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Finland) and the Registo Português de Transplantação on Donation, Procurement, Transplant and
Follow up of Organs, Tissues and Cells (RPT, Portugal). According to the evaluation conducted it

was concluded that (i) registries collect the most relevant clinical indicators defined by clinicians
and experts of the sector in question; (ii) at present time only EBMT and ECCTR hold individual
patients’ data, whereas other SoHO sectors do not have such detailed data; (iii) objectives of the
registries are to promote scientific knowledge and to assess the efficacy of the different therapies 7
amongst the stakeholders; (iv) there are some limitations for regulatory purposes (e.g. level of
detail and completeness of data for different BTCs); (v) Tissue & Cell registries are considered
valuable and useful for the future development of the work foreseen by the WP8.

Deliverable 8.2. Defining a risk-based set of criteria to assess whether the current clinical data fit
to a new processing or testing protocols for Blood, Tissues and Cells therapeutics is undergoing

the evaluation of the EAB and after collecting their feedback will be submitted on the participant
portal for EC evaluation.

Deliverable D8.3 (Methodological framework to evaluate quality and safety of human Blood, Cell,
and Tissue therapeutics based on clinical outcome data requested for authorisation processes
upon introduction of innovation to the current processing and testing protocols) will be prepared
and the work divided in Expert groups. Next WP8 meeting was scheduled for Feb 5th 2020 in
Brussels.

Deliverable D8.4 (Data model of information on clinical outcome of application of human Blood,
Cell, and Tissue therapeutics) will be prepared mostly in co-operation with WP9 leader Paul-
Ehrlich-Institut, DE but also with WP5, 6 and 7.

WP 9 - Knowledge sharing on PPA between EU CAs (Winfried

Kammer, PEI, Germany)

WP9 will develop the knowledge sharing database. The tool will support the complete
assessment of PPA by providing/sharing information and increasing efficiency.

The main expectation of the tool will be: 1) Supporting assessors; 2) Harmonization and
Standardization (by use); 3) Balancing benefit and risk; 4) Supporting assessment of novel PPA;
5) Direct assessment information; 6) Assessment algorithms and matrices (to be discussed); 7)
Data from application; 8) Clinical outcome data (prepared); 9) Kind of a tool box?; 10) Data
sharing platform; 11) Knowledge sharing platform; 12) User-friendliness; 13) Ergonomic
software; 14) Flexibility / Adaptability.

This report is part of the project/joint action ‘785269/GAPP’ which has received funding from the European Union’s Health Programme (2014-2020). The content of this report represents the views of
the author only and is his/her sole responsibility; it can not be considered to reflect the views of the European Commission and/or the Consumers, Health, Agriculture and Food Executive Agency or any
other body of the European Union. The European Commission and the Agency do not accept any responsibility for use that may be made of the information it contains.
GAPP JA | Deliverable 0.0