GAPP Joint Action (JA) participates at the Joint ESHRE ASRM biannual Virtual Meeting 2021 on the 8th-10th April which brings the best of established and emerging approaches for diagnosis and treatment in Reproduction and Embryology, providing a forum for the exchange and discussion of new clinical and scientific ideas in the field between North America and Europe.
GAPP contributes to the discussions through its work on assessing the quality and safety of the Preparation Process Authorisation (PPA), of blood, tissues and cell (BTC) establishments and procedures, which will be determining the harmonisation and standardisation processes in the EU on
- authorisation of changes in donation, procurement and collection, processing, preservation storage and distribution;
- donor testing, pathogen reduction and sterilisation steps, and
- clinical data to the current processing and testing protocols for human BTC therapeutics, providing also a methodology framework
GAPP JA guidelines for Competent Authorities (CA) on quality and safety identify the need for regular updating based on the evolution of research, therapeutics and information technologies. Furthermore, GAPP JA puts down the concept of an information system with solutions on maintaining guidelines up-to-date, easily accessible and transparent.
It must be noted that currently European Blood, Tissues and Cells Directives do not cover clinical assessment nor clinical follow-up as a result of Medically Assisted Reproductive (MAR) techniques using donor gametes or donated embryos. There is consensus that human applications of certain novel BTC require assessment of clinical efficacy/effectiveness and should be collated to support the PPA and include requirements to confirm the clinical outcome data.
GAPP JA deliverables should be considered an integral part of the generic guidance and interpreted as an important milestone for the improvement of practices and the safety of BTC recipients in Europe. Additional guidance document will be finalised in the coming months.
GAPP JA guidelines are available online:
Assessing the quality and safety of donor testing, pathogen reduction and sterilisation steps as part of Preparation Process Authorisation (PPA)