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Medical remedies
Matěvosova, Elena ; Rajchl, Jiří (advisor) ; Svoboda, Petr (referee)
Medical devices Abstract The subject of this master thesis is the issue of medical devices. This thesis focuses on its reimbursement regulation. The work is divided into six chapters. The introductory explanation is devoted to the concept of medical device and it analyzes both the European definition of medical device and the national legal definition. The next part of the chapter emphasizes various division of these products, namely its variants, types and also classification of medical devices according to risk classes. The second chapter describes legal sources. The attention is paid to international sources of law, then furthermore to European law, from current directives to new regulations, which will come into force in 2020. In this chapter is generally discussed what changes this new regulations bring, as it is further elaborated in the next chapter. Last but not least, the national sources of law are analyzed. The legal regulation enriched by the outline of the future legal regulation awaiting the area of medical devices is widely mentioned. The next chapter defines institutions. The Ministry of Health and the State Institute for Drug Control are the key institutions in the field of medical devices, however, they are not the only authorities to carry out state administration in the field of medical...
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Criminal Liability within Pharmacy
Kolář, David ; Sovová, Olga (advisor) ; Císařová, Dagmar (referee)
The main purpose of this thesis is to analyse the possible application of criminal liability instruments within pharmacy. Chapter 1 introduces the general aspects and processes within pharmacy, general terms, and short preview to the life cycle of innovative medicinal products. Chapter 2 contains the general definition and requirements of liability. There is also a short comparison of additional types of liability (such as civil, employee's, administrative and disciplinary) that can be applicable within pharmacy. The purpose of this comparison is to specify differences between individual liabilities and to prove that they can be applied conjointly. As an example of such a use I have described the "heparin murder" case. Chapter 3 is dedicated to criminal liability, with the explanation of general terms, especially crime, unlawfulness, offender, or grounds of justification. Chapter 4 focuses on the criminal liability of natural persons. After the general introduction in the first part, a list of potential crimes committable within pharmacy is given. Chapter 5 summarizes the criminal liability of legal persons. The first part focuses on the history of implementation in the Czech Republic, general terms, and definition of a legal person as a subject of criminal liability. The second part contains...
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Launching medical devices on the market
Dvořáková, Jitka ; Svoboda, Petr (advisor) ; Millerová, Ivana (referee)
The issue of launching medical devices on the market became more intense in the last few decades in connection to the expansion of the pharmaceutical industry and legal area. This legal area is still mostly undescribed and it stands in the shadow of known and more discussed medical products. Proper legal theoretical analysis is often completely absent. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the launching of the medical devices on the market, including other processes related to this issue. Emphasis is places on the concept of medical device, the responsibility of the manufacturer and the nature of notified body. The author focuses on the subsequent conformity assessment process and process of registration. The process of notification and exemption from this obligation and administrative nature of selected documents. The thesis is divided into eleven chapters and the introductory chapter focuses on a general introduction to the field of pharmaceutical law, namely the regulation of medical devices, including the definition of basic questions in the work under study. The second chapter deals with the analysis of sources of legal regulation of medical devices. The chapter is divided into sources of the law of the Czech Republic and...
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Clinical trials of medical products for human use in the Czech Republic
Baloušek, Filip ; Kryska, David (advisor) ; Svoboda, Petr (referee)
The issue of legislative and ethical requirements on research of innovative medicines became more intense in connection to the expansion of the pharmaceutical industry in last few decades. This master thesis aims to complexly describe and analyse theoretical bases of current legislative regulating the process of clinical trials of medicinal products for human use in the Czech Republic, as well as to take a closer look to the issue of ethical review administered by specialized ethical review committees. The author also deals with some specific responsibilities of the committees from the perspective of administrative law, especially focusing on aspects of legal nature of the positive opinions, which are one of the conditions for commencement of a clinical trial. The thesis is divided into nine chapters and the introductory chapter is focused on the general outline of the issue of clinical trials of medicines for human use in the Czech Republic. The aim of the second chapter is to define the basic concepts stated in the Czech medicinal products act, which are specific for this area of pharmaceutical law. The next chapter analyses the relevant competencies of individual state authorities over the clinical studies. The fourth chapter contains the list of sources of law, whereas a particular emphasis is...
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Specific of patent law in pharmaceutical industry
Volšanský, Petr ; Pítra, Vladimír (advisor) ; Růžička, Michal (referee)
1 ABSTRACT SPECIFIC OF PATENT LAW IN PHARMACEUTICAL INDUSTRY This thesis scopes on particularities of patent law with regard to pharmaceuticals. It describes the basics of patent law while focusing mainly on international treaties, in particular on systems established by EPC and TRIPS. The patent system in USA and in the Czech Republic is also noted. This thesis is divided into seven chapters. In the first chapter named sources of law international institutions, treaties and situation in European union, USA and Czech Republic are described here. This chapter also deals with basic legal instruments such as patent, corporate invention or utility model. The next chapter is focused on individual conditions that need to be met in order to grant a certain patent - the most basic are novelty, inventive step and industrial applicability. The following chapter deals with problems associated with costly development of new drugs and the need of companies to get the longest possible protection for their inventions. A special chapter addresses exceptions to the stiff patent regulation. Described in the next chapter is the compulsory license, a legal instrument not very particular in the Czech Republic but relevant in some developing countries used in order to secure better availability of drugs to society. Other...
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