Der europarechtlich vorgeprägte und national stark ausdifferenzierte Bedarfsplanungs- und Genehmigungsablauf für Hoch- und Höchstspannungsleitungsvorhaben ist durch ein umfassendes Beteiligungsregime zu Gunsten der Öffentlichkeit ausgestaltet. Im Rahmen der gegenständlichen Arbeit wurden sowohl die formellen als auch die informellen Beteiligungsmöglichkeiten der Öffentlichkeit analysiert, klassifiziert, kritisch hinterfragt und hinsichtlich der verschiedentlich anwendbaren normativen Vorgaben miteinander verglichen. Hierbei haben unter anderem europarechtlich das Vierte Energiebinnenmarktpaket aus den Jahren 2018 und 2019, national das Gesetz zur Beschleunigung des Energieleitungsausbaus aus dem Jahr 2019 und das Planungssicherstellungsgesetz aus dem Jahr 2020 sowie föderal das Umweltverwaltungsgesetz aus dem Jahr 2014 besondere Berücksichtigung gefunden. Insgesamt konnte die aktuelle Gesetzeslage, Rechtsprechung und Literatur bis Ende Juni 2020 in die vorliegende Untersuchung eingearbeitet werden.:Teil 1: Einführung Teil 2: Grundlagen der Öffentlichkeitsbeteiligung im Netzausbau Teil 3: Öffentlichkeitsbeteiligung im Rahmen der Bedarfsplanung Teil 4: Öffentlichkeitsbeteiligung im Rahmen der Korridor- und Trassenplanung Teil 5: (Temporäre) Wirkungen des PlanSiG auf die Öffentlichkeitsbeteiligung Teil 6: Gesamtbetrachtung zur Verbesserung des Beteiligungsregimes / The planning and approval process for high and extra high voltage power line pro- jects, which is predefined by European law and differentiated by German law, is designed in favour of the public through a comprehensive participation regime. In the context of this work, both the formal and the informal opportunities for public participation were analysed, classified, critically questioned and compared with one another in terms of the various normative requirements. Among other things, the Fourth European Internal Energy Market Package from 2018 and 2019, the national law to accelerate the expansion of power lines from 2019, and the law to ensure proper planning and approval procedures from 2020 as well as the federal law to standardise environmental administration law and to strengthen public participation in the environmental field from 2014 have been given special consideration. Overall, the current legal situation, the case law and the literature until the end of June 2020 have been incorporated into the present study.:Teil 1: Einführung Teil 2: Grundlagen der Öffentlichkeitsbeteiligung im Netzausbau Teil 3: Öffentlichkeitsbeteiligung im Rahmen der Bedarfsplanung Teil 4: Öffentlichkeitsbeteiligung im Rahmen der Korridor- und Trassenplanung Teil 5: (Temporäre) Wirkungen des PlanSiG auf die Öffentlichkeitsbeteiligung Teil 6: Gesamtbetrachtung zur Verbesserung des Beteiligungsregimes

O constante crescimento mundial da Pesquisa Clínica no desenvolvimento de novas drogas foi responsável pelo aumento do interesse em traçar as atividades desenvolvidas pelas Autoridades Regulatórias. Os dados foram obtidos através de revisão bibliográfica sistemática, destacando o tempo de aprovação dos protocolos clínicos e as normatizações vigentes: no Brasil, Estados Unidos da América, União Europeia, Canadá e Japão. Além disso, observou-se a atuação de profissionais experientes na realização de atividades no Comitê de Ética para Análise de Projetos de Pesquisa (CAPPesq) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP). Com isso, foi possível identificar as diferenças significantes em relação à legislação e ao sistema regulatório dos países em questão. Deficiências no sistema regulatório brasileiro responsáveis pela demora no tempo de aprovação foram constatadas. Com a identificação destes fatores, foram elaboradas sugestões relacionadas à qualificação dos profissionais atuantes, organização das atividades desempenhadas pelas Autoridades Regulatórias e possíveis alterações administrativas. A diferente atuação das autoridades analisadas pode servir como fonte de aprimoramento do sistema regulatório nacional e, consequentemente, aprimorar o processo para aprovação e realização de protocolos clínicos com medicamentos testados no Brasil. / The world-wide Clinical Research for new drug development growth was responsible for the increase of interest in following the regulatory authorities activities. Data were collected through a systematic literature review.The main facts observed were clinical protocols time approval and guidelines in Brazil, United States of America, European Union, Canada and Japan. In addition, it was observed the activities realized by experienced professionals of the IRB of the University of São Paulo School of Medicine. Significant legislation and regulatory system differences between the countries were identified. Some deficiencies at Brazilian regulatory system, suggestions regarding the acting professionals qualification, organization of the regulatory authorities activities and possible administrative changes were discussed. The different performance of the regulatory authorities can serve as a source to upgrade the national regulatory system and consequently lead to improvements in process of approval and realization of clinical protocol with drugs tested in Brazil.

O constante crescimento mundial da Pesquisa Clínica no desenvolvimento de novas drogas foi responsável pelo aumento do interesse em traçar as atividades desenvolvidas pelas Autoridades Regulatórias. Os dados foram obtidos através de revisão bibliográfica sistemática, destacando o tempo de aprovação dos protocolos clínicos e as normatizações vigentes: no Brasil, Estados Unidos da América, União Europeia, Canadá e Japão. Além disso, observou-se a atuação de profissionais experientes na realização de atividades no Comitê de Ética para Análise de Projetos de Pesquisa (CAPPesq) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (HCFMUSP). Com isso, foi possível identificar as diferenças significantes em relação à legislação e ao sistema regulatório dos países em questão. Deficiências no sistema regulatório brasileiro responsáveis pela demora no tempo de aprovação foram constatadas. Com a identificação destes fatores, foram elaboradas sugestões relacionadas à qualificação dos profissionais atuantes, organização das atividades desempenhadas pelas Autoridades Regulatórias e possíveis alterações administrativas. A diferente atuação das autoridades analisadas pode servir como fonte de aprimoramento do sistema regulatório nacional e, consequentemente, aprimorar o processo para aprovação e realização de protocolos clínicos com medicamentos testados no Brasil. / The world-wide Clinical Research for new drug development growth was responsible for the increase of interest in following the regulatory authorities activities. Data were collected through a systematic literature review.The main facts observed were clinical protocols time approval and guidelines in Brazil, United States of America, European Union, Canada and Japan. In addition, it was observed the activities realized by experienced professionals of the IRB of the University of São Paulo School of Medicine. Significant legislation and regulatory system differences between the countries were identified. Some deficiencies at Brazilian regulatory system, suggestions regarding the acting professionals qualification, organization of the regulatory authorities activities and possible administrative changes were discussed. The different performance of the regulatory authorities can serve as a source to upgrade the national regulatory system and consequently lead to improvements in process of approval and realization of clinical protocol with drugs tested in Brazil.

The aim of the thesis Credit registers and their usage is to evaluate the impact of credit registers usage in banking sector. The first part of the thesis focuses on description of credit registers, their creation and functioning at the level of the European Union. The second part describes and compares credit registers in the Czech Republic. The last part analyses the influence of negative information obtained from credit registers on the approval process and the use of registers when offering credit products to clients. In this part the positive influence of the use of credit registers in the banking sector is proved. The method of description and descriptive analysis is used in the thesis.

This diploma thesis focuses on drug approval efficiency. It is obvious that the drug approval process is lengthy and expensive. The question that arises is whether the length of the drug approval process, as well as associated costs, leads to better safety. The first part briefly summarizes the history of the drug regulation and the drug legislative in the Czech Republic. Also focuses on the theory of economic regulation and the theory of bureaucracy. The second part deals with the drug approval process for new drugs, describes preclinical and clinical testing in relation to the analysis of Sam Peltzman. The third part compares drug approval process in different markets. The last part summarizes off-label prescribing, especially in pediatric.

The main aim of the thesis is to introduce the reader to the issues of preparation and management of buildings from the perspective of the investor. The task of the thesis is to describe the course of individual phases of the project life cycle from the perspective of the investor and creat the relevant documentation for project management. The output of the thesis is a practical demostration of the above-mentioned issues on a real project for a specific client and an analysis of the planned and actual costs needed to ipmplement the project.

This study examines the development of Volvo Group Trucks Operations Powertrain Production (Volvo GTO PTP) in Skövde, focusing on the implementation of processes for new products intended for both internal and external customers. Previously, the company solely supplied products within the Volvo Group, functioning as an Original Equipment Manufacturer (OEM). With the opportunity to adhere to the supplier-specific quality standard IATF 16949:2016, an extension of the ISO 9001:2015 quality standard. Volvo GTO PTP aims to enhance product and process development through the adoption of the Advanced Product Quality Planning (APQP) method. Unlike the existing project models, Develop Product and Aftermarket Product Portfolio (DVP) and Project Steering Model (PSM), used by Volvo GTO PTP, the APQP method validates product and process development together.   This study investigates the relationship between the current project models, DVP and PSM, and the APQP model, identifying areas within APQP that require further development. Interviews and thematic analysis were conducted to assess the current state of APQP, with an evaluation matrix employed for quantitative analysis. Findings reveal a knowledge gap within Volvo GTO PTP, wherein comprehension of APQP activities and their correlation with DVP and PSM is lacking. Critical activities for execution and management within the APQP model include measurement system analysis (MSA), checking aids, records of customer-specific requirements, part submission warrant, and Production Part Approval Process (PPAP). Furthermore, organizational culture-related deficiencies contribute to the difficulties in adopting a holistic project perspective due to siloed working practices.    The integration of APQP in the existing project models is recommended to Volvo GTO PTP in Skövde, as many APQP activities are already established or easily implementable. This integration facilitates the clear definition and demonstration of interplay between different project models, clarifying deliveries and the release of product and process development. To avoid reactive approaches to problem management, it is advisable to explicitly define responsibility for risk management and activities within the APQP model. The demand for APQP activities emphasizes their interconnectedness and creates a natural flow within the project model, contributing to an improved organizational culture and understanding of APQP. Ultimately, the APQP model establishes favorable conditions for reducing quality-related costs during the introduction of new products and product changes, ensuring appropriate preparedness in quality management. Compliance with IATF 16949:2016 also offers Volvo GTO PTP in Skövde the opportunity to obtain certification.

La presente tesis de investigación tiene un enfoque cualitativo que resuelve el problema de las empresas consultoras, que no establecen un Plan de Gestión de Calidad (P.G.C.) en diseño y dificultan la ejecución de un Proyecto de Edificación. Por lo cual se trazó el objetivo de elaborar un Plan de Gestión de Calidad en diseño de Proyectos de edificación, con el fin de optimizar el control de los procesos de diseño y de su documentación resultante. Para ello se utilizó la metodología de diseño no experimental, de tipo exploratorio y descriptivo-correlacional. Donde la observación, inspección y registro de cualidades cualitativas en los procesos de diseño y su documentación; fueron analizadas. Obteniéndose los siguientes resultados: El control de procesos de diseño y su documentación, optimiza el diseño del proyecto, y es necesaria para la aprobación del proyecto. El cumplimiento de los requisitos del PGC asegura la validación del diseño del proyecto. This thesis is a qualitative research approach that solves the problem of consulting firms, not establish a Quality Management Plan in design and difficult to execution of a building project. Therefore the objective of developing a Quality Management Plan in projects design of building, in order to optimize process control and its design resulting documentation. For this purpose we used the non-experimental design methodology, type exploratory and descriptive-correlational. Where observation, inspection and registration of qualitative attributes in the design process and its documentation; were analyzed. Then the following results were obtained: Process control and documentation design, optimizes the design of the project, and is necessary for the approval and validation of the project. Compliance with the requirements of Q.M.P ensures the validation of the project design.

The present diploma thesis ‘Practical Division of a Real Estate – Agricultural Farmstead‘ is concerned with actual division of an agricultural homestead in XXX, the district of Olomouc. Based on the local examination which has been performed and after analyzing documents acquired from the owners, conclusions were drawn as to the possibility of dividing the estate while adhering to the applicable regulations of the civil procedure, construction law, construction technology, operational technology and economy. Valid price guidelines were used to determine the price of the estate and a comparative price of the estate was also estimated. Both price levels were also determined for the individual parts established by the practical division of the estate. The thesis consists of two basic sections. The first section focuses on theory, explaining the problem of practical division of an estate and providing a description of work of a certified expert drawing up this type of expert opinion. The second section comprises a practical part, which contains the expert opinion on the actual division of the agricultural homestead in the town of XXX in the Olomouc district.