Strategy on Training and Capacity Building

The ICH Steering Committee recognises the importance of training in helping to facilitate the implementation of ICH Guidelines both in its own regions and beyond.

Training in ICH Regions

In the ICH regions, the need for oversight on training with respect to ICH Guidelines is generally left to each region’s discretion. One exception to this is in relation to MedDRA, where the ICH MedDRA Management Board oversees the provision of training to MedDRA subscribers worldwide.

The Steering Committee however acknowledges that from time to time there is benefit in coordinating training activities so as to ensure consistency in the manner in which Guidelines are implemented, particularly where new and complex concepts are introduced. The 2010 ICH Quality Implementation Working Group training on the ICH Q8, Q9 and Q10 Guidelines is one such example. Leveraging with external organisations, ICH experts coordinated to develop and deliver the same training programme in each of the three ICH regions.

Training Beyond the ICH Regions

There is an increasing interest from non-ICH regions in the utilisation of ICH Guidelines, and as a consequence, training and capacity-building have become a key focus of the ICH Steering Committee (SC).

In 2006, the Global Cooperation Group (a subset of the ICH SC) implemented a strategy for addressing the training and capacity needs to help ensure the most effective use of resources, opportunities and the realisation of desired outcomes. Formal procedures to assist the SC in the review and prioritisation of requests for training were also developed.

Over the past few years, the GCG has responded to numerous requests for training, providing ICH expertise both for the development of training programmes and for the delivery of the training itself. To expand as broadly as possible the benefits of such training, the materials from GCG-endorsed training events are made available on the ICH website.

In June 2013, the ICH SC adopted a new format for the GCG which was incorporated into a standing agenda item of the SC agenda entitled Global Cooperation (GC) session. The GC session maintains past GCG arrangements regarding RHIs/DRAs/DoH participation and the scope of activities related to the implementation of ICH Guidelines and capacity building.

The ICH MedDRA Management Board also coordinates closely with the SC to offer assistance to countries and regions where there is an interest to implement MedDRA.



"Training is key to promoting a better understanding and proper implementation of ICH Guidelines"

Mike Ward
Health Canada