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Medical devices regulatory framework
Honegr, Jan ; Staša, Josef (advisor) ; Vedral, Josef (referee)
Charles University in Prague, Faculty of Law Department of Administrative law Candidate: PharmDr. Jan Honegr, Ph.D. Supervisor: JUDr. Ing. Josef Staša, CSc. Title of diploma thesis: Medical devices regulatory framework The subject of this diploma thesis is the regulatory framework for the so-called "general" medical devices with a slight overlap in the field of in-vitro medical devices. The presented work aims to describe the impact of the planned change in the regulatory framework for medical devices on economic operators in the field of production and distribution of medical devices in the Czech Republic. In this work I gradually deal with the historical development of the regulatory framework for goods in the European Communities and subsequently the European Union and the specific regulation of for medical devices. I deal in detail with the multilevel regulatory framework and the relationships between its components. I focus in more detail on the key change in the regulatory framework, which is represented by the hitherto ineffective EU Medical Devices Regulation 2017/745 and government bills to prepare the Czech legal system for the adoption of this directly effective European Union legislation. The main parts of the work are chapters 5 and 6 in which, I deal with the potential impacts of the...
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Telecommunications regulation
Selby, Alice ; Pomahač, Richard (advisor) ; Pítrová, Lenka (referee) ; Bejček, Josef (referee)
The content of my work has been chosen on the basis that I have spent most of my career working as a regulatory lawyer in telecommunications. I started my career as a lawyer at the Czech Telecommunications Office and after few years I moved to the Ministry of Transport, which was then also responsible for telecommunications, and its strategy and legislation. Finally I joined Radiomobil (now T-Mobile Czech Republic) where I have spent 15 years to date. The development of technologies in the last 20 years is without a doubt fascinating. It is exciting to observe the sector regulation trying to catch up with the fast moving technological developments, and often aiming at attempting to regulate what cannot be regulated. At the same time we can witness the overregulated European telecommunications market gasping for air in comparison with other regions as it becomes less and less attractive to investments and investors, which is evidenced by the major European companies leaving the European markets and moving their activities into the less regulated regions of the world. A direct consequence of that is the consolidation of the European telecommunications markets. At the same time there are very high expectations on the part of both regulatory bodies and customers in the field of broadband development...
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Influence of BASEL III regulation on risk management in banking
Havlíček, Radek ; Blahová, Naďa (advisor) ; Pour, Jiří (referee)
The diploma thesis focuses on the regulatory framework of the BASEL III in coherence with risk management and measurement of market and credit risks. The accent is focused upon methodology of calculation and determination of the capital requirements of above mentioned risks. In the introductory part of the thesis are mentioned basic procedures regarding risk management as well as theoretical methodology and development of calculation of the capital requirements in coherence with current standard BASEL III. In the practical part of the thesis are presented capital management policies with regards to BASEL III in Deutsche Bank AG, globally presented institution and Komerční banka, a.s., operating on the Czech market. Accented are mainly the expositions of the institutions and the size of the capital required by the regulatory framework.
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