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Bridging communities in the field of nanomedicine
European Commission Joint Research Centre, Italy.
Université Grenoble Alpes, France.
CNRS Université de Lorraine, France.
CMC External Innovation, France.
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2019 (English)In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 106, p. 187-196, article id S0273-2300(19)30110-2Article in journal (Refereed) Published
Abstract [en]

An early dialogue between nanomedicine developers and regulatory authorities are of utmost importance to anticipate quality and safety requirements for these innovative health products. In order to stimulate interactions between the various communities involved in a translation of nanomedicines to clinical applications, the European Commission's Joint Research Centre hosted a workshop titled "Bridging communities in the field of Nanomedicine" in Ispra/Italy on the 27th -28th September 2017. Experts from regulatory bodies, research institutions and industry came together to discuss the next generation of nanomedicines and their needs to obtain regulatory approval. The workshop participants came up with recommendations highlighting methodological gaps that should be addressed in ongoing projects addressing the regulatory science of nanomedicines. In addition, individual opinions of experts relevant to progress of the regulatory science in the field of nanomedicine were summarised in the format of a survey.

Place, publisher, year, edition, pages
2019. Vol. 106, p. 187-196, article id S0273-2300(19)30110-2
Keywords [en]
Nanomedicine, critical quality attributes, immune effects, regulatory science, standardization, workshop
National Category
Engineering and Technology
Identifiers
URN: urn:nbn:se:ri:diva-39784DOI: 10.1016/j.yrtph.2019.04.011PubMedID: 31051191Scopus ID: 2-s2.0-85065518457OAI: oai:DiVA.org:ri-39784DiVA, id: diva2:1343148
Available from: 2019-08-15 Created: 2019-08-15 Last updated: 2019-08-19Bibliographically approved

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