Page 2 - GAPP Newsletter Issue 1 Jan2019
P. 2
GAPP Join Action
About GAPP
GAPP Joint Action (JA) is a 36 month project aim-
ing at facilitating the development of a common
and optimal approach to assess and authorise
preparation processes in blood and tissues es-
tablishments (BEs and TEs), adapting require-
ments as prescribed by Article 29 of Directive Objectives
2002/98/EC and Article 28 of Directive 2004/23/
EC. Eighteen (18) European countries are in-
volved with representatives from Competent Achieve a comprehensive review of existing
Authorities (CA) and Scientific Societies aiming procedures in Member States for Blood, Tis- 01
to configure European Recommendations for sue and Cell preparation process authorisa-
optimal preparation of Blood, Tissues and Cells tion, identifying strengths and weaknesses
for therapeutic application. European organisa- and proposing good practices that will be
tions will also contribute their scientific experi- feasible for all Member States to implement.
ence in GAPP.
Develop a concept model for a European
GAPP Goals: The key objective of the Αction is knowledge-sharing platform that can sup- 02
to facilitate the development of a common and port CAs in the assessment and evaluation
optimal approach to assess and authorise prep- of novel preparation processes of products.
aration processes in BEs and TEs. Particular at-
tention will be devoted to innovative processes
under development in the sectors. Develop an international network of experts
trained by the Joint Action that can support 03
Specific objective(s) of the Action: The specific CAs in the assessment and evaluation of
objectives of the GAPP Joint Action can be sum- preparation processes of Blood, Tissues and
marized on the following. Cells.
Develop a knowledge-sharing platform on
preparation processes of Blood, Tissues 04
and Cells to facilitate sharing of informa-
tion among European Countries. CA inspec-
tors will be trained specifically to assess and
authorise preparation processes of tissues,
cells, reproductive cells and blood products.
2 GAPP - Newsletter 1
