Joint HMA/EMA Office of Training Steering Group (OTSG)
Who are we?
The Joint HMA/EMA Office of Training Steering Group is a group of experienced assessors and regualtory experts from HMA and EMA chaired by a Head of Agency. It received its mandate from HMA and EMA following the adoption of the "Strategy for regulatory and scientific training within the European Regulatory Network " 2010. The provision of harmonised, high quality training has previously been indentified by both HMA and EMA as key activity which would enhance the quality and consistency of the work of the European Regulatory Network and Strategy concluded that the best means to allow for such harmonisation was through the creation of an EU Office of Traning (the "Office"). As a next step, The Steering Group was formed to oversee the establishment of this Office which will operate as a "virtual" office in the first instance.
Our responsibilities
- To manage the creation of the EU Office of Training
- To provide strategic guidance to its subsequent operation
- To act as a link between the Office, HMA and EMA, receiving, scrutinising and passing on reports on its operation
- To identify, seek and obtain the resources necessary for the operation of the Office
- To act as a referral body in resolving issues related to the composition of Subject matter Expert Groups which cannot be resolved within the group or at Office level
Key documents
Current activities:
In the first year of operation the Steering Group madated the Expert Group on Quality of pahrmaceuticals with which it has cooperated in the process of defining a framework for competenece requirements for assessors of quality of pharmaceuticals. The Steering Group has also surveyed the National Competent Authorities and the World Wide Web for existing regulatory and scientific training and has created a list of such events. The results of these initiatives are being presented to the HMA in April 2011.
Contact: networktraining@ema.europa.eu