Knowledge sharing on PPA between EU CAs

Objectives
This WP aims at laying the grounds for a future implementation of the criteria catalogues resulting from WP 6-8, thus allowing for a standardised, electronically supported assessment of quality, safety and efficacy of blood, cells and tissues,
in the case of state-of-the-art processing procedures as well as in the case of innovative processing procedures.

Description of work and role of partners
From a methodological point of view the work will be performed in three blocks:
A) Building on the data models set up in WP 6, 7, 8, these data models will be integrated into a structure that will display the dependencies of 1) preparation methods, preparation steps, in-process controls and related results, 2) testing methods, results and specifications of the final product, 3) clinical outcome data demonstrating efficacy and safety of the product upon application to a patient
B) Building the framework for an electronically supported authorization process based on the integrated data model: Identification and evaluation of checkpoints critical to approval of blood, cells and tissues
C) Development of the concept of a platform to implement A, B. Part A, B and C will be developed in parallel. Part A covers the building on the data models set up in WP 6, 7, 8. The activities will be developed as follows and according to the indicated timeline:
IT security and data privacy concepts, data access concepts (3 months)
Organization and Structure of the electronically usable criteria catalogues and of the platform (3 months)
Architecture design for criteria catalogue and platform based on international standardization efforts and previously derived requirements: architecture model, description of data exchange/integration and security components (e.g. identification and authentication, Authorization, Logging, pseudonymization and anonymisation) (6 months)
Aggregation of the data structures of the data sets on authorised preparation processes, testing methodologies and clinical outcome criteria to a common domain model and specification of data structures and data semantic using existing standards as a technical representation of the domain model (12 month)

Expected Deliverables
D9.1 Integrated data model
D9.2 Framework for an electronically supported authorization process
D9.3 Concept of a platform to implement A, B

WP9 Leader: Paul Ehrlich Institut (PEI), Germany