natgillin/translations-raw huggingface dataset:
The level of international interest in the Agency's veterinary activities of regulatory authorities from outside the EU is expected to be high, and support to these various organisations will continue. 
Za veterinarske dejavnosti Agencije se pričakuje veliko zanimanje regulativnih organov na mednarodni ravni zunaj EU, podpora tem različnim organizacijam pa se bo nadaljevala.
Seven applications to establish MRLs for new substances in products for food animals are forecast, and the number of applications for extensions or modifications of MRLs is expected to increase to nine 
Predvidenih je sedem vlog za določitev MRL za nove učinkovine v izdelkih za živali, namenjene za prehrano, število vlog za povečanje ali spremembo MRL pa naj bi predvidoma naraslo na devet.
The orphan drug fund allocated by the European Union budgetary authority for 2005 amounts to € 3,700,000. 
Proračunski organ Evropske unije je skladu za zdravila sirote za leto 2005 dodelil 3,700.000 EUR.
Establishment of effective working relations with the European Food Safety Authority 
Vzpostavitev uspešnih delovnih odnosov z Evropsko agencijo za varno hrano.
From 1993 to 1997, she was seconded to the European Commission (DG XII) as scientific secretary for COST actions in the field of chemistry, with responsibility for coordination of research networks and organisation of scientific conferences and workshops in Europe. 
Od 1993 do 1997 je bila poslana v Evropsko komisijo (DG XII) kot znanstvena sekretarka za ukrepe COST na področju kemije, odgovorna za usklajevanje raziskovalnega omrežja ter organiziranje znanstvenih konferenc in delavnic v Evropi.
ICH-E2E: Pharmacovigilance Planning To be incorporated in revised Volume 9 (see above) 
ICH-E2E: Pharmacovigilance Planning Vključi se v revidirani Zvezek 9 (glej zgoraj)
Number of meetings 
Število zasedanj
ICH activities will continue with two meetings in 2005, and reinforced support and coordination from the Agency will be provided in accordance with the new pharmaceutical legislation 
Dejavnosti ICH se bodo nadaljevale z dvema zasedanjema leta 2005, Agencija pa bo zagotavljala okrepljeno podporo in usklajevanje v skladu z novo farmacevtsko zakonodajo.
To progress the development of a programme of corporate projects (25 out of 50 corporate IT projects) while providing support to all IT activities related to the Agency's increased responsibility. 
Nadaljevati razvijanje programa podjetniških projektov (25 od 50 podjetniških projektov IT), ob hkratnem zagotavljanju podpore vsem dejavnostim IT, povezanimi s povečanimi pristojnostmi
To improve the provision of information in the post-authorisation phase in accordance with the new legislation on variations 
Izboljšati obveščanje v fazi po izdaji dovoljenja v skladu z novo zakonodajo o spremembah.
Fellow of the Institute of Quality Assurance, UK. 
Članica Združenja za zagotavljanje kakovosti, Združeno kraljestvo.
The EMEA devoted significant effort in 2004 to drawing up a ‘Road Map', in consultation with its stakeholders, setting out the Agency's vision for the years to come and the measures that need to be put in place to respond to the changing environment in which it exists. 
EMEA si je leta 2004 po posvetovanju s svojimi zainteresiranimi stranmi zelo prizadevala pripraviti usmeritveni načrt ("Road Map"), v katerem so predstavljeni vizija Agencije za prihodnja leta in ukrepi, ki jih bo treba uvesti kot odgovor na spreminjajoče se okolje Agencije.
Streamlining the procurement procedure and the management of contracts 
Poenostavitev postopka javnega naročanja in upravljanja pogodb.
It should be noted that pharmacovigilance is a priority area for the Agency and that, as a consequence, the EMEA will continue and further strengthen its efforts in order to ensure the safe use of products licensed in accordance with the centralised procedure. 
Treba je poudariti, da je farmakovigilanca za Agencijo prednostno področje in da bo zato EMEA še naprej krepila svoja prizadevanja za zagotovitev varne uporabe izdelkov, za katere je bilo izdano dovoljenje po centraliziranem postopku.
The document management system allows for better implementation of requirements of the Agency's quality policy, helps to manage the large number of documents being created by the Agency, and will automate certain publishing and communication activities. 
Sistem vodenja dokumentacije bo omogočil boljše izvajanje zahtev kakovostne politike Agencije, pomagal pri urejanju velikega števila dokumentov, ki jih sestavi Agencija, ter avtomatiziral določene dejavnosti objavljanja in sporočanja.
Released for consultation September 2004. 
Dano v posvetovanje septembra 2004.
Increasing bilateral cooperation with the US Food and Drug Administration following the signing of confidentiality arrangements in September 2003 and the similar agreement proposed with the US Department of Agriculture for certain classes of veterinary medicines 
Krepitev dvostranskega sodelovanja z Upravo za hrano in zdravila ZDA po podpisu dogovorov o zaupnosti septembra 2003 in podobnega sporazuma, ki ga je predlagalo Ministrstvo za kmetijstvo ZDA za določene razrede veterinarskih zdravil.
Contribution (see SWP) 
Prispevek (glej SWP)
Adequate implementation of the concept of risk management plans 
Ustrezno izvajanje koncepta načrtov obvladovanja tveganja.
Following the outcome of the CVMP audit in October 2004, implementation of its recommendations to strengthen the quality assurance system in relation to the CVMP procedures 
Po opravljeni reviziji CVMP oktobra 2004 izvajanje njenih priporočil za krepitev sistema zagotavljanja kakovosti v zvezi s postopki CVMP.
These estimates relate to centrally authorised products 
Te ocene veljajo za centralno odobrene izdelke.
The European Union Telematics strategy for pharmaceuticals is agreed between Member States, the EMEA and the European Commission. 
O telematski strategiji Evropske unije za farmacevtske izdelke se dogovorijo države članice, EMEA in
To enhance the overall quality of the EU regulatory system through the availability of top-quality scientific expertise and an adequate quality assurance system, in close collaboration with national competent authorities 
Izboljšati celotno kakovost regulativnega sistema EU z razpoložljivostjo vrhunskega znanstvenega strokovnega znanja in izkušenj ter ustreznim sistemom zagotavljanja kakovosti v tesnem sodelovanju s pristojnimi nacionalnimi organi.
The year 2005 will be a defining one for the European Medicines Agency: it marks the 10th anniversary of the Agency's creation, and it sees the full entry into force of new legislation that will shape its future development. 
Leto 2005 bo za Evropsko agencijo za zdravila odločilno: zaznamovala ga bo deseta obletnica ustanovitve Agencije in začetek popolne veljavnosti nove zakonodaje, ki bo oblikovala njen prihodnji razvoj.
Procedures for the certification of PMFs and VAMFs were implemented in 2004. 
Postopki za certificiranje PMF in VAMF so bili uvedeni leta 2004.
Honorary member of the Pharmaceutical Society of Great Britain since 2003 and honorary fellow of the Royal College of Physicians since 2004. 
Farmacevtskega društva Velike Britanije od leta 2003 in častni član Kraljevske akademije zdravnikov od leta 2004.
The level of international activity is expected to continue to increase, taking into account the Agency's reinforced role in an enlarged European Union, resulting in an increasing interest in the Agency's work from non-EU regulatory authorities 
Predvidoma se bo raven mednarodne dejavnosti še naprej krepila glede na okrepljeno vlogo Agencije v razširjeni Evropski uniji, kar povzroča povečano zanimanje regulativnih organov, ki niso iz EU, za delo Agencije.
He was also involved in numerous multinational project management and business analysis assignments, including managing the implementation of a worldwide information management system for clinical trials on behalf of a Swiss-based pharmaceutical company. 
Sodeloval je tudi pri mnogih nalogah s področja večnacionalnega vodenja projektov in poslovne analize, vključno z vodenjem izvajanja svetovnega informacijskega sistema za vodenje kliničnega preizkušanja v imenu farmacevtske družbe s sedežem v Švici.
In 1987, he joined Coopers & Lybrand where he was a senior management consultant specialising in the management and financial control of large, primarily IT-related, projects. 
Leta 1987 se je pridružil Coopers & Lybrandu, kjer je bil višji svetovalec za management, specializiran za vodenje in finančni nadzor velikih projektov, povezanih predvsem z IT.
Coordination of activities in the context of the joint audit programme for GMP inspectorates to ensure maintenance of consistent quality standards and harmonised approaches 
Usklajevanje dejavnosti v okviru skupnega revizijskega programa za inšpektorate za dobro proizvodno prakso, da se zagotovi vzdrževanje doslednih standardov kakovosti in usklajenih pristopov.
He undertook long-term assignments as a management consultant until January 1997, when he joined the EMEA. 
Prevzel je dolgoročne naloge kot svetovalec managementa vse do januarja 1997, ko se je pridružil EMEA.
The EMEA was given the responsibility to implement the EU telematics strategy and projects agreed by the European Commission, Member States and the Agency, which, once implemented, will increase efficiency of the network, provide better information to users of medicinal products, and contribute to the safe and effective use of medicinal products. 
EMEA je bila zaupana odgovornost za izvajanje telematske strategije EU in projektov, dogovorjenih med Evropsko komisijo, državami članicami in Agencijo, ki bodo, ko bodo izvedeni, povečali učinkovitost mreže, zagotavljali boljšo obveščenost uporabnikov o zdravilih ter prispevali k varni in učinkoviti uporabi zdravil.
By 1987, he had gradually moved from full-time interpreting to full-time software development. 
Do 1987 je postopno opuščal polno zaposlitev tolmača in prevzemal polno zaposlitev na področju razvijanja programske opreme.
Following the audit of the CVMP conducted in October 2004, the Agency and Committee members will ensure the necessary responses to opportunities for improvement are implemented in full, to optimise the working practices of the Committee, its working parties and the secretariat. 
Po reviziji CVMP, opravljeni oktobra 2004, bodo Agencija in člani odbora zagotovili, da se bodo potrebni ukrepi za možno izboljšanje stanja izvajali v celoti, zato da se vzpostavijo najboljši možni delovni postopki odbora, njegovih delovnih skupin in sekretariata.
Following the first PMF applications received in 2004, seven applications are forecast for 2005. 
Po prvih vlogah za PMF, prejetih v letu 2004, je za leto 2005 predvidenih sedem vlog.
Implementation of legislative provisions in relation to financial incentives for SMEs and creation of a dedicated service within the Agency 
Izvajanje zakonskih določb o finančnih spodbudah za majhna in srednje velika podjetja ter ustanovitev namenske službe v okviru Agencije.
Impact of Process Analytical Technologies on quality aspects of assessment and inspection 
Vpliv postopkovnih analitičnih tehnologij na kakovostne vidike ocenjevanja in pregledovanja.
There will be continued technical support to the Commission in its membership of Codex Alimentarius, and the Agency and CVMP will continue their representation at other international forums, including the WHO, OIE and FAO. 
Nadaljevala bo z zagotavljanjem tehnične podpore Komisiji in njenemu članstvu v Codex Alimentarius, Agencija in CVMP pa bosta še naprej zastopana v drugih mednarodnih forumih, vključno z WHO (Svetovna znanstvena organizacija), OIE (Mednarodni urad za epizootije) in FAO
Initiatives outlined in the Agency's Road Map coupled with the implementation of the new pharmaceutical legislation will further contribute to the reinforcement of an effective and robust European regulatory system. 
Pobude iz usmeritvenega načrta Agencije bodo skupaj z izvajanjem nove farmacevtske zakonodaje še dodatno prispevale h krepitvi učinkovitega in trdnega evropskega regulativnega sistema.
Development of a meeting management system to automate the meeting management process 
Razviti sistem vodenja sestankov, da se avtomatizira postopek vodenja sestankov.
He joined the secretariat of the European Parliament in 1989, serving on the secretariats of the Committee on Research, Technological Development and Energy, of the Committee on Budgets and, latterly, of the Parliament's Bureau and Conference of Presidents. 
Leta 1989 se je pridružil sekretariatu Evropskega parlamenta in nato delal v sekretariatih Odbora za raziskave, tehnološki razvoj in energijo, Odbora za proračun in v zadnjem času Predsedstva in konference predsednikov Parlamenta.
Implementation of the electronic document management system remains a priority in the area of document management and publishing as it is the bedrock for effective document management at the Agency and for publishing of core business information to the web interface. 
Izvajanje sistema elektronskega vodenja dokumentacije ostaja prednostna naloga na področju vodenja in objavljanja dokumentacije, saj je to osnova učinkovitega vodenja dokumentacije v Agenciji in objavljanja osnovnih poslovnih informacij na spletnem vmesniku.
Enlargement of the Community to 25 Member States may mean that there is a greater challenge in reaching consensus in the mutual recognition procedure, with the potential for an increase in referrals to the CVMP for arbitration (Article 33) on the grounds of potential risk to human or animal health, or to the environment 
Razširitev Skupnosti na 25 držav članic bi lahko pomenila, da je težje doseči soglasje v postopku vzajemnega priznavanja, kar pomeni možnost povečanja števila predložitev zadev Odboru za veterinarska zdravila (CVMP) v arbitražo (člen 33) zaradi možne nevarnosti za zdravje ljudi ali živali ali za okolje.
Support the European contribution to international discussions on GMP/quality systems in cooperation with the FDA and within the ICH and VICH framework 
Podpora evropskemu prispevku k mednarodnim razpravam o dobri proizvodni praksi/sistemih kakovosti v sodelovanju s FDA ter v okviru ICH in VICH.
Career to date: Mr Wathion first worked as a pharmacist in a retail pharmacy. 
Dosedanja poklicna pot: G. Wathion je najprej delal kot farmacevt v maloprodajni lekarni.
Following this she worked on a short-term contract at the European Commission (DG XI) and then in industry at Pfizer (formerly SmithKline Beecham Animal Health) as a regulatory affairs manager. 
Potem je kratek čas delala za Evropsko komisijo (DG XI), nato pa v industriji za Pfizer (bivši SmithKline Beecham Animal Health) kot vodja regulativnih zadev.
The joint CHMP/CVMP Quality Working Party will also meet four times in 2005 as it continues with the development of EU quality guidelines. 
Skupna delovna skupina CHMP/CVMP za kakovost se bo leta 2005 prav tako sestala štirikrat in nadaljevala razvijanje kakovostnih smernic EU.
In order to address urgent situations, a system of provisional measures is foreseen. 
Za obravnavanje nujnih okoliščin je predviden sistem začasnih ukrepov.
Contribution to EMEA and HMA activities 
Prispevek k dejavnostim EMEA in HMA
Business continuity plan - the exercising and testing of the plan will be carried out 
Načrt zveznosti poslovanja - potekale bodo vaje in preizkušanje načrta.
Contribution to the activities of the European Monitoring Centre for Drugs and Drug Addiction through extended contribution to EU joint actions 
Prispevek k dejavnostim Evropskega centra za spremljanje drog in zasvojenosti z drogami z večjo pomočjo skupnim ukrepom EU.
Increased complexity of managing multilingual submissions of product information due to the increase in number of languages following enlargement and to tighter deadlines introduced by the new legislation 
Večja zahtevnost obravnavanja večjezičnega pošiljanja informacij o izdelkih zaradi večjega števila jezikov po širitvi in krajših rokov, ki jih je uvedla nova zakonodaja.
The EMEA receives safety reports from within and outside the EU concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products. 
EMEA prejema varnostna poročila o centralno odobrenih zdravilih iz EU in zunaj nje ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.
Continuous implementation of EMEA transparency policy measures adopted by the EMEA Management Board in October 2003 relating to European public assessment reports, information on referral procedures, inspection-related activities, meeting summaries, summaries of opinions, and question and answer documents 
Stalno izvajanje ukrepov za preglednost politike EMEA, ki jih je sprejel njen upravni odbor oktobra 2003 in se nanašajo na evropska javna poročila o oceni, obveščanje o postopkih za predložitev, dejavnosti, povezane z izvajanjem inšpekcijskih pregledov, povzetke sestankov, povzetke mnenj ter na dokumente z vprašanji in odgovori.
Definition and establishment of the dictionaries to be implemented centrally, together with an agreed process for managing dictionary maintenance 
Opredelitev in vzpostavitev slovarjev, ki se bodo izvajali centralno, skupaj z dogovorjenim postopkom za vodenje vzdrževanja slovarjev.
Implementation of a pilot programme for parallel scientific advice with the US Food and Drug Administration and monitoring of its effectiveness 
Izvajanje pilotskega programa vzporednega znanstvenega svetovanja Uprave za hrano in zdravila ZDA ter spremljanje njegove učinkovitosti.
To implement confidentiality arrangements with the FDA on inspection-related activities 
Izvajati dogovore o zaupnosti s FDA pri dejavnostih, povezanih z inšpekcijskimi pregledi.
Career to date: Mr Salvatore acted as a private practice lawyer from 1991 to 2004, dealing with arbitration and litigation cases mainly in the fields of public procurement, competition, international trade and contracts. 
Dosedanja poklicna pot: G. Salvatore je bil od 1991 do 2004 odvetnik z zasebno prakso in se je v glavnem ukvarjal z arbitražnimi in pravdnimi zadevami s področja javnega naročanja, konkurence, mednarodne trgovine in pogodb.
A number of other important issues that have an impact on the Agency's operations will also require attention: the emergence of innovative new medical technologies and therapies; the increasing globalisation of the pharmaceutical industry and its regulatory environment; the competitiveness of Europe's biotechnology, pharmaceutical and healthcare industries; and the increased expectations of civil society with regard to information, communication and transparency. 
Pozornost bo treba nameniti tudi številnim drugim pomembnim vprašanjem, ki vplivajo na delovanje Agencije: pojav novih inovativnih medicinskih tehnologij in terapij, vse večja globalizacija farmacevtske industrije in njenega regulativnega okolja, konkurenčnost evropske biotehnologije, farmacevtska in zdravstvena industrija ter povečana pričakovanja civilne družbe glede obveščanja, sporočanja in preglednosti.
Implementation of Directive 2001/20/EC and of the new legislation will add to demands on community inspection resources 
Izvajanje Direktive 2001/20/ES in nove zakonodaje bo povečalo povpraševanje po virih skupnosti za izvajaje inšpekcijskih pregledov.
Major corporate IT programmes for 2005 include an electronic document management system and a meeting management system. 
Med pomembnejše podjetniške programe IT za leto 2005 spadata elektronski sistem vodenja dokumentacije in sistem vodenja sestankov.
Operation, maintenance, support and further development of two important sub-systems: product information management system (PIM) and user identity management, together with legally enforceable digital signatures. 
Izvajanje, vzdrževanje, podpiranje in nadaljnji razvoj dveh pomembnih podsistemov: sistem upravljanja informacij o izdelkih in upravljanje identitet uporabnikov, skupaj s pravnomočnimi digitalnimi podpisi.
Article 30 referrals are mainly initiated in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States. 
Predložitve iz člena 30 se uvedejo predvsem, da se v Skupnosti uskladijo pogoji za izdajo dovoljenj za izdelke, ki so jim države članice že izdale dovoljenja.
A moderate increase in parallel distribution compared to 2004 is forecast. 
Predvideva se skromno povečanje vzporedne distribucije v primerjavi z letom 2004.
The number of requests for clarification on the list of MRLs is significant and is expected to remain at approximately 200 
Trendi: Število zahtev za pojasnitev seznama MRL je precejšnje, po predvidevanjih naj bi ostalo pri številki približno 200.
In 1986 she joined the French National Scientific Research Centre (CNRS) as Chargé de recherche 1ère classe and became officer for European affairs in 1991. 
Leta 1986 se je pridružila francoskemu Nacionalnemu znanstveno raziskovalnemu centru (CNRS) kot Chargé de recherche 1. razreda in leta 1991 postala uradnica za evropske zadeve.
From 1992 to 1998 he served as director-general of AIDES Fédération Nationale. 
Od leta 1992 do 1998 je bil generalni direktor AIDES Fédération
The EMEA will continue to fulfil its obligations under the new EU legislation with regard to coordination of pharmacovigilance responsibilities, with particular emphasis on effective communication to healthcare professionals and other interested parties. 
EMEA bo nadaljevala izpolnjevanje svojih obveznosti iz nove zakonodaje EU v zvezi z usklajevanjem odgovornosti za farmakovigilanco, s posebnim poudarkom na učinkovitem obveščanju zdravstvenih strokovnjakov in drugih zainteresiranih strani.
The agreed action plan for revision of the programme requires an update of all documentation and SOPs at both the EMEA and EDQM. 
Dogovorjeni akcijski načrt za revizijo programa zahteva posodobitev celotne dokumentacije in standardnih operativnih postopkov v EMEA in EDQM.
The number of marketing authorisation applications for orphan medicinal products is expected to remain unchanged at 10 applications 
število vlog za izdajo dovoljenja za promet z zdravili sirotami bo predvidoma ostalo nespremenjeno pri desetih vlogah.
The Agency continues its role in coordinating the input and participation of the EU at VICH, and will be represented at the VICH 3 conference scheduled to take place in Washington DC in May 2005. 
Agencija bo še naprej imela svojo vlogo pri usklajevanju prispevkov in sodelovanja EU pri VICH ter bo poslala svoje predstavnike na konferenco VICH 3, ki naj bi predvidoma potekala maja 2005 v
Conduct analysis and assessment of the Executive Director's annual activity report for 2004 
Analiziral in ocenil letno poročilo izvršnega direktorja o delu v letu 2004.
To encourage greater exchange of information and dialogue on post-authorisation and safety of medicines, and to contribute to the effective utilisation of available EU resources in advancing effective pharmacovigilance for all veterinary medicines 
Spodbujati večjo izmenjavo informacij ter dialog o dejavnostih po izdaji dovoljenja in o varnosti zdravil ter prispevati k učinkoviti uporabi razpoložljivih virov EU pri razvijanju učinkovite farmakovigilance za vsa veterinarska zdravila.
He was the UK representative of the Biotechnology Working Party, involved in the generation of many guidelines relating to biotechnology and biological products. 
Bil je predstavnik združenega kraljestva v Delovni skupini za biotehnologijo in sodeloval pri oblikovanju številnih smernic za biotehnološke in biološke izdelke.
The new legislation introduced a simplified registration procedure for traditional herbal medicinal products in the EU Member States and established a Committee on Herbal Medicinal Products (HMPC). 
Nova zakonodaja je uvedla poenostavljeni postopek registracije tradicionalnih zeliščnih zdravil v državah članicah EU in ustanovila Odbor za zeliščna zdravila.
In addition, the Agency provides advice to sponsors of designated orphan medicines. 
Agencija svetuje tudi sponzorjem zdravil, določenih za zdravila sirote.
The forecast for electronic reporting for non-centrally authorised products in relation to EU and non-EU cases is 15,000 
Napoved za elektronsko poročanje o izdelkih, ki so bili odobreni necentralno, za primere iz EU in zunaj nje znaša 15.000.