European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



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ITCC - Innovative Therapies for Children with Cancer

Number of peer reviewed publications in the last 5 years 10 http://www.itcc-consortium.org/publications.php
Number of competitive grants obtained in the last 5 years 7 Publications constitute on one hand the contribution of the network in terms of implication in the design of studies and the recruitment conducted within ITCC, as well as research articles on innovative designs, pre-clinical evaluations and regulatory aspects.
Access to expert groups Yes - The individual members of the ITCC network form a group of experts in the field of paediatric oncology/haematology and new drug development, including biology, pharmacology and methodology - The ITCC network has established joint programms and collaboration with the European paediatric tumour groups which are in charge of late phase II and phase III trials (e.g. SIOPEN, IBFM, EpSSG, SIOPE-Brain,….). Full Paediatric Investigation Plans can be designed and delivered, up to phase III. - The ITCC will develop its activity within the frame of the FP7 ENCCA network of excellence (European Network for Cancer research in Children and Adolescents) that will be launched Q1 2011.
Capacity to answer external scientific questions Yes
Site feasibility Yes The Accreditation and Quality committee evaluates the capacity of member institution to participate to ITCC trials. Site feasibility is being run by the sponsor.
Participant recruitment Yes Recruitment is performed by the sponsors. ITCC is provided on an annual basis by the sponsor with the recruitment numbers per ITCC centre.
Budget calculation for studies Yes Sponsorship agreement is currently elaborated between the coordinating sponsors within ITCC which will include recommendations for budget calculations.