natgillin/translations-raw huggingface dataset:
The latter will help to maintain and improve the quality of translations of non-product information documents.
Te slednje bodo pomagale vzdrževati in izboljševati kakovost prevodov dokumentov z informacijami, ki se ne nanašajo na proizvod.
Thanks to the new legislation, the Agency was able to introduce a number of procedures which provide faster availability of most-needed medicines and assure high quality of the results of the work performed.
Zaradi nove zakonodaje je Agencija lahko uvedla številne postopke, ki zagotavljajo hitrejšo dostopnost najbolj potrebnih zdravil in visoko kakovost rezultatov opravljenega dela.
It also deals with other emerging therapies and new technologies that are not within the scope of the upcoming regulation on advanced therapies and which will strongly influence the Agency's work in this field.
Ukvarja se tudi z drugimi novimi terapijami in tehnologijami, ki ne spadajo v področje predvidene uredbe o naprednih terapijah in ki bodo močno vplivale na delo Agencije na tem področju.
1.3 Support for innovation and access to medicines
1.3 Podpora inovacijam in dostopnost zdravil
21 Expenditure on data processing 22 Movable property and asset costs 23 Other administrative expenditure 24 Postage and communications 25 Expenditure on formal and other meetings
21 Odhodki za obdelavo podatkov 22 Premično premoženje in s tem povezani stroški 23 Drugi upravni odhodki 24 Poštnine in obveščanje 25 Izdatki za uradna in druga srečanja
In addition, following the entry into force of the legislation on access to documents, the Agency expects there to be 100 such requests, compared to 50 requests in 2006 (a single request may encompass hundreds of documents).
Poleg tega Agencija pričakuje, da bo po začetku veljavnosti zakonodaje o dostopu do dokumentov tovrstnih zahtevkov 100, medtem ko jih je bilo v letu 2006 le 50 (en sam zahtevek lahko obsega stotine dokumentov).
Fostering this spirit of cooperation and seeking practical solutions to present and future challenges brought by developments in our field will be my final, but nonetheless important, priority for 2007.
Spodbujati sodelovanje in iskanje praktičnih rešitev za sedanje in prihodnje izzive, ki jih prinaša razvoj na našem področju, bo moja zadnja, vendar kljub temu pomembna prednostna naloga v letu 2007.
Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting a small number of patients in the European Community.
Zdravila sirote so namenjena diagnosticiranju, preprečevanju ali zdravljenju smrtno nevarnih ali kronično izčrpavajočih bolezni, ki prizadenejo majhno število bolnikov v Evropski skupnosti.
Over 4 000 experts are used by the EMEA in its scientific evaluation work.
EMEA pri svojem znanstvenem ocenjevalnem delu uporablja več kot 4000 strokovnjakov.
The number of referrals triggered by safety concerns where there is a Community interest is expected to remain low, with only 1 predicted for 2007.
Pričakuje se, da bo število napotitev zaradi varnostnih pomislekov, kjer obstaja interes Skupnosti, ostalo nizko, saj se za leto 2007 napoveduje le ena.
The Agency will design, plan and carry out refurbishment projects in the new space to make it fully equipped for the needs of the Agency's delegates and staff.
Agencija bo oblikovala, načrtovala in izvedla obnovitvene projekte v novih prostorih, da bodo popolnoma opremljeni za potrebe odposlancev in osebja Agencije.
The Agency forecasts the number of serious adverse reaction reports will rise to well over 400, with 64 PSURs4 being submitted (54 were submitted in 2006).
Agencija predvideva, da bo število poročil o resnih neželenih učinkih precej preseglo številko 400, saj je bilo predloženih 64 PSUR4 (v letu 2006 jih je bilo predloženih 54).
The table below provides an overview of the development of the systems in 2007.
Spodnja tabela vsebuje pregled razvoja sistemov v letu 2007.
This will be done through various initiatives, which will also include development and maintenance of a scientific memory database.
To bo izvedla prek različnih pobud, ki bodo zajemale tudi razvoj in vzdrževanje zbirke podatkov znanstvenega pomnilnika.
The Agency will participate in the multi-beneficiary programme dedicated to supporting the participation of Croatia and Turkey in the work of certain Community agencies.
Agencija bo sodelovala v programu, namenjenem več upravičencem, katerega cilj je podpirati sodelovanje Hrvaške in Turčije pri delu določenih agencij Skupnosti.
The external evaluations will continue into late 2007.
Zunanja ocenjevanja se bodo nadaljevala daleč v leto 2007.
Any comments on the content of this draft SME User Guide should also be forwarded to the SME office.
Kakršne koli pripombe o vsebini tega osnutka Vodnika za uporabnike iz malih in srednje velikih podjetij pošljite Uradu za mala in srednje velika podjetja.
This increase is due, to a large extent, to the entry into force of the new legislation modifying the scope of procedures and introducing new procedures.
Razlog za to povečanje je predvsem dejstvo, da je začela veljati nova zakonodaja, ki spreminja področje postopkov in uvaja nove postopke.
The level of access will take into account the requirement to guarantee personal data protection as well as the commercial confidentiality of some of the data stored in EudraVigilance.
Pri ravni dostopa se bo upoštevala zahteva po zagotovitvi varstva osebnih podatkov in poslovni zaupnosti nekaterih podatkov, shranjenih v EudraVigilance.
This system is intended to act as a central repository for controlled terms for the European medicines network.
Namen tega sistema je delovati kot osrednje skladišče za nadzorovane izraze za evropsko mrežo zdravil.
Work will continue on implementing the vision outlined in the long-term strategies prepared by the EMEA and the national competent authorities.
Še naprej se bo izvajala vizija, začrtana v dolgoročnih strategijah, ki so jo pripravili EMEA in pristojni nacionalni organi.
2.3 Initial evaluation
2.3 Začetna ocena
The first version of this database will be delivered early in 2007.
Prva različica te zbirke podatkov bo na voljo na začetku leta 2007.
Expertise needed in the working parties will be addressed together with the Heads of Medicines Agencies.
Potrebno strokovno znanje in izkušnje delovnih skupin bodo obravnavani skupaj z vodji agencij za zdravila.
5.3 Meetings and conferences at the EMEA
5.3 Sestanki in konference v EMEA
The Agency issues certificates of medicinal products to support the work of health authorities outside the European Union, in particular in developing countries.
Agencija izdaja potrdila za zdravila, da bi podprla delo zdravstvenih organov zunaj Evropske unije, zlasti v državah v razvoju.
− Strengthen cooperation on pharmacovigilance, EU telematics, scientific advice, support to SMEs and communication;
− krepitev sodelovanja na področju farmakovigilance, telematike EU, znanstvenega svetovanja, podpore malim in srednje velikim podjetjem ter obveščanja;
E-procurement tools, systems and procedures will be introduced and developed in 2007.
V letu 2007 bodo uvedeni in razviti sistemi, orodja, in postopki za e-naročila.
The EMEA, together with the European Commission, plans to continue preliminary discussions with the Japanese medicines agency (MHWL/PMDA) in order to explore the possibility of setting up confidentiality arrangements similar to those concluded with the FDA.
EMEA namerava skupaj z Evropsko komisijo nadaljevati predhodne pogovore z japonsko agencijo za zdravila (MHWL/PMDA) zato, da bi preučili možnost oblikovanja dogovorov o zaupnosti, ki so podobni dogovorom, sklenjenim s FDA.
The strategy aims to increase efficiency and enhance transparency, and to support and facilitate the operation of procedures established by legislation.
Strategija je namenjena povečanju učinkovitosti in preglednosti ter podpori in spodbujanju izvajanja postopkov, ki jih določa zakonodaja.
A fifth scientific committee, the Paediatric Committee, will be established in the second quarter of 2007.
V drugi četrtini leta 2007 bo ustanovljen peti znanstveni odbor - Odbor za pediatrijo.
The Agency will receive entirely new responsibilities in the field of paediatric medicines.
Agencija bo prevzela popolnoma nove odgovornosti na področju zdravil za pediatrično uporabo.
Innovation and research are the primary driving forces for new medicines, and, consequently, motors for improved public and animal health.
Inovacije in raziskave so glavna gonilna sila za nova zdravila ter posledično tudi gibalo za boljše zdravje ljudi in živali.
The detection, evaluation and tracking of potential safety issues will be reinforced through the availability of the EudraVigilance Data Warehouse and Analysis System.
Odkrivanje, ocenjevanje in spremljanje morebitnih varnostnih vprašanj bodo okrepljena z razpoložljivostjo sistema za shranjevanje in analizo podatkov EudraVigilance.
The number of submissions for scientific advice for veterinary medicines will increase to 16 for 2007.
Število vlog za znanstveno svetovanje glede zdravil za uporabo v veterinarski medicini se bo v letu 2007 povečalo na 16.
The Agency will complete the development of the communication and transparency strategy and begin its implementation during 2007.
Agencija bo dokončala razvoj strategije o obveščanju in preglednosti ter jo v letu 2007 začela izvajati.
Firstly, the Agency will further improve the EudraVigilance database and individual case safety reporting.
Prvič, Agencija bo še naprej izboljševala zbirko podatkov EudraVigilance in varnostno poročanje o posameznih primerih.
GMP (including PMF) GCP (including pharmacovigilance) GLP
GMP (vključno s PMF) GCP (vključno s farmakovigilanco) GLP
The Agency's task-force on innovation will continue its work, and the EMEA/CHMP think-tank on innovation will finalise its report in the beginning of the year.
Delovna skupina Agencije za inovacije bo nadaljevala svoje delo, ustvarjalna enota EMEA/CHMP za inovacije pa bo na začetku leta dokončala svoje poročilo.
The number of type-I and II variations will change in line with the growing number of centrally authorised products.
Število sprememb tipa I in II se bo spremenilo v skladu z vse večjim številom zdravil, odobrenih po centraliziranem postopku.
Safety of veterinary medicines in the post-authorisation phase and the need to implement and further improve a risk-management approach to this important issue will continue to be a high priority for the Agency in 2007.
Varnost zdravil za uporabo v veterinarski medicini po izdaji dovoljenja ter potreba po uresničevanju in nadaljnjem izboljševanju pristopa obvladovanja tveganj v tej pomembni zadevi bosta ostali pomembni prednostni nalogi za Agencijo v letu 2007.
The factors influencing the growing number of meetings to be held at the Agency in 2007 include: the increasing responsibilities of the Agency (paediatric legislation); a growing interest in the centralised procedure (leading to more meetings with applicants); activities in the field of innovation; and intensified cooperation in the network (including training activities).
Dejavniki, ki vplivajo na rastoče število sestankov, organiziranih na Agenciji v letu 2007, vključujejo: vedno večje odgovornosti Agencije (pediatrična zakonodaja); rastoče zanimanje za centralizirani postopek (kar vodi k vedno večjemu številu sestankov z vlagatelji); dejavnosti na področju inovacij in intenzivnejše sodelovanje v mreži (vključno z dejavnostmi usposabljanja).
− Operate and increase the effectiveness of marketing authorisation procedures for facilitating availability of medicines, while maintaining the highest quality standards.
− izvajanje in povečanje učinkovitosti postopkov izdajanja dovoljenj za promet za omogočanje dostopnosti zdravil ob ohranjanju najvišjih standardov kakovosti.
The number of meetings and increasing number of staff due to the growing responsibilities of the Agency made it necessary for the Agency to acquire additional office space in 2006.
Precejšnje število sestankov in rastoče število zaposlenih zaradi vedno večjih odgovornosti Agencije, je EMEA prisililo v pridobitev dodatnega pisarniškega prostora v letu 2006.
Parallel-distribution notifications transferred from 2005 to 2006 Parallel-distribution notifications
Obvestila o vzporedni distribuciji, prenesena iz leta 2005 v leto Obvestila o vzporedni distribuciji
Work will continue on improving the cost-effectiveness of arrangements for working parties, including a review of their mandates, the distribution of work, and the support provided by the secretariat.
Nadaljevalo se bo delo na področju izboljševanja stroškovne učinkovitosti ureditev za delovne skupine, vključno s pregledom njihovih pooblastil, razdeljevanjem dela in podporo, ki jo nudi sekretariat.
During 2007, it is anticipated that the high-level design will be completed, that the system will be prototyped, and that work on the first production version will be initiated.
Pričakuje se, da bo med letom 2007 končan načrt na visoki ravni, da bo sistem dobil svoj prototip in da se bo začelo delo na prvi proizvodni različici.
The MMS financial module will speed up the process of reimbursing delegates and provide clearer information to delegates and national competent authorities.
Finančni modul MMS bo pospešil postopek povračila stroškov odposlancem ter zagotovil jasnejše informacije odposlancem in pristojnim nacionalnim organom.
The Agency will rationalise the certification process in 2007.
Agencija bo v letu 2007 racionalizirala nekatere postopke certificiranja.
− Further implement the EMEA transparency measures and increase the openness of the Agency's activities to underpin its corporate governance;
− nadaljnje izvajanje ukrepov EMEA za preglednost in večja odprtost dejavnosti Agencije, da se poudari podjetniško upravljanje;
The Agency's highlights for this year will include completion of the two-year process-improvement exercise.
V tem letu se bo Agencija posvetila dokončanju dveletnega izboljševanja postopkov.
The Agency will work to carry out GMP, GCP7, GLP8 and pharmacovigilance inspections within the required timelines and to the required quality level.
Agencija si bo prizadevala, da bodo inšpekcijski pregledi GMP, GCP7, GLP8 in farmakovigilance opravljeni v zahtevanih rokih in na zahtevani ravni kakovosti.
Work will also commence in the area of paediatric pharmacovigilance.
Začelo se bo tudi delo na področju pediatrične farmakovigilance.
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.
Agencija izraža dobrodošlico predstavnikom Bolgarije in Romunije kot polnopravnih članic Evropske mreže zdravil in dejavnih udeleženk pri delu Agencije.
EU reports (centrally authorised products) Non-EU reports (centrally authorised products) EU reports (nationally authorised products) Non-EU reports (nationally authorised products)
Poročila EU (proizvodi z dovoljenji po centraliziranem postopku) Poročila zunaj EU (proizvodi z dovoljenjem po centraliziranem postopku) Poročila EU (proizvodi z dovoljenjem po
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.
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.
Unmet training needs in critical areas will be identified and processes for advanced educational exchange will be established.
Opredeljene bodo potrebe po usposabljanju na kritičnih področjih in določeni procesi za izmenjavo v visokošolskem izobraževanju.
− Further stimulate complementarities in the network and develop adequate work-sharing and resource-planning activities across the network;
− nadaljnje spodbujanje dopolnjevanja v mreži in razvoj ustreznih dejavnosti delitve dela ter načrtovanja virov v mreži;
The Agency will also liaise with responsible US institutions to exchange relevant information on veterinary medicines.
Agencija se bo tudi povezala s pristojnimi institucijami ZDA in si izmenjala ustrezne informacije o veterinarskih zdravilih.
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.
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.
The planned development of the analytical and reporting functions of the EudraVigilance Data Warehouse will support this goal.
Načrtovani razvoj analitičnih in poročevalskih funkcij sistema shranjevanja podatkov EudraVigilance bo v podporo temu cilju.
European Review System (Pre-installation)
European Review System (predhodna namestitev)
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.
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.
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.
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.
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.
Agencija bo še naprej uspešno in koristno sodelovala s FDA ter uvedla ukrepe za poglobitev tega sodelovanja s povezovanjem postopkov za vzporedno znanstveno svetovanje.
− 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;
− 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;
To undertake the above tasks, the EMEA will establish a new scientific committee (the Paediatric Committee) and related processes.
Zaradi izvajanja zgornjih nalog bo EMEA ustanovila nov znanstveni odbor (Odbor za pediatrijo) in vzpostavila z njim povezane postopke.
The Agency anticipates around 50 requests for scientific advice relating to paediatric medicines.
Agencija pričakuje približno 50 vlog za znanstveno svetovanje v zvezi z zdravili za pediatrično uporabo.
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.
Ta obravnava ozka grla v razvoju zdravil ter lahko močno in daljnosežno vpliva na to, kako bodo v prihodnje potekale raziskave na področju zdravil.
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.
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.
Secondly, the EMEA will continue to work with the national competent authorities to establish an intensive drug monitoring system.
Drugič, EMEA bo še naprej sodelovala s pristojnimi nacionalnimi organi zaradi vzpostavitve intenzivnega sistema za spremljanje zdravil.
Together with the Member States, the Agency will continue to work on encouraging a reporting culture on pharmacovigilance issues.
Agencija bo skupaj z državami članicami še naprej spodbujala kulturo poročanja o vprašanjih farmakovigilance.
The Agency also plans to improve the electronic records management system, to include mail registration and electronic archiving solutions.
Agencija načrtuje tudi izboljšanje elektronskega sistema vodenja evidenc, da bi vključila registriranje pošte in elektronske rešitve arhiviranja.
In addition to evaluation of received applications, the Agency will continue the provision of information on post-authorisation activities.
Agencija bo poleg ocenjevanja prejetih vlog še naprej zagotavljala informacije o dejavnostih po izdaji dovoljenja.
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.
Agencija bo ponovno preučila svoje prevajalske politike, da bi upoštevala povečanje večjezičnih komunikacijskih dejavnosti, ter razvila terminologijo in zbirke podatkov prevajalskih spominov.
The Agency is active in the field of advanced therapy medicinal products such as gene therapy, somatic cell-therapy and human tissue-engineered products.
Agencija je dejavna na področju zdravil za napredne terapije, kot so genska terapija, somatsko celično zdravljenje in proizvodi, pridobljenih iz človeških tkiv.
5.1 Infrastructure services at the EMEA
5.1 Infrastrukturne storitve pri EMEA
2.6 Pharmacovigilance and maintenance activities
2.6 Farmakovigilanca in vzdrževalne dejavnosti
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.
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.
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.
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.
It will also address aspects relating to data quality and stakeholders' compliance with expedited reporting timelines.
Obravnavala bo tudi vidike, povezane s kakovostjo podatkov in izpolnjevanjem rokov pospešenega poročanja s strani zainteresiranih strani.
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.
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.
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.
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.