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Posts Taged in-vitro-diagnostic

New Webinar: Introduction to regulatory aspects of in vitro diagnostic (IVD) medical devices

On November 25th, CIBER-BBN organized a new webinar on regulatory aspects of in vitro diagnistic (IVD) medical devices.

The European Parliament, in 2016, approved the new regulations that redefined the development of In Vitro Diagnostic (IVD) methods, with the aim of providing a framework of greater safety and transparency for patients, and at the same time renewing the regulations in force in that moment.

This conference is aimed at researchers from the Academy, or any professional interested in clarifying the most important changes in regulations for the development of IVD products. We will have the participation of experts from the national competent authority, and several companies that will explain their experience to bring this type of product to market. Among them: Ramón Martínez Máñez Scientific Director of NANBIOSIS Unit 26 NMR: Biomedical Applications II and Laura Lechuga, Scientific Director of U4 Biodeposition and Biodetection Unit

Registration and program here.

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OITBs OPEN CALL TO FIGHT COVID19 – SafeNMT OITB project

JOINT OITBS OPEN CALL TO FIGHT COVID 19

SAFE-N-MEDTECH OITB project in which CIBER-BBN is a partner througth its ICTS NANBIOSIS, gathers expertise from 28 partners around the World focused in enabling the safe translation of nano-enabled medical technologies from Proof of Concept to markets and clinical practice. The sudden COVID-19 outbreak has meant an unforeseen challenge that requires rapid answers from the Science, Technology and Innovation Community. These is a framework where SafeNMT could deploy all its potential: first, because nanotechnology is a Key Enabling Technology that can contribute to innovative approaches to fight COVID 19 and/or other viral pandemics. Second, because the integration of capabilities in SafeNMT should be a key driver to integrate, accelerate and translate nanotechnology innovations from TRLs 4-5 to TRLs 6-7.

In this context, and in the frame of the Joint OITBs Open Call to fight COVID 19, we aim in opening our services, at no cost, for selected proposals which accomplish the following conditions:

  • Innovations for prevention, diagnostic and/or therapy for COVID 19 based on the use of nanotechnology applied to Medical Devices and In Vitro Diagnostic
  • The expressions of interest should present a solid S&T background and a sufficient technological maturity (starting TRLs 4-5)
  • A clear development pathway, with an initial identification of product needs is encouraged

What we offer (non-exhaustive list, to be agreed with the selected expressions of interest – Consult the services in our catalogue):

  • First evaluation of the project/product based on Health Technology Assessment (HTA) and Healthcare system needs provided by our pool of experts
  • Technology scanning to identify redundancies/synergies
  • Nanomaterial characterization
  • In vitro preclinical research
  • Access to clinical samples and Biobanks
  • Assistance in prototyping and qualification of manufacturing facilities
  • Regulatory advice and support in the adapted European regulation for COVID 19 medical technologies
  • Links to clinical networks
  • Business development coaching, links with business angels, investors, capital risk, etc.

Typically, the project will cover costs related to activities mentioned above, according to the budget limits available. If outstanding expenses beyond the available budget are needed, these will need to be covered by the user. The project won’t be able to cover formal regulatory costs, production costs, clinical development costs or any external costs that might be needed for the testing and production of the nano-enabled Medical Technology/ies.
Please note that all information provided will be treated confidential and is stored only for the purpose of this call.

Submission deadline: October 2nd, 2020, 5:00 p.m. CET.

Applicants will be informed about the outcome of their application in mid October. Activities are envisaged to start beginning of November.
APPLY HERE!

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