Bridging communities in the field of nanomedicine.
Fiche publication
Date publication
avril 2019
Journal
Regulatory toxicology and pharmacology : RTP
Auteurs
Membres identifiés du Cancéropôle Est :
Pr BASTOGNE Thierry
Tous les auteurs :
Halamoda-Kenzaoui B, Baconnier S, Bastogne T, Bazile D, Boisseau P, Borchard G, Borgos SE, Calzolai L, Cederbrant K, Di Felice G, Di Francesco T, Dobrovolskaia MA, Gaspar R, Gracia B, Hackley VA, Leyens L, Liptrott N, Park M, Patri A, Roebben G, Roesslein M, Thürmer R, Urbán P, Zuang V, Bremer-Hoffmann S
Lien Pubmed
Résumé
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 Horizon 2020 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.
Mots clés
Nanomedicine, critical quality attributes, immune effects, regulatory science, standardization, workshop
Référence
Regul. Toxicol. Pharmacol.. 2019 Apr 30;: