FrancophonIA/ELRC3.0 huggingface dataset:
English: The pilot on the assessment of evaluation costs in the national competent authorities is ongoing.
Slovenian: Pilotni projekt ocene stroškov vrednotenja v nacionalnih pristojnih organih še poteka.
English: The Agency is largely on track with the implementation of its main objectives and is adhering to the majority of its performance indicators.
Slovenian: Agencija v splošnem dobro sledi izvajanju svojih glavnih ciljev in upošteva večino svojih kazalnikov uspešnosti.
English: The Budget Committee of the European Parliament indicated that the fee-earning agencies would have access to the surplus revenue from previous years.
Slovenian: Proračunski odbor Evropskega parlamenta je navedel, da bodo imele agencije, ki dobivajo prihodek iz pristojbin, dostop do presežka prihodka iz prejšnjih let.
English: The Management Board discussed that currently there is a lot of duplication in the area of health technology assessment (HTA) among Member States.
Slovenian: Upravni odbor je razpravljal, da je trenutno veliko podvajanja pri ocenjevanju zdravstvenih tehnologij (HTA) med državami članicami.
English: The Commission representative agreed to inform the European Commission of the concerns raised, and reiterated the need to find a timely solution enabling the appointment procedure to be completed by mid 2010.
Slovenian: Predstavnik komisije se je strinjal, da Evropsko komisijo obvesti o izraženih pomislekih, in ponovil, da je treba najti pravočasno rešitev, ki bo omogočila, da se postopek imenovanja konča do sredine leta 2010.
English: The Agency is in the process of developing a new road map.
Slovenian: Agencija trenutno pripravlja nov časovni načrt.
English: The Executive Director has recently attended the European Parliament, where he discussed the topic of pandemic-influenza vaccines.
Slovenian: Izvršni direktor se je pred kratkim udeležil seje Evropskega parlamenta, na kateri je razpravljal o cepivih za pandemično gripo.
English: Setting up a subgroup of the Management Board to replace the Telematics steering committee
Slovenian: Ustanovitev podskupine upravnega odbora, ki bo nadomestila usmerjevalni odbor za telematiko
English: The topic coordinators, Jean Marimbert and Marcus Müllner, have reviewed the proposal and gave positive feedback.
Slovenian: Tematska koordinatorja Jean Marimbert in Marcus Müllne sta predlog pregledala in podala pozitivno povratno informacijo.
English: The Board noted the proposed dates for 2011 as follows: 16 and 17 March, 16 June, 6 October and 15 December.
Slovenian: Upravni odbor se je seznanil s predlaganimi datumi za leto 2011: 16. in 17. marec, 16. junij, 6. oktober in 15. december.
English: The data is provided in line with the costing methodology agreed by the Management Board.
Slovenian: Podatki so pripravljeni v skladu z metodologijo razčlenitve stroškov, ki jo je sprejel upravni odbor.
English: A request will be sent to the Heads of Medicines Agencies and the European Commission to nominate representatives to the committee.
Slovenian: Vodjem agencij za zdravila in Evropski komisiji bo poslana zahteva, da v odbor imenujejo predstavnike.
English: The Board expressed its willingness to meet with Commissioners to discuss the concerns expressed.
Slovenian: Upravni odbor je izrazil pripravljenost, da se sestane s komisarji za razpravo o izraženih pomislekih.
English: Meeting dates for 2010 and provisional meeting dates for 2011
Slovenian: Datumi sej za leto 2010 in predvideni datumi za leto 2011
English: The latter seems to be due to the difficulty experienced by the Member States in allocating scientific resources to work in the field of traditional medicinal products.
Slovenian: Zdi se, da slednje izhaja iz težav držav članic pri dodeljevanju znanstvenih virov za delo na področju tradicionalnih zdravil.
English: The proposal aims to simplify the governance structure, rationalise reporting lines and confirm the appropriate representation of the network.
Slovenian: Namen predloga je poenostaviti strukturo vodenja, racionalizirati poročanje in potrditi ustrezno zastopanje mreže.
English: Update on the pilot project on revision of the payment system
Slovenian: Poročilo o pilotnem projektu o reviziji plačilnega sistema
English: It was reiterated that the overall objective of the exercise is to bring the system better in line with the requirements of good governance and ensure that the remuneration system is justified, manageable and transparent.
Slovenian: Ponovili so, da je splošni cilj tega bolje uskladiti sistem z zahtevami dobrega vodenja in zagotoviti, da je plačilni sistem upravičen, vodljiv in pregleden.
English: The Agency's long-term strategy will be coordinated with the strategy paper of the Heads of Medicines Agencies (HMA).
Slovenian: Dolgoročna strategija bo usklajena s strateškim dokumentom vodij agencij za zdravila (HMA).
English: The Board will be asked to approve the 2010 part of the plan as part of the work programme and budget discussion 2010 in December.
Slovenian: Upravni odbor bo zaprošen, da decembra odobri del načrta za leto 2010 v okviru delovnega programa in razprave o proračunu za leto 2010.
English: This topic will be addressed during the future review of the Fee Regulation.
Slovenian: Ta tema bo obravnavana med prihodnjo revizijo uredbe o pristojbinah.
English: The proposal also links to the ongoing work at HMA-EMEA level, where a joint training team looks into a strategy aimed at further enhancing skills of the regulators.
Slovenian: Predlog se navezuje tudi na tekoče delo na ravni HMA-EMEA, kjer skupna ekipa za usposabljanje raziskuje strategijo za nadaljnjo okrepitev spretnosti in znanja regulatorjev.
English: In view of the reduction of planned revenue, the Agency's senior management is reviewing areas where savings could be made and projects scheduled for 2010 be cut.
Slovenian: Zaradi zmanjšanja načrtovanega prihodka višje vodstvo agencije pregleduje področja, na katerih bi bilo mogoče prihraniti, in projekte, načrtovane za leto 2010, ki bi jih bilo mogoče opustiti.
English: The Management Board wrote to the Commission regarding this issue in June and provided a response to the European Commission's letter in August.
Slovenian: Upravni odbor je junija o tem vprašanju pisal Komisiji in avgusta poslal odgovor na dopis Evropske komisije.
English: The text should read: “The Board discussed the EMEA rules on attachment of staff.
Slovenian: Besedilo bi se moralo glasiti: „Upravni odbor je razpravljal o pravilih agencije EMEA o dodelitvi osebja.
English: − Mike O'Donovan (representative of the patients' organisations).
Slovenian: Mika O'Donovana (predstavnik organizacij bolnikov).
English: Amendments to the implementing rules based on this proposal will be submitted to the Board in December 2009.
Slovenian: Spremembe izvedbenih pravil na podlagi tega predloga so bile upravnemu odboru predložene decembra 2009.
English: The Board thanked the Agency, its staff and the members of the scientific committees for their effective work and the timeliness of the scientific opinions in light of the public-health benefits of the H1N1 pandemic vaccines.
Slovenian: Upravni odbor se je zahvalil agenciji, njenemu osebju in članom znanstvenih odborov za učinkovito delo in pravočasno predložitev znanstvenih mnenj glede koristi pandemičnih cepiv H1N1 za javno zdravje.
English: Implementation of Staff Regulation: Rules on attachment of staff The item was taken off the agenda.
Slovenian: Izvajanje kadrovskih predpisov: pravila o dodelitvi osebja Točka je bila umaknjena z dnevnega reda.
English: While recognising that the interests of the healthcare professionals (HCP) organisations are more diverse than those of the patients, the Board asked to continue to explore ways on how to best develop interaction with healthcare professionals.
Slovenian: Čeprav upravni odbor priznava, da so interesi organizacij zdravstvenih strokovnjakov (HCP) bolj raznoliki od interesov bolnikov, pa je zaprosil, da se še naprej proučujejo načini, kako najbolje razvijati sodelovanje z zdravstvenimi strokovnjaki.
English: The document contains amendments discussed and agreed by the telematics steering committee in relation to the new pharmaceutical package and the funding gap.
Slovenian: Dokument vsebuje spremembe, o katerih so razpravljali in se o njih dogovorili na usmerjevalnem odboru za telematiko v zvezi z novim farmacevtskim svežnjem in primanjkljajem v financiranju.
English: While the Management Board is awaiting a reply from the Commission to its latest correspondence, the Board considers that this issue remains open, and expects that the publication of the vacancy notice will not proceed without the outstanding issue being resolved.
Slovenian: Medtem ko upravni odbor čaka na odgovor Komisije na njegov zadnji dopis, šteje, da to vprašanje ostaja odprto, in pričakuje, da prosto delovno mesto ne bo objavljeno, dokler se to vprašanje ne reši.
English: Collaboration between the regulators and the HTA bodies also needs to be developed, in order to reduce avoidable differences in requirements in both fields.
Slovenian: Treba je razvijati tudi sodelovanje med regulatorji in organi za ocenjevanje zdravstvenih tehnologij, da bi se zmanjšale razlike v zahtevah na obeh področjih, ki se jim je mogoče izogniti.
English: A correction was introduced under point 16 of the minutes (rules on attachment of staff).
Slovenian: V točko 16 zapisnika je bil vnesen popravek (Dodelitev osebja).
English: A significant amount of resources was allocated to work relating to the H1N1 pandemic.
Slovenian: Veliko sredstev je bilo dodeljenih za raziskave pandemične gripe H1N1.
English: Some members of the Board requested additional time to review the proposal ahead of its approval.
Slovenian: Nekateri člani upravnega odbora so prosili za dodaten čas, da predlog pregledajo pred odobritvijo.
English: The work to develop and introduce qualitative indicators will commence.
Slovenian: Začela se bo priprava in uvajanje količinskih kazalnikov.
English: The present proposal contains comments received and also includes a new proposal for quantitative performance indicators - compliance with set timelines.
Slovenian: Zdajšnji predlog vsebuje prejete pripombe in vključuje nov predlog količinskih kazalnikov uspešnosti ter skladnost s časovnim okvirjem.
English: Members of the Parliament raised a number of questions, including ones about the use of single versus two doses of the approved vaccines and the use of the vaccines in children and pregnant woman.
Slovenian: Poslanci Evropskega parlamenta so postavili številna vprašanja, vključno z vprašanjem o uporabi enega oziroma dveh odmerkov odobrenega cepiva in uporabi cepiv za otroke in nosečnice.
English: − 3 members of the Management Board, plus 1 representative of the patients' organisations which are members of the Management Board;
Slovenian: 3 člani upravnega odbora in en predstavnik organizacij bolnikov, ki so člani upravnega odbora;
English: The proposal should be finalised for the March 2010 Management Board meeting.
Slovenian: Predlog mora biti dokončno oblikovan do seje upravnega odbora, ki bo potekala marca 2010.
English: Consultation on appointment of a CVMP member
Slovenian: Posvetovanje o imenovanju člana odbora CVMP
English: The changes to the procedure will be introduced in the future revision of the EMEA policy on the handling of conflicts of interests.
Slovenian: Spremembe postopka bodo uvedene pri prihodnji reviziji politike agencije EMEA glede obravnavanja navzkrižij interesov.
English: Item 11 (rules on attachment of staff) was taken off the agenda taking into account the interpretation of the Staff Regulations provided by the European Commission whereby the proposed rules may not be applied to govern the attachment of EMEA staff.
Slovenian: Točka 11 (Dodelitev osebja) je bila umaknjena z dnevnega reda zaradi upoštevanja razlage Evropske komisije o Kadrovskih predpisih, po kateri se predlagana pravila ne smejo uporabljati za urejanje dodelitve osebja EMEA.
English: Lisette Tiddens-Engwirda was nominated as chair of the committee.
Slovenian: Lisette Tiddens-Engwirda je bila imenovana za predsednico odbora.
English: Participants at the sixty-fourth meeting of the Management Board London, 1 October 2009
Slovenian: Udeleženci štiriinšestdesete seje upravnega odbora London, 1. oktobra 2009
English: The Board noted that at present there is no legal basis to request fees for site visits or to compensate national competent authorities for the work carried out for site visits in the context of advanced therapy medicinal products.
Slovenian: Upravni odbor je ugotovil, da trenutno ni pravne podlage za zahtevo po pristojbinah za obiske lokacij ali povračilo nacionalnim pristojnim organom za delo v okviru obiskov lokacij v zvezi z zdravili za napredno zdravljenje.
English: Some deviations from the work programme were recorded, relating to the number and complexity of referrals in the veterinary field, which requires significant scientific resources, and to lower-thanplanned productivity of the Committee on Herbal Medicinal Products (HMPC).
Slovenian: Zabeleženo je bilo nekaj odstopanj od delovnega programa v zvezi s številom in zapletenostjo napotitev na veterinarskem področju, za katere je potrebno veliko znanstvenih virov, in nižjo produktivnostjo Odbora za zdravila rastlinskega izvora (HMPC) od načrtovane.
English: The Board heard that the current estimate for revenue from fees is €8.5m lower than originally forecast, due to a decrease in the proportion of fee-earning applications expected to be received.
Slovenian: Upravni odbor je zvedel, da je po sedanji oceni prihodek od pristojbin za 8,5 milijona EUR manjši od prvotne napovedi, ker je bilo število plačljivih vlog manjše od pričakovanega.
English: There is a significant increase in applications for authorisation of generic medicinal products, with 31 applications received.
Slovenian: Število vlog za izdajo dovoljenja za generična zdravila se je zelo povečalo, saj je agencija prejela 31 vlog.
English: The Board reiterated the need to agree on telematics projects well in advance, to enable the national competent authorities to develop their IT systems in line with the needs at the EU level.
Slovenian: Upravni odbor je znova ponovil, da morajo biti sporazumi o projektih telematike sprejeti precej pred izvedbo, da se nacionalnim pristojnim organom omogoči razvijanje sistemov informacijske tehnologije v skladu s potrebami na ravni EU.
English: Mandate of the Ad Hoc Pharmacovigilance Inspectors Working Group
Slovenian: Pristojnosti ad hoc delovne skupine inšpektorjev za farmakovigilanco
English: The authority will be informed about the concerns expressed by the Board with regards to the suitability of the nominee.
Slovenian: Organ bo obveščen o pomislekih upravnega odbora glede primernosti kandidata.
English: The Board asked the task force to further elaborate its proposal on the training of experts involved in the work of the committees in the light of the significant training already provided by the Agency.
Slovenian: Upravni odbor je zaprosil projektno skupino, da dodatno izpopolni svoj predlog o usposabljanju strokovnjakov, vključenih v delo odborov, glede na obsežno usposabljanje, ki ga je že zagotovila agencija.
English: − Hans-Georg Wagner.
Slovenian: Hansa-Georga Wagnerja.
English: The procedure will enable the Agency to inform the nominating authority of a potential conflict of interests of a nominee at the start of the nomination procedure.
Slovenian: Postopek bo agenciji omogočil, da obvesti organ za imenovanje o morebitnem navzkrižju interesov kandidata na začetku postopka imenovanja.
English: The Board stated, however, that the final decision as to the nomination lies with the Member State.
Slovenian: Upravni odbor pa je vseeno izjavil, da končno odločitev o imenovanju sprejme država članica.
English: The Board also endorsed the proposal to establish a procedure for advanced screening of potential conflicts of interests ahead of the nomination.
Slovenian: Upravni odbor je tudi potrdil predlog o vzpostavitvi postopka za napredno pregledovanje morebitnih navzkrižij interesov pred imenovanjem.
English: EMEA mid-year report 2009
Slovenian: Vmesno poročilo agencije EMEA za leto 2009
English: The Agency is now preparing a report based on the data received, and will submit the report to the December Management Board meeting, at which time the Board will also be able to discuss options for a possible decision in the future.
Slovenian: Agencija zdaj na podlagi prejetih podatkov pripravlja poročilo, ki ga bo upravnemu odboru predložila za decembrsko sejo, na kateri bo ta lahko razpravljal o možnostih za morebitne prihodnje odločitve.
English: Telematics master plan 2009-2013
Slovenian: Glavni načrt za telematiko 2009-2013
English: The Agency will consider this information in the context of the ongoing revision of the Agency's policy governing the handling of conflicts of interest and will inform the corresponding parties accordingly.
Slovenian: Agencija bo te informacije proučila v okviru tekoče reforme politike agencije, ki ureja obravnavanje navzkrižij interesov, in bo zadevne strani obvestila o izidu.
English: The findings will be presented to the EMEA Management Board topic coordinators and to the Management Board in December.
Slovenian: Ugotovitve bodo decembra predstavljene tematskim koordinatorjem upravnega odbora agencije EMEA in upravnemu odboru.
English: Feedback form the members is expected in a week's time, following which the proposal will be finalised and re-presented at the October Heads of Medicines Agencies meeting, and later submitted for adoption by the Board in December.
Slovenian: Povratne informacije članov se pričakuje v enem tednu, nato bo predlog dokončno oblikovan in znova predstavljen na oktobrskem sestanku vodij agencij za zdravila, zatem pa predložen v sprejetje na decembrski seji upravnega odbora.
English: The members noted the update report from the European Commission on a range of topics, including: the European Commission's work in the field of pandemic influenza, progress on the inter-service consultation on the variations regulation, the entry into force of the new regulation on maximum residue limits, and work in the field of health technology assessment.
Slovenian: Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno z: delom Evropske komisije na področju pandemične gripe, napredkom pri posvetovanju med službami o uredbi o spremembah, začetku veljavnosti uredbe o najvišjih mejnih vrednostih ostankov in delom pri ocenjevanju zdravstvenih tehnologij.
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: the development of the new HMA strategy paper, expected to be completed by the end of 2010; the ongoing discussion on transparency issues, with focus on commercially confidential information; and the reflection on the future of the veterinary medicines legislation.
Slovenian: Člani so se seznanili s posodobljenim poročilom vodij agencij za zdravila o različnih temah, vključno z: razvojem novega strateškega dokumenta HMA (Heads of Medicines Agencies), za katerega se pričakuje, da bo dokončan do konca leta 2010; tekočo razpravo o vprašanjih preglednosti, s poudarkom na komercialni zaupnosti podatkov, in razmislekom o prihodnji zakonodaji na področju veterinarske medicine.
English: Amendments to the CV template for experts and to the EMEA letter inviting nominations were introduced.
Slovenian: Uvedene so bile spremembe v zvezi s predlogo življenjepisa za strokovnjake in dopisom agencije EMEA za poziv k imenovanju.
English: It was asked that for future versions of the telematics master plan the document should be tabled with track changes for a more easy comparison with previous versions.
Slovenian: Prosili so, naj bodo dokumenti prihodnjih različic glavnega načrta za telematiko oblikovani z vključeno funkcijo Sledi spremembam za lažjo primerjavo s prejšnjimi različicami.
English: A robust system to monitor the safety and efficacy of vaccines has been put in place, in cooperation with the European Centre for Disease Prevention and Control.
Slovenian: V sodelovanju z Evropskim centrom za preprečevanje in obvladovanje bolezni je bil uveden učinkovit sistem nadzora varnosti in učinkovitosti cepiv.
English: [EXT/548688/2009] Further to the decision of the Telematics steering committee and the proposal of the European Commission, the Management Board adopted the decision to create the EMEA Management Board Telematics Committee (MBTC) as a subgroup of the Management Board.
Slovenian: [EXT/548688/2009]Po odločitvi usmerjevalnega odbora za telematiko in predlogu Evropske komisije je upravni odbor sprejel odločitev o ustanovitvi odbora za telematiko pri upravnem odboru agencije EMEA (MBTC) kot podskupine upravnega odbora.
English: Thomas Lönngren Patrick Le Courtois David Mackay Andreas Pott Hans-Georg Wagner Noël Wathion Sylvie Benefice Riccardo Ettore Martin Harvey Allchurch Frances Nuttall John Purves
Slovenian: Thomas Lönngren Patrick Le Courtois David Mackay Andreas Pott Hans-Georg Wagner Noël Wathion Sylvie Bénéfice Riccardo Ettore Martin Harvey Allchurch Frances Nuttall John Purves
English: The letter informed the Board, inter alia, that these persons were members of an editorial team for a book, which was sponsored by a pharmaceutical company.
Slovenian: Upravni odbor se je z dopisom med drugim seznanil, da sta bili ti osebi člana uredniškega odbora za izdajo knjige, ki jo je finančno podprla neka farmacevtska družba.
English: The patients' representative on the Board asked to address in the reflection paper the increasing difficulty of patients' representatives to participate in the Agency's activities due to resource constraints.
Slovenian: Predstavnik bolnikov v upravnem odboru je prosil, naj se v proučitvenem dokumentu obravnavajo tudi vse večje težave predstavnikov bolnikov glede sodelovanja v dejavnostih agencije zaradi omejenih virov.
English: Report from the Task force on scientific qualifications of CHMP and CVMP members
Slovenian: Poročilo projektne skupine za znanstvene kvalifikacije članov odborov CHMP in CVMP
English: [EMEA/MB/518171/2009] The Board adopted the following meeting dates for 2010: 17 and 18 March, 10 June, 7 October and 16 December.
Slovenian: [EMEA/MB/518171/2009] Upravni odbor je sprejel naslednje datume sej za leto 2010: 17. in 18. marec, 10. junij, 7. oktober in 16. december.
English: A reflection paper, which will be presented at the December meeting, will provide proposals on further involvement of patients' and consumers' organisations in the Agency's activities, including in the scientific review process.
Slovenian: V proučitvenem dokumentu, ki bo predstavljen na decembrski seji, bodo navedeni predlogi o nadaljnjem vključevanju organizacij bolnikov in potrošnikov v dejavnosti agencije in tudi v postopek znanstvene presoje.
English: [EMEA/MB/358420/2009] The agenda was adopted.
Slovenian: [EMEA/MB/358420/2009] Dnevni red je bil sprejet.
English: The mandate has been endorsed by the Heads of Medicines Agencies.
Slovenian: Pristojnosti so potrdili vodje agencij za zdravila.
English: The Board's substantial concern remains that the grading level proposed by the European Commission is too low.
Slovenian: Upravni odbor najbolj skrbi, da je razvrstitev tega delovnega mesta na lestvici, ki jo predlaga Evropska komisija, prenizka.
English: The Management Board was notified of the letter received about a former member of the Management Board and a CHMP alternate Member concerning their past activities.
Slovenian: Upravni odbor je bil obveščen, da je prispel dopis o nekdanjem članu upravnega odbora in o nadomestnem članu Odbora za zdravila za uporabo v humani medicini (CHMP) v zvezi z njunimi preteklimi dejavnostmi.
English: Minutes of the sixty-fourth meeting of the Management Board
Slovenian: Zapisnik štiriinšestdesete seje upravnega odbora
English: − 3 members of the Heads of Medicines Agencies;
Slovenian: 3 člani izmed vodij agencij za zdravila;
English: Inguna Adoviča
Slovenian: Inguna Adovica