natgillin/translations-raw huggingface dataset:
If Vivanza is taken with a high fat meal, the onset of activity may be delayed.
Zdravilo Vivanza lahko začne učinkovati pozneje, če se zaužije s hrano, ki vsebuje veliko maščob.
• Enhance cooperation within the Network, as well as with European and international partners.
• krepitev sodelovanja znotraj mreže ter z evropskimi in mednarodnimi partnerji;
Improving the quality and efficiency of our work
Izboljšanje kakovosti in učinkovitosti našega dela
This is exacerbated by the low number of new antimicrobials having been authorised over the past few years.
Težavo zaostruje majhno število novih protimikrobnih učinkovin, odobrenih v zadnjih nekaj letih.
The environment in which the Agency operates is constantly changing and evolving.
Okolje delovanja agencije se nenehno spreminja in razvija.
To account for this, the Agency will reinforce its support to these stakeholder groups as well.
V ta namen bo tudi okrepila svojo podporo tem interesnim skupinam.
Antimicrobial resistance and other public health threats
Protimikrobna odpornost in druge grožnje za javno zdravje
Planning for changes within the Agency, which will arise as a result of the implementation of the revised legislation, will start in 2015.
Načrtovanje sprememb znotraj agencije, do katerih bo prišlo zaradi izvajanja revidirane zakonodaje, se bo začelo v letu 2015.
Structure of the work programme 2015
Uvod k delovnemu programu agencije za leto 2015
The implementation of the data-integration programme is the key activity for the Agency in this area.
Izvajanje programa povezovanja podatkov je ključna dejavnost agencije na tem področju.
The European medicines regulatory network (Network) is the cornerstone of the work and success of the European system.
Evropska regulativna mreža za zdravila (mreža) je osnova dela in uspešnosti evropskega sistema.
Information technology and social media
Informacijska tehnologija in družbeni mediji
In light of the above influences and other business environment factors, the Agency has set out the following priorities for 2015:
Agencija si je ob upoštevanju zgoraj predstavljenih vplivnih dejavnikov in drugih dejavnikov poslovnega okolja za leto 2015 zastavila naslednje prednostne naloge:
The process for evaluating medicines is constantly evolving.
Postopek vrednotenja zdravil se nenehno spreminja.
The network has access to thousands of experts from Member States across Europe, allowing it to source the best-possible expertise for the regulation of medicines in the European Union (EU).
Mreža ima dostop do na tisoče strokovnjakov iz vseh držav članic, kar ji omogoča razpolaganje z najboljšim možnim strokovnim znanjem za zakonsko ureditev zdravil v Evropski uniji (EU).
This means the environment trends, workload forecasts and implementation of a number of objectives and activities described in this work programme will impact the national authorities and their work as well.
To pomeni, da bodo okoljski trendi, napovedi delovne obremenitve ter uresničevanje oziroma izvajanje številnih ciljev in dejavnosti, ki so opisani v tem delovnem programu, vplivali tudi na nacionalne organe in njihovo delo.
Scientific advancement and managing complexity to facilitate patient access to medicines
Znanstveni napredek in obvladovanje kompleksnosti za lažji dostop bolnikov do zdravil
In 2015, the Agency will be capitalising on its recent programme to increase the effectiveness and efficiency of activities.
Agencija bo v letu 2015 izkoriščala svoj novi program za povečanje učinkovitosti in uspešnosti dejavnosti.
Antimicrobial resistance (AMR) is a growing problem for both humans and animals.
Protimikrobna odpornost je pri ljudeh in živalih vse večji problem.
Robust internal processes and expansion of the overall capabilities of the Network will be required.
Potrebni bodo zanesljivi notranji procesi ter razširitev celotnih zmogljivosti mreže.
• Further increase transparency and implement stakeholder and communication strategies.
• nadaljnje povečevanje preglednosti in izvajanje strategij za deležnike in komunikacijskih strategij;
• Improve quality, integration and accessibility of data held by the Agency.
• izboljšanje kakovosti, povezanosti in dostopnosti podatkov agencije.
The final elements of the EU's pharmacovigilance legislation will be implemented during 2015 and 2016.
Končni elementi zakonodaje EU o farmakovigilanci bodo uveljavljeni v letih 2015 in 2016.
The European medicines regulatory system is based on a network of around 50 human and veterinary medicines regulatory authorities ('national competent authorities', or NCAs) from the 31 European Economic Area countries and the European Medicines Agency.
Evropski regulativni sistem za zdravila temelji na mreži, ki jo tvori približno 50 regulativnih organov za zdravila za uporabo v humani in veterinarski medicini (pristojnih nacionalnih organov) iz 31 držav Evropskega gospodarskega prostora in Evropska agencija za zdravila.
The revised and improved processes, and the improved ways of working, will be embedded across the organisation as part of the transition into the continuous improvement phase.
V celotno organizacijo bodo vključeni spremenjeni in izboljšani procesi ter izboljšani načini dela kot del prehoda v fazo stalnega izboljševanja.
The Clinical Trials Regulation was published in May 2014, assigning the Agency the responsibility for developing the systems necessary to implement the Regulation.
V uredbi o kliničnem preskušanju, ki je bila objavljena maja 2014, je bila agenciji dodeljena odgovornost za razvoj sistemov, potrebnih za izvajanje uredbe.
The discussions are expected to continue in the next years, with the legislation expected to be adopted in 2016.
Razprave naj bi se nadaljevale v naslednjih letih, zakonodaja pa naj bi bila sprejeta leta 2016.
At the same time, there is increasing awareness of the need to avoid duplication of work done by regulators across the world and use global resources more effectively.
Istočasno se povečuje zavedanje, da je treba preprečiti podvajanje dela regulativnih organov po svetu in učinkoviteje uporabljati svetovne vire.
To manage this, and to improve pharmacovigilance activities and the safety of European patients, the Agency will be developing further data sources.
Da se bo agencija lahko spopadla s tem ter izboljšala dejavnosti farmakovigilance in varnost evropskih bolnikov, bo razvijala dodatne vire podatkov.
• Ensure efficient crisis management and responsiveness to public health threats, including addressing antimicrobial resistance and the availability of anti-infective treatments.
• zagotavljanje učinkovitega kriznega upravljanja in odzivnosti na grožnje za javno zdravje, vključno z bojem proti protimikrobni odpornosti in razpoložljivostjo zdravil za zdravljenje okužb;
The NCAs and the Agency will also need to prepare for the upcoming revision of the fee legislation, to ensure adequate financing and sustainability of the Network.
Pristojni nacionalni organi in agencija se bodo morali pripraviti tudi za prihodnjo revizijo zakonodaje o pristojbinah, da se zagotovita ustrezno financiranje in vzdržnost mreže.
Efficiency is key to the successful delivery of the Agency's activities and to coping with the growing number of responsibilities and increasing complexity of the regulatory procedures.
Učinkovitost je ključna za uspešno izvajanje dejavnosti agencije ter obvladovanje vse številnejših odgovornosti in vse večje zapletenosti regulativnih postopkov.
EMA/773839/2014 Rev. 1 Management Board
EMA/372777/2015
Key influences
Ključni vplivni dejavniki
The Agency will also be developing and improving its public health crisis response mechanisms, building on the past experience of pandemic influenza and the ongoing work on Ebola.
Poleg tega bo razvijala in izboljševala svoje mehanizme odzivanja na krizne razmere na področju javnega zdravja, pri čemer se bo opirala na pretekle izkušnje s pandemijo gripe in sedanje delo v zvezi z ebolo.
The Agency will also continue implementing the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project, which collects information on how antimicrobial medicines are used in animals across the EU, and thus allows for a better understanding of the risk factors that lead to the development and spread of antimicrobial resistance.
Agencija bo tudi še naprej izvajala projekt evropskega nadzora rabe protimikrobnih sredstev v veterini (ESVAC), ki zbira informacije o načinih uporabe protimikrobnih zdravil pri živalih po celotni EU in tako prispeva k boljšemu razumevanju dejavnikov tveganja, ki vodijo k razvoju in širjenju protimikrobne odpornosti.
As a result, development of the EU Clinical Trial Portal and Database, and other associated systems, will be one of the key focus areas of the Agency in the coming years.
Razvoj portala in podatkovne zbirke EU o kliničnih preskušanjih ter drugih s tem povezanih sistemov bo zato eno od prednostih področij njenega delovanja v prihodnjih letih.
At the same time, the ability to manage the increasing workload is on occasion limited by the current capacity of the Network, and finding sustainable solutions for maintaining and increasing the Network's capacity will be an important focus area.
Poleg tega zmožnost obvladovanja vse večje delovne obremenitve občasno omejuje tudi sedanja zmogljivost mreže, zato bo iskanje vzdržnih rešitev za ohranjanje in povečanje zmogljivosti mreže pomembna prednostna naloga.
Hence, the Agency will additionally support efforts to increase international worksharing in all areas, as well as support convergence of international practices and work within international coalitions to encourage better and more effective use of global regulatory resources.
Zato bo agencija dodatno podpirala prizadevanja za povečanje mednarodne delitve dela na vseh področjih ter konvergenco mednarodnih praks in dela znotraj mednarodnih koalicij, da bi spodbudila boljšo in učinkovitejšo uporabo svetovnih regulativnih virov.
Ensuring more prospective medicines reach their patients in such an environment requires adapting and simplifying our processes and approaches, making them more open, flexible and easier to navigate for the sponsors, especially the SMEs.
Da bi v takšnem okolju zagotovili, da bolnike doseže več potencialnih zdravil, moramo prilagoditi in poenostaviti naše postopke in pristope, da bi ti postali bolj odprti, prožni in enostavnejši za sponzorje, zlasti MSP.
This includes integrated support to early stages of medicines development, covering legally established scientific advice, orphan designation, paediatric procedures and support to SMEs.
To vključuje zagotavljanje celostne podpore v zgodnjih fazah razvoja zdravil, kar zajema pravno določeno znanstveno svetovanje, postopek določitve za zdravilo siroto, pediatrične postopke in podporo za MSP.
It will be an opportunity to look back at how much has been achieved in promoting public and animal health over 20 years and to plan for the future.
Ob tej priložnosti bomo lahko ocenili dosežke več kot dvajsetletnega spodbujanja javnega zdravja in zdravja živali ter pripravili načrt za prihodnost.
• Provide technical support to the European Commission during the co-decision process for the proposal on revision of the veterinary medicines legislation in the Council and the European
• zagotavljanje tehnične podpore Evropski komisiji med postopkom soodločanja v Evropskem parlamentu in Svetu o predlogu za revizijo zakonodaje o zdravilih za uporabo v veterinarski medicini;
Society wants to see the outcomes of clinical trials, pharmacovigilance and other stages of the medicines lifecycle.
Družba želi videti rezultate kliničnih preskušanj, farmakovigilance in drugih faz življenjskega cikla zdravil.
Increasing numbers of manufacturing sites located, and clinical trials conducted outside the EU will continue to be a trend.
Trend povečevanja števila proizvodnih obratov in opravljanja kliničnih preskušanj zunaj EU se bo nadaljeval.
As part of this change, the volume of data and information to be managed and the number of procedures to be run will increase significantly over the next years.
Kot del te spremembe se bo v naslednjih letih znatno povečal obseg podatkov in informacij, ki jih je treba upravljati, ter postopkov, ki jih je treba izvajati.
All aspects of the work of the Agency, from the initial evaluation through to postauthorisation monitoring, are thus becoming subject to more intense scrutiny by the stakeholders and the community as a whole, with impact on public trust in the Agency's work.
Vsi vidiki dela agencije, od začetnega ocenjevanja do spremljanja po pridobitvi dovoljenja za promet, so tako pod vedno bolj skrbnim drobnogledom deležnikov in skupnosti kot celote, kar vpliva na javno zaupanje v njeno delo.
18 December 2014
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In addition, the Agency is reviewing the available regulatory tools and their use, to allow patient access to medicines for conditions with unmet medical need, and exploring concepts such as adaptive pathways and specific mechanisms to support innovative medicines with high public-health potential.
Poleg tega agencija pregleduje razpoložljiva regulativna orodja in njihovo uporabo, da bi bolnikom omogočila dostop do zdravil za bolezenska stanja, za katera zdravstvene potrebe niso izpolnjene, ter raziskuje koncepte, kot so prilagodljivi postopki in posebni mehanizmi za podpiranje inovativnih zdravil z velikimi obeti za javno zdravje.
European medicines regulatory network
Evropska regulativna mreža za zdravila
To deliver on its responsibilities, the EMA works closely with the NCAs.
Da bi lahko izpolnjevala svoje dolžnosti, agencija tesno sodeluje z pristojnimi nacionalnimi organi.
• Deliver business activities to a high level of quality, efficiency and consistency in both the human and veterinary areas.
• zagotavljanje poslovnih dejavnosti z visoko stopnjo kakovosti, učinkovitosti in doslednosti, in sicer tako humani kot veterinarski medicini;
In addition, the requests from stakeholders will increasingly relate not only to accessing data, but also to interpretation and analyses of those data.
Poleg tega se bodo zahteve deležnikov vse bolj nanašale na razlago in analizo teh podatkov ter ne samo na dostop do njih.
Patients, consumers and healthcare professionals demand more and better information to support their decision-making, together with high levels of transparency from industry and regulators.
Bolniki, potrošniki in zdravstveni delavci zahtevajo vse bolj obsežne in kakovostne informacije, da bi jim pomagale pri odločanju, ter visoko raven preglednosti pri industriji in regulativnih organih.
In the coming years, the Agency expects a significant increase in its activities, both in terms of volumes (e.g. scientific advice and pharmacovigilance) and in terms of complexity of products, scientific issues and procedures, due to the scientific development.
Agencija pričakuje, da se bodo zaradi znanstvenega razvoja njene dejavnosti v prihodnjih letih znatno povečale, tako z vidika obsega (npr. znanstveno svetovanje in farmakovigilanca) kot z vidika kompleksnosti proizvodov, znanstvenih vprašanj in postopkov.
This year, 2015, will be the 20th anniversary of the inauguration of the EMA, and the beginning of not only centralised approval of medicines, but of the whole European medicines network.
Agencija bo v letu 2015 praznovala 20. obletnico svoje ustanovitve, s tem pa tudi začetka ne samo centralizirane odobritve zdravil, pač pa tudi evropske mreže za zdravila kot take.
The implementation of the policy on access to clinical data will also be a significant aspect of the Agency's transparency initiatives.
Pomemben vidik pobud agencije za preglednost bo tudi izvajanje politike dostopa do kliničnih podatkov.
Transparency of the decision-making process throughout the lifecycle of medicines remains a key driver.
Preglednost postopka odločanja v celotnem življenjskem ciklu zdravil je ključnega pomena.
As part of this work, the Agency will continue contributing to the work of the Transatlantic Task Force on Antimicrobial Resistance (TATFAR), which aims to increase levels of communication, coordination and cooperation between the EU and the United States on human and veterinary antimicrobials.
V tem okviru bo še naprej prispevala k delu Čezatlantske skupine za protimikrobno odpornost (TATFAR), ki si prizadeva povečati raven komuniciranja, usklajevanja in sodelovanja med EU in Združenimi državami na področju uporabe protimikrobnih učinkovin v humani in veterinarski medicini.
Therefore, the EMA will continue its collaboration with its EU and international partners on a number of initiatives aimed at limiting the development of AMR.
Zato bo s svojimi partnerji iz EU in mednarodnimi partnerji še naprej sodelovala pri številnih pobudah za omejevanje razvoja protimikrobne odpornosti.
To address the above scientific and societal trends, the Agency is reinforcing its development support to various stakeholder groups, and has undertaken a number of initiatives to ensure early dialogue to foster drug development and improve regulatory pathways for early patient access to medicines.
Da bi se odzvala na zgoraj navedene znanstvene in družbene trende, agencija krepi svojo razvojno podporo različnim interesnim skupinam in je sprožila več pobud, da bi tako zagotovila čim zgodnejši dialog za pospešitev razvoja zdravil in izboljšanje regulativnih postopkov z namenom omogočiti bolnikom čim prejšnji dostop do zdravil.
• Facilitate early stages of medicines development in both the human and veterinary areas.
• olajšanje začetnih faz razvoja zdravil za uporabo v humani in veterinarski medicini;
This will affect the way the scientific committees evaluate medicines, and consequently the workload of the Agency, both in its endeavour to support the scientific assessment of the committees and in its role as a key provider of training, technical and methodological guidance for the scientific work.
To bo vplivalo na način, kako znanstveni odbori vrednotijo zdravila, in posledično na delovno obremenitev agencije, tako kar zadeva njeno prizadevanje za podpiranje znanstvenega ocenjevanja odborov kot njeno vlogo ključnega ponudnika usposabljanja ter tehničnih in metodoloških smernic za znanstveno delo.
As a result of full implementation of the legislation, the coordinating role of the Agency in the monitoring of all EU medicines, irrespective of their route of authorisation, will increase, and with it the scope of the Agency's responsibilities in the pharmacovigilance field.
S polnim izvajanjem zakonodaje se bo povečala usklajevalna vloga agencije pri spremljanju vseh zdravil EU, ne glede na način njihove odobritve, s tem pa tudi obseg njenih odgovornosti na področju farmakovigilance.
The revision of the EU's veterinary medicines legislation, with the aim of significantly simplifying the regulatory requirements, while maintaining a high level of protection of human and animal health, is expected to impact the Agency's activities once the legislation is adopted.
Pričakovati je, da bo sprejetje revidirane zakonodaje EU o zdravilih za uporabo v veterinarski medicini, katere namen je občutno poenostaviti regulativne zahteve, hkrati pa ohraniti visoko raven varovanja zdravja ljudi in živali, vplivalo na dejavnosti agencije.
To address these developments, the Agency continues to consolidate and enhance its collaboration with and support to the NCAs through a number of initiatives, including a revised training and competence development programme in cooperation with national authorities, promoting the national experts programme, and prioritising its information technology development programme with projects that support the work, effectiveness and efficiency of the NCAs.
Agencija se teh novih izzivov loteva tako, da s številnimi pobudami še naprej utrjuje in krepi svoje sodelovanje s pristojnimi nacionalnimi organi in podporo le-tem, med drugim s spremenjenim programom usposabljanja in razvijanja sposobnosti v sodelovanju z nacionalnimi organi, spodbujanjem nacionalnega programa za strokovnjake in namenjanjem prednostne vloge programu za razvoj informacijske tehnologije s projekti, ki podpirajo delo, učinkovitost in uspešnost pristojnih nacionalnih organov.
The increasing workload will call for higher involvement of the NCAs.
Zaradi naraščajoče delovne obremenitve bo potrebno večje sodelovanje pristojnih nacionalnih organov.
At the same time, the face of the pharmaceutical industry is evolving, with an increasing number of small or medium-sized enterprises (SMEs) undertaking the early stages of medicines development.
Hkrati se spreminja struktura farmacevtske industrije, saj se začetnih faz razvoja zdravil vse pogosteje lotevajo mala in srednja podjetja (MSP).
Following closely these developments and ensuring availability of the required expertise will therefore be important.
Natančno spremljanje tega razvoja dogodkov in zagotavljanje razpoložljivosti potrebnega strokovnega znanja bosta še naprej na njenem dnevnem redu.
• Implement pharmacovigilance legislation and the clinical trials legislation.
• izvajanje zakonodaje o farmakovigilanci in kliničnem preskušanju;
As the Agency regulates both human and veterinary medicines, it is well placed to implement the 'One Health' approach and follow its application in tackling the AMR, both in its own work and through collaboration with its European and international partners.
Agencija skrbi za zakonsko ureditev zdravil za uporabo v humani in veterinarski medicini, zato lahko izvaja pristop „eno zdravje“ in spremlja njegovo uporabo v boju proti protimikrobni odpornosti, in sicer tako pri svojem delu kot na podlagi sodelovanja s svojimi evropskimi in mednarodnimi partnerji.
The ever-increasing role of information technology in health-related matters, including use of e-health records and databases, mobile communications and social media by consumers and healthcare professionals, also demands that surveillance methods evolve to consider these developments.
Vse večja vloga informacijske tehnologije v zadevah, povezanih z zdravjem, vključno z uporabo evidenc in podatkovnih zbirk e-zdravja, mobilnih komunikacij in družbenih medijev s strani potrošnikov in zdravstvenih delavcev, zahteva tudi spremembo metod spremljanja, ki morajo upoštevati te novosti.
As a result, increased focus on ensuring that medicines tested and manufactured outside the EU meet the EU requirements will drive efforts to develop and strengthen collaboration with international partners regarding collaborative inspections, information exchange, capacity building and greater mutual reliance.
Posledično bo vse večja osredotočenost na zagotavljanje, da zdravila, ki so preizkušena in proizvedena zunaj EU, ustrezajo zahtevam EU, spodbudila prizadevanja za razvoj in krepitev sodelovanja z mednarodnimi partnerji, kar zadeva skupne preglede, izmenjavo informacij, krepitev zmogljivosti in večje vzajemno zaupanje.
In a continuous effort to meet the demands for increased efficiency of operations, while increasing the level of service the Agency provides, data management has become a key activity in creating an integrated, shared environment that provides a single, accurate, consistent source of data for the Agency, its partners and stakeholders.
Upravljanje podatkov je zaradi nenehnega prizadevanja za izpolnjevanje zahtev po večji učinkovitosti operacij in istočasnega povečevanja ravni storitev, ki jih zagotavlja agencija, postalo ključna dejavnost pri ustvarjanju povezanega skupnega okolja, ki zagotavlja enoten, natančen in dosleden vir podatkov za agencijo ter njene partnerje in deležnike.
The coming years will see an increasing need to consider aspects such as patients' values and preferences, the needs of other stakeholders (e.g. health-technology assessment bodies, or HTAs) when planning clinical research programmes and post-authorisation measures, the impact of 'real life' evidence data, and others.
V prihodnjih letih se bo povečevala potreba po upoštevanju vidikov, kot so vrednote in želje bolnikov, potrebe drugih deležnikov (npr. organov za ocenjevanje zdravstvenih tehnologij) pri načrtovanju programov kliničnih raziskav in ukrepov po pridobitvi dovoljenja za promet, učinek podatkov o dokazih iz prakse itd.