WORKPACKAGES OF THE DEMONSTRATION PROJECT

Objectives

Manage the project to international standards with special attention paid to financial, logistics, information, coordination issues and in terms of qualityReport to funders and project board on a regular basis on progress particularly seeking permissions for deviations or exceptions outside accepted tolerances.Meet agreed timelines for deliverables and outputs

Workpackage 1: 'Management of the Project, outreach and communication – here included 3 regional seminars

ApproachThe overall governance of the project will be the responsibility of the Project Board comprising the funder as the Executive, representatives of the users, the suppliers i.e. the BRCs, reprentatives ensuring quality assurance and not least the project manager. The duties of the project board will be to oversee the delivery of the agreed outputs. The day to day management will be through the secretariat. The secretariat will comprise the project or general manager, executive secretary, quality manager, IT support, plus administrative support.

Task 1.1.Project monitoringCoordination of scientific activities between partners and networking activities in line with the work plan; Coordination of the knowledge management activities;Monitoring of the achievements to control the scientific quality of the results;Preparation of the detailed work stage plans for approval by the Project Board;Risk management through appropriate mitigation measures and contingency plansEvaluation of project outputs through user feedback and surveys

Task 1.2 Administrative and Financial ManagementDay-to-day administrative and logistic issues (including meeting organisation and follow-up); Appraisal, monitoring and control of the project costs;Assistance to individual project partners on specific administrative issues; Technical and financial reporting to the Project Board and funders; Periodic reports; Minutes of all the project management meetings; Annual technical and financial reports;

Task 1.4 Draw together elements from work packages to deliver a capacity building programme for the GBRCN

Task 1.3 GBRCN architecture and outreachDevelop a partner agreement to facilitate exchange of materials and data across the network; Co-ordinate input and feedback from partners on all work package elements concerning governance, operations and activities of theenvisaged GBRCN and all demonstration project products/outputs.Design the architecture of future GBRCN Secretariat; tasks, responsibilities, power, governing board, to lay down basis for further expansion, to lay down rules for secretariat – establish mechanisms to decide on host country after trial phase; establish and test membership rulesWork with the user community to identify gaps, anticipate and deliver needsWork with partners to deliver a single voice on key issues impacting on BRC operationsProduce publicity material on the GBRCN and its outputs, Design a web portal for the demonstration project (a test site for the future GBRCN); Design future work programmes for the GBRCN; establishing links to scientific communities and programmes;Organisation of three regional seminars (1) Europe: Portugal/Spain with bridging to South America and Africa; (2) Asia: China (3) Africa: Uganda/Kenya; Organisation of one/two status seminars vis-a-vis the German government

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Partner 14 -

Uganda

Partner 13 -

Spain

Partner 12 -

Portugal

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Kenya

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China

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Brazil

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ObjectivesTo implement mechanisms for third party assessment of partner operations to OECD best practiceTo ensure the networking activities have a common platform and that all partner BRCs operate high standards Provide outreach beyond the demonstration project

Description of work and role of participantsOperations must be transparent and give the recipients of services from the network confidence in the quality and value of the materials, information and support they are provided with. BRC’sare implementing the best practice alongside applicable international standards and official certification and/or accreditation mechanisms (e.g. ISO 9000 series certification). This work package offers a way forward to do this in a harmonised and co-ordinated way and offers a standard for others to implement.

Workpackage 2: BRC quality management and implementing common standards and protocols

Task 2.1: Harmonisation of methods and biological material. The work package harmonizes the principal methods used by the different partners, to validate the critical ones, and to authenticate the most used strains through inter-laboratory assays.

Task 2.2: Exchange and preparation of harmonised Standard Operation Procedures. Partners will share experiences, practices and standard operating procedures thus providing content for common SOPs, training manuals and courses, and an information resource

Task 2.3: Analysis of the different existing methods for standards implementation, including a review for example GLP, GMP and ISO mechanisms for implementing the best practice. Partners will work together with accreditation bodies to to provide an appropriate implementation mechanism and deliver certifying/accreditation/audit bodies with guidance for compliance to best practice. The work package will result in common transparent mechanisms across the network for delivery ofproducts and services and a document that can be offered as a standard for the operation of BRCs for adoption by an international body such as ISO.

Task 2.4: Produce e-learning tools to assist in building capacity drawing on project output from work package 6

Workpackage 2: BRC quality management and implementing common standards and protocols

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Workpackage 3: Capacity Building in legal background for common approaches explored to implement agreed principles on biosafety, biosecurity, risk assessment, ownership and management of IP enforced by existing national, regional and global legislation

ObjectivesTo design and implement common approaches to compliance with legislation, regulations and international conventions to ease the load on BRCs and reduce the confusion of user community through the plethora of different procedures

Description of work and role of participantsThere are numerous areas where policy, regulations or legislation impact on the operations of BRCs. Several actors are developing approaches to compliance. This work package will look at existing activities, liaise with key players and deliver common approaches for compliance by BRCs. These areas comprise biosafety, biosecurity, risk assessment, ownership and management of IP.

Task 3.1: compilation of legislative and activity information for delivery online via the web portal

Task 3.2: Discussions and agreements on harmonized approaches to legislative background for work in a BRC; accessioning and delivery, access to biological material; work with, authentication, identification, storage

Task 3.3: Develop approaches to the implementation of the OECD Best Practice Guidelines on Biosecurity in partner collections; define extent to which they are already followed, define obstacles and how to overcome these

Items to be considered for a Code of Conduct are:Raising awareness of risks and regulations within the BRC’s. This can for

example be done by education and training of employees and publication of information (website)

Risk assessment. This involves several categories requiring different procedures: humans, livestock, crops, environment (invasive potential), toxins

Accessibility. This concerns limitations and barriers for the acquisition c.q. distribution of both material and information

AccountabilityInformation and communicationShipment and transportSubtask 3.3.1 keep close links with e.g. WHO, EBSA and CEN

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Workpackage 3: Capacity Building in legal background

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