Bridging communities in the field of nanomedicine
Halamoda-Kenzaoui, Blanka; Baconnier, Simon; Bastogne, Thierry; Bazile, Didier; Boisseau, Patrick; Borchard, Gerrit; Borgos, Sven Even F.; Calzolai, Luigi; Cederbrant, Karin; Di Felice, Gabriella; Di Francesco, Tiziana; Dobrovolskaia, Marina A.; Gaspar, Rogério; Gracia, Belén; Hackley, Vincent A.; Leyens, Lada; Liptrott, Neill; Park, Margriet; Patri, Anil; Roebben, Gert; Roesslein, Matthias; Thürmer, René; Urbán, Patricia; Zuang, Valérie; Bremer-Hoffmann, Susanne
Journal article, Peer reviewed
Published version
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https://hdl.handle.net/11250/2689352Utgivelsesdato
2019Metadata
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Originalversjon
Regulatory toxicology and pharmacology. 2019, 106 187-196. 10.1016/j.yrtph.2019.04.011Sammendrag
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