European Medicines Agency - Regulatory - Regulation of medicines

5 -Training and educational capacity to build competencies

    Description

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I-BFM-SG - International BFM Study Group
Evidence of collaboration with regulatory authorities Yes Many members of the I-BFM-SG network have been involved in several initiatives of the regulatory authorities.
Capacity to provide competent consultation to regulatory authorities Yes see above
Formal meetings for clinical trials Yes The development of each clinical trial includes, is achieved through several meetings of the steering commitees. Once/twice x year 1-2 meetings of the Disease Committees (i.e ALL, AML…) are organized to update/plan/ discuss the different ongoing research projects, including the clinical studies. The Annual meeting offers the opportunity for all National delegations to have un update of the entire activiets of the network.
Training courses given over the last 2 years Yes No training course were planned at the network levels, but this activity occurs at National levels for each specific clinical study. However, for example for AIEOP-BFM ALL 2009 study a common two days course was organized for the launch and the presentation of the study to the different National delegations.
Training courses received over the last 2 years No
Promotion of participation in clinical trials in countries with limited resources Yes The ALL IC-BFM 2002 was one of the most successful example of a clinical trial in chilhood ALL conducted by countries with limited resources, as regular members of the network (Argentina, Poland, Chile, Czech Rep., Hungary, Israel, Serbia, Hong Kong, Croatia, Slovakia, Uruguay and Slovenia) or as partcipating members (Ukraine, Cuba and Moscow). The network, in particular BFM-Germany, has provided the methodological support for study design, data management and analysis.
List of Countries