Page 8 - GAPP Newsletter Issue 1 Jan2019

The aim of the meeting was to discuss the work and interconnection among the

technical WPs and was held in Agence de la biomédecine premises, in Paris. The
following were discussed and decided:

First Technical meeting (September 20-21, 2018)

WP5 will develop a template form for Preparation Process Authorisation (PPA), terms for

0 authorisation, overview of single authorisation steps, organisational model definition of
types of authorisations.
The work will start with a desk based reviews of frameworks for medical device, medicines,
herbals to ATMP, EMA notes for guidance. Contextually a survey will be circulated among
National CAs and a multicountry workshop will be organised.

WP6 is dealing with the definition of key quality and safety criteria. For blood JPAC wrote
the red book for authorisation which is very specific for any type of product and will share it
with the group.
The aim of WP7 is to prepare the technical Annex 2 devoted to the assessment and authorisa- 0
tion methods related to donor testing, microbial inactivation etc. Annex 2 will contain some
remarks on common and distinct criteria regarding the aim of reducing the risk of infectious
disease transmission i.e.: 1) Common criteria about donor testing (e.g. HIV 1&2, HTLV 1&2,
HBV, HCV, CMV, Syphilis) or emerging threats (Zika, West Nile Virus, etc.); 2) Distinct criteria
(e.g. microbial inactivation, sterilisation of final products, the peculiarities of constraints to
achieve an adapted environment without compromising the chances of fertilization, embryo
development, etc).
Source of information will be: already existing guidelines such as EDQM: Guide to the prepa-
ration, use and quality assurance of blood components (vers.19, 2017); Guide to the quality
and safety of tissues and cells for human application (vers.3, 2017); European Pharmacopoe-
ia; the quality and safety guidelines of EMA and ICH; results of TRANSPOSE project; ESHRE
guideline and good practices; other available national guidelines.

WP8 is to introduce systematic methodologies for the evaluation of clinical data, as part of
0 the authorisation of processing activities. About technical requirements of follow-ups the
work plan foresees to use VISTART Principles and EuroGTP II outcome (Good Practices) to
determine the minimal requirements for clinical data abiding to VISTART principle and tak-
ing advantages of already existing registries, EuroGTP, MS practices and EuroGTP II Survey.
Concerning the NCAs assessment procedures of evaluation and authorisation (i.e types
of authorisations; how assessment should be performed; documents and inspections re-
quired; need for external expertise; technical committees, etc.) WP8 will take advantage of
VISTART WP5B survey, GAPP survey, specific Partners’ experiences and finally Pharma and
3rd countries scenarios.

8 GAPP - Newsletter 1