Suchergebnisse

Na osnovi podataka iz pretkliničkih i kliničkih ispitivanja farmaceutska kompanija koja želi staviti lijek na tržište Europske unije predlaže plan upravljanja rizicima koji agencija za lijekove odobrava neposredno prije stavljanja lijeka na tržište. Plan upravljanja rizicima definira mjere koje kompanija poduzima pri praćenju i minimizaciji rizika povezanih s lijekom. Mjere praćenja lijeka na tržištu mogu biti osnovne, tj. rutinske (prijavljivanje nuspojava, pisanje periodičkih izvješća, detekcija i analiza signala) te dodatne (dodatne studije). Sigurnu primjenu lijeka koju provode zdravstveni djelatnici i pacijenti omogućavaju rutinske mjere minimizacije rizika (prenošenje informacije o lijeku putem sažetka ili upute o lijeku) te dodatne mjere (poput edukacijskih materijala, pisma liječnicima ili programa prevencije trudnoće). Plan upravljanja rizicima ažurira se tijekom životnog ciklusa lijeka na osnovi novih informacija kako bi se osigurao pozitivan omjer koristi i rizika od lijeka te njegova sigurna primjena koju provode zdravstveni djelatnici i pacijenti. Osim toga,farmaceutska kompanija i agencija za lijekove mogu poduzeti i druge mjere edukacije zdravstvenih djelatnika i pacijenata radi smanjenja rizika povezanih s lijekovima. ; Based on non-clinical and clinical findings pharmaceutical companies needs to agree on a Risk Management Plan (RMP) with the authority at the time of drug approval in the European Union. RMP defines measures that a company needs to implement to collect more information and mitigate risk related to drug use. Measures are defined as either routine pharmacovigilance (reporting of adverse events, periodic reports, safety signal detection) or as additional measures (post-authorization safety studies). Safe drug use by healthcare providers and patients is assured by routine risk minimization measures (communication of information through the summary of products characteristics and patient information leaflet) and additional measures (such as educational materials, letters to healthcare providers and pregnancy prevention programs). RMP is updated during product life-cycle based on new information to assure positive benefit/risk of the drug and safe drug use by healthcare providers and patients. Pharmaceutical companies and health authorities may also take other actions to educate healthcare professionals and patients in order to decrease risks related to drug use.

Svjetska ekonomska kriza zahvatila je zemlje Zapadnog Balkana. Recesija koju je karakteriziralo smanjenje privredne aktivnosti, pad potrošnje i povećanje zaposlenosti bila je praćena smanjenjem javnih prihoda. Posljedica takvog stanja je budžetska neravnoteža koja se manifestirala u vidu strukturnog budžetskog deficita i rasta javnog duga. Fiskalna konsolidacija u svim zemljama bila je neophodna. U procesu fiskalne konsolidacije dolazi do promjene pojedinih elemenata fiskalne politike koji se razlikuju od zemlje do zemlje. U tom procesu , struktura javnih prihoda i javnih rashoda se mijenja. Postavlja se pitanje koliko je fiskalna konsolidacija bila uspješna i u kojoj mjeri. Dinamička panel analiza pomoću PMG procjenitelja u šest zemalja Zapadnog Balkana, za period od 2004-2016. godine pokazala je da fiskalna konsolidacija ima pozitivan utjecaj na ekonomski rast. Dakle, zemlje Zapadnog Balkana moraju voditi odgovorne financije kako bi potakle ekonomski rast. ; The global economic crisis has not spared the countries of the Western Balkans. The ensuing recession, characterized by a decline in economic activity, a decline in consumption and an increase in unemployment, went hand in hand with drops in public revenues. This in turn resulted in budget imbalances that manifested in structural budget deficits and higher public debt. Fiscal consolidation was deemed necessary across the board. In this process, certain fiscal policy elements varied among countries. The structure of public revenues and public expenditures changed. The question is whether the fiscal consolidation was successful and to what extent. Dynamic panel analysis using PMG estimator in six Western Balkan Countries for the period 2004-2016 has shown that fiscal consolidation has positive impact on economic growth in this region. So, Western Balkan Countries have to conduct responsible public finances in order to encourage economic growth.

In regions troubled by ethnic based conflict violence often erupts abruptly and severely. Peacemakers, then, follow unconditional paths to prevent conflict escalation. The article analyzes the ways in which post-conflict constitutional designs shape the state structure through constitutional amendments. Peace agreements as bases for constitutional reform, the article claims, have reformatory but also obstructive implications. Seeing the Ohrid Framework Agreement as a case study, the paper analyzes its implications on the development of the political system in Macedonia. On one side OFA serves as a criterion for the Macedonian Euro-Atlantic integration and a driving force for the creation of a functioning multicultural society. On the other side, the procedural and substantive flaws of the agreement undermine its absorbability in the society. In procedural sense, OFA hindered its own implementation through the used terminology and the drafting process. In substantial sense, agreement's goals and provisions reached beyond the purpose of peace agreements and underestimated the complexity of the conflicting issues at stake. ; In regions troubled by ethnic based conflict violence often erupts abruptly and severely. Peacemakers, then, follow unconditional paths to prevent conflict escalation. The article analyzes the ways in which post-conflict constitutional designs shape the state structure through constitutional amendments. Peace agreements as bases for constitutional reform, the article claims, have reformatory but also obstructive implications. Seeing the Ohrid Framework Agreement as a case study, the paper analyzes its implications on the development of the political system in Macedonia. On one side OFA serves as a criterion for the Macedonian Euro-Atlantic integration and a driving force for the creation of a functioning multicultural society. On the other side, the procedural and substantive flaws of the agreement undermine its absorbability in the society. In procedural sense, OFA hindered its own implementation through the used terminology and the drafting process. In substantial sense, agreement's goals and provisions reached beyond the purpose of peace agreements and underestimated the complexity of the conflicting issues at stake.

Većina postojećih konstrukcija projektirana je tako da se odupre samo statičkim opterećenjima. Brojni istraživači ukazuju da u projektnoj fazi treba razmotriti i iznenadna opterećenja. Površine mnogih građevina izvedene su ab pločama koje su pod utjecajem iznenadnih opterećenja poput iznenadnih padova različitih elemenata, odrona kamenja ili vojnih djelovanja. Nelinearna analiza ab ploča u radu je provedena primjenom računalnog programa ABAQUS. Određeni su i detaljno analizirani parametri udara kao što su ubrzanja, brzine, pomaci, udarne sile i energetski kapaciteti za svaku ploču. ; Most of the existing structures are designed to resist static loads only. Various researchers indicate that sudden loads affecting structural members should also be considered in the design phase. Surfaces of many structures are covered with concrete slab members that are under the effect of sudden loads such as accidental drops, rock falls, or military attacks. A non-linear analysis of RC slabs is performed in this study using the Abaqus software. Impact parameters such as accelerations, velocities, displacements, impact forces, and energy capacities, are determined for each slab.

U radu se analiziraju neki problemi upravnih sudova koji se javljaju u praksi Europskog suda za zaštitu ljudskih prava te sudova nekih država članica Europske unije. Posebna pažnja posvećena je pravu na suđenje u razumnom roku, izvršenju sudskih odluka, pravu na hitne sudske mjere i suspenzivnom učinku tužbe. Zaključuje se da se glavna problematika znanstvenog istraživanja, kada je riječ o upravnom sporu, bavi pitanjem, osim očitog trenda europeizacije načela upravnog spora usmjerenog prema europeizaciji postupovnog prava u cjelini, je li moguće uočiti konvergencijske trendove u odnosu na pravne učinke odluka upravnih sudova u Europskoj uniji. ; Certain problems of administrative courts appearing in the jurisprudence of the European Court for the Protection of Human Rights and of some EU member states are analysed in the paper. Particular stress is on the right to trial within reasonable time, execution of court decisions, right to emergency court measures, and suspending effect of the lawsuit. There is an obvious trend of Europeanization of the principles of administrative dispute, which is consistent with general Europeanization of administrative law.It is concluded that scientific research in the field of administrative dispute is mainly concerned with the question of whether it is possible to spot convergence trends with regard to legal effects of administrative courts' decisions in the European Union.

Hrvatsko civilno društvo dugi je niz godina polako, ali sigurno, napredovalo u svojoj viziji i cilju. Ulaskom Hrvatske u Europsku Uniju, akterima civilnog društva otvorile su se nove mogućnosti, kako financiranja, tako i realizacije cijelog niza projekata. Osim toga, novootvorenim mogućnostima financiranja različitih projekata i pridavanjem sve većeg značaja priznavanju vještina i znanja stečenih neformalnim učenjem (Crnčić Sokol i Kostanjčar Suljada, 2009, 95), otvara se put za primjenu sociološke perspektive, teorije i metodologije na novo područje validacije i evaluacije vještina i znanja stečenih neformalnim te informalnim obrazovanjem. Ovaj se rad, stoga, usmjerava na razmatranje implikacija razvoja projekata neformalnog obrazovanja čiji su nositelji upravo udruge civilnog društva. Probleme formalnog priznavanja vještina i znanja stečenih neformalnim kanalima obrazovanja stavlja u prvi plan. U fokusu se rada nalazi metodološki problem mjerenja učinka projekata neformalnog obrazovanja na sudionike. Koristeći se kvantitativnom metodologijom (te strukturiranim upitnikom kao mjernim instrumentom) istraživanje je dizajnirano kao kvazi-eksperimentalno istraživanje. Glavnu istraživačku strategiju predstavlja akcijsko evaluacijska ideja s ciljem mjerenja i jasnog evaluiranja promjena koje su se dogodile kod sudionika projekta BeAlive 2014 u odnosu na specifične ciljeve samog projekta, što rezultira otvaranjem metodološke rasprave o načinima evaluacije, validacije i mjerenja promjena te učinaka projekata neformalnog obrazovanja. ; Croatian civil society has for many years, slowly but surely, advanced in its vision and purpose. Due to the Croatian accession to the European Union, the civil society has acquired new possibilities for funding and implementation of a wide range of projects. In addition to these, the increasing importance of recognizing the skills and knowledge gained informally (Crnčić Sokol and Kostanjčar Suljada, 2009, 95), opened the way for the application of sociological perspectives, theories and methodology to a new research area; the validation and evaluation of the skills and knowledge gained through non-formal and informal education. This paper, therefore, focuses on the implications of the development of non-formal education projects within civil society. The paper firstly addresses the problems with formal recognition of the skills and knowledge acquired through alternative channels of education. The focus of the work is the methodological problem of measuring the impact of non-formal education projects and programs on the participants/users. Using quantitative methodology (and structured questionnaire as a measuring instrument), the research was designed as a quasi experimental study. Action-evaluation design represented the main research strategy with the idea of assessing and clearly evaluating changes that the BeAlive 2014 project participants experienced, in relation to the specific project objectives and goals. This resulted in opening a methodological discussion on the ways to evaluate, validate and measure the changes and effects of non-formal education projects.

Enormna opterećenost bolestima, lošim ishodima učenja u visokom obrazovanju u Južnoj Africi i njihova interakcija u smislu utjecaja na produktivnost ljudskih resursa iziskuju istraživanja za konkretne smjernice u okviru politike. U tom smislu, svrha ovog rada je istražiti ovaj odnos, zajedno s drugim čimbenicima, promatrajući ljudske resurse iz perspektive zdravlja, upisa u visoko obrazovanje (HEE) i diplomiranih studenata visokog obrazovanja (HEG). U istraživanju se primjenjuje model vremenskih serija s autoregresijskim distribuiranim pomacima (ARDL) s podacima koji obuhvaćaju razdoblje od 1980. do 2015. godine. Studija je pokazala da, dok BDP raste, stope zaposlenosti i HEE imaju pozitivan učinak na produktivnost u Južnoj Africi; kapital i životni vijek su inverzni u odnosu na produktivnost. Naime, rezultati ovog istraživanja potvrđuju hipotezu da bez odgovarajućeg školskog sektora usmjerenog na potrebne vještine, široko rasprostranjena antiretroviralna terapija u prevenciji HIV-a stanovništva, a s tim i njihovo preživljavanje, negativno utječe na produktivnost. Nadalje, rezultati potvrđuju da uključivanje u obrazovanje djeluje pozitivno na produktivnost, jer obuhvaća pojedince koji su djelomično vješti u programima potrebnim gospodarstvu. Naposljetku, potvrđena je i hipoteza da su ishodi učenja diplomskih studija negativni u odnosu na produktivnost zbog neusklađenosti vještina diplomanata i potreba gospodarstva. Stoga se predlaže da se u okviru politike za povećanje produktivnosti u Južnoj Africi, poduzmu zajednički napori u školskom i zdravstvenom sektoru. ; The huge burden of diseases, poor higher educational outcomes in South Africa and their interaction on affecting productivity of human capital requires investigation for a context –specific policy advice. To this effect, the purpose of this paper is to investigate this relationship, alongside other factors, viewing human capital from the perspective of health, higher education enrolment (HEE) and higher education graduates (HEG). The study adopts time series autoregressive distributive lag (ARDL) with data covering the period 1980 - 2015. The study has found that, while GDP grows, employment rates and HEE have a positive impact on productivity in South Africa; capital stock and life expectancy exhibited an inverse relationship with productivity. These findings support the hypothesis that widespread antiretroviral therapy and resulting survival, without corresponding school sector focus on needed skills, relate negatively to productivity. The findings further support that enrolments affect positively productivity because they comprise individuals who are partly skilled in programs needed by the economy. Finally, they support the hypothesis that graduate outputs relate negatively to productivity because of mismatch of graduation skills and the economy's need. As a policy suggestion, combined effort at school and health sector is needed in South Africa for increased productivity.

U ovome radu prikazani su rezultati teorijskog i empirijskog istraživanja kojim su utvrđena dugoročna razvojna obilježja brdsko-planinskih područja u Republici Hrvatskoj, kao i učinci dosadašnjeg sustava potpore njihovom razvoju. Polazeći od teorijske i strateške razrade problematike razvoja brdsko-planinskih područja, svrha ovog istraživanja bila je analizirati ukupna demografska, ekonomska i fiskalna kretanja u brdsko-planinskim područjima Republike Hrvatske u usporedbi s prosječnim kretanjima na nacionalnoj razini. S tim u vezi, cilj istraživanja bio je kritički i empirijski ispitati učinkovitost i nedostatke dosadašnjeg sustava potpore razvoju brdsko-planinskih područja u kontekstu ostvarenja zakonski postavljenih ciljeva hrvatske regionalne politike. Rezultati provedenog istraživanja ukazuju na povećanje divergencije u cjelokupnom razvoju Republike Hrvatske i razvoju njezinih brdsko-planinskih područja, ali i na neučinkovitost državnih intervencija u zaustavljanju tog procesa. Ključni razlozi za to su relativno mala izdašnost državnih pomoći, zatim nedostatak kvalitetnih kriterija za njihovo dodjeljivanje te provedba neadekvatnih mjera i instrumenta za poticanje razvoja brdsko-planskih područja. ; This paper presents the results of theoretical and empirical research that determines the longterm development characteristics of mountain areas in the Republic of Croatia, as well as the impact of the previous system of support for their development. Based on the theoretical and strategic analysis of the development problems of mountain areas, the aim of this research was to analyse the demographic, economic and fiscal dynamics of mountain areas in Croatia by comparing them with the average trends at the national level. Therefore, the aim of this research was to critically and empirically examine the efficiency and shortcomings of the previous system of support for mountain area development within the framework of the legally defined objectives of Croatian regional policy. The results of the conducted research ...

In today's world, the mass media are the key players in the processes of language innovation & change. New words stem from the recognition of the new contents of the reality or the newly-created awareness of its phenomena. Journalists are central actors in that process. They can be mediators -- when recognizing a language innovation as expressively suggestive &/or communicationally necessary -- or their authors -- spontaneous creators at first, & alter conscious promoters. Using the examples of the creation, spreading & semantic profiling of the words tajkunara (tycoon-dwelling), betonizacija (squeezing as many houses & parking lots as possible on a tract of land, without any parks, playgrounds, & communal spaces), apartmanizacija (rampant construction of insipid housing developments on the Adriatic coast), & its variant apartmanija, 1999-2004, the authors shows that the role of journalists & the mass media in general is not only to shape a critical social awareness & to participate in the debate on socially relevant topics, but also to (co)create new terms & thus vitally contribute to their adoption. 10 References. Adapted from the source document.

In today's world, the mass media are the key players in the processes of language innovation & change. New words stem from the recognition of the new contents of the reality or the newly-created awareness of its phenomena. Journalists are central actors in that process. They can be mediators -- when recognizing a language innovation as expressively suggestive &/or communicationally necessary -- or their authors -- spontaneous creators at first, & alter conscious promoters. Using the examples of the creation, spreading & semantic profiling of the words tajkunara (tycoon-dwelling), betonizacija (squeezing as many houses & parking lots as possible on a tract of land, without any parks, playgrounds, & communal spaces), apartmanizacija (rampant construction of insipid housing developments on the Adriatic coast), & its variant apartmanija, 1999-2004, the authors shows that the role of journalists & the mass media in general is not only to shape a critical social awareness & to participate in the debate on socially relevant topics, but also to (co)create new terms & thus vitally contribute to their adoption. 10 References. Adapted from the source document.

The essay analyzes & categorizes rhetorical methods in destructive communication. Journalistic destructive rhetoric is mostly evident in the yellow press & political communication. Such rhetoric avoids argumentation & focuses on the satanization of individuals, ideas, or things it wishes to discredit. According to the author, this type of rhetoric primarily ensues from the inability of a journalist to gain prominence in a more positive way, which represents a contemporary form of herostratism. Since contemporary media give journalists too much influence in society, some have tried to impose themselves in politics & society as the ultimate arbiters in deciding on what is right & what is not. The conclusion of this analysis is that this phenomenon ought to be studied by means of multilateral strategies; otherwise, the public cannot successfully cope with the negative consequences of this journalistic anomaly. 10 References. Adapted from the source document.

With the emergence of TV, pre-election campaigns in US shifted its focus from the content & the platform to the image of candidates who became well-packaged products. The biggest election turnout in US occurred exactly at the time of the emergence of this media; however, the percentages of voters' turnout plummeted in the 1990s. Enhanced by the attributes of TV as a media, the focus on "how" rather than on "what" did not achieve absolute results, & voters responded to the invasion of political image producers with voting abstinence. The latest chapter in pre-election campaigning is the Internet. With its properties & the rapid expansion of the users' net, the new media offers different conditions of communication with voters & is becoming a powerful -- & so far, insufficiently utilized -- weapon in the hands of pre-election strategists. 8 Tables, 1 Graph, 23 References. Adapted from the source document.