419 resultados para harmonization


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Tutkimuksen päätavoitteena oli selvittää, mitä vaikutuksia IAS-tilinpäätösstandardien käyttöön siirtyminen aiheuttaa suomalaisten pörssiyritysten tilinpäätöksissä ja taloushallinnossa. Tähän tavoitteeseen edettiin alatavoitteiden avulla. Näitä olivat tilinpäätösten kansainvälisen harmonisoinnin, Euroopan Unionin IAS-asetuksen ja itse IAS-tilinpäätöksen selvittäminen. Tutkimusaineisto koostuu kirjallisuudesta ja suomalaisille pörssiyrityksille tehdystä kyselystä. Tutkimuksen teoriaosassa käytetään käsiteanalyyttista ja empiirisessä osassa nomoteettista tutkimusotetta. Tutkielman mukaan tiedon lisääntyminen lisää myönteisyyttä IAS-standardistoa kohtaan. Henkilöstön koulutus onkin avainasemassa siirtymäprojektissa. Toinen merkittävä vaikutus on uuden laskentaohjeistuksen luontitarve. Merkittävin standardi vaikutuksiltaan on IAS 14 Segmenttiraportointi.

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This paper investigates the fiscal sustainability of an emerging, dollarized, oil-exporting country: Ecuador. A cointegrated VAR approach is adopted in testing, first, if the intertemporal budget constraint is satisfied in Ecuador and, second, in identifying the permanent and transitory shocks that affect a fiscal policy characterized by inertia and a heavy dependence on oil revenues. Following confirmation that the debt-GDP ratio does not place the Ecuadorian budget under any pressure, we reformulate the model and identify two forces that push the fiscal system out of equilibrium, namely, economic activity and oil revenues implemented in the government budget. We argue that Ecuador needs to recover control of its monetary policy and to promote the diversification of its economy in order that non-oil tax revenues can replace oil revenues as a pushing force. Finally, we calculate quarterly elasticities of tax revenues with respect to Ecuador’s GDP and that of eight Eurozone countries. We illustrate graphically how the Eurozone countries with low positive or high negative elasticities’ levels suffer debt problems after the crisis. This finding emphasizes the pressing need for Ecuador to strengthen the connection between its tax revenues and output, and also suggests that the convergence of these elasticities in the Eurozone might contribute to the success of an eventually future fiscal union.

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Human biomonitoring (HBM) is an effective tool for assessing actual exposure to chemicals that takes into account all routes of intake. Although hair analysis is considered to be an optimal biomarker for assessing mercury exposure, the lack of harmonization as regards sampling and analytical procedures has often limited the comparison of data at national and international level. The European-funded projects COPHES and DEMOCOPHES developed and tested a harmonized European approach to Human Biomonitoring in response to the European Environment and Health Action Plan. Herein we describe the quality assurance program (QAP) for assessing mercury levels in hair samples from more than 1800 mother-child pairs recruited in 17 European countries. To ensure the comparability of the results, standard operating procedures (SOPs) for sampling and for mercury analysis were drafted and distributed to participating laboratories. Training sessions were organized for field workers and four external quality-assessment exercises (ICI/EQUAS), followed by the corresponding web conferences, were organized between March 2011 and February 2012. ICI/EQUAS used native hair samples at two mercury concentration ranges (0.20-0.71 and 0.80-1.63) per exercise. The results revealed relative standard deviations of 7.87-13.55% and 4.04-11.31% for the low and high mercury concentration ranges, respectively. A total of 16 out of 18 participating laboratories the QAP requirements and were allowed to analyze samples from the DEMOCOPHES pilot study. Web conferences after each ICI/EQUAS revealed this to be a new and effective tool for improving analytical performance and increasing capacity building. The procedure developed and tested in COPHES/DEMOCOPHES would be optimal for application on a global scale as regards implementation of the Minamata Convention on Mercury.

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The fight against doping in sports has been governed since 1999 by the World Anti-Doping Agency (WADA), an independent institution behind the implementation of the World Anti-Doping Code (Code). The intent of the Code is to protect clean athletes through the harmonization of anti-doping programs at the international level with special attention to detection, deterrence and prevention of doping.1 A new version of the Code came into force on January 1st 2015, introducing, among other improvements, longer periods of sanctioning for athletes (up to four years) and measures to strengthen the role of anti-doping investigations and intelligence. To ensure optimal harmonization, five International Standards covering different technical aspects of the Code are also currently in force: the List of Prohibited Substances and Methods (List), Testing and Investigations, Laboratories, Therapeutic Use Exemptions (TUE) and Protection of Privacy and Personal Information. Adherence to these standards is mandatory for all anti-doping stakeholders to be compliant with the Code. Among these documents, the eighth version of International Standard for Laboratories (ISL), which also came into effect on January 1st 2015, includes regulations for WADA and ISO/IEC 17025 accreditations and their application for urine and blood sample analysis by anti-doping laboratories.2 Specific requirements are also described in several Technical Documents or Guidelines in which various topics are highlighted such as the identification criteria for gas chromatography (GC) and liquid chromatography (LC) coupled to mass spectrometry (MS) techniques (IDCR), measurements and reporting of endogenous androgenic anabolic agents (EAAS) and analytical requirements for the Athlete Biological Passport (ABP).

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The European Forum on Epilepsy Research (ERF2013), which took place in Dublin, Ireland, on May 26-29, 2013, was designed to appraise epilepsy research priorities in Europe through consultation with clinical and basic scientists as well as representatives of lay organizations and health care providers. The ultimate goal was to provide a platform to improve the lives of persons with epilepsy by influencing the political agenda of the EU. The Forum highlighted the epidemiologic, medical, and social importance of epilepsy in Europe, and addressed three separate but closely related concepts. First, possibilities were explored as to how the stigma and social burden associated with epilepsy could be reduced through targeted initiatives at EU national and regional levels. Second, ways to ensure optimal standards of care throughout Europe were specifically discussed. Finally, a need for further funding in epilepsy research within the European Horizon 2020 funding programme was communicated to politicians and policymakers participating to the forum. Research topics discussed specifically included (1) epilepsy in the developing brain; (2) novel targets for innovative diagnostics and treatment of epilepsy; (3) what is required for prevention and cure of epilepsy; and (4) epilepsy and comorbidities, with a special focus on aging and mental health. This report provides a summary of recommendations that emerged at ERF2013 about how to (1) strengthen epilepsy research, (2) reduce the treatment gap, and (3) reduce the burden and stigma associated with epilepsy. Half of the 6 million European citizens with epilepsy feel stigmatized and experience social exclusion, stressing the need for funding trans-European awareness campaigns and monitoring their impact on stigma, in line with the global commitment of the European Commission and with the recommendations made in the 2011 Written Declaration on Epilepsy. Epilepsy care has high rates of misdiagnosis and considerable variability in organization and quality across European countries, translating into huge societal cost (0.2% GDP) and stressing the need for cost-effective programs of harmonization and optimization of epilepsy care throughout Europe. There is currently no cure or prevention for epilepsy, and 30% of affected persons are not controlled by current treatments, stressing the need for pursuing research efforts in the field within Horizon 2020. Priorities should include (1) development of innovative biomarkers and therapeutic targets and strategies, from gene and cell-based therapies to technologically advanced surgical treatment; (2) addressing issues raised by pediatric and aging populations, as well as by specific etiologies and comorbidities such as traumatic brain injury (TBI) and cognitive dysfunction, toward more personalized medicine and prevention; and (3) translational studies and clinical trials built upon well-established European consortia.

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[Summary] 2. Roles of quality control in the pharmaceutical and biopharmaceutical industries. - 2.1. Pharmaceutical industry. - 2.2. Biopharmaceutical industry. - 2.3. Policy and regulatory. - 2.3.1. The US Food and Drug Administration (FDA). - 2.3.2. The European Medicine Agency (EMEA). - 2.3.3. The Japanese Ministry of Work, Labor and Welfare (MHLW). - 2.3.4. The Swiss Agency for Therapeutic Products (Swissmedic). - 2.3.5. The International Conference on Harmonization (ICH). - - 3. Types of testing. - 3.1. Microbiological purity tests. - 3.2. Physiochemical tests. - 3.3. Critical to quality steps. - 3.3.1. API starting materials and excipients. - 3.3.2. Intermediates. - 3.3.3. APIs (drug substances) and final drug product. - 3.3.4. Primary and secondary packaging materials fro drug products. - - 4. Manufacturing cost and quality control. - 4.1.1. Pharmaceutical manufacturing cost breakdown. - 4.1.2. Biopharmaceutical manufacturing cost breakdown. - 4.2. Batch failure / rejection / rework / recalls. - - 5. Future trends in the quality control of pharmaceuticals and biopharmaceuticals. - 5.1. Rapid and real time testing. - 5.1.1. Physio-chemicals testing. - 5.1.2. Rapid microbiology methods

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The objective of this study was to find out how project success can be measured in a case where the output of a project is an intangible information product, what kind of framework can be used to evaluate the project success, and how the project assessment can be done in practice. As a case example, the success of a business blueprint project was assessed from the product point of view. A framework for assessing business blueprint project success was made based on a literature review. Furthermore, separate frameworks for measuring information product quality and project costs were developed. The theory of business blueprinting was discovered not to be firmly institutionalized and it is briefly covered in the thesis. The possible net benefits from the strategic business process harmonization were noted to be much more significant than the costs of the business blueprint project. The project was seen as a sufficient success from the viewpoint of the created output.

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Traducción del Anteproyecto de Propuesta Directiva concerniente a la armonización de las reglas de determinación de los beneficios imponibles, de marzo de 1988.

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Zidovudine (AZT) and stavudine (D4T) are nucleoside reverse transcriptase inhibitors extensively used in human immunodeficiency virus (HIV) infected patients. In order to evaluate the quality of these drugs, two stability indicating HPLC methods were developed. The validated methods were applied in quantitative determination of AZT, D4T and their induced degradation products in capsule preparations. The stability studies were conducted at controlled temperature and relative humidity conditions based on the International Conference on Harmonization stability studies protocol for Zone IV areas. Easy sample preparation and low-cost make these methods especially useful for quality control and stability studies of AZT and D4T in drug products.

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El treball que es presenta conté un text articulat sobre la part de teoria general del contracte (arts. 612-1 i següents) del llibre sisè del Codi Civil de Catalunya. El procés de codificació civil que es viu a Catalunya justifica aquest treball, que podria ser útil per a elaboració del llibre sisè del CCCat dedicat a les obligacions i els contractes. El treball consta d’una proposta de text articulat, amb el seus respectius comentaris a cada article. Es tracta del capítol segon del títol primer del llibre sisè, i es divideix en les següents seccions: 1) El contracte, els seus elements essencials, i la seva eficàcia; 2) La formació del contracte; 3) La interpretació del contracte; i 4) La ineficàcia del contracte, que inclou l’anàlisi dels vicis del consentiment. El treball ha pres com a referència les principals propostes d’harmonització del dret contractual (Principis Unidroit [PICC], Principis de Dret Contractual Europeu [PECL], Marc Comú de Referència [DCFR], i l’Instrument Opcional sobre Compravenda Europea [CESL] i la regulació dels codis més moderns (entre ells, el del Quebec, l’Holandès, el Portuguès o l’Italià) i les seves propostes de reforma (el projecte Terrè a França, i la Propuesta de Modificación del Código Civil Español en materia de obligaciones y contratos). En la proposta presentada s’incorporen institucions no regulades en el Codi civil espanyol actualment vigent a Catalunya en la seva condició de dret supletori, i s’omplen algunes llacunes d’aquest cos legal. Es poden citar, entre elles, les clàusules abusives dels contractes, el canvi en les circumstàncies essencials del contracte, el contracte per a persona per designar, la responsabilitat per culpa in contrahendo, les cartes d’intencions, el règim de l’oferta i l’acceptació del contracte, els contractes preparatoris, els drets de preferència, la possibilitat d’anul·lació del contracte per concessió d’un avantatge injust a alguna de les parts, i el règim dels contractes en frau de creditors.

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A cleaning validation method was developed and validated, based on swabbing sampling and simultaneous chromatographic determination of sulfamethoxazole (SMX) and trimethoprim (TMP) residues. The method presented limits of detection of 0.06 mg mL-1 for SMX and 0.09 mg mL-1 for TMP. It was considered selective, precise, accurate and robust according to the guidelines from ANVISA, the Brazilian regulatory agency, and International Conference on Harmonization. Mean swab recovery factors of 98.5% for SMX and 97.7% for TMP were obtained for spiked stainless steel plates. The method was successfully applied to the assay of actual swab samples collected from eleven points on an equipment surface.

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Today’s business world demands more and more internal and external integration and transparency among companies at all fields. Integrated ERP (enterprise resource planning) systems offer a possibility to improve business practices and procedures by providing a unified view on the business including all functions and departments. Due to the obvious benefits, the popularity of integrated ERP systems keeps growing. The implementation of ERP systems has however proven risky. The implementation projects tend to be long, extensive, and costly – and often they end up in a failure. Due to the significant task and role changes ERP implementation brings to almost everybody in the company, training has been identified as one of the most critical success factors of an ERP implementation. To ensure that the training is conducted in the most effective and successful manner, the training outcomes should be evaluated. So far, training evaluation has however gained only limited attention at most companies investing in different training programs. Uponor corporation has initiated a large ERP implementation and process harmonization program in 2004. Thousands of end-users have been trained during this project so far, and the work still continues until the project is completed in 2010. In this thesis, the evaluation of end-user training in Uponor’s ERP program is brought further from the current state of performing the basic participant satisfaction survey in the end of each class. The results show that in order to reach reliable training effectiveness evaluation results, not only the reaction towards training but also transfer of skills and attitudes and the final results of the training program should be evaluated.

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The chemical industries worldwide are passing through a very particular moment of re-adaptation due to the implementation of an European regulation called, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). In Brazil, the Brazilian Chemical Industry needs urgently a specific guide of chemical products stability. The main purpose of this work is to present a proposal of a guide of stability for chemical products based on the reference guides of the International Conference on Harmonization (ICH). Thus, this work proposes an innovation in terms of methodology which will be useful for shelf life definition purpose for chemical industry products.

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Tämän tutkimuksen tavoitteena oli selvittää Imatran kaupungin teknisen toimen nykyinen tietojärjestelmäarkkitehtuuri, sekä selvittää, kuinka hyvin käytettävät tietojärjestelmät tukevat teknisen toimen tuottamaa omakotirakentajan palveluprosessia. Työn teoriaosassa syvennyttiin palvelujen hallintaan, tietojärjestelmiin ja paikkatietojärjestelmiin. Työn empiirisessä osassa tutkittiin, kuinka toimiva käytössä oleva järjestelmäkokonaisuus on. Tutkimus osoitti, että käytössä olevat tietojärjestelmät ja ohjelmistot ovat tehokkaita ja tarkoituksenmukaisia. Teknologian kehittämisen lisäksi tulee kiinnittää huomiota työskentelytapojen kehittämiseen ja yhtenäistämiseen esimerkiksi sähköisen prosessin seurantalomakkeen, tietokantojen päivittämisen, sekä paperisten aineistojen digitoimisen avulla. Tietojärjestelmäarkkitehtuurin tulee olla yksinkertainen ja päällekkäisiä toimintoja kannattaa välttää. Paikkatietojärjestelmien muuttaminen selainpohjaisiksi tehostaa eri tietolähteiden hyödyntämistä. Henkilöstön riittävä tietojärjestelmäkoulutus on tärkeää.

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Tutkielman tavoitteena oli selvittää, tulisiko Suomen konserniavustuslakia muuttaa vastaamaan paremmin EU-säädöksiä ja kansainvälistyvää yritystoimintaympäristöä. Näkökulmana uudistustarpeelle käytettiin Ruotsissa vuonna 2010 tehtyä lakiuudistusta, joka sallii rajat ylittävän niin sanotun konsernivähennyksen tietyissä erityistilanteissa. Tutkimus nojautuu lisäksi kahteen merkittävään EU-tuomioistuimen ratkaisuun koskien rajat ylittäviä tuloksentasauksia sekä primäärisen EU-oikeuden määräyksiin. Tarkastelusta on rajattu kokonaan pois konserniavustuksen yhtiöoikeudellinen ulottuvuus. Tutkimus toteutettiin käyttämällä lainopillista sekä de lege ferenda – menetelmää. Tutkimuksessa päädyttiin ehdottamaan Suomeen Ruotsin mallin mukaista rajat ylittävää niin sanottua konsernivähennystä, joka sallittaisiin tietyissä erityistilanteissa. Tutkimuksessa selvisi lisäksi, että EU:ssa on vireillä useita yritysverotuksen harmonisointiin liittyviä hankkeita mm. yhtenäisen veropohjan osalta, mutta varsinaisiin toimenpiteisiin esimerkiksi direktiivien muodossa ei ole vielä ryhdytty.