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Browsing by Subject "päätöksenteko"

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  • Sandström, Saana (2015)
    Manufacturing execution systems (MES) are computer systems which are used for controlling and automating manufacturing processes. They are increasingly adapted in pharmaceutical industry. Implementation solutions differ, however, and there is no single solution which would be the optimal one for all facilities. Each manufacturing facility has their unique properties and needs which have to be reflected in the implementation. A successful MES project will bring plenty of benefits such as more efficient use of resources and automated data transfer, but the roll out phase might turn to be problematic if the processes of the organization have not been analysed thoroughly enough at decision making. This creates the need for systematic analysis of possible to-be implementation scenarios which is based on the value-drivers of the organization and considers the decision from multiple viewpoints. This study presents a holistic value driver-based framework with a mathematical weighing method to allow for a systematic and scientifically justified decision for identification of the optimal implementation depth of equipment management (EQM) in MES. A Delphi study method was utilized in this study to create the framework. The framework was developed based on literature and brainstorming sessions with experts and validated by means of a Delphi questionnaire round with expert panel consisting of professionals representing the major stakeholders of MES system in a pharmaceutical manufacturing facility. Classical additive weighing method was applied to create a mathematical basis for valuation and comparison of the scenarios. The robustness of mathematical method was tested by means of a sensitivity analysis. A benchmarking survey was done to obtain information on current implementation solutions and decisions leading to current situation. The presented method not only addresses the costs but also takes into account intangible factors. Intangible factors include aspects such as good manufacturing practice (GMP) quality and user acceptance which are not directly transferable into quantitative units but are crucial both for pharmaceutical industry and the success of the implementation project. The framework describes the decision in the form of a value tree with three main branches, namely GMP, cost and process&organization which cover the main viewpoints important for the decision. The presented method also allows the weighing of different factors according to current needs of the facility and decision in question. Hence, the presented framework leads the decision maker through a systematic and comprehensive analysis of different to-be scenarios for EQM implementation. The benchmarking survey identified three major factors of a successful MES implementation, namely effort in design phase, well-defined processes and close discussion with production. The value drivers valued highest by the expert panelists were related to GMP quality. As a use case, the presented framework was applied in a parenterals clinical manufacturing facility to evaluate six different to-be scenarios and based on the results one of them was selected by the management to be implemented. The results from the use case indicate that the framework is a valuable tool in a decision making process, and encourage the further utilization of the framework in future implementation decisions.
  • Halonen, Henna (2013)
    In Finland pharmaceutical policy is a part of health policy. It concerns social decision making on pharmaceutical sector and people and organizations around pharmaceuticals. Pharmaceutical policy 2020 strategy was prepared by the Ministry of Social Affairs and Health, based on a stakeholder (administrative authorities, education and research, industry, medicine wholesalers, patients, pharmacies, professional organizations, public sector) analysis. In Finnish politics this is an assignment of a new kind of evidence-informed policy making (EIPM), which is participative, transparent and democratic. The two main objectives of this study were to evaluate the present state of pharmaceutical policy in Finland and discern the emphasis of pharmaceutical policy by the stakeholders' point of view in the future. The study gave the possibility to a deeper analysis of stakeholders' opinions of the Finnish pharmaceutical policy in the beginning of the year 2010 than it was possible in the official Pharmaceutical policy 2020 strategy document. Besides this, research itself was a way of practicing evidence-based policy. The SWOT-analysis were conducted among key-stakeholders as a main material of this qualitative research (n=19, response rate 59). SWOT analyses included present strengths, weaknesses, opportunities and threats regarding Finnish drug discipline of a stakeholder's point of view. Furthermore, an e-survey (n=10, response rate 31) was conducted in the end of the strategy process in order to enablegive the stakeholders to give feedback of the Pharmaceutical policy 2020 strategy process. The survey also measured that was the consensus among stakeholders reached during the strategy process. It prevailed a very good mutual understanding. Results of the research were clearly readable on the official strategy paper as well as the research could go deeper in the details of stakeholders' words than the official strategy paper. The most important emphases in the results were noticeable: condense the cooperation of stakeholders among the drug discipline to ensure efficient, good quality and patient safe pharmaceutical service and better utilizing of pharmaceutical knowledge among social and public health service. The results of this research can be utilized later as a starting point to measure how Pharmaceutical policy 2020 strategy has came true. With help of this study it's also possible to verify the strategy process and Finnish national medicine policy in the 2020 decade. In Ministry of Social Affairs and Health it is also possible to think, what kind of legislative changes it demands to implement the needed changes among the drug discipline.