FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency will work to carry out GMP, GCP7, GLP8 and pharmacovigilance inspections within the required timelines and to the required quality level.
Slovenian: Agencija si bo prizadevala, da bodo inšpekcijski pregledi GMP, GCP7, GLP8 in farmakovigilance opravljeni v zahtevanih rokih in na zahtevani ravni kakovosti.
English: Work will also commence in the area of paediatric pharmacovigilance.
Slovenian: Začelo se bo tudi delo na področju pediatrične farmakovigilance.
English: The Agency looks forward to welcoming representatives of Bulgaria and Romania as full members of the European medicines network and active participants in the work of the Agency.
Slovenian: Agencija izraža dobrodošlico predstavnikom Bolgarije in Romunije kot polnopravnih članic Evropske mreže zdravil in dejavnih udeleženk pri delu Agencije.
English: EU reports (centrally authorised products) Non-EU reports (centrally authorised products) EU reports (nationally authorised products) Non-EU reports (nationally authorised products)
Slovenian: Poročila EU (proizvodi z dovoljenji po centraliziranem postopku) Poročila zunaj EU (proizvodi z dovoljenjem po centraliziranem postopku) Poročila EU (proizvodi z dovoljenjem po
English: The Agency will collaborate closely with Member States in the European Surveillance Strategy (ESS) to foster a joint approach to optimising the efficiency of EU veterinary pharmacovigilance for all medicinal products authorised in the Community.
Slovenian: Agencija bo z državami članicami tesno sodelovala pri evropski strategiji nadzora (ESS), da bi pospešila skupni pristop k optimizaciji učinkovitosti veterinarske farmakovigilance v EU za vsa zdravila, ki imajo dovoljenje za promet v Skupnosti.
English: Unmet training needs in critical areas will be identified and processes for advanced educational exchange will be established.
Slovenian: Opredeljene bodo potrebe po usposabljanju na kritičnih področjih in določeni procesi za izmenjavo v visokošolskem izobraževanju.
English: − Further stimulate complementarities in the network and develop adequate work-sharing and resource-planning activities across the network;
Slovenian: − nadaljnje spodbujanje dopolnjevanja v mreži in razvoj ustreznih dejavnosti delitve dela ter načrtovanja virov v mreži;
English: The Agency will also liaise with responsible US institutions to exchange relevant information on veterinary medicines.
Slovenian: Agencija se bo tudi povezala s pristojnimi institucijami ZDA in si izmenjala ustrezne informacije o veterinarskih zdravilih.
English: A significant task for the Agency in 2007 is to implement the paediatric medicines regulation by ensuring effective cooperation between the Scientific Advice Working Party and the new Paediatric Committee.
Slovenian: Pomembna naloga Agencije v letu 2007 je izvajanje uredbe o zdravilih za pediatrično uporabo z zagotavljanjem učinkovitega sodelovanja med Delovno skupino za znanstveno svetovanje in novim Odborom za pediatrijo.
English: The planned development of the analytical and reporting functions of the EudraVigilance Data Warehouse will support this goal.
Slovenian: Načrtovani razvoj analitičnih in poročevalskih funkcij sistema shranjevanja podatkov EudraVigilance bo v podporo temu cilju.
English: European Review System (Pre-installation)
Slovenian: European Review System (predhodna namestitev)
English: In addition, it will develop the concept of the ‘multistrain' dossier to promote authorisation of vaccines against antigenically variable viruses such as avian influenza, bluetongue and foot-and-mouth disease.
Slovenian: Poleg tega bo razvila zamisel o „večsevnem“ („multistrain“) projektu da bi spodbudila izdajanje dovoljenj za cepiva proti antigensko spremenljivim virusom, kot so aviarna influenca, bolezen modrikastega jezika ter slinavka in parkljevka.
English: In order to meet the expectations of patients' organisations and sponsors and the requirements of the legislation, and to create an environment for innovation and research in this area, the Agency will continue to provide incentives during the development and initial marketing authorisation phases.
Slovenian: Da bi Agencija izpolnila pričakovanja organizacij bolnikov in sponzorjev ter zakonodajne zahteve in da bi ustvarila okolje za inovacije in raziskave na tem področju, bo med razvojem in v začetnih fazah izdajanja dovoljenja za promet še naprej nudila spodbude.
English: The Agency will continue its successful and useful cooperation with the FDA and will introduce measures to deepen this cooperation by consolidating procedures for parallel scientific advice.
Slovenian: Agencija bo še naprej uspešno in koristno sodelovala s FDA ter uvedla ukrepe za poglobitev tega sodelovanja s povezovanjem postopkov za vzporedno znanstveno svetovanje.
English: − Further improve the Agency's contribution towards the provision of high-quality and timely information on medicines in all official EU languages to patients and healthcare professionals; Contribute to the work of the Pharmaceutical Forum, particularly in the area of provision of information to patients;
Slovenian: − nadaljnje izboljšanje prispevka Agencije k zagotavljanju visokokakovostnih in pravočasnih informacij o zdravilih v vseh uradnih jezikih EU bolnikom in zdravstvenim strokovnjakom; prispevek k dejavnostim Farmacevtskega foruma, zlasti na področju dajanja informacij bolnikom;
English: To undertake the above tasks, the EMEA will establish a new scientific committee (the Paediatric Committee) and related processes.
Slovenian: Zaradi izvajanja zgornjih nalog bo EMEA ustanovila nov znanstveni odbor (Odbor za pediatrijo) in vzpostavila z njim povezane postopke.
English: The Agency anticipates around 50 requests for scientific advice relating to paediatric medicines.
Slovenian: Agencija pričakuje približno 50 vlog za znanstveno svetovanje v zvezi z zdravili za pediatrično uporabo.
English: The latter aims to address bottlenecks in the development of medicines, and may have a strong and wide-reaching impact on how research in medicines is done in the future.
Slovenian: Ta obravnava ozka grla v razvoju zdravil ter lahko močno in daljnosežno vpliva na to, kako bodo v prihodnje potekale raziskave na področju zdravil.
English: It will extend the dialogue with academia and society at large to identify expertise, expectations and bottlenecks relating to the area of new treatment solutions.
Slovenian: Poglobila bo dialog z akademskim svetom in družbo na splošno zato, da bi se opredelila strokovno znanje, pričakovanja in ozka grla na področju novih rešitev za zdravljenje.
English: Secondly, the EMEA will continue to work with the national competent authorities to establish an intensive drug monitoring system.
Slovenian: Drugič, EMEA bo še naprej sodelovala s pristojnimi nacionalnimi organi zaradi vzpostavitve intenzivnega sistema za spremljanje zdravil.
English: Together with the Member States, the Agency will continue to work on encouraging a reporting culture on pharmacovigilance issues.
Slovenian: Agencija bo skupaj z državami članicami še naprej spodbujala kulturo poročanja o vprašanjih farmakovigilance.
English: The Agency also plans to improve the electronic records management system, to include mail registration and electronic archiving solutions.
Slovenian: Agencija načrtuje tudi izboljšanje elektronskega sistema vodenja evidenc, da bi vključila registriranje pošte in elektronske rešitve arhiviranja.
English: In addition to evaluation of received applications, the Agency will continue the provision of information on post-authorisation activities.
Slovenian: Agencija bo poleg ocenjevanja prejetih vlog še naprej zagotavljala informacije o dejavnostih po izdaji dovoljenja.
English: The Agency will re-examine its translation policies, to take into account the increase in multilingual communication activities, and will develop the terminology and translation memory databases.
Slovenian: Agencija bo ponovno preučila svoje prevajalske politike, da bi upoštevala povečanje večjezičnih komunikacijskih dejavnosti, ter razvila terminologijo in zbirke podatkov prevajalskih spominov.
English: The Agency is active in the field of advanced therapy medicinal products such as gene therapy, somatic cell-therapy and human tissue-engineered products.
Slovenian: Agencija je dejavna na področju zdravil za napredne terapije, kot so genska terapija, somatsko celično zdravljenje in proizvodi, pridobljenih iz človeških tkiv.
English: 5.1 Infrastructure services at the EMEA
Slovenian: 5.1 Infrastrukturne storitve pri EMEA
English: 2.6 Pharmacovigilance and maintenance activities
Slovenian: 2.6 Farmakovigilanca in vzdrževalne dejavnosti
English: The Agency faces challenges in the area of document management stemming from the next wave of EU enlargement, which will impact on multilingual communication and translation activities, and implementation of the legislation on access to documents.
Slovenian: Agencija se ukvarja z izzivi na področju upravljanja dokumentov, ki bodo posledica naslednjega vala širitve EU, kar bo vplivalo na večjezično komunikacijo in prevajalske dejavnosti, in na področju izvajanja zakonodaje o dostopu do dokumentov.
English: This EMEA work programme for 2007 has been shaped by a number of factors in the rapidly developing medicines regulation environment, most notably the entry into force of the legislation on paediatric medicines.
Slovenian: Na delovni program EMEA za leto 2007 so vplivali številni dejavniki v hitro razvijajočem se regulativnem okolju zdravil, predvsem začetek veljavnosti zakonodaje o zdravilih za pediatrično uporabo.
English: It will also address aspects relating to data quality and stakeholders' compliance with expedited reporting timelines.
Slovenian: Obravnavala bo tudi vidike, povezane s kakovostjo podatkov in izpolnjevanjem rokov pospešenega poročanja s strani zainteresiranih strani.
English: In addition, the work on paediatric investigation plans will impact on activities within other areas, including scientific advice, quality and post-authorisation areas, as well as risk-management plans.
Slovenian: Poleg tega bo delo na načrtih pediatričnih raziskav vplivalo na dejavnosti na drugih področjih, vključno z znanstvenim svetovanjem, področjema kakovosti in faze po izdaji dovoljenja, ter načrti obvladovanja tveganj.
English: In addition to its evaluation of orphan-designation applications, the Agency will collaborate with international partners, particularly through increased provision of protocol assistance in parallel with the US Food and Drug Administration.
Slovenian: Poleg ocenjevanja vlog za določitev zdravil sirot bo Agencija sodelovala z mednarodnimi partnerji, zlasti v smislu večjega zagotavljanja pomoči pri protokolu vzporedno z Uradom za prehrano in zdravila (FDA) iz ZDA.
English: Final accounts 2005 10 Appropriation/Budget 2006 as of 31 December 2006 Appropriation/Budget 2007 as adopted by the Management Board on 19 December 2006
Slovenian: Zaključni računi 2005. 10 Odobrena proračunska sredstva/proračun za 2006 z dne 31. decembra 2006.
English: 2.8 Medicines for children
Slovenian: 2.8 Zdravila za otroke
English: The Agency expects to complete the remaining internal evaluation work and follow-up with new Member States in the context of the EC-Canada MRA, which will now include Bulgaria and Romania.
Slovenian: Agencija pričakuje dokončanje preostalega notranjega ocenjevanja in spremljanja z novima državama članicama glede sporazuma o medsebojnem priznavanju med ES in Kanado, kar zdaj vključuje Bolgarijo in Romunijo.
English: Plasma master file (PMF).
Slovenian: Glavni dosje plazme (Plasma master file, PMF).
English: The Agency expects to receive in 2007 the first variations to similar biological products and first updates of opinions given to medicinal products intended for non-EU markets.
Slovenian: Agencija pričakuje, da bo v letu 2007 prejela prve spremembe biološko podobnih zdravil in prve spremembe mnenj, izdanih za zdravila, ki niso namenjena trgom EU.
English: A trend seen in scientific advice is the high interest shown by industry, with a significant increase in the number of requests from year to year translating into a high workload and, thus, the need for effective management of procedures.
Slovenian: Gibanje, ki ga je mogoče opaziti na področju znanstvenega svetovanja, je veliko zanimanje industrije, ki se kaže v precejšnjem povečevanju števila vlog iz leta v leto, kar pa pomeni veliko delovno obremenitev in s tem tudi potrebo po učinkovitem upravljanju postopkov.
English: The EMEA expects that the number of parallel-distribution notifications for 2007 will stabilise at approximately 1,000.
Slovenian: EMEA pričakuje, da se bo število obvestil o vzporedni distribuciji v letu 2007 ustalilo in doseglo približno 1000 obvestil.
English: 5.2 Information technology
Slovenian: 5.2 Informacijska tehnologija
English: The EMEA and the network partners will establish a rolling twoyear work plan for the period 2007-2009 and will take forward a project designed to set up a network of academic centres for the intensive monitoring of targeted medicines.
Slovenian: EMEA in partnerji mreže bodo oblikovali dvoletni krožni delovni načrt za obdobje 2007-2009 ter nadaljevali projekt, namenjen vzpostavitvi mreže akademskih centrov za intenzivno spremljanje ciljnih zdravil.
English: The Agency provides secretarial support to the Coordination groups for mutual recognition and decentralised procedures (human and veterinary products) (CMD)(h) and CMD(v)), and to their subgroups/working groups, in accordance with the approved rules of procedure.
Slovenian: Sekretariat Agencije daje podporo Usklajevalnima skupinama za postopke medsebojnega priznavanja in za decentralizirane postopke (zdravila za uporabo v humani medicini in zdravila za uporabo v veterinarski medicini) (CMD)(h) in CMD(v)) ter njunim podskupinam/delovnim skupinam, v skladu z odobrenim poslovnikom.
English: Close collaboration between the EMEA, the European Directorate for the Quality of Medicines and the national authorities in the programme continues to prove invaluable in assuring effective and continued post-marketing surveillance of the quality of medicines.
Slovenian: Tesno sodelovanje med EMEA, Evropskim direktoratom za kakovost zdravil in nacionalnimi organi po tem programu se še naprej kaže kot neprecenljivo pri zagotavljanju učinkovitega in stalnega nadzora kakovosti zdravil po izdaji dovoljenja.
English: In 2007, the European medicines network will continue its work to address trends relating to the growing complexity and the number of tasks performed at Community level, as well as the advent of novel therapies and technologies.
Slovenian: V letu 2007 bo Evropska mreža zdravil nadaljevala obravnavanje trendov, povezanih z vse večjo zapletenostjo in številčnostjo nalog, ki se izvajajo na ravni Skupnosti, ter tudi delo v zvezi s prihodom novih tehnologij in terapij.
English: This is a result of recognition and appreciation by potential applicants of improvements to the veterinary scientific advice procedure, as well as growing confidence in the industry through experience with the procedure.
Slovenian: To je posledica dejstva, da morebitni vlagatelji priznavajo in cenijo izboljšave v postopku znanstvenega svetovanja na področju veterine, ter tudi vse večjega zaupanja v industrijo zaradi dobrih izkušenj s postopkom.
English: A production system is anticipated that will be able to make available sets of controlled terms, subject to the establishment of a formal process for the control of such terms.
Slovenian: Pričakuje se, da bo proizvodni sistem zmožen proizvesti nabore nadzorovanih izrazov v skladu z vzpostavitvijo uradnega postopka za kontrolo takih izrazov.
English: For product quality defects and other recalls see www.emea.europa.eu/inspections/defectinstructions.html for instructions and contact points.
Slovenian: Za pomanjkljivosti proizvodov in druge preklice pojdite na naslov www.emea.europa.eu/inspections/defectinstructions.html, ki vsebuje navodila in kontaktne osebe.
English: It will develop, with the Commission and Member States, guidelines for transparency of the paediatric clinical-trials database.
Slovenian: Skupaj s Komisijo in državami članicami bo razvila smernice za preglednost zbirke podatkov o pediatričnih kliničnih preizkušanjih.
English: In addition to the new tools we have already implemented, we want to work with Member State authorities and academic centres on establishing networks of experts to run intensive drug-monitoring programmes that will actively study the safety of targeted medicines.
Slovenian: Poleg novih orodij, ki smo jih že uvedli, želimo sodelovati z organi držav članic in akademskimi središči ter oblikovati mreže strokovnjakov, ki bodo vodile intenzivne programe spremljanja zdravil in dejavno preučevale varnost ciljno usmerjenih zdravil.
English: 2.4 Establishment of maximum residue limits
Slovenian: 2.4 Določitev mejne vrednosti ostankov
English: − Progress the implementation of the European Risk Management Strategy (ERMS), in close collaboration with the national competent authorities, leading to a more efficient system for supervising the safety of medicinal products;
Slovenian: − nadaljnje izvajanje evropske strategije obvladovanja tveganja v tesnem sodelovanju s pristojnimi nacionalnimi organi, s čemer se bo dosegel učinkovitejši sistem nadzorovanja varnosti zdravil;
English: 301 Evaluations
Slovenian: 301 Ocenjevanje
English: PIM (Product Information Management) (In pilot production)
Slovenian: PIM (upravljanje informacij o proizvodu) (v pilotski izdelavi)
English: Stimulation of innovation
Slovenian: Spodbujanje inovacij:
English: In addition to handling notifications, the Agency plans to review and update its guidance on parallel distribution to improve the efficiency of parallel-distribution notification processes, and will publish parallel-distribution notifications issued by the EMEA on its website.
Slovenian: Poleg obravnave obvestil namerava Agencija pregledati in posodobiti svoje smernice o vzporedni distribuciji, da bi izboljšala učinkovitost postopka obveščanja o vzporedni distribuciji, in na svoji spletni strani objaviti obvestila o vzporedni distribuciji, ki jih izda EMEA.
English: General EU contribution EU contribution for SME policy EU contribution for Paediatrics policy n/a 0.00 2,647 1.71
Slovenian: Prispevek EU za pediatrično politiko n/a 0,00 2.647 1,71
English: Work will include background upgrading of the underlying infrastructure followed by the delivery of improved systems for importing and exporting sets of data.
Slovenian: Delo bo vključevalo nadgradnjo ozadja osnovne infrastrukture, ki ji bo sledila zagotovitev izboljšanih sistemov za uvažanje in izvažanje naborov podatkov.
English: The Agency will review its post-authorisation activities during the ongoing process-improvement exercise to further increase efficiency.
Slovenian: Agencija bo pregledala svoje dejavnosti po izdaji dovoljenja v okviru izboljševanja postopkov, ki trenutno poteka, da bi še bolj povečala učinkovitost.
English: In line with the legislation, development will focus on products authorised using the centralised procedure in this first phase.
Slovenian: V skladu z zakonodajo bo v tej prvi fazi razvoj osredotočen na proizvode, za katere je bilo izdano dovoljenje po centraliziranem postopku.
English: Agency activities in the information technology area will seek to address the growing requirement to provide and maintain a paperless meeting room environment, high levels of service availability and good quality of IT service.
Slovenian: Pri svojih dejavnostih na področju informacijske tehnologije si bo Agencija prizadevala obravnavati rastoče zahteve po zagotavljanju in vzdrževanju okolja za sestanke brez papirja, visokih ravni razpoložljivosti storitev in dobro kakovost informacijsko-tehnoloških storitev.
English: This will enable the Agency to ensure the provision of reliable and robust IT services to its staff, delegates and all users of pan-European systems.
Slovenian: To bo Agenciji omogočilo, da bo svojemu osebju, odposlancem in vsem uporabnikom vseevropskih sistemov lahko zagotovila zanesljive in trdne informacijsko-tehnološke storitve.
English: To step up the provision of veterinary pharmacovigilance information, the Agency plans to increase reporting on pharmacovigilance information to the stakeholders.
Slovenian: Za pospešitev zagotavljanja informacij o veterinarski farmakovigilanci načrtuje Agencija povečanje sporočanja informacij o farmakovigilanci zainteresiranim strankam.
English: Incentives are provided because such medicines might, for economic reasons, not otherwise be developed.
Slovenian: Takih zdravil zaradi ekonomskih razlogov morda ne bi razvijali, zato so ponujene spodbude.
English: Medicines agencies have traditionally relied on spontaneous reporting of adverse reactions, and the EMEA EudraVigilance database remains a key tool for this.
Slovenian: Agencije za zdravila se tradicionalno opirajo na spontano poročanje o neželenih učinkih in zbirka podatkov EMEA EudraVigilance ostaja ključno orodje na tem področju.
English: These projects have been agreed as being EudraNet, EudraVigilance, EudraPharm, electronic submissions, clinical trials and good manufacturing practice databases.
Slovenian: Dogovorjeno je bilo, da ti projekti vključujejo EudraNet, EudraVigilance, EudraPharm, elektronsko pošiljanje vlog, klinična preizkušanja in zbirke podatkov o dobri proizvodni praksi.
English: The Agency will introduce additional information-technology tools to track applications for veterinary scientific advice, and will measure the level of satisfaction with the new procedure in order to make additional improvements, if needed.
Slovenian: Agencija bo uvedla dodatna orodja informacijske tehnologije za prejemanje vlog za znanstveno svetovanje na področju veterine ter izmerila raven zadovoljstva z novim postopkom, da bi po potrebi izvedla dodatne izboljšave.
English: The Agency expects that the number of applications in the post-authorisation area of veterinary medicines will remain largely unchanged.
Slovenian: Agencija pričakuje, da bo število vlog na področju dejavnosti po izdaji dovoljenja za veterinarska zdravila ostalo pretežno nespremenjeno.
English: Annex 4 EMEA contact points Pharmacovigilance and product quality defect reporting
Slovenian: Priloga 4 Kontaktne osebe EMEA Farmakovigilanca in poročanje o pomanjkljivosti izdelkov
English: Subject to successful conclusion of pilot activities for both new marketing authorisation applications and post-authorisation activities, the system will go into full production during the year.
Slovenian: Ob uspešnemu zaključku pilotskih dejavnosti za nove vloge za dovoljenje za promet in dejavnosti po izdaji dovoljenja za promet bo sistem med letom začel delovati s polno zmogljivostjo.
English: − Promote the participation of patients and healthcare professionals in the work of the Agency.
Slovenian: − spodbujanje sodelovanja bolnikov in zdravstvenih strokovnjakov pri delu Agencije.
English: If justified, desktop videoconferencing facilities will be developed and pilot web broadcasts of scientific meetings may be carried out in 2007.
Slovenian: Če bodo upravičene, se bodo razvijale tudi zmogljivosti za namizne videokonference in morda bodo v letu 2007 izvršeni pilotni prenosi znanstvenih sestankov.
English: Both GMP5 and PMF6 inspections numbers are expected to rise relative to 2006.
Slovenian: Agencija pričakuje, da se bo število inšpekcijskih pregledov na področju GMP5 in PMF6 v primerjavi z letom 2006 povečalo.
English: As part of the activities, the EMEA will prepare EPAR3 summary updates for line extensions that lead to major changes in the indications or conditions of use.
Slovenian: V okviru teh dejavnosti bo EMEA pripravljala povzetke sprememb EPAR3 za razširitev indikacij, ki pomenijo velike spremembe v indikacijah ali pogojih uporabe.
English: To better prepare itself and the network for the advent of new therapies and technologies, the Agency will promote early dialogue with sponsors of potential applications for advanced therapies and emerging products and technologies.
Slovenian: Da bi Agencija sebe in mrežo bolje pripravila na prihod novih tehnologij in terapij, bo spodbujala zgodnji dialog s sponzorji morebitnih vlog za napredne terapije ter nove proizvode in tehnologije.