Using a Systems Theory approach allows a person to analyze the intertwined elements of the drug development system and the potential influences of the environment. Thomas Hughes's Large Technological Systems (LTS) Theory is one that could be used for this purpose; however, it falls short in its ability to address the complexity of current day regulatory environments. This dissertation provides a critical analysis of Hughes's LTS Theory and his phases of evolution as they apply to the United States (U.S.) system for biologic drug research, development and labeling. It identifies and explains potential flaws with Hughes's LTS Theory and provides suggested improvements. As an alternative approach, this dissertation explores the concept of "techno-regulatory system" where government regulators play an integral part in system innovations and explains why such systems do not always follow Hughes's model. Finally, this dissertation proposes a hybrid version of Hughes's systems approach and uses it to explain the changes that occurred in the drug approval system in response to the push for, opposition, and inclusion of, pediatric research in drug development during the period 1950-2003. / Ph. D.

Barnkonventionen ratificerades i Sverige för 31 år sedan och inkorporerades i svensk lag den 1 januari 2020. Barnkonventionen betraktar barn som rättighetsbärare. Syftet i denna uppsats var att undersöka hur man inom barn och unga i socialtjänsten arbetar med barn i olika åldrar med anknytning till barnkonventionen samt att undersöka hur socialtjänsten uppfattar samverkan med andra professioner i förhållande till konventionen. För att besvara syftet intervjuades fyra socialsekreterare. Materialet från intervjuerna har analyserats genom en kvalitativ innehållsanalys. Resultatet tolkades med hjälp av det barndomssociologiska perspektivet och samverkansteori. Resultatet visade att bilden av barn som rättighetsbärare var förankrad inom socialtjänsten med fokus på att barnet skulle höras och vara delaktigt. Vidare framkom att information gällande hur barnkonventionen skulle omsättas i det praktiska arbetet var efterfrågat. Det fanns brist på resurser i förhållande till det arbete som barnkonventionen krävde. Slutsatsen är att synsättet på barn som rättighetsbärare överensstämde med barndomssociologin. Bristande utbildning, rättspraxis och organisatoriska förutsättningar såsom budget riskerade att minska barnkonventionens inflytande i ärenden. Inom samverkan riskerade även resursbrist för professioner att minska barnkonventionens inflytande i ärenden. Korrekta förväntningar på varandras professioner och deras handlingsutrymme betraktades öka barnkonventionens inflytande i samverkan. / The Convention on the Rights of the Child was ratified in Sweden 31 years ago and incorporated into Swedish law on 1 January 2020. The convention considers children to be rights holders. The purpose of this essay was to investigate how the social services work with children of different ages in connection with the convention and to investigate how the social services perceive collaboration with other professions in relation to the convention. To answer the purpose, four social secretaries were interviewed. The material from the interviews has been analyzed through a qualitative content analysis. The results were interpreted with the help of the childhood sociological perspective and collaboration theory. The results showed that the image of children as rights holders was rooted in the social services with a focus on the child being heard and involved. Furthermore, it emerged that information regarding how the convention was to be implemented in the practical work was requested. There was a lack of resources in relation to the work required by the convention. The conclusion is that the view of children as rights holders was in line with the sociology of childhood. Lack of education, case law and organizational conditions such as the budget risked reducing the influence of the convention in matters. In collaboration, a lack of resources risked reducing the influence of the convention in the matter. Correct expectations of each other's professions and their scope for action were considered to increase the influence of the convention in collaboration.