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Recent Advantages per Area

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, ANSM, EBMT

Work Package 6 has two parts: the identification of the criteria that need to be taken into account in
authorising products and preparation processes and the identification and description of methods
to evaluate them. A necessary preliminary step was to identify all the processes and products from a
wide range of sources, including, but not limited to, European legislation and EDQM guides.

WP6 provisionally submitted Milestone 24 in July 2020 completing the first part of the work.
In Rome in October 2019, the expert groups started part II; identifying evaluation methodologies
supporting the use of risk-based approaches and integrating the results of EuroGTPII whilst building
on the extensive experience of MHRA(UK), PEI(D) and ANSM(F).
Currently WP6 is taking stock of the work that has been accomplished in part II and the availability
of experts for its completion. There should be a draft of the evaluation methods section by the end
of the year. We are sharing, our preliminary results with WP5, WP9 and WP10 and WP9 has already
incorporated the structure of our criteria into the integrated data model presented in D9.1.

Prior to the Oct 2019 meeting in Rome the WP6 expert sub-groups were restructured, with a specific
tissues group led by Dr Isabelle Martinache (Agence de la biomédecine ABM) being separated from
a specific Haematopoietic Stem Cells group led by Eoin McGrath (EBMT). MHRA(UK) also requested
that the leadership of the Blood Expert Subgroup be transferred to the ANSM(F) represented by Dr
Imad Sandid. The expert subgroups continue to be productive and active and led by highly competent
domain experts (Professor Dominique Royère continues to lead the MAR group).

Finally, Katia Bruneau’s(ABM) contract regrettably reached its term at the end of June 2020 and
we miss her unique energy; Nigel Strang (ABM) accepted Samuel Arrabal’s request to continue her
excellent work as of June 2020.

TECHNICAL ANNEX 2 TO OVERALL GUIDANCE: ASSESSING THE QUALITY AND SAFETY OF DO-
WP7 NOR TESTING, PATHOGEN REDUCTION AND STERILISATION STEPS AS PART OF PPA
WP Leader: ABM, France; FIMEA, Finland

WP7 is currently finalizing its main outcome, the Technical annex 2 on assessing the quality and
safety of donor testing, pathogen reduction and sterilization steps as part of Preparation Process
Authorization (PPA). Blood, tissues and cells (BTC) for clinical use bear the risk of carrying number
of infectious agents, which may result in their unintentional transmission, which could then lead to
disease and even death in recipients.

14 GAPP - Newsletter3