Regulatory innovation

• Gül Erdemli, Margarita Grammatikopoulou, Bertil Wagner, Srinivasan Vairavan, Jelena Curcic, Dag Aarsland, Gayle Wittenberg, Spiros Nikolopoulos, Marijn Muurling, Holger Froehlich, Casper de Boer, Niraj M. Shanbhag, Vera J. M. Nies, Neva Coello, Dianne Gove, Ana Diaz, Suzanne Foy, Wim Dartee & Anna-Katharine Brem. Regulatory considerations for developing remote measurement technologies for Alzheimer’s disease research. NPJ | Digital Medicine. DOI: 0.1038/s41746-024-01211-8 (2024)
• A.M.G. Pasmooij, P.G.M. Mol, J.C. Bot, H.G.M. Leufkens. The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report - Pasmooij - Clinical Pharmacology & Therapeutics - Wiley Online Library (2024).
• Renske M.T. ten Ham, Anke M. Hövels, Olaf H. Klungel, Hubert G.M. Leufkens, Andre W. Broekmans, and Jarno Hoekman. Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection. Trends in Pharmacological Sciences, Volume 41, Issue 2, 67-71. (2020)
• Christine C. Gispen‐de Wied, Just Weemers, Wouter Boon, Peter G.M. Mol, Pieter Stolk. Future of the drug label: Perspectives from a multistakeholder dialogue. BJCP. (2019)
• Klein K., Scholl J.H.G., De Bruin M.L., Van Puijenbroek E.P., Leufkens H.G.M., Stolk P. When More Is Less: An Exploratory Study of the Precautionary Reporting Bias and Its Impact on Safety Signal Detection. Clin Pharmacol Ther. (2017)
• Hussaarts L., Mühlebach S., Shah VP., McNeil S., Borchard G., Flühmann B., Weinstein V., Neervannan S., Griffiths E., Jiang W., Wolff-Holz E., Crommelin DJA., de Vlieger JSB. Equivalence of complex drug products: advances in and challenges for current regulatory frameworks. Ann N Y Acad Sci Apr 26. [Epub ahead of print] (2017)
• ​​Klein, K., Scholl, J.H., Vermeer, N.S., Broekmans, A.W., Van Puijenbroek, E.P., De Bruin, M.L., Stolk, P. Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Safety 39, 185-192. (2016)
• Crommelin, D. J., & de Vlieger, J. S. (Eds.). Non-biological complex drugs: the science and the regulatory landscape 20. Springer. (2015) 
• Klein, K., De Bruin, M.L., Broekmans, A.W., Stolk, P. Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers. BioDrugs 29, 373-379. (2015)
• Schellekens, H., Stegemann, S., Weinstein, V., de Vlieger, J. S., Flühmann, B., Mühlebach, S., & Crommelin, D. J. How to regulate nonbiological complex drugs (NBCD) and their follow-on versions: points to consider. The AAPS journal 16, 15-21. (2014)
• Escher. Improving the EU system for the marketing authorization of medicines -  Learning from regulatory practice. Leiden: Escher – The TI Pharma Platform for Regulatory Innovation. (2014) [PDF file]

A full list of publications on non-biological complex drugs co-authored by our team can be found here.