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The work of NorPedMed is based on the EU pediatric regulation of January 2007, which in short may be viewed as a public health assignment, aiming to facilitate development and availability of high quality, ethically researched and appropriately authorized medicines for children. NorPedMed aims to increase the recruiting basis for clinical trials in Norway and to direct research funding to this country.

NorPedMed operates on a non-profit basis and aims to facilitate high quality paediatric clinical trials, in accordance with current regulations and ICH-GCP, for the benefit of children's health. Trials may be sponsored by industry as well as by academic or other institutions. NorPedMed also facilitates recruitment of experts and investigators to work as specialists in relation to sponsors requesting paediatric research expertise. NorPedMed is not a juridical party; i.e. agreements cannot be signed on its behalf. Agreements are made and signed between sponsors, research organizations, hospitals or investigators directly. Moreover, NorPedMed does not process, deal with or compete with trial funding. The administration of trial funding is processed at research organizations and hospitals or hospital districts.

NorPedMed aims to make clinical trials in Norway less time-consuming and less cumbersome to perform, and to make infrastructural support more effective. NorPedMed aims to encompass experts in all fields of paediatric medicine, in order to improve the opportunities for clinical trials being conducted in Norway. A long-term aim for NorPedMed is to promote harmonization of the operational models and the paperwork involved in clinical trials in Norway and to reduce their administrative complexities.

NorPedMed aims to establish itself as a nationally and internationally reliable and state-of-the-art paediatric trial network and to increase co-operation and influence in the EU. NorPedMed aims to become a member of the European Network of Paediatric Research at the European Medicines Agency, Enpr-EMA, established by the European Medicines Agency (EMA) in 2010. EnprEMA comprises both national and European networks as well as investigator and research units that have special expertise in paediatric clinical trials. An EnprEMA membership is assessed and updated annually through filing a self-assessment report. NorPedMed submitted the application to become an Enpr-EMA member in june 2016, you can view the application here.

In short, NorPedMed aims to facilitate paediatric clinical trials in Norway; it promotes the concept of “one-stop-shop” and will provide the necessary infrastructural support to achieve this end. NorPedMed is also a member of NordicPedMed, which governs a project developing a joint Nordic Investigators Registry during 2016. The final aim is to establish NordicPedMed as new Nordic network that include investigators working with paediatric clinical trials in all the Nordic countries, in the same registry.
More information regarding NordicPedMed and registrering as an investigator.
Medicines for Children Network, Norway, of which NorPedMed is a subsidary, has funded a few investigator initiated studies. These can be viewed here.

Publisert: 16. jan. 2023 — Oppdatert: 22. mai 2023