Page 7 - INTERIM NEWSLETTER FINAL

th
WP6 Expert Workshop Rome 30 October 2019

The WP6 technical meeting in Rome gave the opportunity for a collaborative work on a consensus
for finalizing Part 1 of WP6 Technical Annex 1 to the Guideline.

WP7 - Technical Annex 2 to overall guidance: assessing the 6

quality and safety of donor testing, pathogen reduction and

sterilisation steps as part of PPA (Anu Puοmila, FIMEA, Finland
and Katia Bruneau, ABM, France)

WP7 has one single deliverable to be prepared by June 2020 and the focus of this annex is
donor/donation testing, pathogen reduction and sterilisation of final products. Subgroup work
was identified as follow: 1) Requirements for selection, validation and performance of
donor/donation infectious marker testing kits and other methods; 2) Requirements and criteria
for laboratories performing donation/donor infectious disease screening and microbiological
testing of Blood components/Tissues/cell grafts; 3) Criteria for validation of pathogen reduction

steps ; 4) Criteria for validation of sterilisation processes; 5) Requirements and criteria for
microbiological quality of the final product.

Milestone 27 (Detailed plan of the Deliverable Technical annex on assessing the quality and safety
of donor/donation testing, pathogen reduction and sterilization steps as part of PPA agreed on)
was achieved in April 2019 and according to this plan the subgroups are working and will meet
face-to-face for a technical workshop in Langen, Germany on 27th February.

The drafting of the deliverable is ongoing and the final draft will be shared for comment in April
2020 and finalized in June 2020.

WP8 - Technical Annex 3 to overall guidance: assessing clinical
data as part of PPA authorisation (Anu Puοmila, FIMEA, Finland;

Jaime Tabera, BST, Spain)

WP8 is focused on the assessing of clinical data as part of the PPA authorisation.

The first Deliverable 8.1 associated to this WP (Defining the current state of the art of existing

collected clinical data) was submitted to EC evaluation on the participant portal. To prepare this
deliverable the main European Tissue & Cell registries were interviewed namely: i) EBMT
(Hematopoietic Stem Cell Transplants & Cell Therapies), ii) ECCTR (Cornea & Cell Transplantation),
iii) ESHRE (MAR). Two national registries the National registry on fertility treatments (THL,

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