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facilitatinG the Authorisation of Preparation Process for blood and tissues and cells [GAPP] [785269] - Joint Actions
Coordination of the action by lead ISS-CNT-CNS

Start month:1 - End month: 36

WP1 will carry out the following activities:
Task 1.1- Organization of general plenary coordination meetings, where Steering Committee will convene: Kick-off (M2), intermediate meetings (M18) and fin...
WP1 will carry out the following activities:
Task 1.1- Organization of general plenary coordination meetings, where Steering Committee will convene: Kick-off (M2), intermediate meetings (M18) and final meeting (M36); interim WP meetings for reaching agreements on specific issues, developing work, and exchanging relevant information, including working progress will be held by conference calls. The final meeting will take place together with the final dissemination conference.
Task 1.2 Project working bodies (Project Committee will be constituted by all partners involved in the Consortium; WPs Steering Committee will be composed of the members of the coordination unit and the leaders of the WPs, being this Steering Committee an operational body for collective decision-making and reporting on the execution of the project).
Task 1.3 A Manual for the financial and administrative management of the JA will be prepared and circulated among partner, where the different reporting periods will be defined, along with management and financial rules and procedures (M4).
The General Management team will include two scientific managers, CNT and CNS General Directors, that will have overall responsibility for the whole joint action, two project management experts, a senior biologist team leader and a senior haematologist leader plus two technical coworkers. Project managers will supervise all the actions and works performed and steer the coordination team/unit.
The whole team, constituted by CNT-CNS staff, will monitor the progress of the Joint Action transversally and vertically, will establish communication with the steering committee on a regular basis, will report to the Directors of the Joint Action.
Dissemination & Communication by lead PGH

Start month:1 - End month: 36

THIS WP WILL BE CO-LEAD BY THE PAPAGEORGIOU GENERAL HOSPITAL AND THE 7TH HELAHT REGION OF CRETE.

WP2 is dedicated to the dissemination of the action and its deliverables. Dissemination refers to the ...
THIS WP WILL BE CO-LEAD BY THE PAPAGEORGIOU GENERAL HOSPITAL AND THE 7TH HELAHT REGION OF CRETE.

WP2 is dedicated to the dissemination of the action and its deliverables. Dissemination refers to the process of making the results and deliverables of the action available to the stakeholders and a wider audience.
Here all actions planned to ensure that the results and deliverables will be made available to the stakeholders and can be used by them will be described. WP2 activities will include the development of the dissemination plan, a stakeholder analysis, identification of target groups, adequacy of channels used to reach them, and actions to ensure proper visibility of European Union co-funding.
The dissemination strategy should pay attention to the transfer of knowledge and to the processes needed for embedding and future take-up. The sustainability of the dissemination actions will be properly addressed.
The Dissemination WP team will include two Project Managers (one from Papageorgiou General Hospital and one from the 7th Health Region Greece) who will have the overall responsibility of the WP, one project mananger expert who will support and monitor all dissemination activities, two haematologists experienced in preparation processes on blood, tissues and cells, two highly qualified administrators, two administration staff, three information technology experts and one web graphic designer. The whole team consists of the staff of the Papageorgiou General Hospital and the 7th Health Region/University Hospital of Heraklionand two subcontractors (one dissemination/communication expert and the graphic designer). An experienced conference organizer will be also subcontracted for the final conference organization
Task 2.1 – Dissemination and Communication Strategy (M1-M36)
The task will define a detailed dissemination strategy to ensure high visibility and impact for the project. In specific, a dissemination plan covering all the duration of the project will be authored describing the aims and objectives of the JA, the actions to be disseminated, the target audiences/groups and stakeholders, the benefits to end users, the dissemination methods/activities, the timescales and responsibilities of the members of the team, the targets, the estimated costs, the evaluation and criteria for success. This task will also include planning for scientific publications in highly-ranked, open access journals, presenting the project concept, vision and results. Interaction and synergies with relevant initiatives/bodies/organizations will also be defined. Emphasis will be given on establishing measures as regards the sustainability of project outcomes. The dissemination strategy will be revised periodically based on the feedback and the achieved results to ensure that the targeted events maximize visibility and that the dissemination activities reach the targeted audience.
In this frame, a dissemination meeting will be held before the revision of the Dissemination Plan, in order to ensure that all partners are “in the same page” regarding the necessary dissemination and communication activities.
Task 2.2 – Dissemination and Communication Package (M1-M36)
A multi-strand approach will be used to ensure the effectiveness of the dissemination actions of the Consortium. This includes:
2.2.1 Configuration of the project Identity: Design the project logo, production of a design for printed material, production of banners, posters, flyers, preparation of the newsletters, production of video material, as well as official project templates for PowerPoint presentation. The Layman Brochure will be as well developed at month 3. The Brochure will address to all target groups including general public and it will contain a short description of the project, the aims of the work packages as well as the list of all the associated and collaborating partner organizations involved in the Action. Α downloadable electronic version will be available in the
Evaluation by lead MOH - HR

Start month:1 - End month: 36

The progressive achievements of Action activities and quality of deliverables will be continuously monitored and reported to the PPM. All associated partners and project events participants will contr...
The progressive achievements of Action activities and quality of deliverables will be continuously monitored and reported to the PPM. All associated partners and project events participants will contribute to the work of the WP3 by providing their own evaluation of all events attended. EAB will give expertise within their competences in evaluation of specific scientific/expert issues addressed in events and outputs of the Action where such an expertise is applicable.

The work will be carried out in two aspects: internal and external evaluation.
Within all relevant project’s events (including outputs) following elements will be evaluated:
-organisational elements (venue, traveling organisation, accommodation and related information…),
-technical elements (core materials and information flow, course, content and goal of the event, etc) and
- professional/scientific elements (deliverables).
The WP leader will produce an interim and final report, with executive summary shared with internal and external stakeholders. The final evaluation report will be focused on the outcomes and the reached objectives but also on the impact of the Action having in focus particularly sustainability of outcomes. Evaluation reports will be a standing item on Steering Committee meeting agendas, ensuring that quality of outputs in both means accuracy and contemporaneity is always a top priority.

At the beginning of the project, in cooperation with EAB where applicable, will be defined sets of indicators according to SMART criteria (paying in particular attention to have quantifiable indicators wherever possible) to assess performance. Set of indicators will be established for each specific objective of the project and will comprise:
- Output indicators linked to results
- Impact indicators linked to objectives
For single deliverable quality and applicability will be assessed based on, for example, following quality indicators:
timelines of outputs
comprehensiveness of collected data
critical/analytical nature of conclusions
clarity of conclusions/proposals
realistic nature of conclusions/proposals
adequacy of MS representation
clarity of information presented and recorded.

Surveys will be conducted through questionnaires structured as following:
enabling analysis and grading
reasonably short (up to 10 questions)
simple language
minimal likelihood of misunderstanding
close ended format (fixed answer set)
dichotomous questions (yes/no) preferred
requests for narrative answers avoided
even number rating scale (to avoid „golden middle” answers)
opportunity for expressing opinion (one open ended question)

Through the whole duration of the project WP leader and EAB will tightly cooperate aiming to produce timely and harmonized WP3 outputs. To achieve that leader and EAB will have 2 technical meetings which can be organized as video/teleconference if considered appropriate or back-to back to other project event (such as technical or plenary meeting for example).

Task 3.1. Definition of a project evaluation plan
In the first 6 months of JA lifetime project evaluation plan will be defined.

Task 3.2 Internal evaluation
Through the task all relevant project’s events and outputs, such as technical meetings, plenary meetings, workshops/trainings, deliverables etc. will be assessed and evaluated.
The work methodology will include:
1. Data recording out of routine documentation of horizontal WPs and pre-release deliverables (training materials, guidelines, operations manual, recommendations, results of pilot projects, etc.),
2. Surveys,
3. Observation (support, early reaction, data security) with a calendar of milestones.

Task 3.3. External evaluation
Through the task all professional/scientific elements of each project’s event and output, such as technical meetings, plenary meetings, workshops/training, deliverables etc will be assessed and evaluated under guidance and with inputs of EAB, to be composed of 6 internation
Integration in national policies and sustainability by lead IVO

Start month:24 - End month: 36

WP4 will set up a model for CA´s in the MS to incorporate the results of the JA into policies at national/local level. Along with such policies WP4 will provide additional input to the work of WP2 (...
WP4 will set up a model for CA´s in the MS to incorporate the results of the JA into policies at national/local level. Along with such policies WP4 will provide additional input to the work of WP2 (dissemination) and evaluate the acceptance (at the CA and the professional level) of the results in this JA. Toward the end of the action (M30) the analysis of possible barriers and obstacles to integration and sustainability of JA results in single countries will be performed as part of the general survey on integration in national policies and recommendations for overcoming these will be added as parte of final sustainability report. Consensus about the criteria in the process for authorisation when introducing new methods in Blood, Tissues and Cells including ART, will eventually create recommendations of good practice among the professionals and acceptance of future regulations. The issues and plans for development and subsequent sustainability of the knowledge-sharing platform whose concept model will be defined under WP9 will be as well analysed and clarified.


At the CA level:
In particular the deliverables from WP5 will provide the basis for recommendations, depending on the various institutional organisations in the different MS.
Also the deliverables from WP5 with guidance on what to authorize, how to apply for authorization, definition of significant changes of processes as well as suitable teams for authorization will be important parts to integrate at the level of CA in the different MS.
Likewise the guidance on assessment of validations from the work of WP6 and the impact of clinical data from WP8, will have to be implemented at the CA level and included in the customized tool-box for the different MS.
Most likely it will be necessary to define a minimal requirement at the CA level and maybe rate the suggested recommendations from basic/acceptable to a desired level. We have to take into account that some MS already have working processes for authorization and licencing of new methods (at least in some areas in this sector) whereas others do not. Thus, the plan for implementation will be created as a ladder where the CA can introduce the recommendations/ requirements stepwise which will facilitate adjustments also at the CA level.

At the professional level:
An important part in implementation and sustainability of requirements and recommendations is to obtain consensus at the professional level. The results of the JA should be accepted by the professionals, preferably through international organisations (EBA, ESHRE, EATB, EEBA JAICE etc). These organisations are included as collaborating partners in WP6. WP8, with focus on clinical data as part of the authorization will have the output from other projects as a basis (VISTART, EuroGTP and ECCTR) where professional organisations have participated. WP4 suggest that the deliverables from WP6 and WP8 should be presented at the European meetings held by these associations, also described in the dissemination plan by WP2.
In this WP, the National Tissue Council (within the Swedish Association of Local Authorities and Regions) will be collaborating partners. The Tissue Council have working groups for Blood, ART, HPC and one for each regenerative tissue and one of their tasks is to provide guidance to tissue establishments. Thus, their role as collaborative partners will be to provide expertise and evaluate the recommendations and added value of the results from the JA and provide recommendations to the tissue establishments at the national level.

Work plan
Task 4.1 A pilot for integration of PPA in national policies in SE

In Sweden, it is the National Board of Health and Welfare (Socialstyrelsen) that is the regulatory CA transposing the Swedish laws on Blood safety and Quality and safety for tissues and cells respectively into regulatory acts. Thus, these acts regulate what should be done whereas IVO has the mandate to write regulatory acts on how it should be
Development of Overall Guidance on organization of PPA system by lead HPRA

Start month:2 - End month: 32

This WP will develop guidance on how a Preparation Process Authorisation programme should or could be organised. This WP will take advantage of the results of the VISTART Joint Action as far as analys...
This WP will develop guidance on how a Preparation Process Authorisation programme should or could be organised. This WP will take advantage of the results of the VISTART Joint Action as far as analysis of existing procedures and drafting of authorisation principles for novel processes is concerned, as well as the outcomes of the EUSTITE, EUROGTPII and ECCTR projects, that should however be extended to the blood sector. In order to ensure comprehensive consideration and review of VISTART WP5B, EUROGTP II and ECCTR outputs and to ensure that development of the relevant technical annexes and guidelines, leaders of these projects/actions/WP will be involved in two devoted meetings. Revision of guidance for blood establishments will be as well ensured by adhoc subgroup.
Lessons learned from experience in the systems for authorisation of medicinal products and medical devices at national and EU level will be examined and compared with existing experience in the TCB fields.
The following activities will be included:
- Development, circulation and analysis of results of a questionnaire survey of MS to explore and have a comprehensive picture of existing PPA systems – supplementing the VISTART WP5 Part B survey.
- Desk-based review of product authorisation systems in place in other relevant sectors (e.g. medicines, medical devices)
- Organization of a multi-country workshop to further explore organizational and procedural models identified by the survey and to identify strengths, weaknesses and best practices.
- Development of general good practice guidelines for PPA – putting a system and Standard Operating Procedures in place at the Member State level, including a methodology to inform blood and tissue establishments (BE/TE) regarding those procedures.
The guidelines shall include:
• An overview of the single authorisation steps from the request submitted by a BE/TE to the release of authorisation by CA
• Timing of application for PPA
• Definition of significant change in preparation process
• Terms for application (also building on the outcomes of VISTART WP6 - manual for inspections)
• Organisational models and mandates of the CAs responsible for the PPA
• Optimal composition of the assessing team in the CA (members' qualifications, background, use of external experts etc.), definition of inspectors’ involvement,
• Definition of types of authorisation (e.g. full, conditional, temporary – taking into account the outcomes of VISTART WP5 part B)
• Recommendations on how to analyse and address ethical issues.
• Development of model template forms for PPA.

Task 5.1 Review and revision of the outcomes of EUSTITE, VISTART WP5B, EUROGTPII and ECCTR projects results
Revision of the results of VISTART WP5B, EUROGTP II and ECCTR projects related to the authorisation of preparation processes for tissues and cells, so as to be applicable to blood establishments.

Task 5.2 Survey
Design a survey to review the implementation of the outputs from the previous projects and to have a comprehensive overview of the PPA systems in place in each of the Member States.

Task 5.3 Desk-based review of existing PPA systems in place in other relevant sectors

Task 5.4 Multi-country workshop
This workshop will have the objective of further exploring the different organisational models for PPA used by the various Member States and also to identify the associated common best practices.

Task 5.5 Development of Good Practice Guidelines for PPA
Elaborate good practice guidelines for PPA based on the requirements defined by the European Directives, analysis of the outputs of previous projects and the review and analysis conducted as part of this work package, in order to define a common approach and methodology.

Technical Annex 1 to overall guidance: authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution* (including labelling and package inserts) by lead NBC

Start month:1 - End month: 30

This WP will be led by the National Blood Centre of Lithuania (NBC)
The WP leader will be supported by experts from two other partners from Lithuania, the LUHS Kaunas Clinic and the Santaros Clinic. ...
This WP will be led by the National Blood Centre of Lithuania (NBC)
The WP leader will be supported by experts from two other partners from Lithuania, the LUHS Kaunas Clinic and the Santaros Clinic. This team will monitor the progress of the WP6 transversally and vertically, establishing communication with other partners and the co-ordinators of the Joint Action.
Regarding the general organization of the WP this work package will deal with two issues:
Part 1: Definition of the critical characteristics/properties (criteria) for each category of blood component, tissue or cell type (referring to EU blood legislation 2004/33/EC, EDQM blood component monographs and Tissue & Cell guidance). Examples of characteristics/properties might be the vitality of cells following processing, biomechanical strength parameters, a minimum volume, tissue integrity, a minimum number of motile spermatozoa. Where such criteria have already been defined by others, particularly for blood components, the group will review and build on established standards.
Part 2: Guidance on the assessment of methods to demonstrate achievement/maintenance of the critical characteristics/properties for each category of SoHO, in particular where changes are proposed/implemented in one of the preparation steps. The guidance will take into account the degree of risk to the patient from the blood component or tissue and cell product based on parameters such as historical data, degree of change in processing or testing. Evidence will include published and laboratory studies conducted by the applying BE/TE criteria identified under Part One and used to determine the depth of validation needed e.g. when the new process has been validated elsewhere, compared to cases where the new process has not been validated before. For reproductive T&C, the validation will take into account long term results regarding the health of the newborn baby. The methods proposed for the demonstration of compliance with the criteria could include in vitro validation studies or in-process verification steps.
The work of Part I will be developed by the organization of three (3) technical meetings for each sub-group. Meetings are going to be held at the same time and place and working groups will work in parallel sessions. During the technical meetings (M 3, M 8, M 13) the working group will determine and further elaborate the scope of characteristics/properties criteria, evaluate existing criteria and methodology, review the existing variety of examples, published studies, etc.
The work of Part II will be developed by the organization of three (3) technical meetings for each sub-group (M18, M.22, M.25). During the technical meetings the working group will study of the depth validation needed, identifying the cases when validation is applicable to the new process; evaluate the draft guidance of the characteristics/properties criteria for each category of blood component, tissues and cells, especially considering proposed changes implementation.
At M27 the closing technical meeting with participants of Part 1 and 2 will take place to agree on the last amendments needed in the definitive version of the guidance documents.
Finally as associated partner in this WP and to achieve at best WP9 objectives, PEI will work in parallel in this WP in order to build a data model of information on preparation processes (authorisation of changes in donation, procurement and collection, processing, preservation, storage and distribution (including labelling and package inserts).

Technical Annex 2 to overall guidance: assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA by lead ABM

Start month:2 - End month: 26

this WP will be co-lead by ABM, France and FIMEA, Finland

The work will be developed by teleconferences, emails and during four technical meetings.
During the 1st technical meeting (M2) the working g...
this WP will be co-lead by ABM, France and FIMEA, Finland

The work will be developed by teleconferences, emails and during four technical meetings.
During the 1st technical meeting (M2) the working group will be split in subgroups in relation to different tasks (see below) and will define the general methodological approach.
During the further three technical meetings (M8, M14, M20), the working group will focus on the following topics/chapters of the technical annex:
Assessing and authorising methods related to donor testing, microbial inactivation, microbial status of final products;
Requirements for selection, validation and performance of donor infectious marker testing kits and other methods;
Requirements and criteria for laboratories performing donor testing;
Criteria for validation of microbial inactivation steps;
Criteria for validation of sterilisation processes.
Concerning the division of tasks between involved WP leaders and partners:
o ABM will be in charge of the ART field.
o FIMEA will be in charge of the blood field.
o For the Tissue&Cells field: ABM will be in charge of the HSC part, FIMEA of the other Tissues&Cells part.
At M25-26, the 4th final technical meeting will take place in order to agree on the last amendments needed in the definitive version of the deliverable.
Finally as associated partner in this WP and to achieve at best WP9 objectives, PEI will work in parallel in this WP in order to build a data model of information on testing procedures (assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA).
Technical Annex 3 to overall guidance: assessing clinical data as part of PPA authorisation by lead FIMEA

Start month:1 - End month: 30

Part A)
(1) Specification of a set of existing clinical data appropriate to provide information on the quality and safety of human blood, cell, and tissue therapeutics once applied to patients, ...
Part A)
(1) Specification of a set 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 manufacturing and testing protocols (6 months)
(2) Specification of appropriate risk-assessment models taking into account cumulative and aggregative risk assessment (1.5 months)
(3) Specification of criteria, appropriate to define “innovation” in manufacturing and testing protocols for human blood, cell, and tissue therapeutics taking into account the output of work package 5b of VISTART (1.5 months)
(4) Specification of a 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 manufacturing and testing protocols for human blood, cell, and tissue therapeutics (6 months)
(5) Review of data set by experts and stakeholders for completeness and relevance (3 months)

Part B)
(6) Setting up tools for data compilation (2 months)
(7) Proof of concept: data acquisition, evaluation of quality and validity of data ( 12 months)
(8) Definition of a methodological framework, appropriate to allow for an appropriate degree of harmonization as well as for an appropriate degree of flexibility, 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 manufacturing and testing protocols for human blood, cell, and tissue therapeutics (12 months in parallel to 6 / 7)

Teleconferences, e-mails and five technical meeting will be carried out. During the first technical meeting (M2) practical working plan will be discussed and responsibilities agreed. Second, third and fourth technical meetings will be held at M8, M11 and M23 to finalise D8.1, D8.2 and D8.3 and a fourth technical meeting at M31 to finalise D8.4.

As an associated partner in this WP and to achieve at best WP9 objectives, PEI will work in this WP in order to build a data model of information on clinical outcome of application of human blood, cell, and tissue therapeutics, building also bridges to existing clinical databases such as ECCTR, EBMT, EuroGTPs, registries.

Knowledge sharing on PPA between EU CAs by lead PEI

Start month:12 - End month: 36

From a methodological point of view the work will be performed in three blocks:
A) Building on the data models set up in WP 6, 7, 8, these data models will be integrated into a structure that will dis...
From a methodological point of view the work will be performed in three blocks:
A) Building on the data models set up in WP 6, 7, 8, these data models will be integrated into a structure that will display the dependencies of 1) preparation methods, preparation steps, in-process controls and related results, 2) testing methods, results and specifications of the final product, 3) clinical outcome data demonstrating efficacy and safety of the product upon application to a patient
B) Building the framework for an electronically supported authorization process based on the integrated data model: Identification and evaluation of checkpoints critical to approval of blood, cells and tissues
C) Development of the concept of a platform to implement A, B. Part A, B and C will be developed in parallel. Part A covers the building on the data models set up in WP 6, 7, 8. The activities will be developed as follows and according to the indicated timeline:
IT security and data privacy concepts, data access concepts (3 months)
Organization and Structure of the electronically usable criteria catalogues and of the platform (3 months)
Architecture design for criteria catalogue and platform based on international standardization efforts and previously derived requirements: architecture model, description of data exchange/integration and security components (e.g. identification and authentication, Authorization, Logging, pseudonymization and anonymisation) (6 months)
Aggregation of the data structures of the data sets on authorised preparation processes, testing methodologies and clinical outcome criteria to a common domain model and specification of data structures and data semantic using existing standards as a technical representation of the domain model (12 month)

Training courses and manual for training by lead KCBTiK

Start month:20 - End month: 36

The work of WP10 is strictly connected to the final results of the WP5, WP6, WP7, WP8 and WP9,
This WP will be led by the KCBTiK, a budgetary unit submitted to the Polish Ministry of Health, which ta...
The work of WP10 is strictly connected to the final results of the WP5, WP6, WP7, WP8 and WP9,
This WP will be led by the KCBTiK, a budgetary unit submitted to the Polish Ministry of Health, which tasks include the supervision and inspection of tissue and cell banks in Poland as well as the organisation of training courses on the recovery, collection, testing, processing, sterilization, storage and distribution of tissues and cells.
Task 1: design of training course.
Considering how extensive will be deliverables provided by the above-mentioned WPs, in the second part of the project two technical meetings will be convened by the WP leader. During the first technical meeting of WP10 (M20) the working group will agree on the design of the face-to-face training course contents: training materials incl. examples, case studies etc. After the first face-to-face training course, a summary will be provided by tutors with practical details and prepare the issues concerning a manual content will be discussed as well. At M35 the closing technical meeting will take place to agree on the last amendments needed to the definitive version of manual.
Task 2: face-to-face training
The face-to-face training courses will take place at M30 and M33 and each of them will last 2 full days at least, including theoretical and practical training. The arrival of participant shall be planned a day before the beginning of the course and their departure shall be planned the day after the ending of the course. The training courses will be organised in Poland and all the EU CA from both blood and tissue and cells fields will be invited to attend it.
Task 3: Manual for training CA inspectors
The training course designed and held in this work package will be documented. All materials such as lectures, examples, case studies will be used as the basis for the preparation of the Deliverable 10.1 “Manual for training CA inspectors that assess and authorize preparation processes of tissue, cell, and blood products”. The manual will be made available at M36 to all Blood, Tissue and Cell Competent Authorities in electronic version downloadable from project website and from ECAS, so that they can use them for national or regional inspector training in the future.

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