Personal profile
Link to Utrecht University staff page
Expertise related to UN Sustainable Development Goals
In 2015, UN member states agreed to 17 global Sustainable Development Goals (SDGs) to end poverty, protect the planet and ensure prosperity for all. This person’s work contributes towards the following SDG(s):
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SDG 1 No Poverty -
SDG 3 Good Health and Well-being -
SDG 8 Decent Work and Economic Growth -
SDG 9 Industry, Innovation, and Infrastructure -
SDG 13 Climate Action -
SDG 14 Life Below Water
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Publication network from the last five years
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Safety population size and duration of exposure prior to approval of new medicines: A database analysis of medicines centralised approved in the European Union between 2011 and 2023
Bouwman, L., Leufkens, H., Sepodes, B. & Torre, C., 9 Feb 2026, In: PloS one. 21, 2, e0342698.Research output: Contribution to journal › Article › Academic › peer-review
Open AccessFile -
Through the lens of marketing authorization holders: experience in use of real-world data and real-world evidence in drug development and regulatory submissions in EU
Eskola, S. M., Gigov, A., Leufkens, H. G. M., Bate, A., De Bruin, M. L. & Gardarsdottir, H., 4 Feb 2026, (E-pub ahead of print) In: British Journal of Clinical Pharmacology.Research output: Contribution to journal › Article › Academic › peer-review
Open Access -
A new European platform for advancing regulatory science research
Barbier, L., Moscariello, P., Leufkens, H. G., Herold, R. & Pasmooij, A. M. G., Jul 2025, In: Nature Reviews Drug Discovery. 24, 7, p. 485-486 2 p.Research output: Contribution to journal › Comment/Letter to the editor › Academic › peer-review
Open AccessFile -
Challenges and opportunities of adding CFTR modulators for cystic fibrosis to the WHO essential medicines list
Costa, E., van den Ham, H. A. & Leufkens, H. G. M., Sept 2025, In: Journal of Cystic Fibrosis. 24, 5, p. 920-922 3 p.Research output: Contribution to journal › Article › Academic › peer-review
Open AccessFile -
Differential times of submission and approval of CFTR modulators for the treatment of Cystic Fibrosis in the United States and the European Union
Costa, E., Girotti, S., Mathieu, C., Castellani, C., Ross, J. S., Taylor-Cousar, J. L. & Leufkens, H. G. M., Jan 2025, In: Journal of Cystic Fibrosis. 24, 1, p. 125-132 8 p.Research output: Contribution to journal › Article › Academic › peer-review
Open AccessFile
Activities
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Drivers of Safety Related Regulatory Actions
Leufkens, B. (Invited speaker)
4 Oct 2010Activity: Talk or presentation › Invited talk › Popular
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The Impact of Periodic Safety Update Reporting on Safety-Related Regulatory Actions
Leufkens, B. (Invited speaker)
7 Jan 2010Activity: Talk or presentation › Invited talk › Academic
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Determinants of Safety Related Regulatory Actions of Biopharmaceuticals
Leufkens, B. (Invited speaker)
3 Nov 2010Activity: Talk or presentation › Invited talk › Academic
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The contribution of Periodic Safety Update Reporting on Safety-Related Regulatory Actions
Leufkens, B. (Invited speaker)
15 Apr 2010Activity: Talk or presentation › Invited talk › Academic
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Presentationa at Braunschweig conference: Drugs, Living things and the problems of Standardization
Leufkens, B. (Invited speaker)
25 Mar 2010Activity: Talk or presentation › Invited talk › Academic