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A main Deliverable of the WP is a Catalogue of existing clinical data appropriate to provide

WP8 information on the quality and safety of human blood, cell, and tissue therapeutics once
applied to patients, under the conditions of current state-of-the-art processing and testing
protocols. The Deliverable has been finalized.
Another Deliverable of this WP is a catalogue of risk-based set of criteria, appropriate to
evaluate the established catalogue of clinical data for completeness and suitability in case of
introduction of innovation to the current processing and testing protocols for human blood,
cell, and tissue therapeutics. This Deliverable is currently being drafted by the WP8 leaders.
Finally, the structure of a third Deliverable of this WP has been drafted and two subgroups
of invited experts and collaborating beneficiaries will start working on that. This Deliverable
concerns 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 for human
blood, cell, and tissue therapeutics.

KNOWLEDGE SHARING ON PPA BETWEEN EU CAS
WP9 WP Leader: PEI, Germany
Started in May 2019, the WP9 aims at laying the grounds for a future implementation of the
criteria catalogues resulting from WP6 WP7 and WP8, 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. A platform will be generated that will contain all the relevant
information like a kind of guidance.
It will include knowledge sharing content including a teaching part and an access to Member
State assessments.

TRAINING COURSES AND MANUAL FOR TRAINING

WP10 WP Leader: KCBTiK/NCTCB, Poland
The work of WP10 is strictly connected to the final results of the WP5, WP6, WP7, WP8 and
WP9. On the basis of agreed documents: “Overall Guidance on organization of PPA system”
and technical annexes, this WP will organise training courses and prepare “Manual for
training CA inspectors that assess and authorize preparation processes of tissue, cell, and
blood products”, to disseminate the approach throughout Member States.

10 GAPP - Newsletter2