natgillin/translations-raw huggingface dataset:
The Agency and its partners in the European medicines network must ensure that they have the scientific resources necessary to address these challenges, both in the short term and further into the future.
Agencija in njeni partnerji v Evropski mreži zdravil si morajo kratkoročno in dolgoročno zagotoviti znanstvena sredstva za te izzive.
The Management Board plans to review the system of remuneration for provision of scientific services to the EMEA in order to improve compliance with existing legislation.
Upravni odbor namerava preučiti sistem plačila za zagotavljanje znanstvenih storitev EMEA, da bi zagotovili večje upoštevanje obstoječe zakonodaje.
In the field of inspections, the EMEA will actively participate in the international discussions on worksharing and cooperation on all types of inspections with the FDA and WHO.
Na področju inšpekcijskih pregledov bo EMEA aktivno sodelovala v mednarodnih razpravah o delitvi dela ter sodelovanju z uradom FDA in SZO pri vseh vrstah pregledov.
EXECUTIVE DIRECTOR Thomas Lönngren
IZVRŠNI DIREKTOR Thomas Lönngren
Also important in 2008 will be a focus on initiatives to improve the monitoring of risks of medicines, facilitate the availability of medicines for human and veterinary use, and strengthen transparency, communication and provision of information to stakeholders, in particular patients and healthcare professionals.
V letu 2008 bo pomembna naloga tudi osredotočenje na pobude za izboljšanje spremljanja tveganj pri zdravilih, za omogočanje dostopa do zdravil za uporabo v humani in veterinarski medicini ter za okrepitev preglednosti, poročanja in zagotavljanja informacij ciljnim skupinam, zlasti bolnikom in zdravstvenim delavcem.
The Agency will carry out activities to assess the impact and consistency of its scientific opinions.
Agencija bo izvajala dejavnosti ocenjevanja vpliva in skladnosti svojih znanstvenih mnenj.
The main focus in this area will be the further strengthening of the quality and consistency of assessment of postauthorisation applications, in particular, extensions.
Glavni poudarek na tem področju bo nadaljnje izboljševanje kakovosti in skladnosti ocenjevanja vlog po izdaji dovoljenja za promet, predvsem kar zadeva razširitve.
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organization.
Agencija EMEA izdaja potrdila o zdravilu v skladu z ureditvami, ki jih je določila Svetovna zdravstvena organizacija.
This will in turn increase access to essential postauthorisation information and will better equip the network for safeguarding public and animal health.
To bo povečalo dostop do pomembnih informacij po izdaji dovoljenja za promet in bo mrežo bolje opremilo za varovanje zdravja ljudi in živali.
In the area of information technology, the Agency will progress the deployment of best-practice-support processes based on the IT Infrastructure Library (ITIL) service management.
Na področju informacijske tehnologije bo Agencija pospešila uvedbo postopkov podpore najboljšim praksam, ki temeljijo na upravljanju storitev Knjižnice infrastrukture informacijske tehnologije (ITIL).
The main factors influencing the Agency's activities in the area of pharmacovigilance relate to the implementation of the paediatric and advanced therapy legislation.
Glavni dejavniki, ki vplivajo na dejavnosti Agencije na področju farmakovigilance, so povezani z izvajanjem zakonodaje o pediatriji in zakonodaje o naprednih terapijah.
This work is carried out in the face of increasing volume and complexity of activities.
To delo bo izvajala kljub zvečanemu številu in kompleksnosti dejavnosti.
The Agency, in accordance with a WHO scheme, issues certificates of medicinal products to support the work of health authorities outside the European Union, in particular in developing countries.
V skladu s shemo SZO izdaja Agencija potrdila o zdravilih v podporo dela zdravstvenih organov zunaj Evropske unije, zlasti v državah v razvoju.
The Agency will continue to provide administrative and financial support to these enterprises and will facilitate electronic reporting by SMEs of adverse-drug-reaction data through the EudraVigilance system.
Agencija bo še naprej nudila administrativno in finančno podporo tem podjetjem in omogočala njihovo elektronsko poročanje o neželenih učinkih zdravil prek sistema EudraVigilance.
Within the animal-health industry, priorities are expected to remain directed predominantly towards the small-animal and immunologicals sectors of the market.
Znotraj sektorja za zdravje živali bodo prednostne naloge ostale usmerjene predvsem v tržne sektorje za male živali in imunološke izdelke.
The Agency will then continue to elaborate data-analysis and signal-detection tools that will enhance the Agency's surveillance role within the regulatory network of the European Union.
Agencija bo nato nadaljevala izpopolnjevanje orodij za obdelavo podatkov in prepoznavanje signalov, ki bodo okrepili njeno nadzorno vlogo znotraj regulativne mreže Evropske unije.
Work in this area will continue and the next phase of business-continuity solutions, including IT aspects, will be implemented.
Delo na tem področju se bo nadaljevalo in Agencija bo izvajala naslednjo fazo rešitev na področju neprekinjenega poslovanja, vključno z informacijsko-tehnološkimi vidiki.
This will include building on its successful collaboration with the US Food and Drug Administration (FDA) as a model for co-operation with the Japanese and Canadian authorities.
To vključuje bogatenje njenega uspešnega sodelovanja z Uradom za živila in zdravila (FDA) iz ZDA kot modela za sodelovanje z japonskimi in kanadskimi pristojnimi organi.
The Agency will advance projects such as EU Telematics Controlled Terms and Product Information Management (PIM), together with a number of other systems mentioned in the relevant sections of this work programme.
Agencija bo razvijala projekte, kot sta telematsko nadzorovani izrazi EU (EU Telematics Controlled Terms) in Upravljanje s produktnimi informacijami (Product Information management, PMI), ter številne druge sisteme, ki so navedeni v odgovarjajočih poglavjih tega delovnega programa.
In the field of information provision, the Agency will consolidate related activities into the EMEA programme on provision of information.
Na področju zagotavljanja informacij bo Agencija združila sorodne dejavnosti v program EMEA o zagotavljanju informacij.
Meeting management and conferences
Upravljanje srečanj in konference
In addition, such medicines benefit from market exclusivity.
Poleg tega pa tržna ekskluzivnost ugodno vpliva na taka zdravila.
The EMEA shall continue to ensure that necessary risk-minimisation measures have been put in place prior to the granting of marketing authorisations for medicinal products.
Agencija EMEA bo še naprej zagotavljala, da so nujni ukrepi za zmanjševanje tveganja opravljeni pred izdajo dovoljenja za promet z zdravili.
As described earlier, the Agency will also ensure that due account is taken of ethical standards in clinical trials performed in non-EU countries, as part of the assessment of post-authorisation applications.
Kot je že opisano, bo Agencija skrbela za upoštevanje etičnih standardov pri kliničnih preskušanjih, ki se izvajajo v državah zunaj EU, in to bo del njene ocene vlog po izdaji dovoljenja za promet.
PRE-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Patrick Le Courtois
VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEDICINI PRED IZDAJO DOVOLJENJA ZA PROMET Vodja: Patrick Le Courtois
As part of this initiative, the Agency will launch a revised survey with IFAH-Europe of its procedures for authorisation of veterinary medicinal products.
Kot del te pobude bo Agencija z IFAH-Europe začela revidirano anketo o njenih postopkih za izdajo dovoljenj za promet z zdravili za uporabo v veterinarski medicini.
In order to ensure high-quality assessment of the new types of applications, the Agency will review the scientific expertise available in the Agency and its committees and, if needed, will seek complementary expertise/experience in close collaboration with Member States.
Da bi Agencija zagotovila visokokakovostni postopek za ocenjevanje novih vrst vlog, bo preučila znanstveno znanje in izkušnje v Agenciji in njenih odborih ter po potrebi dodajala znanje/izkušnje v tesnem sodelovanju z državami članicami.
This work is carried out in the context of the confidentiality arrangements with the US FDA.
To sodelovanje se bo odvijalo na podlagi dogovora o zaupnosti z uradom FDA iz ZDA.
The EMEA decided to review existing practices and to introduce necessary changes to improve the efficiency and effectiveness of the document- and information-management processes.
Odločila se je, da preuči dosedanje načine dela in uvede potrebne spremembe za povečanje smotrnosti in učinkovitosti postopkov upravljanja z dokumenti in informacijami.
While last year the Agency focused its efforts on implementing the Paediatric Regulation, the dominant regulatory issue in 2008 will be the implementation of a new regulation on advanced-therapy medicinal products.
Medtem ko se je Agencija lansko leto posvetila izvajanju pediatrične uredbe, bo glavna regulativna dejavnost v letu 2008 izvajanje nove uredbe o zdravilih za napredno zdravljenje.
Total grade AD AST 11
Stopnja AD skupaj AST 11
The number of procedures is difficult to predict and the impact on the workload of the CHMP and EMEA secretariat will be carefully monitored.
Težko je predvideti število postopkov, vpliv na delovno obremenitev Odbora za zdravila za uporabo v humani medicini (CHMP) ter sekretariata agencije EMEA pa bo skrbno nadzorovan.
The Agency anticipates that the number of requests for scientific advice and protocol assistance will continue to increase in 2008.
Agencija pričakuje, da se bo število vlog za znanstveno svetovanje in pomoč pri protokolu v letu 2008 še povečalo.
The EMEA receives safety reports and product-quality-defect reports from within the EU and outside concerning centrally authorised medicinal products, and coordinates action relating to the safety and quality of medicinal products.
EMEA prejema varnostna poročila in poročila o pomanjkljivosti izdelkov za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku v Evropski uniji in zunaj nje, ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.
The Agency expects that the number of variations and line extensions in the veterinary field will also increase in accordance with the increased number of products that will be on the market.
Agencija pričakuje, da se bo število sprememb in razširitev indikacij v veterinarski medicini tudi povečalo skladno z večjim številom zdravil na trgu.
This includes the publication of agendas and minutes of meetings of the Management Board, as well as of information from various EMEA committees on non-product-related issues; and providing access to the EudraVigilance database and to information on paediatric clinical trials (EU telematics project), in line with agreed access policies.
To vključuje objavljanje dnevnega reda in zapisnikov sej upravnega odbora in informacij različnih odborov EMEA o zadevah, ki niso povezane z zdravili, ter omogočanje dostopa do podatkovne baze EudraVigilance in do informacij o kliničnih preskušanjih v pediatriji (EU telematski projekt), skladno z dogovorjeno politiko o dostopu.
Improve the transparency of EMEA activities; provide access to EudraVigilance data, information on clinical trials, data held in EudraGMP and EMEA documents in general, in line with agreed access policies.
Izboljšati preglednost dejavnosti agencije EMEA; omogočiti dostop do podatkov EudraVigilance, podatkov o kliničnih preskušanjih, podatkov v dokumentih EudraGMP in dokumentih EMEA na splošno, skladno z dogovorjeno politiko dostopa;
Consolidate and enhance activities relating to medicinal products for paediatric use, building on the experience gained in the first year of operation of new procedures; commence work on the implementation of the strategy for the network of paediatric research.
Utrditi in okrepiti dejavnosti, ki zadevajo zdravila za uporabo v pediatriji, nadgrajevati izkušnje iz prvega leta delovanja novih postopkov; začeti projekt izvajanja strategije za mrežo raziskav v pediatriji;
On the other hand, it is expected that marketing-authorisation holders will make more voluntary use of the summary of product characteristics (SPC) harmonisation procedure to streamline the harmonisation of product information and optimise post-approval maintenance of their products across the EU.
Na drugi strani pa se pričakuje, da bodo imetniki dovoljenj za promet z zdravili prostovoljno dejavneje uporabljali usklajevalni postopek za povzetek glavnih značilnosti zdravila (SPC), da bi po vsej EU racionalizirali usklajevanje informacij o zdravilih in vzdrževanje zdravil po izdaji dovoljenja za promet.
The Agency's Management Board has introduced a set of measures to support the availability of medicinal products for veterinary use.
Upravni odbor Agencije je uvedel ukrepe za podporo dostopnosti zdravil za uporabo v veterinarski medicini.
The Agency contributes to the facilitation of innovation and availability of medicines through a number of its scientific activities, such as implementation of the orphan medicinal products policy, scientific advice, and management of accelerated assessment procedures, among others.
Agencija prispeva k spodbujanju inovacij informacij in dostopnosti zdravil s svojimi številnimi znanstvenimi dejavnostmi, kot so med drugim izvajanje politike zdravil sirot, znanstveno svetovanje in upravljanje postopkov za pospešeno ocenjevanje.
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and the EMEA.
Farmakovigilanca in poročanje o pomanjkljivosti izdelkov Stalno spremljanje varnosti zdravil po izdaji dovoljenja za promet („farmakovigilanca“) je pomemben element dela pristojnih nacionalnih organov in agencije EMEA.
In addition, the Agency is an active participant in EU-level initiatives, including the Innovative Medicines Initiative, European Technology Platform for Global Animal Health and the 7th Framework Programme.
Poleg tega Agencija dejavno sodeluje v pobudah na ravni EU, vključno s pobudo za inovativna zdravila, evropsko tehnološko platformo za globalno zdravje živali ter 7. okvirnim programom.
POST-AUTHORISATION EVALUATION OF MEDICINES FOR HUMAN USE Head: Noël Wathion
VREDNOTENJE ZDRAVIL ZA UPORABO V HUMANI MEICINI PO IZDRAJI DOVOLJENJA ZA PROMET Vodja: Noël Wathion
In order to help the pharmaceutical industry improve the quality of their submissions, the Agency will identify common application difficulties encountered by the industry and will provide necessary feedback.
Da bi Agencija farmacevtski industriji pomagala pri izboljševanju kakovosti njenih vlog, bo opredelila splošne težave, s katerimi se srečuje industrija pri vlogah, ter dala potrebne povratne informacije.
Transparency, provision of information and interaction with patients and healthcare professionals
1.2 Preglednost, zagotavljanje informacij ter sodelovanje z bolniki in zdravstvenimi delavci
IT systems will be updated or newly developed to support the core activities.
Agencija bo posodobila ali pa na novo razvila sisteme informacijske tehnologije, da bodo v oporo glavnim dejavnostim.
Appropriation/Budget 2007 as of 31 December 2007.
3 Odobrena proračunska sredstva/proračun za leto 2007 z dne 31. decembra 2007.
These initiatives include the establishment of procedures for the provision of advice on biomarkers and development of guidance for advanced-therapy medicinal products.
Med te pobude spadajo vzpostavitev postopkov za svetovanje glede bioloških označevalcev in razvoj smernic za zdravila za napredne terapije.
The Agency expects that these measures will contribute to the number of requests for scientific advice in 2008 reaching 20.
Agencija pričakuje, da bodo ti ukrepi prispevali k temu, da bo v letu 2008 z za znanstveno svetovanje 20.
Support for innovation and availability of medicines
1.3 Podpora inovacijam in dostopnost zdravil
This will be done through the implementation of a new process to streamline preparation of CVMP assessment reports and the creation and updating of European public assessment reports (EPARs).
To se bo doseglo z izvajanjem novega postopka za racionalizacijo priprav poročil o oceni CVMP ter s pripravo in posodobitvijo evropskih javnih poročil o oceni zdravila (EPAR).
The Agency expects a continuation of the long-term trend for a gradual increase in the number of applications for marketing authorisation of veterinary medicinal products.
Agencija pričakuje nadaljevanje dolgoročnih smernic počasne rasti števila vlog za izdajo dovoljenja za promet z zdravili za uporabo v veterinarski medicini.
In preparation for the entry into force of the new legislation, the Agency will establish a new, sixth, scientific committee in 2008, and will develop the necessary procedures for the assessment of advanced-therapy medicinal products.
Za pripravo na začetek veljavnosti nove zakonodaje bo Agencija v letu 2008 uvedla nov, šesti znanstveni odbor in razvila potrebne postopke za oceno zdravil za napredne terapije.
This approach will assist with the provision of reliable and robust IT services to staff, delegates and all users of pan-European systems.
Ta pristop bo Agenciji omogočil, da bo svojemu osebju, odposlancem in vsem uporabnikom vseevropskih sistemov lahko zagotovila zanesljive in trdne informacijsko-tehnološke storitve..
Continue implementation of the EMEA Road Map and contribute to the implementation of the Heads of Medicines Agencies strategy paper; commence preparation of the EMEA Road Map
Nadaljevati izvajanje usmeritvenega načrta EMEA in prispevati k izvajanju strateškega dokumenta vodij agencij za zdravila; začeti pripravo usmeritvenega načrta EMEA za obdobje
Cooperation with the US FDA also covers paediatric medicinal products.
Sodelovanje z ameriškim uradom FDA zajema tudi zdravila za uporabo v pediatriji.
Develop and implement the EMEA communications strategy and information-related aspects of the EMEA Road Map in order to adapt the current EMEA information practices and improve the provision of information to all stakeholders.
Razviti in izvajati komunikacijsko strategijo EMEA in z informacijami povezane vidike usmeritvenega načrta EMEA, da se prilagodijo trenutni informacijski postopki EMEA ter se izboljša zagotavljanje informacij vsem ciljnim skupinam;
Enhance collaboration with the Heads of Medicines Agencies and national competent authorities, thereby contributing to the network of excellence, in particular through initiatives in the fields of safety of medicines, resource planning, competence development, the medical information network,
Razširiti sodelovanje z vodji agencij za zdravila in nacionalnimi pristojnimi organi in s tem prispevati k mreži odličnosti, zlasti s pobudami na področju varnosti zdravil, načrtovanja virov,
Annex 1 EMEA structure
Priloga 1 Organizacijska shema agencije EMEA
Integrated management at the Agency
1.7 Integrirano upravljanje Agencije
The variety of scientific-advice requests will also increase, from advice on products subject to the centralised procedure, to alternative clinical-trial design, to programmes for products intended for non-EU markets.
Večja bo tudi raznolikost vlog za znanstveno svetovanje, od nasvetov o zdravilih, za katera velja centralizirani postopek, do alternativnih oblik izvajanja kliničnega preskušanja in programov za zdravila, namenjena za trge zunaj EU.
Following receipt of the first applications for paediatric investigation plans (PIPs) and waivers during 2007 - the first year of implementation of the regulation on paediatric medicines - the number of applications is expected to be maintained during 2008, with around 400 clinical indications in new PIP and paediatric-waiver applications.
Po prejemu prvih vlog za načrte pediatričnih raziskav (PIP) in sisteme opustitev v letu 2007, prvem letu izvajanja uredbe o zdravilih v pediatriji, se pričakuje, da bo tudi v letu 2008 število vlog ostalo na enaki ravni, kar pomeni približno 400 kliničnih indikacij v novih vlogah za načrte pediatričnih raziskav in pediatrične sisteme opustitev.
Measures include the provision of free scientific advice to veterinary companies developing medicines for minor uses or minor species.
Med ukrepi so zagotavljanje brezplačnega znanstvenega svetovanja veterinarskim podjetjem, ki razvijajo zdravila za manj pomembne indikacije ali vrste.
To assure high quality standards for the assessment of risk-management plans for paediatric medicines, the Agency will extend the existing peer-review system to the field of paediatric medicines.
Da bi Agencija zagotovila visokokakovostne standarde za oceno načrtov za obvladovanje tveganja pri zdravilih za uporabo v pediatriji, bo svoj sedanji sistem medsebojnih pregledov stanovskih strokovnjakov razširila tudi na področje zdravil za uporabo v pediatriji.
The Agency will continue to contribute to these efforts, in particular through its support to the Innovative Medicines Initiative, the 7th Framework Programme and the European Technology Platform for Global Animal Health.
Agencija bo še naprej delovala na tem področju, zlasti s svojo podporo pobudi za inovativna zdravila, 7. okvirnemu programu in evropski tehnološki platformi za globalno zdravje živali.
The EMEA will work throughout the year to prepare for its entry into force, by setting up a sixth scientific committee - the Committee for Advanced Therapies - and by introducing the necessary procedures for evaluating advanced-therapy medicines.
Agencija EMEA se bo celo leto pripravljala na začetek veljavnosti uredbe z ustanovitvijo šestega znanstvenega odbora (Odbora za napredne terapije) in z uvedbo potrebnih postopkov za vrednotenje zdravil za napredne terapije.
In addition, the Agency will work to implement initiatives proposed by the EMEA/CHMP Think-Tank on innovative drug development, will continue its support to small and medium-sized enterprises, and will undertake projects to assess the impact and consistency of the Agency's scientific opinions.
Hkrati bo Agencija izvajala pobude, ki jih bodo predlagale ustvarjalne enote EMEA/CHMP, za razvoj inovativnih zdravil, nadaljevala svojo podporo malim in srednje velikim podjetjem ter razvijala projekte za oceno vpliva in usklajenosti znanstvenih mnenj Agencije.
The Community database of manufacturing authorisations and GMP certificates, EudraGMP, will be expanded to contain a module with negative inspection outcomes (EU telematics project).
EudraGMP, podatkovna baza Skupnosti o dovoljenjih za proizvodnjo in potrdilih GMP, bo še razširjena in bo vsebovala modul z negativnimi rezultati inšpekcijskih pregledov (telematski projekt EU).
This will also include development of guidance documents for applicants.
Med naloge spada tudi razvoj navodil za predlagatelje.
The Agency plans to have 42 centrally authorised products verified for quality and compliance with authorised specifications.
Agencija namerava preizkusiti 42 zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku, da preveri njihovo kakovost in oceni spoštovanje odobrenih določb.
Collaboration with Member States in the area of medicines for children will also cover information on off-label paediatric use of medicines in Member States, and the implementation of a strategy for the exchange of paediatric information.
V sodelovanje z državami članicami na področju zdravil za otroke spadajo tudi informacije o uporabi zdravil, ki ni v skladu z odobrenimi indikacijami, v pediatriji v državah članicah in izvajanje strategije za izmenjavo informacij v pediatriji.
The quality of centrally authorised medicinal products placed on the market is supervised through the sampling and testing programme.
Kakovost zdravil, za katera je bilo izdano dovoljenje za promet po centraliziranem postopku, se na trgu nadzoruje s programom vzorčenja in preskušanja.