Pflegeschulungen für Angehörige mit Migrationshintergrund und Kompetenzbildungen für professionell Pflegende

Background

The proportion of people in need of care with a migration background and therefore the demand for qualified nursing staff will increase. So far, however, considerations and concepts aiming to improve the care situation (including cultural sensitivity) for people in need of care with a migration background are lacking.

Objective

The following questions are addressed on the basis of care training for relatives with migration background and competence development for health care professionals: What content should the care training/competence development take into account? What are the limits regarding planning and implementation, and what are the suggestions for improvements?

Materials and methods

The development of care training and competence development was based on a needs and resources assessment (in the form of a systematic literature review, an expert workshop, semistructured interviews with relatives with migration background who are providing nursing care). A training manual that has been published includes research results and findings and is applicable to other target groups and settings.

Results and discussion

A transcultural training manual was developed and tested for use in outpatient care. It consists of two parts: training for relatives providing nursing care and competency training for health care specialists. It enables the planning, preparation, and implementation of training courses and includes theoretical background knowledge, practical exercises, and didactic advice. When using the manual, however, the target group should be planned at an early stage and individual needs and resources of course participants should be taken into account.

     

Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective

Purpose

This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been genetically modified, or not, or expanded ex vivo, and applied systemically or to an anatomical site different to that of their origin; comments applicable to one product may not be applicable to others, so bespoke development is needed, for all elements - quality, preclinical and clinical.

Methods

After establishing how the product is produced, proof of potential for therapeutic efficacy, and then safety, of the product need to be determined. This includes understanding biodistribution, persistence and toxicity, including potential for malignant transformation. These elements need to be considered in the context of the intended clinical development.

Results

This article describes regulatory mechanisms available to developers to support product development that aim to resolve scientific issues prior to marketing authorization application, to enable patients to have faster access to the product than would otherwise be the case.

Conclusions

Developers are encouraged to be aware of both the scientific issues and regulatory mechanisms to ensure patients can be supplied with these products.