natgillin/translations-raw huggingface dataset:
The issue of using and reimbursing external experts was also raised.
Odprto je bilo tudi vprašanje uporabe in plačevanja zunanjih strokovnjakov.
The budget is €13.6 million lower than the preliminary draft budget adopted in March 2009.
Proračun je za 13,6 milijona EUR manjši od predhodnega predloga proračuna iz marca 2009.
The presented priorities, objectives and projects follow proposals made to the Board in March 2009, and include:
Predstavljene prednostne naloge, cilji in projekti upoštevajo predloge, predložene upravnemu odboru marca 2009, in vključujejo:
Work will be undertaken in 2010 to address this challenge.
V letu 2010 se bo začelo delo za obvladovanje tega izziva.
The members noted the update report from the European Commission on a range of topics, including:
Člani odbora so se seznanili s posodobljenim poročilom Evropske komisije v zvezi z več temami, vključno s:
The document has now been submitted for translation.
Dokument je bil posredovan v prevajanje.
Both documents will then be presented to the Board.
Oba dokumenta bosta nato predložena upravnemu odboru.
It was clarified by the representative of the European Commission that at this point the revision of the decision is no longer possible.
Predstavnik Evropske komisije je pojasnil, da sprememba odločitve na tej točki ni več mogoča.
European Commission also referred to the need to reduce the surplus, and noting that the surplus of 2008 needs to be used in 2010.
Predstavnik Evropske komisije se je skliceval tudi na potrebo po zmanjšanju presežka in ugotovil, da je treba presežek iz leta 2008 uporabiti v letu 2010.
Topic coordinators will meet to further elaborate their proposal.
Tematski koordinatorji se bodo sestali in nadalje oblikovali svoj predlog.
The next Management Board meeting will last two days.
Naslednja seja upravnega odbora bo trajala dva dni.
The Management Board was informed that a confidentiality arrangement is under preparation with Switzerland.
Upravni odbor je bil obveščen, da je v pripravi dogovor o zaupnosti s Švico.
H1N1 pandemic update
Najnovejše informacije o pandemiji H1N1
The budget is in line with the work programme and totals €198.2 million (1.95% increase over the 2009 budget), which includes a general EU contribution of €32.6 million and the €4.5 million orphan medicinal products fund.
Proračun je skladen z delovnim programom in znaša 198,2 milijona EUR (1,95-odstotno povečanje v primerjavi s proračunom za leto 2009), kar vključuje splošni prispevek EU v višini 32,6 milijona EUR in 4,5 milijona EUR iz sklada za zdravila sirote.
The funding gap has reappeared and multi-annual funding solutions need to be found.
Znova je nastala vrzel pri financiranju, zato je treba poiskati večletne rešitve v zvezi s financiranjem.
The EVVet status report is updated continuously and is also available on the EVVeT website.
Poročilo o stanju EVVet se stalno posodablja in je na voljo tudi na spletni strani EVVeT.
The European Commission reserved their position with regard to the expected total amount of the general EU contribution, pending the decision of the European Parliament.
Evropska komisija je pridržala svoje stališče v zvezi s pričakovanim skupnim zneskom splošnega prispevka EU v pričakovanju odločitve Evropskega parlamenta.
• transparency and interaction with stakeholders;
• preglednost in sodelovanje z zainteresiranimi stranmi;
United Kingdom Kent Woods European Parliament
Združeno kraljestvo Kent Woods Evropski parlament
The number of people vaccinated with the three vaccines is growing.
Število oseb, cepljenih z zadevnimi tremi cepivi, narašča.
Declaration of conflicts of interests
Izjava o navzkrižju interesov
The work in the Committee for Medicinal Products for Human Use and various groups is ongoing.
Delo v Odboru za zdravila za uporabo v humani medicini in različnih skupinah stalno poteka.
The first report on pharmacovigilance of the three pandemic vaccines was published and was very well received by stakeholders.
Objavljeno je bilo prvo poročilo o farmakovigilanci zadevnih treh pandemskih cepiv, ki so ga zainteresirane strani zelo dobro sprejele.
• Letter from EURODIS (dated 7 December 2009).
• Dopis zveze EURODIS (z dne 7. decembra 2009).
A merger of the two committees should be considered.
Treba je razmisliti o združitvi obeh odborov.
Financial compensation for Members States' participation in linguistic checks
Finančno nadomestilo za udeležbo držav članic v jezikovnih pregledih
Payment system to Member States
Sistem plačil državam članicam
The Board will receive the updated document one week before the start of the consultation, to allow for any final comments to be made.
Upravni odbor bo prejel posodobljen dokument teden dni pred začetkom posvetovanja, da se omogoči predložitev kakršnih koli končnih pripomb.
The Agency also undertook to review in two years' time whether the doubling of the daily allowance meets financial requirements of patients/consumers' representatives.
Poleg tega se je zavezala tudi, da bo v dveh letih preverila, ali podvojitev dnevnice izpolnjuje finančne zahteve predstavnikov bolnikov/potrošnikov.
The strategy supersedes the road map to 2010, the implementation of which finishes next year, and outlines the Agency's strategic direction for the coming five years.
Ta strategija nadomešča časovni načrt do leta 2010, katerega izvajanje se bo končalo naslednje leto, v njej pa je orisana strateška usmeritev agencije za naslednjih pet let.
The Executive Director thanked the European experts and the Committee for continuous work in the field of pandemic vaccines.
Izvršni direktor se je zahvalil evropskim strokovnjakom in odboru za neprekinjeno delo na področju pandemskih cepiv.
• international cooperation (particularly important in light of the number of clinical trials and amount of manufacturing being done in countries outside the EU);
• mednarodno sodelovanje (posebno pomembno zaradi števila kliničnih preskušanj in obsega proizvodnje v državah zunaj EU);
As part of the new identity, the Agency will discontinue the use of the current acronym ‘EMEA' and will use either the full name ‘European Medicines Agency' or simply ‘the Agency'.
V okviru nove podobe bo prenehala uporabljati sedanjo kratico „EMEA“ in bo uporabljala bodisi polno ime „Evropska agencija za zdravila“ bodisi preprosto „agencija“.
Once adopted, the Agency will proceed with the implementation.
Agencija bo po njegovem sprejetju predlog začela izvajati.
London, 10 December 2009
London, 10. decembra 2009
• support to research;
• podporo raziskavam;
No conflicts of interests were declared.
Nihče ni navedel, da obstaja navzkrižje interesov.
The development takes into account specific needs of the user groups: healthcare professionals, patients and industry.
Pri razvoju se upoštevajo posebne potrebe skupin uporabnikov: zdravstvenih delavcev, bolnikov in industrije.
• discussion on the Cross-border Healthcare Directive;
• razpravo o Direktivi o čezmejnem zdravstvenem varstvu;
The Agency launched its new visual identity on 8 December 2009.
Agencija je novo vizualno podobo predstavila dne 8. decembra 2009.
The Agency will continue weekly publication of pharmacovigilance reports on the vaccines.
Agencija bo še naprej tedensko objavljala poročila o farmakovigilanci teh cepiv.
Public consultation on the road map will last three months, during which time meetings with stakeholders will be organised.
Javno posvetovanje o časovnem načrtu bo trajalo tri mesece, med tem pa bodo organizirani sestanki z zainteresiranimi stranmi.
The Member States need to find ways to increase the availability of resources to work in the area of herbal medicinal products.
Države članice morajo poiskati načine za izboljšanje razpoložljivosti virov za delo na področju zdravil rastlinskega izvora.
ICT planning and priorities 2010
Načrtovanje in prednostne naloge v zvezi z IKT za leto 2010
The acronym ‘EMEA' is not well known amongst the Agency's stakeholders such as healthcare professionals and patients in the EU.
Kratica „EMEA“ ni dobro poznana med zainteresiranimi stranmi agencije, kot so zdravstveni delavci in bolniki v EU.
Implementation rules regarding training for staff
Izvedbena pravila glede usposabljanja za osebje
Budget and establishment plan 2010 and staff policy plan
Proračun in kadrovski načrt za leto 2010 in načrt kadrovske politike
In addition to information provided in the previous version, the plan also looks at how to integrate EU telematics systems with those of the national competent authorities.
V načrtu se poleg informacij, predloženih v prejšnji različici, proučuje tudi način, kako telematske sisteme EU integrirati s sistemi nacionalnih pristojnih organov.
At the request of the Board, the Agency will provide an estimated amount of resources that are needed to implement the future revised framework of interaction.
Agencija bo na zahtevo upravnega odbora zagotovila ocenjeni znesek virov, potrebnih za izvajanje prihodnjega spremenjenega okvira sodelovanja.
• availability of medicines.
• razpoložljivost zdravil.
The new organisational structure has also been put in place as of 8 December 2009 and has had a positive impact on the activities of the Agency.
Dne 8. decembra 2009 je bila vzpostavljena tudi nova organizacijska struktura, ki pozitivno vpliva na dejavnosti agencije.
Professor Larry Phillips of the London School of Economics will lead the discussions.
Razpravo bo vodil profesor Larry Phillips z „London School of Economics“.
The establishment plan increases staffing numbers by 37 posts, brining the maximum permissible number of temporary agents to 567.
V kadrovskem načrtu je opredeljeno povečanje števila osebja za 37 delovnih mest, kar pomeni, da je največje dovoljeno število začasnih uslužbencev 567.
The decision is taken following a very positive pilot phase, during which patients/consumers' representatives participated in three meetings of the PhVWP.
Odločitev se sprejme po zelo pozitivni poskusni fazi, v kateri so na treh sestankih skupine PhVWP sodelovali predstavniki bolnikov/potrošnikov.
The plan also takes into account the expected impact of upcoming legislative proposals on pharmacovigilance and falsified medicines.
V načrtu se upošteva pričakovani vpliv prihodnjih zakonodajnih predlogov na farmakovigilanco in ponarejena zdravila.
The new Human EudraVigilance report will now be produced twice a year, with the next report, which will be published, planned for June 2010.
Novo poročilo o podatkovni bazi EudraVigilance za zdravila za uporabo v humani medicini se bo zdaj pripravljalo dvakrat na leto, naslednje poročilo, ki bo objavljeno, pa je načrtovano za junij 2010.
The Board saw that the challenge in this area will be to assure consistency of the assessment of generic medicines across the EU.
Upravni odbor je ugotovil, da bo izziv na tem področju zagotavljati doslednost pri ocenjevanju generičnih zdravil v EU.
The Executive Director met with Mr John Dalli to discuss the trends in the pharmaceutical environment and future challenges.
Izvršni direktor se je sestal z Johnom Dallijem in z njim razpravljal o usmeritvah v farmacevtskem sektorju in prihodnjih izzivih.
The European Commission representative informed that the Commission has recently adopted the text of the vacancy notice and the grade AD14.
Predstavnik Evropske komisije je sporočil, da je Komisija pred kratkim sprejela besedilo objave prostega delovnega mesta in razreda AD14.
However, many countries expressed reservation regarding their ability to record on an ongoing basis.
Vendar so številne organizacije izrazile pomisleke glede njihove sposobnosti stalnega evidentiranja.
• Charter of the Internal Audit Service of the Commission.
• Listina službe Komisije za notranjo revizijo.
The Board was concerned that not all national competent authorities provided data in the pilot phase (18 out of 46 invited), and that the data made available by the participating national competent authorities is still preliminary.
Upravni odbor je izrazil zaskrbljenost, ker v poskusni fazi podatkov niso predložili vsi nacionalni pristojni organi (18 od 46 povabljenih) in ker so podatki, ki so jih dali na voljo sodelujoči nacionalni pristojni organi, še vedno predhodni.
The amendments concern the doubling of the daily allowance for representatives of specific organisations, changes to the rules regarding hotel accommodation, and travel-ticket changes.
Spremembe se nanašajo na podvojitev dnevnic za predstavnike posebnih organizacij, spremembe pravil v zvezi s hotelsko nastanitvijo in spremembe vozovnic.
The representatives, with proven experience in medicines regulation, will be selected taking into account well-defined selection criteria, on the basis of a call for expressions of interest.
Predstavniki z dokazanimi izkušnjami z zakonskim urejanjem zdravil bodo izbrani ob upoštevanju dobro opredeljenih izbirnih meril na podlagi razpisa za prijavo interesa.
10(b) Amendments to the Management Board rules of procedure
10(b) Spremembe poslovnika upravnega odbora
18 March 2010 EMA/MB/806136/2009
18. marca 2010 EMA/440680/2011
The decision will be taken by the Executive Director on the basis of a shortlist of candidates.
Izvršni direktor sprejme odločitev na podlagi ožjega seznama kandidatov.
Prof. Phillips is engaged with the Agency in the work on methodologies for benefit/risk assessment.
Profesor Phillips sodeluje z agencijo na področju metodologij za oceno razmerja med koristmi in tveganji.
The number of generic medicinal products for which authorisation is being sought through the centralised procedure is growing.
Število generičnih zdravil, za katera je vložena vloga za izdajo dovoljenja za promet z zdravilom na podlagi centraliziranega postopka, narašča.
The Board members were invited to review the document within the next few weeks and to provide comments.
Člani upravnega odbora so bili pozvani, naj v naslednjih nekaj tednih dokument proučijo in predložijo pripombe.
• strengthening the European medicines network;
• krepitev evropske mreže zdravil;
Status report on EudraVigilance implementation
Poročilo o stanju izvajanja podatkovne baze EudraVigilance
Members noted that the Management Board Telematics Committee has not yet discussed the telematics master plan since the committee has not yet been fully established.
Člani so ugotovili, da odbor za telematiko upravnega odbora še ni razpravljal o glavnem načrtu telematike, ker odbor še ni v celoti vzpostavljen.
It was acknowledged that pharmacovigilance and safety of medicines remains a priority area within which the focus should now be on looking into both risks and benefits throughout a medicinal product's lifecycle.
Priznano je bilo, da farmakovigilanca in varnost zdravil ostajata prednostno področje, na katerem je treba glavno pozornost namenjati obravnavi tveganj in koristi v celotnem življenjskem ciklu zdravila.
• publication of the guidelines on variations;
• objavo navodil o spremembah;
The Board was concerned that large groups of herbal products may have to be removed from the market due to the very small number of entries on the list of traditional herbal medicinal products.
Upravni odbor je izrazil zaskrbljenost, da bo morda treba s trga odstraniti velike skupine zeliščnih proizvodov zaradi zelo majhnega števila vnosov na seznamu tradicionalnih zdravil rastlinskega izvora.
Draft agenda for 10 December 2009 meeting
Osnutek dnevnega reda za sejo dne 10. decembra 2009
Reflection paper on the further involvement of patients and consumers in the Agency's activities
Študija o nadaljnjem vključevanju bolnikov in potrošnikov v dejavnosti agencije
The attention of the Board was drawn to the amendments aimed at promoting language training of staff, to enable them to comply with the requirement of the staff regulations.
Pozornost upravnega odbora je bila usmerjena na spremembe, katerih cilj je spodbujanje jezikovnega usposabljanja osebja, da se jim omogoči skladnost z zahtevo iz kadrovskih predpisov.
The meeting underlined that good coordination between the Management Board's and the Heads of Medicines Agencies' telematics committees is essential.
Na seji je bilo poudarjeno, da je dobro usklajevanje med odboroma za telematiko upravnega odbora in vodji agencij za zdravila bistvenega pomena.
An implementation plan is being prepared and will be finalised once the comments stemming from the public consultation on the road map have been reviewed and necessary amendments have been made.
V pripravi je izvedbeni načrt, ki bo dokončan, ko bodo pregledane vse pripombe iz javnega posvetovanja o časovnem načrtu in opravljene potrebne spremembe.
• move of the Pharmaceutical Units F2 and F3 (cosmetics and medical devices) to DG Sanco;
• prehodom farmacevtskih enot F2 in F3 (kozmetični izdelki in medicinski pripomočki) pod GD
Moreover, members also meant that, whereas over the years the agencies have adapted to the current system, a change may adversely affect the financing of some of the national competent authorities and weaken their ability to contribute to the non-fee related activities, and consequently impact on the effectiveness of the network.
Poleg tega so člani odbora med drugim menili, da - čeprav so se agencije z leti prilagodile sedanjemu sistemu - sprememba lahko negativno vpliva na financiranje nekaterih nacionalnih pristojnih organov in oslabi njihovo sposobnost prispevanja k dejavnostim, ki niso povezane s pristojbinami, in posledično vpliva na učinkovitost mreže.
According to the data collected, the benefit/risk balance of the vaccines remains positive.
Glede na zbrane podatke ostaja razmerje med koristmi in tveganji pozitivno.
Members discussed the needs to understand the relevant positions of regulators and health-technology assessment bodies and to ensure that cost-benefit analysis does not become a part of the regulatory assessment of medicines.
Člani so razpravljali o potrebah po razumevanju ustreznih stališč regulatorjev in organov za ocenjevanje zdravstvene tehnologije ter zagotavljanju, da analiza stroškov in koristi ne postane del regulativnega ocenjevanja zdravil.
The Board appointed Kent Woods as the Board's representative in the selection process at the European Commission.
Upravni odbor je Kenta Woodsa imenoval za predstavnika upravnega odbora v izbirnem postopku pri Evropski komisiji.
Cooperation with the Swiss medicines authority
Sodelovanje s švicarskim organom za zdravila
• focus on core business (including addressing the growing volume of activities in such areas as post-authorisation activities and orphan medicinal products);
• osredotočenost na osnovno dejavnost (vključno z obravnavo naraščajočega števila dejavnosti na področjih, kot so dejavnosti po izdaji dovoljenja za promet z zdravilom in zdravila sirote);
Meeting with the Commissioner designate for health and consumer policy
Sestanek s kandidatom za komisarja za zdravje in varstvo potrošnikov
The Board discussed the need to consider options for addressing the gap between the workload and the number of temporary agents.
Upravni odbor je razpravljal o potrebi po proučitvi možnosti za reševanje vrzeli med delovno obremenitvijo in številom začasnih uslužbencev.
• Presentation on the Road Map to 2015.
• Predstavitev časovnega načrta do leta 2015.
Taking into consideration the outcomes of the pilot and the estimated impact on the Agency's budget, and in light of the observations made by the Court of Auditors and the European Commission, the Executive Director submitted for adoption a new remuneration system, based on the proposal presented in March and June 2008, which aims to align the remuneration system with the legislative requirements.
Izvršni direktor je ob upoštevanju rezultatov poskusnega projekta in ocenjenega vpliva na proračun agencije ter zaradi ugotovitev Računskega sodišča in Evropske komisije v sprejetje predložil nov plačni sistem na podlagi predloga, predstavljenega marca in junija 2008, katerega namen je uskladiti plačni sistem z zakonodajnimi zahtevami.
It is expected that the new structure will increase the overall efficiency of the Agency's operations, improve the quality of its work and increase the effectiveness of its interaction with stakeholders.
Nova struktura bo po pričakovanjih povečala splošno učinkovitost dejavnosti agencije, izboljšala kakovost njenega dela in okrepila učinkovitost njenega sodelovanja z zainteresiranimi stranmi.
The Board stressed that the national competent authorities are an integral part of the EU network, and highlighted the future role of patients in decision-making in the course of the assessment of medicines.
Upravni odbor je opozoril, da so nacionalni pristojni organi del mreže EU, in poudaril prihodnjo vlogo bolnikov pri odločanju med ocenjevanjem zdravil.
10(a) Management Board Telematics Committee
10(a) Odbor upravnega odbora za telematiko
The reduction is due to lower than requested Community contribution and reduced fee revenue estimates due to the impact of the new regulation on variations and a shift to non-fee or reduced-fee applications.
Zmanjšanje je posledica nižjega prispevka Skupnosti od zahtevanega, znižanih ocen prihodkov iz pristojbin zaradi učinka nove uredbe o spremembah in premika na vloge brez pristojbin ali z znižanimi pristojbinami.
The website will be launched in spring 2010.
Spletna stran bo objavljena pomladi 2010.
The Agency is completing the development of an entirely new public website that offers muchimproved content structure, user-friendliness and functionality for the Agency's audiences.
Agencija končuje pripravo popolnoma nove javne spletne strani, ki ponuja bistveno izboljšano strukturo vsebine, prijaznost do uporabnika in funkcionalnost za ciljne skupine agencije.
The latter is due to a marked difference in the ability of national competent authorities to record time spent on procedures, the lack of full agreement on what constitutes costs, and the need for a longer observation period to capture the full assessment time for various procedures.
Da so podatki predhodni, je posledica izrazite razlike glede sposobnosti nacionalnih pristojnih organov, da evidentirajo čas, porabljen za postopke, pomanjkanja popolnega soglasja o tem, kaj so stroški, in potrebe po daljšem opazovalnem obdobju za zajetje celotnega obdobja ocenjevanja za različne postopke.
• progress on the two legal proposals (pharmacovigilance and falsified medicines legislation);
• napredkom o dveh zakonskih predlogih (zakonodajo v zvezi s farmakovigilanco in ponarejenimi zdravili);
The new report on human EudraVigilance now focuses on how EudraVigilance contributes to the conduct of pharmacovigilance in the EU.
Novo poročilo o podatkovni bazi EudraVigilance za zdravila za uporabo v humani medicini je osredotočeno na to, kako EudraVigilance prispeva k izvajanju farmakovigilance v EU.
The Board reiterated its earlier concern in the area of herbal medicinal products where work is progressing very slowly.
Upravni odbor je vnovič izrazil zaskrbljenost zaradi področja zdravil rastlinskega izvora, na katerem delo poteka zelo počasi.
The proposals include revising the current framework of interaction between the Agency and patients' and consumers' organisations, and providing financial support by doubling the daily allowance in defined cases.
Predlogi vključujejo spremembo sedanjega okvira sodelovanja med agencijo in organizacijami bolnikov ter potrošnikov in zagotavljanje finančne podpore s podvojitvijo dnevnic v določenih primerih.
The report will in future also provide, for centrally authorised products for human use, information on signal management, from signal detection through to follow-up, including feedback provided by rapporteurs and any subsequent regulatory action taken.
Poročilo bo v prihodnje v zvezi z zdravili za uporabo v humani medicini z dovoljenjem za promet, pridobljenim po centraliziranem postopku, zagotovilo informacije o obvladovanju signalov, od zaznave signalov do spremljanja, vključno s povratnimi informacijami, ki jih predložijo poročevalci, in vsemi naknadnimi regulativnimi ukrepi.
The development of the framework has taken longer then planned due to the need to meet two sets of views: those of academia and learned societies on one hand, and those of prescribing physicians and pharmacists on the other.
Razvoj okvirja traja dlje, kot je bilo načrtovano, zaradi potrebe po upoštevanju dveh sklopov potreb: potreb akademske skupnosti po eni ter lečečih zdravnikov in farmacevtov po drugi strani.