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Selected Issues of Medical Device Legislation
Krudenc, Václav ; Šolc, Martin (referee)
Selected Issues of Medical Device Legislation Abstract This thesis deals with the legal regulation of medical devices in force at the time of its creation, with a focus on general medical devices. The thesis is divided into two main parts. In the first part, the thesis focuses on a comprehensive and detailed analysis of the basic definitions of the field of medical devices, including the definition of the conditions under which computer software used in the healthcare sector is considered a medical device. In particular, the definition of a medical device and an in vitro diagnostic medical device are subject to detailed analysis. The second part of the thesis deals in detail with the life cycle of a medical device at the time of the entry into force of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC and Act No. 375/2022 Coll., on medical devices and in vitro diagnostic medical devices. This section discusses in detail the obligations of medical device manufacturers and their authorised representatives where the manufacturer is established outside the European Union. Within this section, emphasis is...
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Influence of early antibiotic treatment on lower airway microbial colonisation in patients receiving mechanical ventilation
Kroupová, Alžběta ; Duška, František (advisor) ; Kukol, Václav (referee)
AJ Introduction: Ventilator-associated pneumonia (VAP) is a significant source of morbidity and mortality among patients undergoing mechanical ventilation. Its development is preceded by colonization of the lower respiratory tract with pathogenic bacteria. The purpose of this study was to investigate how antibiotic therapy administered for non-pulmonary infections affects the colonization of the lower respiratory tract compared to patients not receiving antibiotics. The hypothesis is that antibiotic treatment reduces colonization of the lower respiratory tract but increases the occurrence of multidrug-resistant bacteria. Methods: This was a retrospective observational cohort study conducted on critically ill patients hospitalized at the Department of Anesthesiology and Resuscitation, Third Faculty of Medicine, Charles University, and University Hospital Kralovske Vinohrady. This study is part of an ongoing project aimed at improving the quality of care and preventing VAP in intensive care unit patients. Patients had to meet certain criteria: they had to be on mechanical ventilation for more than 48 hours, have no pre-existing pulmonary diseases upon hospital admission, and not be immunocompromised. The primary outcome was the difference in the proportion of patients with positive microbiological...
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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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Ballistic Missile Defense of the United States: comparison of the 2010 Ballistic Missile Defense Review and 2019 Missile Defense Review
Musilová, Kristýna ; Smetana, Michal (advisor) ; Ludvík, Jan (referee)
1 Annotation Missile defense takes a part of the United States defense strategy since the second half of the 20th century. The approach to the missile defense program has radically changed since. The aim of this bachelor thesis is to compare practice of two subsequent administrations on the basis of the Barack Obama's 2010 Ballistic Missile Defense Review and Donald Trump's 2019 Missile Defense Review. The comparison is performed by an analysis of each of the documents' strategic narratives. The latter document - 2019 MDR - was released in January 2019 and Trump declared its content "revolutionary" and as a "beginning of a new era" of the missile defense program. Despite the extension of the missile defense concept and the introduction of a new space defense program, the current steps of the Trump's administration do not indicate any radical shifts as described by Donald Trump himself. This thesis also presents a historical overview of the U.S. missile defense and aims to examine the recently released 2019 MDR in the context of the missile defense policy development in the last seventy years. On this basis, the bachelor thesis shows that the updated document 2019 MDR is not an "entry to the new era of missile defense", as Donald Trump proclaimed, but a continual follow-up to the plans of previous Obama's...
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Protinádorová směrovaná léčba na bázi HPMA: základní principy pro syntézu konjugátů a převod z laboratoře do kliniky
Říhová, Blanka ; Strohalm, Jiří ; Prausová, J. ; Kubáčková, K. ; Jelínková, Markéta ; Rozprimová, L. ; Šírová, Milada ; Plocová, Daniela ; Etrych, Tomáš ; Šubr, Vladimír ; Mrkvan, Tomáš ; Kovář, Marek ; Ulbrich, Karel
Conjugates of N-(2-hydroxypropyl)methacrylamide with doxorubicin containing human IVIg were used for palliative treatment in patients with advanced cancer. More thena 116 biochemical and immunological parameters were tested. A decrease of some parameters with patological values was seen, and physiological values were occasionally reached, including some TAA.
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