Page 8 - NewsletterVol2

As a final result a common proposal for supporting a sustainable implementation in single
WP4 countries will be agreed upon. The work of WP4 has already started at M15 and a report on
the implementation will be prepared by M26. Following the withdrawn of IVO, Sweden, WP4
is now coordinated by the Romanian National Registry of Hematopoietic Stem Cells Voluntary
Donors (RNDVCSH) and ISS-CNT-CNS.

DEVELOPMENT OF OVERALL GUIDANCE ON ORGANIZATION OF PPA SYSTEM
WP5 WP Leader: HPRA, Ireland; OCATT, Spain
WP5 of the GAPP JA will develop guidance on how a preparation process authorisation (PPA)
system should or could be organised. A WP5 workshop was organised on October 23. The
purpose of this Multi Country Workshop (MCW) to promote discussion to consider and gather
information on the status of Preparation Process Authorisation (PPA) systems, the associated
legislative requirements, guidance and procedures in place across MS CA’s in the field of
tissues and cells and Assisted Reproductive Technology (ART).

The main topics that will be analysed during the MCW are:

a) Framework for Competent Authority;
b) Application process;
c) Risk Assessment;
d) Review and Evaluation;
e) Authorisation.

The workshop will take place at the premises of the European Commission, Albert Borchette
Conference Centre on October 23rd from 14:00 to 18:00.

TECHNICAL ANNEX 1 TO OVERALL GUIDANCE: AUTHORISATION OF CHANGES IN DONATION,
WP6 PROCUREMENT AND COLLECTION, PROCESSING, PRESERVATION, STORAGE AND DISTRIBU-
TION* (INCLUDING LABELLING AND PACKAGE INSERTS)

WP Leader: ABM, France

WP6 is dealing with the definition of key quality and safety criteria of the preparation of blood,
tissues and cells that will be used in patients and consist the basis for the authorization. To
define these criteria, three specific subgroups of experts were generated. The (MHRA) (UK)
led the work on Blood, The Cell Factory - Unit of Cell Therapy and Cryobiology, Fondazione
IRCC Ca’ Granda Ospedale Maggiore Policlinico, Milan led the work on replacement tissues &
cells, and the ABM (France) led the work on Reproductive tissues & cells.

The blood group organized a survey to collect national available procedures and analyse
current practices. They could gather more than 40 existing criteria and 3 evaluation tables,
and suggested a 14 steps evaluation route for novel components. The ART group decided
to include all Medically assisted reproduction activities (MAR) in order to align with EHSRE
recommendations and with the EDQM guides. They listed criteria for biological processes
used in the different preparation steps and specified their key performance indicators that
need to be assessed in the evaluation procedure. Types of products of in the Tissues and Cells
subgroup splited the work . Tissue type categories were defined and the group could share the
high workload between its members to design exhaustive tables of criteria.

8 GAPP - Newsletter2