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Regul Toxicol Pharmacol. 2019 Aug;106:187-196. doi: 10.1016/j.yrtph.2019.04.011. Epub 2019 Apr 30.

Bridging communities in the field of nanomedicine.

Author information

1
European Commission Joint Research Centre (JRC), Ispra, Italy.
2
Université Grenoble Alpes, CEA LETI MlNATEC Campus, Grenoble, France.
3
Université de Lorraine, CNRS, CRAN, INRIA BIGS, Nancy, France.
4
CMC External Innovation, Sanofi, Gentilly, France.
5
Université de Genève, Ecole de Pharmacie Genève-Lausanne, Genève, Switzerland.
6
SINTEF Industry, Trondheim, Norway.
7
Swedish Toxicology Sciences Research Center (Swetox), Södertälje, Sweden.
8
National Center for Drug Research and Evaluation, Istituto Superiore di Sanità, Roma, Italy.
9
Nanotechnology Characterization Laboratory (NCL), Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Sponsored By the National Cancer Institute, Frederick, USA.
10
Faculty of Pharmacy and Institute for Bioengineering and Biosciences of the University of Lisbon, Lisboa Portugal.
11
Department of Medicines for Human Use, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.
12
National Institute of Standards and Technology (NIST), Materials Measurement Science Division, Gaithersburg, USA.
13
Swissmedic, Swiss Agency for Therapeutic Products, Bern, Switzerland.
14
Department of Molecular and Clinical Pharmacology, Institute of Translational Medicine, The University of Liverpool, Liverpool, United Kingdom.
15
RIVM- National Institute for Public Health and the Environment, Bilthoven, Netherlands.
16
U.S. Food & Drug Administration (FDA), Nanotechnology Core Facility, Jefferson, USA.
17
European Commission Joint Research Centre (JRC), Geel, Belgium.
18
Empa - Swiss Federal Laboratories for Materials Science and Technology, St. Gallen, Switzerland.
19
BfArM - Federal Institute for Drugs and Medical Devices, Bonn, Germany.
20
European Commission Joint Research Centre (JRC), Ispra, Italy. Electronic address: susanne.bremer-hoffmann@ec.europa.eu.

Abstract

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.

KEYWORDS:

Nanomedicine; critical quality attributes; immune effects; regulatory science; standardization; workshop

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