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]
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.
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]
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]
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]
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]
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]
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]
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
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]
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
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]