• Contact: networktrainingnoSpam@noSpamema.europanoSpam.eu

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.

• 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

• Clarification of the role of the OTSG in new training initiatives within the network (November 2011)
  Click here

• Strategy for regulatory and scientific training within the European Regulatory Network HERE
• Action Plan for Implementation of the "Strategy for Regulatory and Scientific Training within the European Regulatory Network" (May 2012) HERE

In the first year of operation the Steering Group mandated the Expert Group on Quality of pharmaceuticals with which it has cooperated in the process of defining a framework for competence requirements for assessors of quality of pharmaceuticals.

• Memorandum from the Expert Group of Quality Assessors: work report (April 2011)
  Click here

• Competence requirements and training needs for Quality Assessors (April 2011)
  Click here