FrancophonIA/ELRC3.0 huggingface dataset:
English: The new Human EudraVigilance report will now be produced twice a year, with the next report, which will be published, planned for June 2010.
Slovenian: 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.
English: The Board saw that the challenge in this area will be to assure consistency of the assessment of generic medicines across the EU.
Slovenian: Upravni odbor je ugotovil, da bo izziv na tem področju zagotavljati doslednost pri ocenjevanju generičnih zdravil v EU.
English: The Executive Director met with Mr John Dalli to discuss the trends in the pharmaceutical environment and future challenges.
Slovenian: Izvršni direktor se je sestal z Johnom Dallijem in z njim razpravljal o usmeritvah v farmacevtskem sektorju in prihodnjih izzivih.
English: The European Commission representative informed that the Commission has recently adopted the text of the vacancy notice and the grade AD14.
Slovenian: Predstavnik Evropske komisije je sporočil, da je Komisija pred kratkim sprejela besedilo objave prostega delovnega mesta in razreda AD14.
English: However, many countries expressed reservation regarding their ability to record on an ongoing basis.
Slovenian: Vendar so številne organizacije izrazile pomisleke glede njihove sposobnosti stalnega evidentiranja.
English: • Charter of the Internal Audit Service of the Commission.
Slovenian: • Listina službe Komisije za notranjo revizijo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Spremembe se nanašajo na podvojitev dnevnic za predstavnike posebnih organizacij, spremembe pravil v zvezi s hotelsko nastanitvijo in spremembe vozovnic.
English: 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.
Slovenian: Predstavniki z dokazanimi izkušnjami z zakonskim urejanjem zdravil bodo izbrani ob upoštevanju dobro opredeljenih izbirnih meril na podlagi razpisa za prijavo interesa.
English: 10(b) Amendments to the Management Board rules of procedure
Slovenian: 10(b) Spremembe poslovnika upravnega odbora
English: 18 March 2010 EMA/MB/806136/2009
Slovenian: 18. marca 2010 EMA/440680/2011
English: The decision will be taken by the Executive Director on the basis of a shortlist of candidates.
Slovenian: Izvršni direktor sprejme odločitev na podlagi ožjega seznama kandidatov.
English: Prof. Phillips is engaged with the Agency in the work on methodologies for benefit/risk assessment.
Slovenian: Profesor Phillips sodeluje z agencijo na področju metodologij za oceno razmerja med koristmi in tveganji.
English: The number of generic medicinal products for which authorisation is being sought through the centralised procedure is growing.
Slovenian: Število generičnih zdravil, za katera je vložena vloga za izdajo dovoljenja za promet z zdravilom na podlagi centraliziranega postopka, narašča.
English: The Board members were invited to review the document within the next few weeks and to provide comments.
Slovenian: Člani upravnega odbora so bili pozvani, naj v naslednjih nekaj tednih dokument proučijo in predložijo pripombe.
English: • strengthening the European medicines network;
Slovenian: • krepitev evropske mreže zdravil;
English: Status report on EudraVigilance implementation
Slovenian: Poročilo o stanju izvajanja podatkovne baze EudraVigilance
English: 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.
Slovenian: Člani so ugotovili, da odbor za telematiko upravnega odbora še ni razpravljal o glavnem načrtu telematike, ker odbor še ni v celoti vzpostavljen.
English: 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.
Slovenian: 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.
English: • publication of the guidelines on variations;
Slovenian: • objavo navodil o spremembah;
English: 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.
Slovenian: 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.
English: Draft agenda for 10 December 2009 meeting
Slovenian: Osnutek dnevnega reda za sejo dne 10. decembra 2009
English: Reflection paper on the further involvement of patients and consumers in the Agency's activities
Slovenian: Študija o nadaljnjem vključevanju bolnikov in potrošnikov v dejavnosti agencije
English: 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.
Slovenian: 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.
English: The meeting underlined that good coordination between the Management Board's and the Heads of Medicines Agencies' telematics committees is essential.
Slovenian: Na seji je bilo poudarjeno, da je dobro usklajevanje med odboroma za telematiko upravnega odbora in vodji agencij za zdravila bistvenega pomena.
English: 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.
Slovenian: V pripravi je izvedbeni načrt, ki bo dokončan, ko bodo pregledane vse pripombe iz javnega posvetovanja o časovnem načrtu in opravljene potrebne spremembe.
English: • move of the Pharmaceutical Units F2 and F3 (cosmetics and medical devices) to DG Sanco;
Slovenian: • prehodom farmacevtskih enot F2 in F3 (kozmetični izdelki in medicinski pripomočki) pod GD
English: 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.
Slovenian: 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.
English: According to the data collected, the benefit/risk balance of the vaccines remains positive.
Slovenian: Glede na zbrane podatke ostaja razmerje med koristmi in tveganji pozitivno.
English: 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.
Slovenian: 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.
English: The Board appointed Kent Woods as the Board's representative in the selection process at the European Commission.
Slovenian: Upravni odbor je Kenta Woodsa imenoval za predstavnika upravnega odbora v izbirnem postopku pri Evropski komisiji.
English: Cooperation with the Swiss medicines authority
Slovenian: Sodelovanje s švicarskim organom za zdravila
English: • focus on core business (including addressing the growing volume of activities in such areas as post-authorisation activities and orphan medicinal products);
Slovenian: • 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);
English: Meeting with the Commissioner designate for health and consumer policy
Slovenian: Sestanek s kandidatom za komisarja za zdravje in varstvo potrošnikov
English: The Board discussed the need to consider options for addressing the gap between the workload and the number of temporary agents.
Slovenian: Upravni odbor je razpravljal o potrebi po proučitvi možnosti za reševanje vrzeli med delovno obremenitvijo in številom začasnih uslužbencev.
English: • Presentation on the Road Map to 2015.
Slovenian: • Predstavitev časovnega načrta do leta 2015.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Nova struktura bo po pričakovanjih povečala splošno učinkovitost dejavnosti agencije, izboljšala kakovost njenega dela in okrepila učinkovitost njenega sodelovanja z zainteresiranimi stranmi.
English: 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.
Slovenian: Upravni odbor je opozoril, da so nacionalni pristojni organi del mreže EU, in poudaril prihodnjo vlogo bolnikov pri odločanju med ocenjevanjem zdravil.
English: 10(a) Management Board Telematics Committee
Slovenian: 10(a) Odbor upravnega odbora za telematiko
English: 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.
Slovenian: 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.
English: The website will be launched in spring 2010.
Slovenian: Spletna stran bo objavljena pomladi 2010.
English: 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.
Slovenian: Agencija končuje pripravo popolnoma nove javne spletne strani, ki ponuja bistveno izboljšano strukturo vsebine, prijaznost do uporabnika in funkcionalnost za ciljne skupine agencije.
English: 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.
Slovenian: 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.
English: • progress on the two legal proposals (pharmacovigilance and falsified medicines legislation);
Slovenian: • napredkom o dveh zakonskih predlogih (zakonodajo v zvezi s farmakovigilanco in ponarejenimi zdravili);
English: The new report on human EudraVigilance now focuses on how EudraVigilance contributes to the conduct of pharmacovigilance in the EU.
Slovenian: 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.
English: The Board reiterated its earlier concern in the area of herbal medicinal products where work is progressing very slowly.
Slovenian: Upravni odbor je vnovič izrazil zaskrbljenost zaradi področja zdravil rastlinskega izvora, na katerem delo poteka zelo počasi.
English: 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.
Slovenian: Predlogi vključujejo spremembo sedanjega okvira sodelovanja med agencijo in organizacijami bolnikov ter potrošnikov in zagotavljanje finančne podpore s podvojitvijo dnevnic v določenih primerih.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Topic coordinators (the Vice-chair, Austria, Denmark, the Netherlands, Sweden and Prof. Nisticó) provided positive feedback on the vision outlined in the draft road map.
Slovenian: Tematski koordinatorji (podpredsednik, Avstrija, Danska, Nizozemska, Švedska in prof. Nisticó) so predložili pozitivne povratne informacije o viziji iz osnutka časovnega načrta.
English: It is expected that the strategy will further improve communication and awareness about the Agency amongst the stakeholders.
Slovenian: Strategija bo po pričakovanjih med zainteresiranimi stranmi še izboljšala komuniciranje in ozaveščenost o agenciji.
English: Members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Slovenian: Člani so bili pozvani, naj se izrečejo o kakršnih koli posebnih interesih v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
English: Members suggested engaging with the European Court of Auditors to explain the Board's concern and the benefits of the existing system.
Slovenian: Člani odbora so predlagali, naj se naveže stik z Evropskim računskim sodiščem, da se mu pojasnijo zaskrbljenost upravnega odbora ter koristi obstoječega sistema.
English: A discussion on this topic will be planned during the March 2010 meeting.
Slovenian: Razprava na to temo bo načrtovana na seji marca 2010.
English: Appointment of the Executive Director
Slovenian: Imenovanje izvršnega direktorja
English: Revised reimbursement rules for delegates
Slovenian: Spremenjena pravila o nadomestilih za delegate
English: The chairs and mandates of such committees shall be appointed/adopted by the Board.
Slovenian: Upravni odbor imenuje/sprejme predsednike in mandate takih odborov.
English: European Commission Heinz Zourek Isabel de la Mata
Slovenian: Heinz Zourek Isabel de la Mata
English: The Committee will meet the chairs of all of the telematics implementation groups ahead of the next Management Board meeting.
Slovenian: Odbor se bo pred naslednjo sejo upravnega odbora sestal s predsedniki vseh izvedbenih skupin za telematiko.
English: Some members proposed that, if the system were to be revised, this should be done at a political level.
Slovenian: Več članov odbora je predlagalo, naj se morebitna sprememba sistema izvede na politični ravni.
English: The Board recognised the Executive Director's efforts to revise the system and bring it more into line with the requirements.
Slovenian: Upravni odbor je priznal prizadevanja izvršnega direktorja za spremembo sistema in njegovo boljšo uskladitev z zahtevami.
English: The representative of the European Commission drew the attention of the Board to the fact that a decision of the Board is necessary notably in the light of the observations of the Court of Auditors (also noting that, for example, in the European Chemicals Agency, the reimbursement rate is based on the cost for the national agency involved (rapporteur) multiplied with a country coefficient).
Slovenian: Predstavnik Evropske komisije je pozornost upravnega odbora usmeril na dejstvo, da je odločitev upravnega odbora nujna zaradi ugotovitev Računskega sodišča (ki so se nanašale tudi na dejstvo, da v Evropski agenciji za kemikalije stopnja nadomestil temelji na stroških vključene nacionalne agencije (poročevalke), pomnoženih s koeficientom za državo).
English: Taking into account the recent change of responsibility for the Agency within the European Commission, the members asked to ensure that the road map takes into account DG Sanco's strategic directions.
Slovenian: Člani so ob upoštevanju nedavne spremembe pristojnosti za agencijo pri Evropski komisiji pozvali k zagotovitvi, da časovni načrt upošteva strateške usmeritve GD SANCO.
English: Highlights from the Executive Director
Slovenian: Poudarki izvršnega direktorja
English: The meeting comes ahead of Mr Dalli's hearing at the European Parliament and the Agency's move from the responsibility of the Directorate-General Enterprise and Industry to the Directorate-General Health and Consumers.
Slovenian: Sestanek je potekal pred zaslišanjem g. Dallija pred Evropskim parlamentom in preden so bile pristojnosti za agencijo prenesene z Generalnega direktorata za podjetništvo in industrijo na Generalni direktorat za zdravje in varstvo potrošnikov.
English: A framework of interaction with healthcare professionals is under development and will be presented to the Board in 2010.
Slovenian: V pripravi je okvir sodelovanja z zdravstvenimi delavci, ki bo upravnemu odboru predstavljen leta 2010.
English: • public consultation on the assessment of the functioning of the Clinical Trials Directive (closing date
Slovenian: • javnim posvetovanjem o oceni delovanja Direktive o kliničnih preskušanjih (rok 8. januar 2010);
English: The Board discussed the concern that a higher proportion of the telematics budget will be consumed by maintenance of the systems as more telematics systems come into operation over the years.
Slovenian: Upravni odbor je razpravljal o zaskrbljenosti, da bo vzdrževanje sistemov zahtevalo večji delež proračuna za telematiko, ko bo v naslednjih letih začelo delovati več telematskih sistemov.
English: The topic coordinators (the Chair, Austria and the Netherlands) proposed an alternative solution: to introduce, for a transitional period, a payment system based on Eurostat correction coefficients, and to continue collecting costing data for assessment of centralised applications.
Slovenian: Tematski koordinatorji (predsednik, Avstrija in Nizozemska) so predlagali nadomestno rešitev: v prehodnem obdobju uvesti sistem plačil na podlagi Eurostatovih korekcijskih koeficientov in še naprej zbirati podatke o stroških za oceno centraliziranih vlog za dovoljenje za promet.
English: Report from the Heads of Medicines Agencies The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including: publication of information on e-readiness in each of the national competent authorities; the creation of the network of HMA contacts on medicines advertising; the veterinary SPC harmonisation project; and revision of the action plan in the field of antimicrobial resistance.
Slovenian: Člani upravnega odbora so se seznanili s posodobljenim poročilom vodij agencij za zdravila o več temah, vključno z: objavo informacij o e-pripravljenosti pri vsakem nacionalnem pristojnem organu, oblikovanjem mreže stikov vodij agencij za zdravila o oglaševanju zdravil, projektom za uskladitev povzetkov glavnih značilnosti zdravil v zvezi z zdravili za uporabo v veterinarski medicini in spremembo akcijskega načrta na področju protimikrobne odpornosti.
English: Those national competent authorities also showed that they are able to record the hours spent on centralised applications.
Slovenian: Ti nacionalni pristojni organi so poleg tega dokazali, da lahko evidentirajo ure, ki so jih porabili za centralizirane vloge za dovoljenje za promet.
English: Draft road map to 2015
Slovenian: Osnutek načrta do leta 2015
English: In view of changes within the European Commission of the responsibilities for the Agency, the Management Board expressed its thanks to Heinz Zourek, Director-General of DG Enterprise and Industry, for his significant contribution to the work of the Board and of the Agency.
Slovenian: Upravni odbor se je zaradi sprememb pristojnosti agencije znotraj Evropske komisije zahvalil generalnemu direktorju GD za podjetništvo in industrijo Heinzu Zoureku za njegov pomemben prispevek k delu upravnega odbora in agencije.
English: Participation of patients/consumers' representatives as observers to the PhVWP
Slovenian: Udeležba predstavnikov bolnikov/potrošnikov kot opazovalcev v delovni skupini za farmakovigilanco
English: The Chair thanked the members for the work done during the interactions and correspondence with the European Commission with regard to the vacancy notice and the grading of the Executive Director's post.
Slovenian: Predsednik se je članom zahvalil za delo, opravljeno med sodelovanjem, ter korespondenco z Evropsko komisijo v zvezi z objavo prostega delovnega mesta in razvrstitvijo delovnega mesta izvršnega direktorja.
English: The budget topic coordinators (the Chair, Austria, Germany and the Netherlands) scrutinised the Agency's work programme and budget documents ahead of the Management Board, received responses to their questions and recommended that the Board adopt the documents.
Slovenian: Tematski koordinatorji za proračun (predsednik, Avstrija, Nemčija in Nizozemska) so pred upravnim odborom temeljito pregledali delovni program in proračunsko dokumentacijo agencije, prejeli odgovore na svoja vprašanja in priporočili, naj upravni odbor sprejme dokumente.
English: The publication of the notice is expected in the second week of January 2010.
Slovenian: Objava prostega delovnega mesta se pričakuje v drugem tednu januarja 2010.