2021 Advanced training course on common approaches to preparation process authorisation (PPA) in the blood, tissues & cells, and MAR sectors

Due to the epidemiological contingency, the training course will be delivered remotely.
The target audience are experienced inspectors/assessors for blood establishments (BEs) and tissue establishments (TEs) processing reproductive cells for medically assisted reproduction (MAR) and non-reproductive tissues and cells.
The main reference document will be the “Overall Guidance on organization of PPA system” and the following technical annexes:
– Annex I – authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution;
– Annex II – assessing the quality and safety for donor/donation testing, pathogen reduction and sterilisation steps as part of PPA process;
– Annex III assessing clinical data as part of PPA;
In addition, a concept of a knowledge sharing platform on PPA between European Union CAs will be presented. The platform allows for a standardised, electronically supported assessment of quality, safety and efficacy of blood, cells and tissues, in the case of state-of-the-art as well as
innovative processing procedures.

Opening of the platform: 21/06/2021
The course will be composed of 3 parts:
– E-LEARNING PART (module 1-5) open from 28/06/2021 to 31/08/2021 for all the 100 participants
o Quizzes after each module must be completed before starting next module.
o All quizzes must be completed by participants within 31/08/2021
– LIVE SESSIONS (module 6 – 1 week) – 2 editions, 50 participants each:
o 1st edition 20/09/ – 24/09/2021
o 2nd edition 27/09/ – 1/10/2021
– Q&A (FORUM), FINAL EXAM AND COURSE CLOSING (module 7 – 1 week)
o Forum all participants: 4/10 – 7/10/2021
o Final exam for all participants: 8/10/2021

Download the complete document