Contact
For questions or comments related to DARE-NL or oncological ATMPs, to become a partner or connect for information
contact us at info@dare-nl.nl.
© DARE-NL
ATMP & regenerative medicine
HelpdeskRM (Utrecht University, UMC Utrecht): helpdesk to answer any questions you may have related to regenerative medicine (in Dutch)
Agora toolbox (ECA ATMP Working Group): a collection of documents assembled in the AGORA project on ATMP-related applications, protocols, templates, guidance, training and GMP. Access requires registration for a free membership
ATMP Sweden resources (ATMP Sweden): support resources published by ATMP Sweden such as a regulatory guide, commercial aspects and project reports
T2EVOLVE Stakeholder Ecosystem (T2Evolve): alliance to increase access to TCR or CAR immunotherapy; the stakeholder ccosystem is structured as a hub (bi-monthly meetings) and spokes (working groups). You can join at no cost to stay informed, access meetings and participate in projects
Regulations
ECA tools (ECA foundation): information and interpretation of new or updated GMP guidances aimed to move towards a harmonised set of GMP and GDP guidelines
Regulatory and scientific support (EMA): EMA provides regulatory and scientific support to foster development of new and Support to micro, small and medium-sized enterprises (EMA): The European Medicines Agency (EMA) provides incentives and support for micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use, in order to promote innovation and the development of new medicines.
Costs and lead times
Costing tool: A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings. The publication includes a file to calculate costings, with essential background information in the article.
Dashboard doorlooptijd geneesmiddelen (ministry of Health, Welfare and Sport – VWS): an overview of the phase of reimbursement (submission, assessment or negotiation) of expensive new medicines and lead times per phase (in Dutch)
Clinical trials
Clinical research metadata repository (European Clinical Research Infrastructure Network): a searchable database of all registered clinical studies, together with related documents such as results, papers, protocols and data sets, whenever those objects are available