Page 16 - newsletter3GAPP

KNOWLEDGE SHARING ON PPA BETWEEN EU CAS
WP9 WP Leader: PEI, Germany

WP9 designs a concept and a demonstrator for an online platform. The online platform is developed
to support a complete preparation process authorization (PPA) for blood, tissues and cells (BTC). This
comprises application for PPA by blood/tissue establishments and assessment of PPA application by
national competent authorities. The online platform will further serve for knowledge sharing of data
on PPA procedures. This includes information on national authorization procedures and national/
international requirements and recommendations. WP9 subcontractor, Fraunhofer Institute for
Software and Systems Engineering, is in charge of programming the demonstrator.

As a first step, WP9 created a data model illustrating how the information from WP6, WP7 and
WP8 will be integrated into the online platform. The finalized data model is already submitted as
Deliverable 9.1. Secondly, WP9 started developing a preparation process dossier (PPD) by adapting
the Common Technical Document format for BTC. The PPD, as a framework and template for PPA
application, will be the core of the online platform and Deliverable 9.2. Finally, in Deliverable 9.3, WP9
will combine Deliverables 9.1 and 9.2 and provide a concept for the online platform. Functionalities,
such as authorisation (i. e. benefit-risk analysis) and a description of how the online platform and
templates for PPA application will be adapted and updated, will be addressed in Deliverable 9.3.

TRAINING COURSES AND MANUAL FOR TRAINING
WP10 WP Leader: KCBTiK/NCTCB, Poland

On the basis of agreed documents: “Overall Guidance on organization of PPA system” and
technical annexes, this WP will organize two e-learning training courses (ECTs credit) and prepare
the “Manual for training CA inspectors that assess and authorize preparation processes of tissue,
cell, and blood products”, to disseminate the approach throughout Member States.
Training courses will be organized remotely open to all Member States countries, as well as to
Serbia and Moldova.
On Sept. 24, 2020 during the first WP10 telco with the WP Leaders it was discussed the general
design of the course and participation/role of each partner
Within mid-November, 2020 WP10 Leader and Coordinators will share:

• Announcement of the course with main objectives, number of participants, participant
selection criteria, number of ECTS
• Draft programme of the course with topics, reference documents and potential facilitators/
technical experts
• The course will foresee the use of 2 tools:
• the University of Warsaw platform, which will be mainly used for the storage and consultation
of documentation/material and for recorded lectures and use of a forum for discussion;
• webinars platforms such as zoom or gotomeeting for webinars/live lectures/live exercises (e.g.
a working pool will be organised for each group (for each SoHO) for carrying out the exercises
and consequent discussion and results presentations).

The course will be delivered in 2 editions (5 weeks each):
• 31/05/2021 – 02/07/2021
• 6/09/2021 – 8/10/2021

16 GAPP - Newsletter3