Nanomedicines in the EU: Innovative Therapies and Regulatory Needs

Date & Time 7 December 2022 (16:00 – 17:30 CET)
Location Online

On behalf of the European Alliance for Access to Safe Medicines (EAASM),  in its capacity as coordinator of the Nanomedicine Regulatory Coalition, you are kindly invited to join the upcoming free online educational workshop on “Nanomedicines in the EU: innovative therapies and regulatory needs” which will take place on Wednesday 7 December 2022, from 16:00 to 17:30 CET.

Currently, nanotechnology has a wide range of applications, from transport, electronics, and chemical industry to medicine. Since nanoparticles are similar in scale to the size of molecules and biological systems, their use is particularly useful in the biomedical field to address unmet medical needs. The application of nanotechnology for medical purposes has been termed nanomedicine, i.e. the use of nanomaterials for the diagnosis, monitoring, control, prevention and treatment of diseases.

The regulatory framework for nanomedicines presents critical issues that have not been fully resolved, from adopting a definition of nanomedicine that is harmonised at EU level, to developing protocols and common guidelines for the characterisation, evaluation and control of the nanomedicine production process.

In response to these challenges and on the occasion of the forthcoming EU Pharmaceutical Legislation Revision, patient representatives, academics, representatives of the Food and Drug Administration and the European Medicines Agency will gather at an online event on 7 December 2022. The event will raise awareness of the therapeutic benefits of nanomedicines and represent the occasion to present the results of a survey designed to gather knowledge and views of the EU National Regulatory Authorities on nanomedicines and nanosimilars (off patent follow-on medicines).

The event will conclude with a question-and-answer session on how the European Medicines Agency and European legislation can support the development of a competitive EU nanomedicine industry ensuring patient safety.

Learn more and register here.