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Technical Meetings & Workshops

d) WP8 Technical Meeting, April 20, 2020. A GAPP WP8 video conference Technical Meeting aiming
to review and finalize the 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) took place on April 20, 2020 (hosts Fimea, FI; and BST, ES). GAPP WP Leaders, GAPP
Coordinators, Associated & Collaborating Partners, External Experts and DG SANTE Representatives
participated in the video conference. In addition to the D8.3 work progress, the EU programme of
COVID-19 convalescent plasma collection and supply was presented by Deirdre Fehily & Stefaan
van der Spiegel (DG SANTE). The project was promoted by DG SANTE in collaboration with the
European Blood Alliance (EBA). WP8’s experts and GAPP WP leaders were invited to express their
interest to collaborate in this EC’s initiative.

e) WP5 Coordination Meeting, May 20, 2020. A GAPP WP5 video conference workshop
(Development of Overall Guidance on Organisation of PPA System) took place in May 20, 2020
(hosts: HPRA, Ireland and CatSalut-OCATT, Spain). It was decided that the Guidelines will be
organized according to the following structure: Introduction, Background, Part A (Risk Assessment:
Definition of novelty; Significant changes), Part B (Application Process: New application; Variations),
Part C (Technical Annexes), Part D (Review and Evaluation; Authorisation), Part E (Framework for
Competent Authority). The participants discussed in detail every chapter of the Guidelines.

f) WP7 Technical Meeting, June 15, 2020. A GAPP WP7 video conference Technical Meeting aiming
to review and modify the deliverable D7.1 (Technical Annex 2 to Overall guidance: Assessing the
quality and safety of donor testing, pathogen reduction and sterilization steps as part of PPA)
took place in June 15, 2020 (hosts: Fimea, FI; and ABM, FR) in the presence of GAPP WP leaders,
coordinators and external experts. Requirements for general validation, laboratories and testing
kits, methods for pathogen reduction, sterilization and microbiological quality testing of the final
BTC product were extensively discussed and agreed. Interactions between WP9 GAPP database
and WP7 were also discussed.

This brochure is part of the joint action ‘785269/GAPP’ which has received funding from the European Union’s 5
Health Programme (2014-2020) GAPP - Newsletter3