Benefiaciry: NMI Natural and Medical Sciences Institute at the University of Tübingen
Funding: 01.04.2018 -31.03.2020; 249.978 Euro

Project Description

Progress in medicine hinges on a constant inflow of innovative ideas from the surrounding academic community. In developing test systems for use in preclinical research or clinical development, it is imperative to place a strong focus on high quality from the very beginning, given that these products will be used on patients and will therefore need a marketing authorisation.

However, many academic researchers are completely unfamiliar with the world of quality management and the standards of Good Clinical Practice (GCP), which are an essential requirement that must be met to obtain marketing authorisation. Therefore, they have little experience in this area when they found a company and need assistance.

To make technology transfer more efficient, as is politically and economically desirable, we have set up a programme named “Q4Q – Qualification for Quality”. The aim of this programme is to make compliance with regulatory requirements a manageable task for starting entrepreneurs. The programme provides an opportunity to expand their competences to include quality management issues to help them take the relevant quality guidelines into account at an early stage of their planning.

As a first step, we train and coach scientific staff of our Institute to introduce them to the field of quality management. Based on the findings gained from this first stage, and drawing on the well-founded knowledge available in the development of test systems, we develop a guideline describing the approach to building a QM system and explaining the regulatory framework.

At later stages of the project, the content of the guideline will be communicated to aspiring entrepreneurs and/or start-ups to disseminate the knowledge gained.