natgillin/translations-raw huggingface dataset:
The Board also noted the changed structure of the work programme, which now follows the three strategic areas of the Agency's five-year strategy document.
Seznanil se je tudi s spremenjeno strukturo delovnega programa, ki zdaj temelji na treh strateških področjih petletnega strateškega dokumenta agencije.
This is a new tool for the Agency, and the Management Board discussed this concept in order to provide guidance for a future procedure.
To je novo orodje agencije, upravni odbor pa je razpravljal o tem konceptu, da bi zagotovil smernice za prihodnji postopek.
The pilot project was begun as the result of a request from the European Commission to develop a harmonised approach for the collection and reporting of data from the Member States on the use of antimicrobial agents in animals.
Pilotni projekt se je začel izvajati na zahtevo Evropske komisije glede razvoja usklajenega pristopa k zbiranju in poročanju podatkov iz držav članic o rabi protimikrobnih sredstev pri živalih.
According to the procedure, the Board will issue its recommendations on whether any of the areas of PRAC expertise need strengthening.
V skladu s postopkom bo izdal svoja priporočila, ali je treba okrepiti katero koli področje strokovnega znanja odbora PRAC.
Significant progress was made in other areas, including the launch of the EU clinical-trials register and the new online database of European experts.
Precejšen napredek je bil dosežen na drugih področjih, vključno z uvedbo registra kliničnih preizkusov EU in nove spletne zbirke podatkov o evropskih strokovnjakih.
Annual report 2011
Letno poročilo za leto 2011
The final budget will be adopted once the level of the EU contribution has been decided by the European Parliament and the Council.
Končni proračun bo sprejet, ko bosta Evropski parlament in Svet določila višino prispevka EU.
The annual bilateral between the European Commission/the Agency and the US Food and Drug Administration (FDA) took place from 5 to 7 March.
Od 5. do 7. marca 2012 je potekalo letno dvostransko srečanje Evropske komisije/agencije in ameriške Uprave za hrano in zdravila (US Food and Drug Administration, FDA).
Bilateral with the FDA
Dvostransko srečanje s FDA
The Board was informed that Luc Verhelst took office as the Head of the Agency's Information and Communications Technology Unit.
Upravni odbor je bil obveščen, da je Luc Verhelst nastopil funkcijo vodje Enote za informacijsko in komunikacijsko tehnologijo pri agenciji.
However, the issue that needs to be addressed in this scenario is making every effort to ensure that committee discussions on safety-related signals do not cause misunderstanding by the public.
Vprašanje, ki ga je treba obravnavati v tem primeru, je prizadevanje za zagotovitev, da razprave v odboru o znakih, povezanih z varnostjo, ne povzročijo napačnega razumevanja javnosti.
The legislation states that public hearings may be held in cases of safety concerns.
Zakonodaja določa, da se javne obravnave lahko izvajajo pri varnostnih zadržkih.
The committees should then have sufficient time to debate the cause for divergence and to identify any possibility to converge their views before the final decision is taken.
Odbori morajo nato imeti na voljo dovolj časa za razpravo o vzroku razhajanja in da poiščejo vse možnosti za uskladitev svojih stališč pred sprejetjem končne odločitve.
The Board set up a new group of topic coordinators with responsibility for the Agency's work programme and budget.
Upravni odbor je ustanovil novo skupino tematskih koordinatorjev, ki je odgovorna za delovni program in proračun agencije.
The Agency also requested 21 additional posts, which will be financed from the fee revenue, and plans to reduce the number of contract agents by 7 full-time equivalents (FTEs).
Agencija je zaprosila tudi za 21 dodatnih delovnih mest, ki se bodo financirala iz prihodka od pristojbin, hkrati pa namerava zmanjšati število pogodbenih uslužbencev za sedem ekvivalentov polne zaposlitve.
After entry into force of the new legislation, the system of the peer-reviewer becoming a PRAC rapporteur could be applied for procedures starting after 2 July 2012.
Po začetku veljavnosti nove zakonodaje bi se sistem, po katerem bi strokovni ocenjevalec postal poročevalec odbora PRAC, lahko uporabljal za postopke, ki se začnejo po 2. juliju 2012.
At the same time, the Agency will nominate a contact who will provide permanent support to patient representatives, to facilitate their participation in the work of the Committee.
Hkrati bo imenovala kontaktno osebo, ki bo zagotavljala stalno podporo predstavnikom bolnikov, da jim olajša sodelovanje pri delu odbora.
The document was adopted.
Dokument je bil sprejet.
The report concluded that, in general, performance was stable over the last two years.
Sklepna ugotovitev poročila je bila, da se uspešnost v zadnjih dveh letih na splošno ni spreminjala.
It is also planned to set up a team of scientific writers to deliver high-quality scientific articles for publication in scientific journals.
Načrtuje se tudi ustanovitev skupine piscev znanstvenih besedil za zagotavljanje visokokakovostnih znanstvenih člankov za objavo v znanstvenih zbornikih.
The meeting concluded that this debate needs to continue and pilots should proceed as planned for in the 2012 work programme.
Udeleženci seje so sklenili, da je treba to razpravo nadaljevati, enako tudi izvajanje pilotnih projektov, kot je bilo predvideno v delovnem programu za leto 2012.
• Presentation on annual report 2011.
• Predstavitev o letnem poročilu za leto 2011.
The revised rules will enter into force on 1 April 2012, pending the publication of the Commission Regulation adjusting the aforementioned fees.
Spremenjena pravila bodo začela veljati 1. aprila 2012 po objavi uredbe Komisije o prilagoditvi navedenih pristojbin.
The Board had divergent views about the two approaches.
Stališča upravnega odbora glede teh dveh pristopov so se razhajala.
• introduction of restrictions in case current direct interests of one or more household members have been declared;
• uvedbo omejitev, če je bila podana izjava o trenutnih neposrednih interesih enega ali več članov gospodinjstva;
The Management Board will develop a similar procedure applicable to its members.
Upravni odbor bo razvil podoben postopek, ki se bo uporabljal za vse njegove člane.
The amendments concern:
Spremembe se nanašajo na
These systems should then ensure that all knowledge about the reasons for a decision is shared among concerned committees in a timely manner.
Ti sistemi morajo nato zagotoviti, da se celotno znanje o razlogih za odločitev pravočasno izmenja med zadevnimi odbori.
This would allow the alignment of interests and would pave the way for applying this concept in future regulatory decisions.
Tako bo omogočena uskladitev interesov in utrta pot uporabi tega koncepta pri prihodnjih regulativnih odločitvah.
The Management Board underlined that public hearings should be seen as a new way of engaging and communicating with the public, and not only as an additional tool for transparency.
Upravni odbor je poudaril, da bi bilo treba na javne obravnave gledati kot na nov način vključitve javnosti in komuniciranja z njo, in ne samo kot na dodatno orodje za preglednost.
The representative, supported by other Board members, expressed concerns about the impact of such restrictions on the availability of members/experts from academia.
Predstavnik, ki so ga podprli drugi člani upravnega odbora, je izrazil zaskrbljenost glede učinka takih omejitev na razpoložljivost članov oziroma strokovnjakov iz akademskega sveta.
While members stressed that every effort needs to be made to avoid divergence of opinions, it was recognised that the possibility of having divergent opinions is also a strength of the European system, which is based on checks and balances.
Čeprav so člani poudarili, da si je treba kar najbolj prizadevati za preprečitev razhajanj v mnenjih, je bilo ugotovljeno, da je možnost imeti različna mnenja tudi prednost evropskega sistema, ki temelji na preverjanjih in ravnovesjih.
The new pharmacovigilance legislation, which enters into force in July 2012, introduces a provision that allows public hearings to be held, in the context of the assessment of medicinal products for human use.
Nova zakonodaja o farmakovigilanci, ki je začela veljati julija 2012, uvaja določbo, ki omogoča izvajanje javnih obravnav v okviru ocene zdravil za uporabo v humani medicini.
The meeting was informed that the Agency had received a European Court of Auditors draft audit report on conflicts of interests conducted in 2011.
Udeleženci seje so bili obveščeni, da je agencija prejela osnutek poročila Evropskega računskega sodišča o reviziji navzkrižja interesov, ki je bila izvedena leta 2011.
The document will be published on the Agency's website.
Dokument bo objavljen na spletni strani agencije.
The Board also noted the steep increase in the number of pages released under the access-todocuments legislation: from 8,000 in 2010 to over a million in 2011.
Seznanil se je tudi s precejšnjim povečanjem števila strani, objavljenih na podlagi zakonodaje o dostopu do dokumentov: z 8 000 leta 2010 na več kot milijon leta 2011.
This information would be important for regulators and for society at large in further ensuring that interests of experts contributing to the regulatory assessment of medicines are known.
Te informacije bi bile pomembne za regulatorje in družbo na splošno pri nadaljnjem zagotavljanju poznavanja interesov strokovnjakov, ki sodelujejo pri regulativni oceni zdravil.
The number of national experts would remain unchanged, with 15 FTEs expected.
Število nacionalnih strokovnjakov bi ostalo nespremenjeno, predvidoma 15 ekvivalentov polne zaposlitve.
An update on the implementation of the pharmacovigilance legislation in the run-up to 2 July 2012
Najnovejši podatki o izvajanju zakonodaje o farmakovigilanci do 2. julija 2012
• Adaptive licensing.
• prilagodljivo izdajanje licenc.
Members reiterated their concern at the consistently low number of entries to the list of herbal substances, due to the unavailability of genotoxicity data.
Člani so znova izrazili zaskrbljenost zaradi konstantno majhnega števila vpisov na seznam rastlinskih snovi, in sicer zaradi nerazpoložljivosti podatkov o genotoksičnosti.
• The renewed EU strategy 2011-14 for social corporate responsibility.
• obnovljeno strategijo EU za družbeno odgovornost podjetij za obdobje 2011-2014.
Patient representatives expressed concern that the legislation provides that only one member (and an alternate) representing patients shall be nominated to the PRAC, while for other committees there are two or more members.
Predstavniki bolnikov so izrazili zaskrbljenost, ker zakonodaja določa, da se v odbor PRAC imenuje samo enega člana (in namestnika), ki zastopa bolnike, medtem ko se v druge odbore imenuje dva ali več članov.
Another key opinion of the Board was that hearings should add value to the assessment process by offering views of the patient community or the general public.
Drugo ključno mnenje upravnega odbora je bilo, da bi obravnave morale dodati vrednost postopku ocenjevanja z zagotavljanjem stališč skupnosti bolnikov ali splošne javnosti.
The paper will be discussed by the newly created PRAC, and a final proposal will be submitted to the Board later this year.
Dokument bo obravnaval novo ustanovljeni odbor PRAC, končni predlog pa bo predložen upravnemu odboru pozneje v tem letu.
In addition, a new sector for international and European cooperation has been established, to respond to the growing levels of interaction and activities in this area.
Ustanovljen je bil tudi nov oddelek za mednarodno in evropsko sodelovanje, in sicer kot odziv na čedalje tesnejše sodelovanje in okrepljene dejavnosti na tem področju.
Evaluation of the Agency
Ocenjevanje agencije
This may pose difficulties, as situations may occur when the Board is not in a position to take decisions at the end of the meeting, due to it not having a quorum.
To lahko povzroči težave v primerih, ko na koncu seje upravni odbor ne more sprejeti odločitev, ker ni sklepčen.
With regard to pre-authorisation procedures, the general feeling was that minutes should only be published after procedures are finalised and the European Commission has taken its decision.
Kar zadeva postopke pred pridobitvijo dovoljenja za promet, je bilo splošno mnenje, naj se zapisniki objavijo šele po dokončanju postopkov in sprejetju sklepa Evropske komisije.
With regard to the lack of budget to fully implement the pharmacovigilance legislation, the Board stressed the importance of managing expectations of stakeholders as to what can and cannot be achieved.
Upravni odbor je zaradi nezadostnega proračuna za polno izvajanje zakonodaje o farmakovigilanci poudaril pomen obvladovanja pričakovanj zainteresiranih strani glede tega, kaj je mogoče doseči in česa ni mogoče.
The Agency's financing of the pilot phase will amount to over EUR 350,000 in 2012.
Za financiranje pilotne faze v letu 2012 je agencija namenila več kot 350 000 EUR.
The Board continued discussions held at the meeting of the Heads of Medicines Agencies in February 2012.
Upravni odbor je nadaljeval razpravo, ki je potekala na seji vodij agencij za zdravila februarja 2012.
The audience for the hearings should represent the right balance among the Agency's stakeholders in this area - patients, healthcare professionals, academia and industry.
Občinstvo obravnav bi moralo zastopati ustrezno ravnovesje med zainteresiranimi stranmi agencije na tem področju - bolniki, zdravstvenimi delavci, akademiki in panogo.
The agencies then signed a memorandum of understanding setting out their commitment to fostering cooperation.
Agenciji sta nato podpisali memorandum o soglasju, v katerem sta se zavezali h krepitvi sodelovanja.
Such divergence can be seen as an opportunity to add new views to the scientific debate and to make the final outcome of such debate more robust and of better value.
Na tako razhajanje se lahko gleda kot na priložnost za vključitev novih pogledov v znanstveno razpravo ter za zagotovitev večje zanesljivosti in uporabnosti končnega izida take razprave.
The adopted procedure also puts in place a framework for checking the integrity of the scientific review.
Sprejeti postopek vzpostavlja tudi okvir za preverjanje integritete strokovne presoje.
The minutes were adopted.
Zapisnik je bil sprejet.
The Commission representatives reiterated the importance of providing clear explanations in the case of divergent opinions, as this will also facilitate the task of the Commission in the decision-making phase.
Predstavniki Evropske komisije so znova poudarili pomembnost zagotavljanja jasnih obrazložitev pri razhajanju mnenj, saj bi to zelo olajšalo nalogo Komisije v fazi odločanja.
The concept is being debated among regulators worldwide, and is referred to in the Agency's strategy document on the subject, which states that a key issue for regulators will be whether a more staggered approval concept should be envisaged for situations not covered by conditional marketing authorisations.
O tem konceptu so razpravljali regulatorji po vsem svetu in je naveden v strateškem dokumentu agencije, kjer je določeno, da bo za regulatorje ključno vprašanje, ali je treba predvideti koncept postopnejše odobritve za primere, ki niso zajeti v pogojna dovoljenja za promet.
The Agency and a delegation from the European Food Safety Authority (EFSA) met on 27 January to exchange views on areas of common interest in both scientific and governance fields.
Dne 27. januarja 2012 sta se sestali agencija in delegacija Evropske agencije za varnost hrane (European Food Safety Authority, EFSA), da bi izmenjali stališča o temah v skupnem interesu na znanstvenem področju in na področju upravljanja.
It was suggested that such hearings could be streamed to national competent authorities and that the public could participate in hearings from their premises.
Predlagano je bilo, naj se take obravnave tekoče predvajajo pristojnim nacionalnim organom in da bi javnost v njih lahko sodelovala iz svojih prostorov.
Some members argued that unless benefits of having a different rapporteur can be demonstrated and quantified, they would be unwilling to provide the additional resources needed.
Nekateri člani so menili, da če prednosti drugega poročevalca ne bo mogoče prikazati in ovrednotiti, ne bodo pripravljeni zagotoviti potrebnih dodatnih sredstev.
With regard to assessment activities, the Agency is largely at cruising speed.
Kar zadeva dejavnosti ocenjevanja, je agencija v glavnem na ravni ustaljenega delovanja.
d.) Project 2014
d) Projekt za leto 2014
Chair: Sir Kent Woods
Predsednik: sir Kent Woods
Pharmacovigilance Risk Assessment Committee a.) Consultation procedure on final composition
Odbor za ocenjevanje tveganja na področju farmakovigilance a) Posvetovalni postopek o končni sestavi
In the context of the social corporate responsibility, the meeting considered it appropriate that the pharmaceutical industry should be asked to publish names of experts with whom it cooperates.
Po mnenju udeležencev seje v zvezi z družbeno odgovornostjo podjetij je ustrezno, da se farmacevtsko industrijo zaprosi, naj objavi imena strokovnjakov, s katerimi sodeluje.
Due to the number of budgetary uncertainties for 2013, the decision about which information and communications technology (ICT) projects will be planned for development in 2013 is pending, and the implementation activities for the pharmacovigilance legislation are subject to change.
Zaradi številnih proračunskih negotovosti za leto 2013 še ni bilo odločeno, kateri projekti informacijske in komunikacijske tehnologije (IKT) bodo predvideni za razvoj v letu 2013, izvedbene dejavnosti v zvezi z zakonodajo o farmakovigilanci pa se bodo spremenile.
The Board welcomed the presentation by Hans-Georg Eichler, the Agency's Senior Medical Officer, and provided supportive feedback about the concept and issues raised.
Upravni odbor je pozdravil predstavitev višjega zdravnika agencije Hans-Georga Eichlerja ter zagotovil podporne povratne informacije o konceptu in postavljenih vprašanjih.
• The EU proposal to reform ICH as regards its governance, global outreach and greater transparency.
• predlogom EU za reformo ICH (Mednarodne konference o usklajevanju), kar zadeva njeno upravljanje, svetovno sodelovanje in večjo preglednost;
The evaluation was requested by the European Parliament, and focuses on the impact on the EU and national budgets of a transfer of responsibilities form the national to the European level following the creation of EU agencies.
Oceno je zahteval Evropski parlament in je osredotočena na učinek prenosa odgovornosti z nacionalne na evropsko raven po ustanovitvi agencij EU na proračun EU in nacionalne proračune.
During the visit, the rapporteur informed the Agency that the draft discharge report had already been finalised and any comments made by the Agency during the meeting could not be reflected in the report.
Poročevalka je med obiskom agencijo obvestila, da je osnutek poročila o razrešnici že končan in morebitnih pripomb, ki bi jih agencija dala med srečanjem, v njem ne bo mogoče upoštevati.
On a general note, the Agency agreed to continuously monitor whether the amended rules restrict access to the necessary expertise.
Agencija se je na splošno strinjala s stalnim spremljanjem, ali spremenjena pravila omejujejo dostop do potrebnega strokovnega znanja.
• The international initiative on generics (the debate about whether to make this a standalone initiative or to include it within the ICH).
• mednarodno pobudo za generična zdravila (razpravo o tem, ali naj bo to samostojna pobuda ali naj se vključi v ICH);
• clarification on the membership of an ethics committee;
• pojasnilo v zvezi s članstvom v odboru za etična vprašanja;
When adopting these changes, members voiced their concern that increased tightening of conflicts of interests policies threatens to deny the Agency access to the full range of scientific expertise that is necessary for the highest-quality assessment of medicines.
Člani so ob sprejetju teh sprememb izrazili zaskrbljenost, da zaostrovanje politik o navzkrižju interesov ogroža dostop agencije do celotnega znanstvenega strokovnega znanja, potrebnega za najkakovostnejšo oceno zdravil.
The report does not aim to provide the reasons for delays in submitting assessment reports by rapporteurs and co-rapporteurs.
Cilj poročila ni navesti vzroke, zakaj so poročevalci in soporočevalci zamujali pri predložitvi poročil o ocenjevanju.
The Board stressed the importance of transparency in this context.
Upravni odbor je poudaril, da je pri tem pomembna preglednost.
The Board thanked them for their active involvement and valuable contributions in numerous capacitiesas members, topic coordinators and as a vice-chair - to the successful work of the Board.
Upravni odbor se jim je zahvalil za njihovo dejavno vlogo in koristne prispevke v različnih vlogah (kot člani, tematski koordinatorji in podpredsednik) k uspešnemu delu upravnega odbora.
The adoption of the pharmacovigilance proposal is expected soon.
Predlog o farmakovigilanci bo sprejet predvidoma kmalu;
The meeting also discussed that indicators measuring the quality of reports have to be developed over time, while recognising the difficulty in establishing and monitoring such indicators.
Udeleženci seje so razpravljali tudi o tem, da bo sčasoma treba razviti kazalnike za merjenje kakovosti poročil, ob tem so se strinjali, da sta vzpostavitev in spremljanje takih kazalnikov težki nalogi.
Members stressed the importance of the quality and clarity of the questions asked, so that participants can offer their opinions and answers, and take the discussion forward.
Člani so poudarili pomembnost kakovosti in jasnosti postavljenih vprašanj, da udeleženci lahko zagotovijo svoje mnenje in odgovore ter nadaljujejo razpravo.
The implementation plan has been completed, including the assignment of risk levels, the implementation of mitigation procedures and the provision of training.
Izvedbeni načrt je končan, vključno z določitvijo ravni tveganja, izvajanjem postopkov za ublažitev in zagotavljanjem usposabljanja.
However, members also saw challenges that need to be overcome for this marketing-authorisation route to succeed.
Vendar so člani videli tudi izzive, ki jih je treba odpraviti za zagotovitev uspešnosti tega načina, ki temelji na izdaji dovoljenja za promet.
• clarification on the involvement in academic trials and in publicly funded research/development initiatives;
• pojasnilo v zvezi z vključitvijo v znanstvene preizkuse in javno financirane raziskovalne oziroma razvojne pobude;
c.) Breach of trust policy
c) Politika pri zlorabi zaupanja
Mary Geraldine Baker participated as an observer on Wednesday, 21 March 2012
Mary Geraldine Baker se je seje udeležila kot opazovalka v sredo, 21. marca 2012.
Circulated to the Board by e-mail on 17 January 2012; recorded in the minutes of the next meeting, as relevant.
Poslan upravnemu odboru po e-pošti 17. januarja2012; ustrezno zapisano v zapisniku naslednje seje.
• Presentation on conflicts of interests policy for scientific-committee members and experts.
• Predstavitev o politiki o navzkrižjih interesov za člane znanstvenih odborov in strokovnjake.
The Agency will also publish CVs of all experts in the European experts database, and a project to enable the receipt of electronic CVs and their automated publication was agreed.
Agencija bo objavila tudi življenjepise vseh strokovnjakov v podatkovni zbirki evropskih strokovnjakov, ob tem pa je bil sprejet projekt, ki bo omogočil prejemanje elektronskih življenjepisov in njihovo samodejno objavljanje.
Before publishing it, the amendments clarifying the receipt of grants by an institution and membership in ethics committees will be introduced.
Pred njeno objavo bodo uvedene spremembe, ki pojasnjujejo primere, ko institucija prejme donacije, in članstvo v odborih za etična vprašanja.
• clarification on the follow-up to be taken in case a member intends to be engaged in occupational activities with a pharmaceutical company;
• pojasnilo v zvezi z nadaljnjim spremljanjem, če član namerava opravljati poklicne dejavnosti v farmacevtski družbi;
The decision comes into effect on 1 April 2012.
Sklep začne veljati 1. aprila 2012.