European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies



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ITCC - Innovative Therapies for Children and Adolescents with Cancer

Evidence of collaboration with regulatory authorities Yes - ITCC members contributed to the Paediatric Addendum of the EMA guidance for the development of anticancer drugs in human (CPMP/EWP/569/02 July 2003) - ITCC collaborates closely with EMA both directly and through Accelerate activities for example the 'Paediatric Strategy Forums'; ITCC is a founder member of Accelerate
Capacity to provide competent consultation to regulatory authorities Yes ITCC has the expertise in all fields of paediatric oncology and haematology to provide competent consultation to regulatory authorities.
Formal meetings for clinical trials Yes - for each clinical trial, an investigator meeting is being held at least once a year. - the tumour committees have visioconference calls on a monthly basis to manage ITCC trials portfolio - one General Assembly meeting is held each year.
Training courses given over the last 2 years Yes ITCC has an Education & Training Committee which coordinates education activities including appointment of clinical fellows and collaboration on European training courses in paediatric oncology as well as organising bi-annual ITCC Training Days alternating with bi-annual ITCC Scientific Days.
Training courses received over the last 2 years Yes ITCC host an Annual Meeting which includes external speakers reporting on clinical trials and childhood external investigator meetings can he held alongside.
Promotion of participation in clinical trials in countries with limited resources No
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