TY - JOUR
T1 - Regulatory Science to 2025
T2 - An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy
AU - Hines, Philip A.
AU - Gonzalez-Quevedo, Rosa
AU - Lambert, Apolline I. O. M.
AU - Janssens, Rosanne
AU - Freischem, Barbara
AU - Edo, Jordi Torren
AU - Claassen, Ivo J. T. M.
AU - Humphreys, Anthony J.
N1 - Funding Information:
The authors and the European Medicines Agency wish to thank all the stakeholders who have participated in this research. Special thanks also go to our colleague Laetitia Kpenou for her tireless support and to Paul Blake, Nathalie Bere, and Maria Mavris.
Publisher Copyright:
© Copyright © 2020 Hines, Gonzalez-Quevedo, Lambert, Janssens, Freischem, Torren Edo, Claassen and Humphreys.
PY - 2020/9/23
Y1 - 2020/9/23
N2 - 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 itsRegulatory Science Strategy to 2025and 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.
AB - 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 itsRegulatory Science Strategy to 2025and 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.
KW - regulatory science
KW - regulation
KW - innovation
KW - stakeholder engagement
KW - patient access
KW - benefit-risk assessment
U2 - 10.3389/fmed.2020.00508
DO - 10.3389/fmed.2020.00508
M3 - Article
C2 - 33072771
SN - 2296-858X
VL - 7
JO - Frontiers in medicine
JF - Frontiers in medicine
M1 - 508
ER -