Page 2 - INTERIM NEWSLETTER FINAL

Contents

OVERVIEW OF GAPP INTERIM NEWSLETTER .......................................................................................................... 2

BACKGROUND ......................................................................................................................................................... 2
GAPP INTERIM MEETING ROME ............................................................................................................................. 2
1
General ................................................................................................................................................................ 2
EU COMMISSION FOR GAPP ................................................................................................................................... 3

INTERIM OVERVIEW ON TECHNICAL WP’s ............................................................................................................. 4
WP5 - Development of Overall Guidance on organisation of PPA system (Gerard Sheridan, HPRA, Ireland;
Ruth Barrio, CatSalut, Spain) .............................................................................................................................. 4
WP6 - Technical Annex 1 to overall guidance: authorisation of changes in donation, procurement and
collection, processing, preservation, storage and distribution (Samuel Arrabal, Katia Bruneau, ABM, France)
............................................................................................................................................................................. 4
th
WP6 Expert Workshop Rome 30 October 2019 ............................................................................................. 6
WP7 - Technical Annex 2 to overall guidance: assessing the quality and safety of donor testing, pathogen
reduction and sterilisation steps as part of PPA (Anu Puοmila, FIMEA, Finland and Katia Bruneau, Samuel
ARRABAL, Sari Tähtiharju and Kristiina Järvinen, ABM, France) ........................................................................ 6
WP8 - Technical Annex 3 to overall guidance: assessing clinical data as part of PPA authorisation (Anu
Puοmila, FIMEA, Finland; Jaime Tabera, BST, Spain) ......................................................................................... 6

WP 9 - Knowledge sharing on PPA between EU CAs (Winfried Kammer, PEI, Germany) ................................. 7
INTERIM DISSEMINATION KPI’s .............................................................................................................................. 8
Where can you meet GAPP in the forthcoming international congress? .............................................................. 9

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.
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