5 -Training and educational capacity to build competencies
|
Quality
Management |
Training and
Education |
Public
Involvement |
| Description | ||
|---|---|---|
Name |
ITCC - Innovative Therapies for Children 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 members are members of the EMA Task force in Paediatric Oncology, which is co-chaired by the ITCC president - ITCC members were members of the EMA Committee on Orphan Medical Products Several ITCC members are experts for the CHMP. |
| 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 clinical trial committee has conference 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-ENCCA Training course, 12-14 September, 2012 - FLIMS 14 & 15 ECCO - AACR - EORTC - ESMO Workshop on 'Methods in Clinical Cancer Research' - June 2012 & 2013 - Two CTC Workshops on Quality improvement and new clinical trials ITCC members give lessons on new drug development in several Training courses in Paediatric Oncology, such as those of the European School of Oncology and the Amsterdam School of Paediatric Oncology. |
| Training courses received over the last 2 years | Yes | See above. |
| Promotion of participation in clinical trials in countries with limited resources | Yes | The network may give recommendations on clinical centres outside of its own scope to the sponsor. |
| List of Countries |