FrancophonIA/ELRC3.0 huggingface dataset:
English: Some 18,800 adverse drug reaction (ADR) reports for centrally authorised medicines are expected to be received by paper mail for EU cases, with an additional 3,390 ADR reports from outside the EU
Slovenian: Po pošti naj bi prispelo približno 18.800 poročil o neželenih učinkih zdravil (adverse drug reaction, ADR) za centralno odobrena zdravila za primere iz EU, dodatnih 3390 poročil o ADR pa za primere zunaj EU.
English: Payments received Payments made
Slovenian: Prejeta plačila Izvedena plačila
English: 1.2 Implementation of the new pharmaceutical legislation
Slovenian: 1.2 Izvajanje nove farmacevtske zakonodaje
English: Professional training management directed towards a continuous system of competence development, taking account of the enhanced scientific role of the Agency
Slovenian: Vodenje strokovnega usposabljanja, usmerjenega k neprekinjenemu sistemu razvijanja pristojnosti, ter upoštevanje povečane znanstvene vloge Agencije.
English: Member of the Pharmaceutical Society of Ireland.
Slovenian: Članica Irskega farmacevtskega društva.
English: The EMEA will provide support to workshops with stakeholders, in particular with academic research organisations, organised at the initiative of the COMP and CHMP, on new scientific and methodological aspects.
Slovenian: EMEA bo podpirala delavnice z zainteresiranimi stranmi, zlasti z akademskimi raziskovalnimi organizacijami, organiziranimi na pobudo COMP in CHMP, o novih znanstvenih in metodoloških vidikih.
English: Dr Abadie has been a consultant in cardiology and diabetology since 1984.
Slovenian: Dr. Abadie je bil od leta 1984 svetovalec na področju kardiologije in diabetologije.
English: Contribution to draft prepared by EudraVigilance Working Groups
Slovenian: Prispevek k osnutku, ki so ga pripravile delovne skupine za EudraVigilance
English: The CVMP will meet 11 times during the year.
Slovenian: CVMP se bo med letom sestal enajstkrat.
English: Career to date: David Drakeford worked with Telecom Eireann where he managed the implementation of a national data communication network.
Slovenian: Dosedanja poklicna pot: David Drakeford je delal za Telecom Eireann, kjer je vodil izvajanje nacionalne mreže sporočanja podatkov.
English: The European public assessment reports will have to contain summaries written in a manner that is understandable to the public.
Slovenian: Evropska javna poročila o oceni bodo morala vsebovati povzetke, napisane tako, da bodo razumljivi javnosti.
English: Since October 2004 she has been in charge of establishing the new sector for medical information.
Slovenian: Od oktobra 2004 je odgovorna za ustanovitev novega Sektorja za informacije o zdravilih.
English: Implementation of Lot 2A of EudraCT as a production version
Slovenian: Izvajanje lota 2A Eudra CT kot proizvodne različice.
English: In 1991 he joined the International Regulatory Affairs Division of Glaxo Group Research Limited where he was responsible for the development and submission of a series of international registration applications in a number of therapeutic areas.
Slovenian: Leta 1991 se je pridružil Mednarodni diviziji za regulativne zadeve Glaxo Group Research Limited, kjer je bil odgovoren za razvoj in predložitev vrste vlog za mednarodno registracijo na številnih terapevtskih področjih.
English: A significant impact on the activities of the Agency in 2005 is the introduction of new procedures which reinforce the safety of medicines and facilitate access to new medicines.
Slovenian: Na dejavnosti Agencije v letu 2005 bo močno vplivala uvedba novih postopkov, ki bodo povečali varnost zdravil in olajšali dostop do novih zdravil.
English: Adopt rules for the implementation of the new regulation on fees payable to the EMEA
Slovenian: Sprejel pravila za izvajanje nove uredbe o pristojbinah, ki se plačujejo EMEA.
English: To be finalised following revision of Annex I of Directive 2001/82/EC
Slovenian: Dokončno se oblikuje po reviziji Priloge I k Direktivi 2001/82/ES
English: She has led the Agency's integrated quality management system and internal audit system since November 1999.
Slovenian: Od novembra 1999 vodi sistem integriranega upravljanja kakovosti in sistem notranjih revizij.
English: The legislation provides for a more active role of the Agency in different international forums concerned with regulatory harmonisation.
Slovenian: Zakonodaja predvideva dejavnejšo vlogo Agencije v različnih mednarodnih forumih, ki se ukvarjajo z usklajevanjem zakonov in predpisov.
English: Setting up a ‘visitors' centre' on the EMEA website, including information such as the Delegate manual
Slovenian: Vzpostaviti "center za obiskovalce" na spletni strani EMEA, ki bo vključeval informacije, kot je priročnik za delegate.
English: Her responsibilities there included coordination of regulatory aspects of European procedures and International Conference on Harmonisation (ICH) activities.
Slovenian: Njene tamkajšnje odgovornosti so vključevale usklajevanje regulativnih vidikov evropskih postopkov in dejavnosti v zvezi z Mednarodno konferenco o usklajevanju (ICH).
English: There is only limited market growth foreseen in the veterinary pharmaceutical sector as a result of a reduction in the number of companies and industry's claims that investment in new products is being diverted into defensive research and development
Slovenian: V veterinarskem farmacevtskem sektorju se predvideva samo omejena tržna rast, zaradi manjšega števila zahtev podjetij in industrije, da se naložbe v nove izdelke preusmerijo v netvegane raziskave in razvoj.
English: Encourage development of medicines for minor uses and minor species through implementation of the recommendations of the strategic action plan presented in the Committee for Medicinal Products for Veterinary Use (CVMP) Position Paper regarding Availability of Medicinal Products for Minor Uses and Minor Species, adopted in July 2004.
Slovenian: Spodbujanje razvoja zdravil za manjše uporabe in manj pomembne vrste na podlagi izvajanja priporočil strateškega akcijskega načrta, ki je bil predstavljen v Dokumentu o stališču Odbora za zdravila za uporabo v veterinarski medicini (Committee for Medicinal Products for Veterinary Use, CVMP glede razpoložljivosti zdravil za manjše uporabe in manj pomembne vrste, sprejetem julija 2004.
English: Continued organisation of Infodays, focus groups and bilateral meetings
Slovenian: stalno organiziranje informativnih dnevov, osredotočenih skupin in dvostranskih srečanj.
English: The development of guidelines and procedures resulting from the GMP impact of the review of legislation will form a significant part of the work plan in 2005.
Slovenian: Razvoj smernic in postopkov, ki so posledica vpliva dobre proizvodne prakse iz pregleda zakonodaje, bo zajemal pomemben del delovnega načrta za leto 2005.
English: 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.
Slovenian: Za veterinarske dejavnosti Agencije se pričakuje veliko zanimanje regulativnih organov na mednarodni ravni zunaj EU, podpora tem različnim organizacijam pa se bo nadaljevala.
English: 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
Slovenian: 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.
English: The orphan drug fund allocated by the European Union budgetary authority for 2005 amounts to € 3,700,000.
Slovenian: Proračunski organ Evropske unije je skladu za zdravila sirote za leto 2005 dodelil 3,700.000 EUR.
English: Establishment of effective working relations with the European Food Safety Authority
Slovenian: Vzpostavitev uspešnih delovnih odnosov z Evropsko agencijo za varno hrano.
English: 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.
Slovenian: 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.
English: ICH-E2E: Pharmacovigilance Planning To be incorporated in revised Volume 9 (see above)
Slovenian: ICH-E2E: Pharmacovigilance Planning Vključi se v revidirani Zvezek 9 (glej zgoraj)
English: Number of meetings
Slovenian: Število zasedanj
English: 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
Slovenian: Dejavnosti ICH se bodo nadaljevale z dvema zasedanjema leta 2005, Agencija pa bo zagotavljala okrepljeno podporo in usklajevanje v skladu z novo farmacevtsko zakonodajo.
English: 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.
Slovenian: Nadaljevati razvijanje programa podjetniških projektov (25 od 50 podjetniških projektov IT), ob hkratnem zagotavljanju podpore vsem dejavnostim IT, povezanimi s povečanimi pristojnostmi
English: To improve the provision of information in the post-authorisation phase in accordance with the new legislation on variations
Slovenian: Izboljšati obveščanje v fazi po izdaji dovoljenja v skladu z novo zakonodajo o spremembah.
English: Fellow of the Institute of Quality Assurance, UK.
Slovenian: Članica Združenja za zagotavljanje kakovosti, Združeno kraljestvo.
English: 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.
Slovenian: 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.
English: Streamlining the procurement procedure and the management of contracts
Slovenian: Poenostavitev postopka javnega naročanja in upravljanja pogodb.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Released for consultation September 2004.
Slovenian: Dano v posvetovanje septembra 2004.
English: 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
Slovenian: 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.
English: Contribution (see SWP)
Slovenian: Prispevek (glej SWP)
English: Adequate implementation of the concept of risk management plans
Slovenian: Ustrezno izvajanje koncepta načrtov obvladovanja tveganja.
English: 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
Slovenian: Po opravljeni reviziji CVMP oktobra 2004 izvajanje njenih priporočil za krepitev sistema zagotavljanja kakovosti v zvezi s postopki CVMP.
English: These estimates relate to centrally authorised products
Slovenian: Te ocene veljajo za centralno odobrene izdelke.
English: The European Union Telematics strategy for pharmaceuticals is agreed between Member States, the EMEA and the European Commission.
Slovenian: O telematski strategiji Evropske unije za farmacevtske izdelke se dogovorijo države članice, EMEA in
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Procedures for the certification of PMFs and VAMFs were implemented in 2004.
Slovenian: Postopki za certificiranje PMF in VAMF so bili uvedeni leta 2004.
English: Honorary member of the Pharmaceutical Society of Great Britain since 2003 and honorary fellow of the Royal College of Physicians since 2004.
Slovenian: Farmacevtskega društva Velike Britanije od leta 2003 in častni član Kraljevske akademije zdravnikov od leta 2004.
English: Status vaccines: Sections 4 and 5
Slovenian: Guideline on product information for vaccines: Sections 4 and 5
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Coordination of activities in the context of the joint audit programme for GMP inspectorates to ensure maintenance of consistent quality standards and harmonised approaches
Slovenian: Usklajevanje dejavnosti v okviru skupnega revizijskega programa za inšpektorate za dobro proizvodno prakso, da se zagotovi vzdrževanje doslednih standardov kakovosti in usklajenih pristopov.
English: He undertook long-term assignments as a management consultant until January 1997, when he joined the EMEA.
Slovenian: Prevzel je dolgoročne naloge kot svetovalec managementa vse do januarja 1997, ko se je pridružil EMEA.
English: 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.
Slovenian: 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.
English: By 1987, he had gradually moved from full-time interpreting to full-time software development.
Slovenian: Do 1987 je postopno opuščal polno zaposlitev tolmača in prevzemal polno zaposlitev na področju razvijanja programske opreme.
English: 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.
Slovenian: 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.
English: Following the first PMF applications received in 2004, seven applications are forecast for 2005.
Slovenian: Po prvih vlogah za PMF, prejetih v letu 2004, je za leto 2005 predvidenih sedem vlog.
English: Implementation of legislative provisions in relation to financial incentives for SMEs and creation of a dedicated service within the Agency
Slovenian: Izvajanje zakonskih določb o finančnih spodbudah za majhna in srednje velika podjetja ter ustanovitev namenske službe v okviru Agencije.
English: Impact of Process Analytical Technologies on quality aspects of assessment and inspection
Slovenian: Vpliv postopkovnih analitičnih tehnologij na kakovostne vidike ocenjevanja in pregledovanja.
English: 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.
Slovenian: 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
English: 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.
Slovenian: Pobude iz usmeritvenega načrta Agencije bodo skupaj z izvajanjem nove farmacevtske zakonodaje še dodatno prispevale h krepitvi učinkovitega in trdnega evropskega regulativnega sistema.
English: Development of a meeting management system to automate the meeting management process
Slovenian: Razviti sistem vodenja sestankov, da se avtomatizira postopek vodenja sestankov.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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.
English: Support the European contribution to international discussions on GMP/quality systems in cooperation with the FDA and within the ICH and VICH framework
Slovenian: Podpora evropskemu prispevku k mednarodnim razpravam o dobri proizvodni praksi/sistemih kakovosti v sodelovanju s FDA ter v okviru ICH in VICH.
English: Career to date: Mr Wathion first worked as a pharmacist in a retail pharmacy.
Slovenian: Dosedanja poklicna pot: G. Wathion je najprej delal kot farmacevt v maloprodajni lekarni.
English: 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.
Slovenian: 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.
English: The joint CHMP/CVMP Quality Working Party will also meet four times in 2005 as it continues with the development of EU quality guidelines.
Slovenian: Skupna delovna skupina CHMP/CVMP za kakovost se bo leta 2005 prav tako sestala štirikrat in nadaljevala razvijanje kakovostnih smernic EU.
English: In order to address urgent situations, a system of provisional measures is foreseen.
Slovenian: Za obravnavanje nujnih okoliščin je predviden sistem začasnih ukrepov.
English: Contribution to EMEA and HMA activities
Slovenian: Prispevek k dejavnostim EMEA in HMA
English: Business continuity plan - the exercising and testing of the plan will be carried out
Slovenian: Načrt zveznosti poslovanja - potekale bodo vaje in preizkušanje načrta.
English: Contribution to the activities of the European Monitoring Centre for Drugs and Drug Addiction through extended contribution to EU joint actions
Slovenian: Prispevek k dejavnostim Evropskega centra za spremljanje drog in zasvojenosti z drogami z večjo pomočjo skupnim ukrepom EU.
English: 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
Slovenian: Večja zahtevnost obravnavanja večjezičnega pošiljanja informacij o izdelkih zaradi večjega števila jezikov po širitvi in krajših rokov, ki jih je uvedla nova zakonodaja.
English: 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.
Slovenian: EMEA prejema varnostna poročila o centralno odobrenih zdravilih iz EU in zunaj nje ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.