Epilepsy priorities in Europe: A report of the ILAE-IBE Epilepsy Advocacy Europe Task Force.

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.

Current and future trens in the quality control of pharmaceuticals and biopharmaticals : impacts on Cost of Goods Sold (COGS)

[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

Assessment of an information product project success: case business blueprint

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.

Armonización de la base imponible de los impuestos sobre beneficios societarios en la CEE

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

Stability-indicating methods for quantitative determination of zidovudine and stavudine in capsules

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.

Proposta d’un text articulat sobre teoria general del contracte per al Llibre sisè del Codi Civil de Catalunya

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.

Determinação simultânea de resíduos de sulfametoxazol e trimetoprima em superfícies de equipamentos de produção

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.

Evaluating End-User Training Effectiveness in ERP System Implementation

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.

Definição de shelf life para produtos químicos: a importância de um guia de estabilidade específico para o segmento

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.

Tietojärjestelmät palvelutuotannon tukena

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.

Konserniavustus - vero-oikeudellinen tutkimus vertailukohteina EU:n ja Ruotsin oikeus

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.

Identifying first graders at risk of reading and writing difficulties : creating a group-based screening tool in kiswahili in Tanzania

Early identification of beginning readers at risk of developing reading and writing difficulties plays an important role in the prevention and provision of appropriate intervention. In Tanzania, as in other countries, there are children in schools who are at risk of developing reading and writing difficulties. Many of these children complete school without being identified and without proper and relevant support. The main language in Tanzania is Kiswahili, a transparent language. Contextually relevant, reliable and valid instruments of identification are needed in Tanzanian schools. This study aimed at the construction and validation of a group-based screening instrument in the Kiswahili language for identifying beginning readers at risk of reading and writing difficulties. In studying the function of the test there was special interest in analyzing the explanatory power of certain contextual factors related to the home and school. Halfway through grade one, 337 children from four purposively selected primary schools in Morogoro municipality were screened with a group test consisting of 7 subscales measuring phonological awareness, word and letter knowledge and spelling. A questionnaire about background factors and the home and school environments related to literacy was also used. The schools were chosen based on performance status (i.e. high, good, average and low performing schools) in order to include variation. For validation, 64 children were chosen from the original sample to take an individual test measuring nonsense word reading, word reading, actual text reading, one-minute reading and writing. School marks from grade one and a follow-up test half way through grade two were also used for validation. The correlations between the results from the group test and the three measures used for validation were very high (.83-.95). Content validity of the group test was established by using items drawn from authorized text books for reading in grade one. Construct validity was analyzed through item analysis and principal component analysis. The difficulty level of most items in both the group test and the follow-up test was good. The items also discriminated well. Principal component analysis revealed one powerful latent dimension (initial literacy factor), accounting for 93% of the variance. This implies that it could be possible to use any set of the subtests of the group test for screening and prediction. The K-Means cluster analysis revealed four clusters: at-risk children, strugglers, readers and good readers. The main concern in this study was with the groups of at-risk children (24%) and strugglers (22%), who need the most assistance. The predictive validity of the group test was analyzed by correlating the measures from the two school years and by cross tabulating grade one and grade two clusters. All the correlations were positive and very high, and 94% of the at-risk children in grade two were already identified in the group test in grade one. The explanatory power of some of the home and school factors was very strong. The number of books at home accounted for 38% of the variance in reading and writing ability measured by the group test. Parents´ reading ability and the support children received at home for schoolwork were also influential factors. Among the studied school factors school attendance had the strongest explanatory power, accounting for 21% of the variance in reading and writing ability. Having been in nursery school was also of importance. Based on the findings in the study a short version of the group test was created. It is suggested for use in the screening processes in grade one aiming at identifying children at risk of reading and writing difficulties in the Tanzanian context. Suggestions for further research as well as for actions for improving the literacy skills of Tanzanian children are presented.

Hajautetun tuotannon verkkoonliittäminen - verkkokoodit ja käytännön toimet

Euroopan unionin asettamat uusiutuvan energian lisäämistavoitteet ovat kasvattaneet hajautetun tuotannon määrää Euroopassa. Eri hajautetun tuotannon verkkokoodit asettavat tuotantolaitoksille omat vaatimuksensa, mikä vaikeuttaa eri toimijoita, joten yhtenäiselle verkkokoodille on tarvetta. ENTSO-E onkin luomassa tällä hetkellä Euroopan unionille yhtenäisiä pilottiverkkokoodeja, joiden tarkoitus on myöhemmin kattaa kaikkia tuotantolaitoksia koko Euroopassa. Tämän vuoksi ENTSO-E:n verkkokoodien vaatimuksia on syytä tutkia. Tässä diplomityössä tarkastellaan hajautetun tuotannon nykyisiä ja ENTSO-E:n kehitteillä olevia verkkokoodeja. Työssä tutkitaan myös älykkäiden verkkojen ja verkkokoodien kehitystä. Verkkokoodien vertailuja suoritetaan pohjoismaisesta näkökulmasta, mutta vertailuun on otettu myös muita Euroopan maita. Tarkastelu painottuu siirto- ja jakeluverkkokoodien osalta tuulivoimalle asetettaviin vaatimuksiin. Mikrotuotannon verkkokoodien ja käytännön toimien tarkastelu keskittyy invertterin kautta verkkoonliitettäviin tuotantolaitoksiin, joissa aurinkotuotanto on merkittävin tuotantomuoto.

St. Petersburg Court Chant and the Tradition of Eastern Slavic Church Singing

The present study examines the repertory of liturgical chant known as St. Petersburg Court Chant which emerged within the Imperial Court of St. Petersburg, Russia, and appeared in print in a number of revisions during the course of the 19th century, eventually to spread throughout the Russian Empire and even abroad. The study seeks answers to questions on the essence and composition of Court Chant, its history and liturgical background, and most importantly, its musical relationship to other repertories of Eastern Slavic chant. The research questions emerge from previous literary accounts of Court Chant (summarized in the Introduction), which have tended to be inaccurate and generally not based on critical research. The study is divided into eight main chapters. Chapter 1 provides a survey of the history of Eastern Slavic chant and the Imperial Court Chapel of St. Petersburg until 1917, with special emphasis on the history of singing traditional chant in polyphony, the status of the Court Chapel as a government authority, and its endeavours in publishing church music. Chapter 2 deals with the liturgical background of Eastern chant, the chant genres, and main repertories of Eastern Slavic chant. Chapter 3 concentrates on chant sources: it introduces the musical notations utilised, after which a typology of chant books is presented. The discussion continues with a survey of the sources of Court Chant and their content, the specimens selected for closer analysis, the comparative materials from other repertories, and ends with a commentary on some chant sources that have been excluded. The comparative sources include a specimen from around the beginning of the 12th century, a few manuscripts from the 17th century, and printed and manuscript chant books from the early 18th to early 20th century, covering the geographical area that delimits to the western Ukraine, Astrakhan, Nizhny Novgorod, and the Solovetsky Monastery. Chapter 4 presents the approach and methods used in the subsequent analytical comparisons. After a survey of the pitch organization of Eastern Slavic chant, the customary harmonization strategy of traditional chant polyphony is examined, according to which a method for meaningful analysis of the harmony is proposed. The method is based on the observation that the harmonic framework of chant polyphony derives from the standard pitch collection of monodic chant known as the Church Gamut, specific pitches of which form eight harmonic regions that behave like the usual tonalities of major and harmonic minor. Because of the considerable quantity of comparative chant forms, computer-assisted statistical methods are applied to the analysis of chant melodies. The primary chant forms and their respective comparative forms have been pre-processed into reduced chant prototypes and divided into redactions. The analyses are carried out by measuring the formal dissimilarities of the primary chant forms of the Court Chant repertory against each comparative form, and also by measuring the reciprocal dissimilarities of all chant versions in a redaction, the results of which are subjected to agglomerative hierarchical clustering in order to find out how the chant forms relate to each other. The dissimilarities are determined by applying a metric dissimilarity function that is based on the Levenshtein Distance. Chapter 5 provides the melodic and harmonic analyses of generic chants (chants used for multiple texts of different lengths), i.e., chants for stichera samoglasny and troparia, Chapter 6 of pseudo-generic chants (chants that are used for multiple texts but with certain restrictions), i.e., chants for heirmoi, prokeimena, and three other hymns, and Chapter 7 of non-generic chants, covering nine chants that in the Court repertory are not shared by multiple texts. The results are summarized and evaluated in Chapter 8. Accordingly, it can be established that, contrary to previous conceptions, melodically, Court Chant is in effect a full part of the wider Eastern Slavic chant tradition. Even if it is somewhat detached from the chant versions of the Synodal square-note chant books and the local tradition of Moscow, it is particularly close to chant forms of East Ukraine and some vernacular repertories from Russia. Respectively, the harmonization strategies of Court Chant do not show significant individuality in comparison with those of the available polyphonic comparative sources, the main difference being the part-writing, which generally conforms to western common practice standard, whereas the deviations from this tend to be more significant in other analysed repertories of polyphonic chant. Thus, insofar as the subsequent prevalence of Court Chant is not based on its forceful dissemination by authorities (as suggested in previous literature but for which little tangible evidence could be found in Chapter 1), in the present author’s interpretation, Court Chant attained its dominance principally because musically it was considered sufficiently traditional, and as a chant body supported by the government, was conveniently available in print in serviceable harmonizations.

Supply chain performance management system

The purpose of the study is to determine general features of the supply chain performance management system, to assess the current state of performance management in the case company mills and to make proposals for improvement – how the future state of performance management system would look like. The study covers four phases which consist of theory and case company parts. Theoretical review gives understanding about performance management and measurement. Current state analysis assesses the current state of performance management in the mills. Results and proposals for improvement are derived from current state analysis and finally the conclusions with answers to research questions are presented. Supply chain performance management system consists of five areas: perfor-mance measurement and metrics, action plans, performance tracking, performance dialogue and rewards, consequences and actions. The result of the study revealed that all mills were quite average level in performance management and there is a room for improvement. Created performance improvement matrix served as a tool in assessing current performance management and could work also as a tool in the future in mapping the current state after transformation process. Limited harmonization was revealed as there were different ways to work and manage performance in the mills. Lots of good ideas existed though actions are needed to make a progress. There is also need to harmonize KPI structure.