Work package 1

Scientific, administrative, and financial management

Lead: Klinikum Nürnberg, Prof. Dr. med. Christoph Fusch

Scientific coordination, resource allocation and budgeting, financial and scientific reporting

1.1 Project management
Management Board, Steering Committee, General Assembly, and External Advisory Boards will be established. The project coordinator (PC) assists WP leaders in controlling and reporting, with attention to resource allocation and budget spending. The PC collects and prepares the periodic financial report and submits reports to the EC: PC leads the Management Board (MB), composed of the WP leaders. The MB ensures timely and effective WP execution, suggests corrective actions to address issues, oversees fulfilment of the technical requirements and leads the Management Board (MB), composed of the members of the consortium. MB oversees project strategy, key decisions, operations, and the commercialisation strategy. Project meetings including kick-off meetings, general assembly meetings, annual meetings, and other ad hoc meetings will be organised. Dates/times of monthly conference calls of the general assembly will be organised, dates/venues for annual face-to-face consortium meetings will be decided one year in advance. Periodic risk analysis and decisions on mitigation actions will be undertaken.

1.2 Definition of specifications and interfaces
To comply with the complex specifications of a combined extra-corporeal lung/renal support for neonates, requirements for the ArtPlac system (incl. LRAD, cannulas, tubing, sensors), their interfaces (to patients, for clinical procedures), the needs and constraints in combining extracorporeal lung & renal support in one pumpless device as the central part of the artificial placenta (WP3, WP4) and the resulting changes in the treatment of neonates will be outlined and a clinical treatment guideline developed.

1.3 Product Failure Mode and Effects Analysis (FMEA)
For translation of the ArtPlac system into clinical application after the project, the product failure modes and their effects will be assessed early in the development process to avoid foreseeable design and usability mistakes.

1.4 Regulatory (documentation, test plans, etc.)
Documentation and testing according to international standards and regulations in all project phases to avoid delays in future approval and commercialisation.

1.5 Research ethics board application for animal testing
Drafting and submitting the application for ethical board approval of animal testing along with WP leader.

All Workpackages

ArtPlac

ArtPlac is a preclinical research project dedicated to develop an innovative technology of medical treatments for neonatal intensive care.

funded-by-the-eu

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union. Neither the European Union nor the granting authority can be held responsible for them.