Introduction

The work plan of INSIGHT is based on national networking initiatives of several European countries around a number of main topics regarding the preparedness for and response to major health threats.The work plan is structured around three phases as is depicted in the following figure:

Phase 1

In Phase I an initial assessment has been carried out in which the strengths, weaknesses, needs and capabilities per EU member state and the differences and similarities between the co-operating EU member states will be assessed.

Phase II This phase will consist of sharing knowledge and best practices focussing on:

Risk assessment
In order to define the requirements for priority setting and strategy development, potential risks and calamities will be analysed. Sharing best practices in determining risks will lead to the development of a methodology to assess potential threats.

Networking
The networking process will lead to the actual creation of a European network of national public health institutes. Through sharing knowledge and expertise, the focus of the international network will be on setting priorities, determining requirements for the development, production and registration of essential products, best practices and future approaches. In addition, the networking process consists of considering possibilities to establish a clinical trial network and possibilities to mobilise the industry in order to work together.

Interventions
The activities will be aimed at the definition of possible intervention scenarios in case of sudden outbreaks or deliberate releases of infectious agents, limited to influenza, smallpox, anthrax and SARS. The scenario cases will take into account cost effectiveness and economics of intervention, possible gaps and vaccination developments/requirements as well as budget allocations.

Structure
The structuring activities will be aimed at shaping the European network by determining its modus operandi and programme of action.

In Phase III the results from the second phase will be converged into a policy document in which the current status and recommendations for best practices and improving European preparedness strategies will be outlined. In this phase all results will actively be distributed throughout Europe, primary targets of the report are however national public health authorities and the ministries of public health in the EU member states. Moreover the results will be discussed with the European Commission.

Work package descriptions
Within these three phases, the work plan consists of four highly interactive work packages in which the workload is divided.

Work package 1: Project management
Within this work package lays the responsibility to ensure that INSIGHT reaches its objectives as specified, on time and within budget. Activities within this work package are to manage and co-ordinate the project and the teams of the work packages, assure the coherence within the work packages and an optimal information flow between them, manage the time schedule against the objectives set, manage the available budget against the foreseen deliverables, initiate project meetings, manage communication and information flows (progress, costs etc), communicate and liaise with the European Commission and other stakeholders, prepare and consolidate (progress/management/ financial) reports, based on the reports of the several work package teams.

Within this WP the progress of the work packages will be monitored, with respect to objectives and deliverables set, the time schedule and the available budget. Furthermore, WP1 will co-ordinate and implement all the key administrative and financial decisions in the project and it will ensure the project administration is complete, accurate and in accordance with the guidelines of the European Commission. Contacts with the European Commission and other stakeholders will also go through WP1. In addition, it will organise the regular conference calls and will manage communication and information flows within the consortium, initiating any action required to correct any deviations from the project plan. WP1 will prepare decisions for the advisory board. All management and progress reporting (milestone 4, milestone 6 and milestone 9) will be done through management control reports, yearly control reports, minutes of meetings and conference calls and the yearly cost declarations.

WP1 will also involve the co-ordination of the dissemination of the results by aiming at publishing all non-confidential results and reports and disseminate this information as broadly as possible, through consortium members’ websites, conferences, seminars, workshops and in scientific publications.

Work Package 2: Inventory and priority setting

The objective of this work package is to gain insight in strengths, weaknesses, needs and capabilities per EU member state and to assess differences and similarities between the co-operating EU member states by identifying:

• Country-specific priorities in responding to sudden major health threats.
• Country-specific problems in responding to sudden major health threats.
• Country-specific existing and future plans for preparedness strategies.
• Country-specific capabilities to prepare for and respond to sudden major health threats.
• Existing networks, policies and official documents regarding the preparedness for public health threats.

The initial inventory will contribute to the evaluation and identification of gaps and overlaps in research, development and production of vaccines as well as in common approaches in intervention within the European member states. The outcome of this work package will be a report describing the current status in Europe and a priority list of issues identified (milestone 2). This inventory will set the foundation for the work to be carried out in phase II around networking and work package 3 in which several workshops will be organised. To this end the activities within this work package will consist of a desk study and the development and analysis of a questionnaire that will be send to European health institutes and the European ministries of public health.

For the questionnaire we intend to use the electronic Interactive Dialogue tool. An Interactive Dialogue (ID) is a computer-based program that provides an effective two-way communication channel, either on-line or off-line. The interactive nature of an ID focuses attention and stimulates high quality feedback from management and researchers. This feedback is automatically analysed and instantly available at any time. The response and results of the interactive dialogue will be described in a report (milestone 1). The advantages of using the Interactive Dialogue are: a greatly increased response rate from users, a much-increased level of data captured, easy to sent by email to users throughout Europe, significantly greater reach, simplifying the management of a range of questionnaires for different roles and purposes, feedback is analysed automatically and immediately once returned by the staff member and will be collated into the data reported, reports are instantaneously available in a number of formats.

Work package 3: Networking activities
The focus of work package 3 will be on phases II and III and will consist of two parts: (1) identifying the requirements in order to improve preparedness for emerging diseases or bio-terrorist attacks and (2) the actual networking of European stakeholders in order to create an international platform of national public health institutes.To strengthen the EU member states’ national preparedness and response strategies and to improve European co-operation within this, work package 3 will concentrate on sharing expertise and best practices. The activities of work package 3 will consist of:

• Risk assessment and counting calamities of potential threats, limited to pandemic influenza, smallpox, anthrax and SARS.
• Setting priorities for both short term and long term intervention scenarios.
• Determining possible intervention scenarios, including the identification of assumptions and variables for epidemiological transmission models (with a scenario being the combination of a location – a pathogen – and the method of release of the pathogen; natural or deliberate).
• Identifying requirements for the development, production and registration of essential products.
• Achieving EU-wide accepted cost effectiveness modeling of different intervention methods.
• Defining best practices, which eventually should lead to the identification of common European emergency vaccination goals.

In order to achieve the objectives of work package 3, the following workshops will be organised:

• Workshop 1 (milestone 3): this workshop will be the kick off meeting and will be organised around the outcomes of the initial inventory, risk assessment and setting priorities.
• Workshop 2 (milestone 5): this workshop will be organised around best practices and common goals within emergency vaccination strategies and around interventions, taking into account cost effectiveness.
• Workshop 3 (milestone 8): during this final workshop all previous results and discussions will be reviewed. The main focus of this workshop will be to reach consensus in order to come to the final policy document, concentrating on the theme structure.

All participants of INSIGHT will attend the workshops. Moreover we will expand the network by actively approaching national public health institutes and other stakeholders from member states that are not yet involved. The first two workshops will be preceded by a specific questionnaire. The workshops themselves will be organised as follows:

• Presentations of the co-ordinator of the questionnaire results and presentations by for instance the European Commission, ECDC or industry representatives.
• Discussions around the workshop themes.
• Conclusion and distribution of work.

During the execution of WP3, the release of a progress report will give input to work package 4and will initiate its kick off (milestone 7). 

Work package 4: Development of a European approach

The objective of work package 4 is to present the project’s results on European preparedness strategies and best practices in coping with major health threats in a coherent way in a final policy document (Road Map) (milestone 10). Following the results of WP3 (Structure) the Road Map will also deal with shaping the international network by determining how it should operate and how it should go ahead on the initiatives started within INSIGHT, how decision-making should take place and what the programme of action for the future should be. The policy document will contain recommendations on common emergency vaccination goals, possible intervention scenarios, including cost-effectiveness studies, filling R&D and production gaps, the establishment of a clinical trail network, etcetera (see deliverables). The policy document will be distributed to all relevant stakeholders, especially the national public health authorities in the EU member states and the European ministries of public health. The following activities will be executed in this work package:

• Definition and finalization of common European goals and best practices on immunisation and emergency vaccination in coping with major health threats;
• Definition of possible intervention scenarios in case of sudden outbreaks or deliberate releases of infectious agents, limited to influenza, smallpox, anthrax and SARS;
• Shaping the international network by determining its modus operandi and programme of action;
• Composition of the Road Map in which all project results will be presented in a coherent way;
• Presentation of the project’s results on the final workshop (WP3);
• Dissemination of the final project report to all relevant stakeholders.

Project Team
The Netherlands Vaccine Institute (NVI) is the co-ordinator of the INSIGHT project. Prof. Dr. Bernard van der Zeijst will be responsible for the overall co-ordination of INSIGHT and is the official contact person for the European Union. The day-to-day project management of INSIGHT will be the responsibility of M.Sc. Mariska Zanders, who is assigned as Project Manager. Practical support for the project such as secretarial work, preparation of print work, financial project administration etcetera, as well as financial administrative work will be given by the NVI.The tasks of the management will amongst others consist of:

• Managing and co-ordinating the project
• Assuring the coherence within the work packages
• Managing the time schedule against the objectives set
• Management of the budget available against the deliverables as foreseen
• Initiating project meetings, manage communication and information flows in the project (progress, costs etc)
• Communicating and liaising with the European Commission and other stakeholders
• Preparing and consolidating (progress/management/financial) reports, based on the reports of the several work package teams
• Handling all contacts with the European Commission

Work package teams
Each work package will consist of a work package leader and the technical team that will carry out the research activities. The work package leader will be responsible for the deliverables, time, budget and quality of final results of the work package and all contacts with the project manager. The following work package leaders have been assigned:

Work package	Work package leader	Participants involved
1 Project management	NVI, Prof. Dr. Bernard van der Zeijst NVI, M.Sc. Mariska Zanders	-
2 Inventory	NVI, M.Sc. Mariska Zanders	All
3 Networking	SMI, Dr. Ragnar Norrby	All
4 Strategy development	SSI, Dr. N. Strandberg Pedersen	NVI, SMI

The work package leaders will be responsible for the deliverables concerning time, budget and quality of (final) results of their work packages and for all communication within their work package and with the project manager. The WP leaders will:

• Manage the sub-team of the respective work package
• Be responsible for the necessary resources within the work package
• Assure the (scientific) quality of the work within the respective work package
• Manage and reach the respective deliverables and milestones of the work package
• Manage the time schedule and available budget of the work package
• Discuss approach and methodologies with the project team
• Prepare draft (progress) reports and financial reports of the work package for the project manager

Advisory board

All heads of the national institutes involved as well as a representative from the ECDC and the Health Security Committee will take place in an advisory board. The members of this board will be responsible for delivering the required national information to the work package leaders and to deliver input during the conferences. Te board will be involved in all approaches, methodologies, conclusions and results coming from INSIGHT and will be included in all major events, milestones en decisions in the project. It is not the intention to always seek for consensus within the advisory board. In case opposite views will occur in the board, these will be specifically included into the project reports.During the course of the project, we will seek to include additional members from outside the core consortium into the advisory board in order to reach a pan European coverage.

 

ECDC

The project director of the ECDC will be involved in the project in order to align any developments within the ECDC with activities and results coming from INSIGHT. Therefore the project director of the ECDC will be invited to participate in the advisory board of INSIGHT. Furthermore, the ECDC will be included in mailing lists of INSIGHT.

 

DG SANCO and the Health Security Programme

The EU Health Security Programme comprises 25 actions grouped under four objectives. Under this programme a workgroup on the development and availability of medical products (including vaccines) against major public health threats has been established. Several experts of partners of INSIGHT are actively involved in this working group. INSIGHT will therefore work in close co-operation with DG SANCO, the programme and the working group.