EU GAPP Joint Action Advanced training course on Common Approaches to PPA authorisation in the blood, tissues & cells, and MAR sectors

GAPP JA launches an Advanced Training course on ‘Common Approaches to PPA Authorisation in the blood, tissues & cells, and MAR sectors’ addressed to European experienced inspectors and assessors.

The 3-month training course consists of 7 modules and is structured as follows:

  • a 2-month e-learning session
  • 2 virtual live-sessions (1 week each), and
  • a week dedicated to a Q+A Forum and the Final Exam

Timeframe:

21/06/2021

OPENING OF THE PLATFORM

 

28/06/2021 – 31/08/2021

E-LEARNING Session

MODULE 1-5

20/09/2021 – 24/09/2021 1st edition
                   OR
27/09/2021 – 1/10/2021 2nd edition

A WEEK-LONG VIRTUAL LIVE SESSIONS

MODULE 6

4/10 /2021 – 7/10/2021

Q&A FORUM

MODULE 7

8/10/2021

FINAL EXAM
CLOSING OF COURSE

 

The course – which will be delivered through the support of the University of Warsaw platform – is due to commence on June 28th 2021 and is free of registration fees. The training course also provides successful participants with No. 4 ECTS (European Credit Transfer and Accumulation System).

After completion of the training, participants will:

  • gain the skill to perform risk assessment for the novel BTC and changes in their

preparation processes, using the EuroGTP II risk assessment methodologies;

  • learn how to define the extent of the required information for PPA based on the level of

risk related to the novel BTC or change in the preparation process;

  • know what to take into account when assessing the aspects affecting the microbiological

quality and safety of blood, tissues and cells (BTC), including

  • competence of laboratories performing donor/donation infectious disease testing

and microbiological testing of BTC,

  • reliability of the donor/donation infectious disease marker test kits,
  • effectiveness of pathogen reduction during BTC processing,
  • effectiveness of sterilisation methods during BTC processing,
  • microbiological status of final BTC products;
  • know how to evaluate the clinical component of the Preparation Process Dossier (PPD);
  • get to know the WP9 platform supporting the application for PPA and assessment of PPA dossiers

To participate:

The CAs will be responsible to nominate the applicants, who should have completed their basic training, should be approved as (lead) inspectors/assessors for one of the specific fields of blood, T&C and/or MAR in their CAs. Previous participation in other European courses (e.g. VISTART, EUBIS, EUSTITE) and/or similar initiatives (e.g. CATIE) is highly recommended.

Details for interested applicants:
https://www.gapp-ja.eu/2021-advanced-training-course-on-common-approaches-to-preparation-process-authorisation-ppa-in-the-blood-tissues-cells-and-mar-sectors/

For further information, please contact:
Izabela Tyszkiewicz, National Centre for Tissue and Cell Banking, Poland
email: izabela.tyszkiewicz@kcbtik.pl     
Livia Cannata, Italian National Blood Centre Rome
email: livia.cannata@iss.it   
Margherita Gentile, Italian National Blood Centre Rome
email: margherita.gentile@iss.it