Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy
The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draf...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2020-09-01
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| Series: | Frontiers in Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/article/10.3389/fmed.2020.00508/full |
| _version_ | 1818846460961095680 |
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| author | Philip A. Hines Philip A. Hines Rosa Gonzalez-Quevedo Apolline I. O. M. Lambert Rosanne Janssens Rosanne Janssens Barbara Freischem Jordi Torren Edo Ivo J. T. M. Claassen Anthony J. Humphreys |
| author_facet | Philip A. Hines Philip A. Hines Rosa Gonzalez-Quevedo Apolline I. O. M. Lambert Rosanne Janssens Rosanne Janssens Barbara Freischem Jordi Torren Edo Ivo J. T. M. Claassen Anthony J. Humphreys |
| author_sort | Philip A. Hines |
| collection | DOAJ |
| description | The pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft its Regulatory Science Strategy to 2025 and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines. |
| first_indexed | 2024-12-19T05:45:55Z |
| format | Article |
| id | doaj.art-1ae4b2be23554e22b52267258989fafa |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-12-19T05:45:55Z |
| publishDate | 2020-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-1ae4b2be23554e22b52267258989fafa2022-12-21T20:33:51ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2020-09-01710.3389/fmed.2020.00508575105Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's StrategyPhilip A. Hines0Philip A. Hines1Rosa Gonzalez-Quevedo2Apolline I. O. M. Lambert3Rosanne Janssens4Rosanne Janssens5Barbara Freischem6Jordi Torren Edo7Ivo J. T. M. Claassen8Anthony J. Humphreys9European Medicines Agency, Amsterdam, NetherlandsUnited Nations University—Maastricht Economic and Social Research Institute on Innovation & Technology (UNU-MERIT), Maastricht University, Maastricht, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsClinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, BelgiumEuropean Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsEuropean Medicines Agency, Amsterdam, NetherlandsThe pace of innovation is accelerating, and so medicines regulators need to actively innovate regulatory science to protect human and animal health. This requires consideration and consultation across all stakeholder groups. To this end, the European Medicines Agency worked with stakeholders to draft its Regulatory Science Strategy to 2025 and launched it for public consultation. The responses to this consultation were analyzed qualitatively, using framework analysis and quantitatively, to derive stakeholders' aggregate scores for the proposed recommendations. This paper provides a comprehensive resource of stakeholder positions on key regulatory science topics of the coming 5 years. These stakeholder positions have implications for the development and regulatory approval of both human and veterinary medicines.https://www.frontiersin.org/article/10.3389/fmed.2020.00508/fullregulatory scienceregulationinnovationstakeholder engagementpatient accessbenefit-risk assessment |
| spellingShingle | Philip A. Hines Philip A. Hines Rosa Gonzalez-Quevedo Apolline I. O. M. Lambert Rosanne Janssens Rosanne Janssens Barbara Freischem Jordi Torren Edo Ivo J. T. M. Claassen Anthony J. Humphreys Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy Frontiers in Medicine regulatory science regulation innovation stakeholder engagement patient access benefit-risk assessment |
| title | Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy |
| title_full | Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy |
| title_fullStr | Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy |
| title_full_unstemmed | Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy |
| title_short | Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy |
| title_sort | regulatory science to 2025 an analysis of stakeholder responses to the european medicines agency s strategy |
| topic | regulatory science regulation innovation stakeholder engagement patient access benefit-risk assessment |
| url | https://www.frontiersin.org/article/10.3389/fmed.2020.00508/full |
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