand Angela A Humphreys Anthony J AJ Papaluca-Amati Marisa M

British journal of clinical pharmacology 20191017 12

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 e ...[more]

PMID: 31426120

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Project description:The Lisbon Strategy was adopted by the Heads of State and Government of the European Union (EU) in 2000. By moving science into a central position for the development of a European knowledge-based economy and society, its adoption at political level seems to have been a powerful catalyst for the increased involvement of scientists in science policy in the EU. Recognising the need for scientists to act collectively in order to contribute to shape the future of science policy in Europe, a pioneering group of European science organisations leaders and representatives, as well as other scientists, initiated a European, interdisciplinary, inclusive movement leading to the creation of the European Research Council (ERC) to support basic research of the highest quality. Having scientists' campaign for the funding of bottom-up research by the EU Framework Programmes exclusively on scientific grounds, and for an ERC, was a unique event in the recent history of European science policy. For the first time, the scientific community acted collectively and across disciplinary or national boundaries as a political actor for the sake of a better science policy for Europe. As is often the case when first-hand experience is gained through the creation of a new organization, novel forms of collaboration arise. The European biomedical community has recently proposed the creation of a strategic action plan for health research (the European Council of Health Research; EuCHR), provisionally translated at present into a Scientific Panel for Health (SPH) research in Horizon 2020, the EU's research-funding programme for the period 2014-2020. The creation of such Scientific Panel should be viewed as an important contribution by the biomedical community as a major political agreement has been reached on the need for a comprehensive and long-term scientific strategy to accelerate research and facilitate innovation at EU level. It is our belief that describing and analyzing the process leading to the creation of the ERC and SPH (2002-2014) should be widely shared with the research community in general, as this may contribute to the understanding of the evolving relations between scientists and science-policy making.

Dataset Information

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

Publications

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

Similar Datasets

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