20.500.12556/RUL-175362 Vloga agencije za zdravila na področju farmacevtske proizvodne zdravil diplomsko delo The role of the medicines agency in the pharmaceutical drug manufacturing sector Za temo diplomske naloge sem si izbrala vpliv javne uprave na farmacevtsko proizvodnjo zdravil, saj me to področje in njena ureditev že kar nekaj časa zelo zanima. Ugotovila sem, da te institucije odločilno vplivajo na pogoje, pod katerimi lahko ali ne smejo delovati farmacevtska podjetja. Pri svojem delu sem uporabila več raziskovalnih metod. Medtem ko sta mi dogmatska in normativna metoda pomagali pri natančnem pregledu zakonodaje in pravil na tem področju, mi je primerjalna metoda pomagala pri razločevanju razlik med evropskimi in drugimi sistemi, podatki Javne agencije Republike Slovenije za zdravila in medicinske pripomočke pa so lahko statistično podali realno sliko. Nadaljnja povezava med delom in prakso je bila študija primera podjetja. Standardi kakovosti in varnosti zdravil so visoki, a hkrati nekoliko zahtevni, saj se morajo podjetja prilagajati nenehnim spremembam in uveljavljanju zahtev, kar posledično vpliva na njihovo učinkovitost in razvoj. To delo je koristno za novince, ki želijo imeti celovit vpogled v zakonodajni okvir, in hkrati za podjetja, ki so v postopku licenciranja. Takšen pristop pomaga razumeti, v kolikšni meri sodelovanje med gospodarstvom in javno upravo prispeva k tako kakovostnemu in varnemu farmacevtskemu okolju. I chose the influence of public administration on pharmaceutical production as the topic of my thesis, as I have been very interested in this area and its regulation for some time. I have found that these institutions have a decisive influence on the conditions under which pharmaceutical companies can or cannot operate. Various research methods were employed in the thesis. The dogmatic and normative approaches facilitated a detailed analysis of the legal and regulatory framework, while the comparative method helped identify differences between European and other regulatory systems. Statistical analysis of data from the Slovenian Medicines Agency (JAZMP) offered a realistic picture of regulatory implementation in practice. Additionally, a case study provided a practical link between theory and real-world challenges. While standards for drug quality and safety are high, they are also demanding, as companies must continually adapt to regulatory changes, which in turn can affect their efficiency and development. This thesis is useful for newcomers seeking a comprehensive overview of the regulatory landscape as well as for companies undergoing licensing procedures. It contributes to a better understanding of how cooperation between the public administration and industry supports the development of a safe and high-quality pharmaceutical environment. upravni postopek farmacevtska industrija JAZMP inšpekcijski nadzor kakovost zdravil dovoljenja regulacija public administration pharmaceutical industry JAZMP regulations medicine quality licensing regulation true false false [T. Goršek] Slovenski jezik Angleški jezik Diplomsko delo/naloga 2025-10-24 12:40:02 2025-10-24 12:40:08 2025-12-10 03:42:40 0000-00-00 00:00:00 2025 0 Ljubljana 0 Ljubljana XIII, 42 str. 0000-00-00 NiDoloceno NiDoloceno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 35.077.3:661.12:3.072.6(497.4)(043.2) 18920 255298563 Gorsek_Tjasa_-_VLOGA_AGENCIJE_ZA_ZDRAVILA_NA_PODROCJU_FARMACEVTSKE_PROIZVODNJE_ZDRAVIL.pdf Gorsek_Tjasa_-_VLOGA_AGENCIJE_ZA_ZDRAVILA_NA_PODROCJU_FARMACEVTSKE_PROIZVODNJE_ZDRAVIL.pdf 1 415E5B78DAD38EA2429CC33855747AB1 7379b1bda4eb9c850523e5e74773437115c34d28150fd11044663a9ab391dc79 860c476b-b0c5-11f0-9328-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=220851 Fakulteta za upravo 0 0 0