Work Package 1 (WP1): Co-ordination and Project Management
Led by Dr. Mark W. Lowdell (UCL)
The work package 1 is dedicated to the management of the consortium, dealing with all legal and administrative aspects. The coordinator and leader of work package 1 evaluates the progress of the project and monitors the timely and concise preparation of the report to the community, the regulatory agencies and policy makers, among other tasks.
Work Package 2 (WP2): Technology Training & Transfer
Led by Dr. Ulrike Köhl (MHH)
- To design training programmes to create the skills needed by academic trialists aiming to develop ATMPs throughout the EU for translation from pre-clinical to early clinical trials.
- To establish training programmes for academic trialists and SMEs in biopharma on process scale-up / scale-out for late stage clinical trials and commercial production of ATMPs.
- To exchange and harmonise training resources within the consortium to establish their own training courses which will be available for on-line learning across the EU and beyond.
- To design web-based training to allow remote participation in the programmes above.
Work Package 3 (WP3): Networking
Led by Dr. Martin Hildebrandt (TUM-MED)
- To establish and maintain a communication structure within the Network of facilities and practitioners in the GMP environment.
- To provide an access to the AGORA Network, via a web based platform as a source of information and discussion forum for interested parties, stakeholders, researchers and the public.
- To design and establish the format needed for the development of a document “toolbox” to be provided for researchers use.
- To efficiently implement a comprehensive web-based project platform based on requirement analysis and specification.
Work Package 4 (WP4): Development of a Toolbox for Researchers
Led by Dr. Anne Dickinson (UNEW)
- To create an on –line tool including a decision tree flow chart to assist product developers in deciding the likelihood that their product is an ATMP and to direct them to the correct contact in their Competent Authority to obtain formal classification.
- To create an on-line tool box of proven GMP-compliant documents for open access availability to end-users to facilitate development of new ATMPs for trial.
- Within the toolbox to provide a comprehensive list of manufacturing facilities with contact details across the EU able to provide advice related to GMP manufacturing of ATMPs.
- To provide risk assessments of non-GMP compliant reagents/consumables which have been used in GMP manufacture to increase availability of critical reagents.
- To provide web-links to relevant European Medicines Agency (EMA) and European Directorate for the Quality of Medicines (EDQM) pages.
Work Package 5 (WP5): Representation and Outreach
Led by Dr. Ineke Slaper-Cortenbach (UMCU)
To represent the facilities within the GMP-network and make a direct link with the authorities/regulators in Europe. Representation of AGORA in front of policy makers including the European Parliament and the European Commission, European and national regulatory authorities, scientific organizations and the scientific community. Communication of the objectives and structure of AGORA to interested parties.