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Structure
Participants
Participants are all individuals or organizational groups who contribute directly to the work of the Brighton Collaboration independent of their level of involvement. Participants are expected to be familiar with the principles and policies of the Brighton Collaboration. Participants can serve in more than one capacity and can be volunteers or staff.
Collaboration with Other Organizations
The Brighton Collaboration seeks broad collaboration with all organizations concerned with various aspects of immunization safety as well as consistency with widely accepted and implemented medical terminology (i.e., MedDRA and WHO-ART).
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Steering Committee
The Steering Committee oversees the overall mission, sets policies, determines the process, strategic goals and objectives, and monitors the growth of the Collaboration. Steering Committee members serve unlimited terms. A rotation of Steering Committee members through a formal election process is anticipated based on growth and emerging needs of the Collaboration. The Steering Committee shall be comprised of seven members.
The Steering Committee consists of seven members. Steering Committee members act as individuals experienced in and concerned with immunization safety research.
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Secretariat
The Secretariat coordinates and manages the work of the Collaboration to meet its objectives. It consists of two General Coordinators, a Scientific Coordinator and a General Manager. It is anticipated to involve additional staff in the Secretariat.
The General Coordinators develop and implement policies, procedures, and strategic plans. They enable the Steering Committee to fulfill its function, and the volunteers to work together efficiently towards the achievement of the Collaboration’s mission, and its annual goals and objectives. The Brighton Collaboration Coordinators are assigned by the Steering Committee and have medical, epidemiological, and public health backgrounds.
The Scientific Coordinator assists the General Coordinators in realizing the scientific targets of the Collaboration. The scientific coordinator is hired by the General Coordinators.
The General Manager assists the General Coordinators in the day-to-day operations of the Collaboration. The General Manager is hired by the General Coordinators.
The Secretariat currently consists of three members with support from the founding general coordinators.
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Working Groups
The Working Groups include several Case Definition Working Groups, the Implementation Working Group, and a Neonatal Immunization Working Group.
The Case Definition Working Groups develop standardized case definitions and guidelines for data collection, analysis, and presentation of AEFI.
The Working Group Coordinators with the assistance of the Brighton Collaboration Coordinators ascertain that the work within the Working Groups is being carried out in accordance with the policies and processes of the Collaboration. The Working Group Coordinators see that the objectives of the Working Groups are met within set time lines. The Working Group Coordinators are selected by the Brighton Collaboration Coordinators.
Working Group Team Leaders serve as chair of their respective Working Group. Working Groups work as multidisciplinary teams consisting of 5 - 20 volunteers with relevant experience in patient care, public health, clinical trials, safety surveillance and safety assessment from developed and developing countries. Should necessary professional or geographical expertise be underrepresented in a Working Group, efforts will be made to recruit additional volunteers. Volunteers are actively sought by the Secretariat, can be recommended, or can volunteer themselves. Volunteers may participate in more than one Working Group.
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Reference Group
The Reference Group serves as a larger body providing a wide range of perspectives to assess the clarity, usefulness and applicability of case definitions and guidelines developed by the Working Groups.
Reference Group volunteers are representatives or individuals from patient care, public health, scientific, pharmaceutical, regulatory and professional organizations from developed and developing countries, who share an interest in promoting vaccine safety. Volunteers are actively sought by the Secretariat, can be recommended, or can volunteer themselves. The largest possible geographic and organizational representation of Reference Group volunteers is aimed for.
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Implementation Group
To achieve the goal of global implementation of vaccine safety standards, a specific action plan was developed in 2006 by the Brighton Collaboration Secretariat with guidance from the
Steering Committee. The major action taken to increase developing country participation was
the creation of the Implementation Working Group, which will specifically target developing country issues and concerns. The goal of this group is to facilitate the use of Brighton Collaboration AEFI definitions around the world. The concept of this Working Group is fairly simple: There are approved and evidence-based standards available; there are people willing to use them, and others who can help and counsel in the process. Bringing these people to one table will be the next logical step to the implementation of vaccine safety standards globally.
Simultaneous with the recruitment process, a comprehensive literature review has been conducted resulting in an EndNote Database of more than 400 relevant articles. A systematic analysis of these publications is currently underway. In analogy with the work process of “traditional” Brighton Working Groups (creating AEFI case definitions), a systematic literature inventory was presented to the Implementation Working Group with the second conference call, along with a draft review paper on “Challenges and Opportunities in the Implementation of Vaccine Safety Standards in Developing Countries” to be
finalized after review and discussion with the working group. This first consensus document of the newly formed working group will be ready for submission in 2008.
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Evaluation Group
The Evaluation Group assesses the applicability, reliability, sensitivity and specificity of standardized case definitions of AEFI using data from pre- and post-licensure vaccine safety studies and post-marketing surveillance systems. The applicability and usefulness of guidelines for data collection, analysis, and presentation will also be assessed.
The group will be formally established pending additional funding. The activities are currently absorbed at a basic level by the present infrastructure of the Collaboration.
The Evaluation Group is anticipated to consist of a Coordinator with experience in medical epidemiology, and researchers and consultants with clinical background and experience in study design and implementation.
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