Cargando…
Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches
The European Union’s Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory...
Autores principales: | , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518420/ https://www.ncbi.nlm.nih.gov/pubmed/33411346 http://dx.doi.org/10.1002/cpt.2152 |
_version_ | 1784584218919043072 |
---|---|
author | Rei Bolislis, Winona Bejeuhr, Gesine Benzaghou, Fawzi Corriol‐Rohou, Solange Herrero‐Martinez, Esteban Hildebrand, Heidrun Hill‐Venning, Claire Hoogland, Hans Johnson, Craig Joos, Angelika Vart, Richard Le Visage, Geneviève Kühler, Thomas C. |
author_facet | Rei Bolislis, Winona Bejeuhr, Gesine Benzaghou, Fawzi Corriol‐Rohou, Solange Herrero‐Martinez, Esteban Hildebrand, Heidrun Hill‐Venning, Claire Hoogland, Hans Johnson, Craig Joos, Angelika Vart, Richard Le Visage, Geneviève Kühler, Thomas C. |
author_sort | Rei Bolislis, Winona |
collection | PubMed |
description | The European Union’s Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory framework. This paper therefore describes bottlenecks identified by industry that occur during the medicinal development process, including those relating to the scientific advice process, pediatric investigation plan (PIP) development, compliance checks, and study submissions, and offers some considerations and insights to address these. Considerations, which are workable within the current legislative framework, focus on an integrated scientific discussion, optimization of PIP procedures and compliance checks, and an alignment of study‐reporting requirements. |
format | Online Article Text |
id | pubmed-8518420 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-85184202021-10-21 Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches Rei Bolislis, Winona Bejeuhr, Gesine Benzaghou, Fawzi Corriol‐Rohou, Solange Herrero‐Martinez, Esteban Hildebrand, Heidrun Hill‐Venning, Claire Hoogland, Hans Johnson, Craig Joos, Angelika Vart, Richard Le Visage, Geneviève Kühler, Thomas C. Clin Pharmacol Ther White Papers The European Union’s Pediatric Regulation has strengthened the development of medicines for children in Europe through its system of obligations and rewards. However, opportunities remain to further optimize pediatric medicine developments, notably in relation to the implementation of the regulatory framework. This paper therefore describes bottlenecks identified by industry that occur during the medicinal development process, including those relating to the scientific advice process, pediatric investigation plan (PIP) development, compliance checks, and study submissions, and offers some considerations and insights to address these. Considerations, which are workable within the current legislative framework, focus on an integrated scientific discussion, optimization of PIP procedures and compliance checks, and an alignment of study‐reporting requirements. John Wiley and Sons Inc. 2021-02-02 2021-10 /pmc/articles/PMC8518420/ /pubmed/33411346 http://dx.doi.org/10.1002/cpt.2152 Text en © 2021 Sanofi. Clinical Pharmacology & Therapeutics published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | White Papers Rei Bolislis, Winona Bejeuhr, Gesine Benzaghou, Fawzi Corriol‐Rohou, Solange Herrero‐Martinez, Esteban Hildebrand, Heidrun Hill‐Venning, Claire Hoogland, Hans Johnson, Craig Joos, Angelika Vart, Richard Le Visage, Geneviève Kühler, Thomas C. Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches |
title | Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches |
title_full | Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches |
title_fullStr | Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches |
title_full_unstemmed | Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches |
title_short | Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches |
title_sort | optimizing pediatric medicine developments in the european union through pragmatic approaches |
topic | White Papers |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8518420/ https://www.ncbi.nlm.nih.gov/pubmed/33411346 http://dx.doi.org/10.1002/cpt.2152 |
work_keys_str_mv | AT reibolisliswinona optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT bejeuhrgesine optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT benzaghoufawzi optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT corriolrohousolange optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT herreromartinezesteban optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT hildebrandheidrun optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT hillvenningclaire optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT hooglandhans optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT johnsoncraig optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT joosangelika optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT vartrichard optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT levisagegenevieve optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches AT kuhlerthomasc optimizingpediatricmedicinedevelopmentsintheeuropeanunionthroughpragmaticapproaches |