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...
| Identifer | oai:union.ndltd.org:nusl.cz/oai:invenio.nusl.cz:356491 |
| Date | January 2017 |
| Creators | Baloušek, Filip |
| Contributors | Kryska, David, Svoboda, Petr |
| Source Sets | Czech ETDs |
| Language | Czech |
| Detected Language | English |
| Type | info:eu-repo/semantics/masterThesis |
| Rights | info:eu-repo/semantics/restrictedAccess |
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