Page 4 - newsletter3GAPP

Expert Workshops are directly related to the core business of the project and aim
to provide assistance in the Technical Annexes preparation.

Technical Meetings & Workshops

This issue, is the third regular edition of the GAPP Newsletter. It highlights mostly the efforts and progression of the
Technical Work Packages (WPs) in order to enhance and strengthen the insight of stakeholders. Despite the COVID-19
pandemic, eight major Technical Meetings were held, mostly virtually, during this 9-month period:

a) WP8 Technical Meeting, February 5, 2020. A joined SANTE-SOHO and GAPP WP8 Technical
meeting on “Effectiveness and outcome measurements for Blood, Tissues and Cells (BTC)” took
place in SANTE premises in Brussels on February 5, 2020 (host: Stefaan van der Spiegel, DG SANTE).
During the meeting the GAPP deliverables D8.1 (catalogue of existing clinical data to provide
information on the quality and safety of human BTC therapeutics once applied to patients) and D8.2
(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 BTC therapeutics) were presented; the GAPP deliverable D8.3
(methodological framework to evaluate quality and safety of human BTC therapeutics based on
clinical outcome data requested for authorization processes upon introduction of innovation to the
current processing and testing protocols for human BTC therapeutics) was discussed for drafting.

b) WP7 Technical Meeting, February 27, 2020. Due to the SARS-CoV-2 outbreak, a GAPP WP7
video conference Technical Meeting replaced the live meeting that had been scheduled to take
place in Langen, on the same date. The aim of the Technical Meeting (host: Fimea, FI; and ABM, FR)
was to gather technical inputs for drafting the GAPP deliverable D7.1 (Technical Annex 2 to Overall
guidance: Assessing the quality and safety of donor testing, pathogen reduction and sterilisation
steps as part of preparation process autorisation - PPA). Anu Puomila (Finnish Medicines Agency,
FIMEA) informed about the scope and aims of the draft guidance developed by WP7 and Winfried
Kammer (Paul-Ehrlich-Institut, DE) introduced the concept of WP9 i.e. development of database in
which GAPP WPs’ outputs will be integrated, as for knowledge sharing between Member States’ CA.
External Experts, GAPP WP leaders and CA representatives participated in this video conference.

c) Coordination Meeting, April 7, 2020. A GAPP WP leaders video conference organized by the
GAPP coordinator Paola Di Ciaccio (Italian National Transplant Centre, Italian National Blood
Centre) took place on April 7, 2020. The aim of this video conference Coordination Meeting was
to have an update from the technical WP leaders after the intermediate meeting and discuss he
impact of the COVID-19 outbreak on the GAPP time schedule deliverables. The GAPP WP leaders
and CA representatives were present in this meeting.

4 GAPP - Newsletter3