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facilitatinG the Authorisation of Preparation Process for blood and tissues and cells [GAPP] [785269] - Joint Actions
Newsletter
Third Newsletter lead by PGH - [D.31]
Type: Other
Published on: 13/01/2021

Third newsletter of GAPP action
Second Newsletter lead by 7TH HRC - [D.30]
Type: Other
Published on: 15/07/2020

second newsletter of GAPP action
newsletter lead by PGH - [D.7]
Type: Other
Published on: 14/03/2019

Each newsletter will provide an overall picture of the improvements of JA activities.
there will be 4 newsletter at Month 9-18-27-36. To be produced and circulated in electronic version only.
Layman
MD4. Layman version of the final report lead by PGH - [D.10]
Type: Demonstrator, pilot, prototype
Published on: 10/06/2022

This is a short (e.g. 10 pages) version of the final report, written for the interested public as a target group. To be produced and circulated in electronic version only.
Final technical and financial report lead by ISS-CNT-CNS - [D.3]
Type: Document, reports...
Published on: 10/06/2022
This report describes the project implementation, problems encountered and the results achieved. Relevant milestones will be annexed to the report.
Final Dissemination and Communication report lead by PGH - [D.8]
Type: Document, reports...
Published on: 10/06/2022

This document is meant to provide a detailed list of dissemination activities conducted by Associated and collaborating partners in their countries.
Recommendations for integration in national/regional /local policies lead by IVO - [D.15]
Type: Document, reports...
Published on: 10/06/2022

This deliverable will provide useful recommendation for the integration in national/regional /local policies of GAPP guide, annexes, knowledge platform and training courses
Multi-stakeholder Conference lead by 7TH HRC - [D.9]
Type: Other
Published on: 11/03/2022

Final dissemination conference
Final evaluation report lead by MOH - HR - [D.13]
Type: Document, reports...
Published on: 11/03/2022
produced on the basis of continuous evaluation and outputs during project. This docuement will collect also the opinion of the EAB on the final outcomes of the action.
Operating Concept of a platform to implement A, B lead by PEI - [D.28]
Type: Demonstrator, pilot, prototype
Published on: 23/02/2022

Operating concept of platform eligible to serve as a template for technical realization of A and B within an electronic tool
MD6. Report on the integration in national policies and sustainability lead by IVO - [D.16]
Type: Document, reports...
Published on: 11/02/2022

This report will highlight the integration of project outcomes in national policies and their possible sustainability
Manual for training CA inspectors for accessing and authorise PP of BTC product lead by KCBTiK - [D.29]
Type: Document, reports...
Published on: 11/02/2022

Manual for training Competent Authorities inspectors that assess and authorise preparation processes of tissue, cell, and blood products
Good practice guideline to authorisation on preparation processes in blood, tissues and cells lead by HPRA - [D.19]
Type: Document, reports...
Published on: 01/12/2021

This documents will collect the good practices to authorisation on preparation processes in blood, tissues and cells
Deployment of updated version of blood risk assessment tool lead by BST - [D.32]
Type: Other
Published on: 01/12/2021

Release of updated version of risk assessment tool for blood professionals
Risk assessment Guide lead by BST - [D.33]
Type: Document, reports...
Published on: 01/12/2021

Update version of EUROGTP-II risk assessment Guide including blood chapter.
Technical Annex on authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution lead by NBC - [D.20]
Type: Document, reports...
Published on: 12/10/2021

This deliverable will be the annex I of the Guide. The document will be focused on authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution. It...
This deliverable will be the annex I of the Guide. The document will be focused on authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution. It will be divided into 3 parts (Blood, tissues, cells and reproductive tissues and cells).
Framework for an electronically supported authorisation process lead by PEI - [D.27]
Type: Document, reports...
Published on: 30/08/2021
definition of a framework for an electronically supported authorisation process
Report on the integration at one national level - a pilot in SE lead by IVO - [D.14]
Type: Document, reports...
Published on: 17/08/2021

Report on the integration at one national level – a pilot in Sweden
Data model of information on clinical outcome of application of human blood, cell, and tissue therapeutics lead by BST - [D.25]
Type: Other
Published on: 25/05/2021

Data model of information on clinical outcome of application of human blood, cell, and tissue therapeutics
Technical annex on assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA. lead by ABM - [D.21]
Type: Document, reports...
Published on: 23/02/2021

Technical annex on assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA.
Extension of the outputs of previous projects, VISTART WP5B, EUROGTP II etc., to be applicable to blood establishments lead by CatSalut - [D.17]
Type: Document, reports...
Published on: 25/11/2020

Analysis of previous projects outputs
Report on the outcome and conclusions of the survey, the deskbased review of PPA in other fields and the multi-country workshop lead by CatSalut - [D.18]
Type: Document, reports...
Published on: 25/11/2020
Report with the conclusions of the survey on present situation, Desk-based review of existing PPA systems in place in other relevant sectors, and working document for the multi-country workshop
Methodological framework to evaluate quality and safety of human blood, cell, and tissue therapeutics based on clinical outcome data requested for authorisation processes upon introduction of innovation to the current processing and testing protocols lead by BST - [D.24]
Type: Document, reports...
Published on: 08/10/2020

Methodological framework to evaluate quality and safety of human blood, cell, and tissue therapeutics based on clinical outcome data requested for authorization processes upon introduction of innovat...
Methodological framework to evaluate quality and safety of human blood, cell, and tissue therapeutics based on clinical outcome data requested for authorization processes upon introduction of innovation to the current processing and testing protocols for human blood, cell, and tissue therapeutics
Integrated data model lead by PEI - [D.26]
Type: Other
Published on: 08/10/2020

Technical concept of platform
Progress Technical and Financial Periodic Report lead by ISS-CNT-CNS - [D.2]
Type: Document, reports...
Published on: 17/07/2020
This report describes the activities carried out, milestones and results achieved in the first half of the project. Deliverables can be attached as annexes. This document covers the period from M1 to ...
This report describes the activities carried out, milestones and results achieved in the first half of the project. Deliverables can be attached as annexes. This document covers the period from M1 to M18
Intermediate evaluation report lead by MOH - HR - [D.12]
Type: Document, reports...
Published on: 18/12/2019
produced on the basis of continuous evaluation of activities and outputs during evaluation period. This docuement will collect also the opinion of the EAB on the intermediate outcomes of the action.
Catalogue of risk-based set of criteria, appropriate to evaluate the established catalogue of clinical data for completeness and suitability in case of introduction of innovation to the current processing and testing protocols for human blood, cell, an lead by FIMEA - [D.23]
Type: Document, reports...
Published on: 18/12/2019
Catalogue of risk-based set of criteria, appropriate to evaluate the established catalogue of clinical data for completeness and suitability in case of introduction of innovation to the current proces...
Catalogue of risk-based set of criteria, appropriate to evaluate the established catalogue of clinical data for completeness and suitability in case of introduction of innovation to the current processing and testing protocols for human blood, cell, and tissue therapeutics
Catalogue of existing clinical data appropriate to provide information on the quality and safety of human blood, cell, and tissue therapeutics once applied to patients, under the conditions of current state-of-the-art processing and testing protocols lead by FIMEA - [D.22]
Type: Document, reports...
Published on: 29/10/2019
Catalogue of existing clinical data appropriate to provide information on the quality and safety of human blood, cell, and tissue therapeutics once applied to patients, under the conditions of current...
Catalogue of existing clinical data appropriate to provide information on the quality and safety of human blood, cell, and tissue therapeutics once applied to patients, under the conditions of current state-of-the-art processing and testing protocols
Dissemination & Communication Strategic Plan lead by PGH - [D.5]
Type: Document, reports...
Published on: 25/01/2019

The dissemination plan of the Joint Action will provide a roadmap for all JA dissemination activities.
Financial manual lead by ISS-CNT-CNS - [D.1]
Type: Document, reports...
Published on: 12/12/2018

The manual will provide the associated partners all the relevant information related to the managment of project funding, the use of the IT portal and the submission of financial statement on the the ...
The manual will provide the associated partners all the relevant information related to the managment of project funding, the use of the IT portal and the submission of financial statement on the the same portal
MD3: Leaflet lead by PGH - [D.4]
Type: Other
Published on: 12/12/2018

A leaflet to promote the project must be produced at the beginning.
MD5. Web-site lead by PGH - [D.6]
Type: Websites, patent filling, videos etc
Published on: 12/12/2018

Each project must have a dedicated web-site / web-pages. This can have a public part and another one accessible only to the applicants. In the private area will be uploaded all the docuements classifi...
Each project must have a dedicated web-site / web-pages. This can have a public part and another one accessible only to the applicants. In the private area will be uploaded all the docuements classified as Confidential
Final evaluation plan, including setting up of EAB lead by MOH - HR - [D.11]
Type: Document, reports...
Published on: 12/12/2018

description of the evaluation system
Details
Start date: 01/05/2018
End date: 31/01/2022
Duration: 36 month(s)
Current status: Finalised
Programme title: 3rd Health Programme (2014-2020)
EC Contribution: € 1 199 824,37