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What We Do
Work Package Architecture
— Data Harmonisation
Main aim: Create a central EU data registry for the harmonised collection of clinical data on patients treated with gene and cellular therapies from cells and tissues of hematopoietic origin to support collaborative studies and regulatory decision making.
Current status: multi stakeholder revision of the EBMT cellular therapies data collection form. Balance the expectations of regulatory authorities and company requirements and the feasibility to collect RWD by centres.
— Standards of Care
Main aims: Develop harmonised guidelines on patient and product management for health care professionals. Reduce inspection burden and redundancies by developing and implementing consensus-driven requirements and qualification standards for clinical teams delivering gene and cellular therapies from cells and tissues of hematopoietic origin.
Current status: committee with HCP, JACIE and pharma representatives to work on harmonization of site qualification standards to reduce inspection burden on centres.
Main aim: leverage the central Registry for gene and cellular therapy as a suitable data source for HTA.
Current status: on hold. Input EUnetHTA in form revision WP1 Data harmonisation
Main aims: Develop a central portal for both patients and caregivers as well as health care professionals to access training and educational materials on cellular therapies and to streamline the training supply to minimise duplication of efforts. Develop a consensus-based curriculum that meets the needs of multiple stakeholders.
Current status: alignment and integration of activities with T2Evolve.
— Policy and Advocacy
Main aims: Represent and promote the interests of the GoCART coalition and its stakeholders in EU policy making by engaging with EU institutions and other relevant stakeholders.
Current status: contribution to the European Commissions public consultation on the revision of the Blood, Tissues and Cells directives submitted.
— Scientific Excellence
Main aim: Stimulate scientific discussion across stakeholders, facilitate the set-up of joint research projects and avoid duplication of scientific efforts.
Current status: first call for retrospective study proposals released. Focus on promoting use of existing Registry data and other sources of RWD and on strengthening multi-takeholder collaboration