FrancophonIA/ELRC3.0 huggingface dataset:
English: Members were concerned that this is a new initiative for the regulatory system and therefore requires thorough preparation in order to meet the significant expectations of stakeholders.
Slovenian: Izrazili so zaskrbljenost, da je to nova pobuda za regulativni sistem, zato so potrebne temeljite priprave, da se izpolnijo velika pričakovanja zainteresiranih strani.
English: Members were also informed that a study to assess the governance of the telematics programme is ongoing.
Slovenian: Člani so bili tudi obveščeni, da se izvaja študija za oceno vodenja telematskega programa.
English: Early in 2012, information on activities to be taken forward in 2012 will be provided through the Agency's website and a new workshop for industry will be organised.
Slovenian: Na začetku leta 2012 bodo na spletni strani agencije objavljene informacije o dejavnostih, ki se bodo nadaljevale v letu 2012, organizirana pa bo tudi nova delavnica za industrijo.
English: If only one audit engagement can take place in 2012, the Management Board expressed a preference for the audit on planning and budgeting.
Slovenian: Če bo v letu 2012 mogoče opraviti le eno revizijo, upravni odbor daje prednost reviziji načrtovanja in oblikovanja proračuna.
English: No additional conflicts of interests were declared.
Slovenian: Nihče ni navedel, da obstaja dodatno navzkrižje interesov.
English: But it was felt that the Agency is not in a position to impose further restrictions on the network, with a condition that any such participation can entail no more than a compensation of reasonable expenses.
Slovenian: Vendar so menili, da agencija mreži ne more naložiti dodatnih omejitev s pogojem, da katera koli takšna udeležba ne sme vključevati ničesar razen nadomestila za razumne izdatke.
English: The carry-over will concern funding of the relocation project, and the implementation of the next phase of the human resource database.
Slovenian: Prenos se bo nanašal na financiranje projekta premestitve in izvajanje naslednje faze podatkovne zbirke o človeških virih.
English: The Agency will not be able to pay rapporteurs until pharmacovigilance fees are introduced with the amendment of the Fee Regulation.
Slovenian: Agencija ne bo mogla plačati poročevalcev, dokler ne bodo s spremembo uredbe o pristojbinah uvedene pristojbine za farmakovigilanco.
English: Meeting with Commissioner John Dalli and Director-General Paola Testori
Slovenian: Srečanje s komisarjem Johnom Dallijem in generalno direktorico Paolo Testori
English: The European Commission provided an update on a number of items, including the following:
Slovenian: Evropska komisija je predstavila najnovejše informacije o več temah, vključno z naslednjim:
English: Results of the study are expected in March 2012.
Slovenian: Rezultati študije bodo predvidoma na voljo marca 2012.
English: The Agency forecasts that the numbers of applications within most of its activity areas will remain largely similar to those of the previous year.
Slovenian: Agencija predvideva, da bo število vlog na večini področij dejavnosti v glavnem ostalo podobno številu iz lanskega leta.
English: Members also asked to revise the wording of Article 2 (5) of the rules of procedure to clarify that civil society representatives can be elected as chair.
Slovenian: Člani so poleg tega pozvali k spremembi besedila člena 2(5) poslovnika za pojasnitev, da je predstavnik civilne družbe lahko izvoljen za predsednika odbora.
English: b.) Implementation of the Pharmacovigilance legislation
Slovenian: b) Izvajanje zakonodaje o farmakovigilanci
English: Declaration of conflicts of interest related to current agenda
Slovenian: Izjava o navzkrižju interesov v zvezi s sedanjim dnevnim redom
English: As more systems go into production, the fixed ICT costs will continue to increase.
Slovenian: Ker bo začelo delovati še več sistemov, se bodo fiksni stroški za IKT še naprej višali.
English: Financial compensation for Member States' participation in the linguistic checking of product related information: Fixed flat hourly cost for 2012
Slovenian: Finančno nadomestilo za sodelovanje držav članic pri jezikovnem preverjanju informacij o zdravilih: fiksna pavšalna urna postavka za leto 2012
English: The Management Board also adopted a revision of the grading of the 23 posts in accordance with Article 32 of the Agency's Financial Regulation.
Slovenian: Upravni odbor je sprejel tudi spremembo razvrstitve 23 delovnih mest v skladu s členom 32 finančne uredbe agencije.
English: A number of projects are under way that will see streamlining of certain procedures and the introduction of more quantifiable elements in the assessment process.
Slovenian: Izvaja se več projektov, ki bodo racionalizirali nekatere postopke in uvedli bolj količinsko opredeljive elemente v postopku ocenjevanja.
English: However, it was explained that the definitions in this policy mirror those adopted for the policy on conflicts of interests of experts, and it would be appropriate to keep both policies in line.
Slovenian: Vendar je bilo pojasnjeno, da opredelitve iz te politike izražajo opredelitve, sprejete za politiko o navzkrižjih interesov strokovnjakov, in da bi bilo ustrezno ohraniti skladnost obeh politik.
English: However, the overall staffing of the Agency will remain at the previous year's level since the Agency will reduce the number of contract agents and seconded national experts by 23 full-time equivalents.
Slovenian: Vendar bo skupno število zaposlenih agencije ostalo na lanskoletni ravni, saj bo agencija zmanjšala število pogodbenih uslužbencev in napotenih nacionalnih strokovnjakov za 23 ekvivalentov polnega delovnega časa.
English: The ICT budget continues to show an increase in expenditure, which results in the decrease in the project development budget.
Slovenian: V zvezi s proračunom za IKT se še naprej višajo izdatki, kar povzroča zmanjševanje proračuna za razvoj projektov.
English: The Board welcomed the framework that aims to strengthen the already existing cooperation with HCPs and to fill remaining gaps.
Slovenian: Pozdravil je okvir, katerega cilj je okrepiti že obstoječe sodelovanje z zdravstvenimi delavci in zapolniti preostale vrzeli.
English: This aspect will be addressed in the ongoing discussion about the review of the Clinical Trials Directive.
Slovenian: Ta vidik bo obravnavan v tekoči razpravi o pregledu direktive o kliničnih preskušanjih.
English: The Board asked to include aspects of today's discussion in the report in order to clarify relevant issues.
Slovenian: Upravni odbor je zahteval, da se v poročilo vključijo vidiki današnje razprave za pojasnitev ustreznih vprašanj.
English: The budget is in line with the work programme and totals €222.5 million (6.5% increase over the 2011 budget), which includes a general EU contribution of €23 million, the 2010 surplus of €9.9 million and the €6 million orphan medicinal products fund.
Slovenian: Proračun je v skladu z delovnim programom in znaša 222,5 milijona EUR (6,5-odstotno povečanje v primerjavi s proračunom za leto 2011), kar vključuje splošni prispevek EU v višini 23 milijonov EUR, presežek iz leta 2010 v višini 9,9 milijona EUR in 6 milijonov EUR iz sklada za zdravila sirote.
English: The extended information sharing is important to enable effective and reliable cooperation for handling various situations and to contribute to an effective use of international inspection resources.
Slovenian: Razširjena souporaba informacij je pomembna, da se omogoči učinkovito in zanesljivo sodelovanje za obvladovanje različnih razmer in za prispevanje k učinkoviti uporabi mednarodnih inšpekcijskih zmogljivosti.
English: The Agency and the network will need to consider ways of reducing the burden of fixed costs through the review and introduction of new technologies that have a cost-saving effect.
Slovenian: Agencija in mreža bosta morali proučiti načine za zniževanje fiksnih stroškov s pregledom in uvedbo novih tehnologij, ki znižujejo stroške.
English: 15 Romania 16 Slovakia 17 Slovenia 18 Sweden 19 United Kingdom 20 Mary Baker 21 Mike O'Donovan by proxy
Slovenian: 15 Romunija 16 Slovaška 17 Slovenija 18 Švedska 19 Združeno kraljestvo 20 Mary Baker 21 Mike O'Donovan po pooblaščencu 22 Lisette Tiddens
English: The report follows the request of the European Parliament during the discharge procedure in 2011 to review the Agency's procurement practices.
Slovenian: Poročilo je bilo pripravljeno na zahtevo Evropskega parlamenta med postopkom podelitve razrešnice leta 2011 za pregled praks javnega naročanja agencije.
English: The main focus of the work programme is the implementation of the new pharmacovigilance legislation and the legislation on falsified medicines.
Slovenian: Glavna pozornost v delovnem programu je namenjena izvajanju nove zakonodaje o farmakovigilanci in zakonodaje o ponarejenih zdravilih.
English: The Agency had taken action to remedy shortcomings identified earlier in the process.
Slovenian: Agencija je sprejela ukrepe za odpravo pomanjkljivosti, ki so bile ugotovljene v zgodnejši fazi postopka.
English: In this area, it was suggested to extend the period during which restrictions apply from two years to five years following the expiry of the conflict.
Slovenian: Na tem področju je bilo predlagano, naj se po izteku navzkrižja interesov podaljša obdobje veljavnosti omejitev z dveh na pet let.
English: A number of interim arrangements will be made pending the completion of the process.
Slovenian: Do dokončanja postopka bo sprejetih več začasnih ureditev.
English: Some of the factors contributing to supply shortages are trade issues, concentration and economics of manufacturing, and the drive for cost savings in healthcare systems.
Slovenian: Nekateri dejavniki, ki prispevajo k nezadostni oskrbi, so trgovinska vprašanja, koncentracija in ekonomika proizvodnje ter usmerjenost k zniževanju stroškov v sistemih zdravstvenega varstva.
English: The Board discussed the importance of sharing the contents of the European clinical trials database with the countries with which the Agency cooperates in the area of clinical trials.
Slovenian: Razpravljal je o pomenu souporabe vsebine podatkovne zbirke o evropskih kliničnih preskušanjih z državami, s katerimi agencija sodeluje na področju kliničnih preskušanj.
English: The report also showed an increase in requests for data from EudraVigilance, a significant increase of Member States working with the EudraVigilance Data Analysis System, and improved compliance with the legal timeframes for the transmission of individual case safety reports.
Slovenian: V poročilu je bilo ugotovljeno tudi povečanje števila zahtevkov za podatke iz sistema EudraVigilance, precejšnje povečanje števila držav, ki uporabljajo sistem EudraVigilance za analizo podatkov, in boljša skladnost z zakonskimi roki za predložitev varnostnih poročil o posameznih primerih.
English: This is then followed by a signal management procedure.
Slovenian: Temu sledi postopek obvladovanja znakov.
English: • Letter from the European Commission, Paola Testori Coggi, regarding EU level support in the field of tissues and cells.
Slovenian: • Dopis Evropske komisije, Paole Testori Coggi, o podpori na ravni EU na področju tkiv in celic.
English: The process to prepare detailed plans and fitting-out requirements is ongoing and should finish in February 2012.
Slovenian: Postopek priprave podrobnih načrtov in zahtev za opremo prostorov poteka in se bo predvidoma končal februarja 2012.
English: The Commission pointed out that the focus should be on what can be done within the current legislative framework in view of the resource implications.
Slovenian: Komisija je poudarila, da je treba glavno pozornost nameniti vprašanju, kaj je mogoče doseči v sedanjem zakonodajnem okviru glede na finančne posledice.
English: Andreas Pott had been appointed as Deputy Executive Director of the Agency effective 1 December 2011.
Slovenian: Andreas Pott je bil s 1. decembrom 2011 imenovan za namestnika izvršnega direktorja agencije.
English: The proposed action plan focuses on the following areas: centralised multi-annual procurement planning, use of negotiated procedures in exceptional circumstances, and the Advisory Committee on Procurement and Contracts.
Slovenian: V predlaganem akcijskem načrtu je glavna pozornost namenjena naslednjim področjem: centraliziranemu večletnemu načrtovanju javnih naročil, uporabi postopkov s pogajanji v izjemnih okoliščinah ter svetovalnemu odboru za javna naročila in pogodbe.
English: The meeting also considered whether additional provisions should be included in respect of attendance at meetings and conferences sponsored by the pharmaceutical industry.
Slovenian: Udeleženci seje so tudi obravnavali, ali bi bilo treba vključiti dodatne določbe v zvezi z udeležbo na sejah in konferencah, ki jih je podpira farmacevtska industrija.
English: This requires the Management Board to have a specific policy that differs in a number of aspects from that of the scientific committees.
Slovenian: Upravni odbor mora zato imeti posebno politiko, ki se v več vidikih razlikuje od politike znanstvenih odborov.
English: The Management Board thanked Hans-Georg for his leadership, skill and contribution to achieving the Agency's objectives over this period, and wished him all the best for his future plans.
Slovenian: Upravni odbor se je Hansu-Georgu zahvalil za vodenje, znanje in prispevek k izpolnjevanju ciljev agencije v tem obdobju in mu zaželel vse najboljše pri njegovih prihodnjih načrtih.
English: The Management Board expressed its condolences to the family and its deepest regret following the death of its valued member Henk Vaarkamp who represented veterinary organisations on the Board for almost 3 years.
Slovenian: Upravni odbor je izrazil sožalje družini in globoko obžalovanje zaradi smrti svojega cenjenega člana Henka Vaarkampa, ki je bil skoraj tri leta predstavnik veterinarskih organizacij v upravnem odboru.
English: • The proposal on information to patients (the provisions related to the pharmacovigilance legislation are now dissociated from the proposal on information to patients; progress on the latter proposal remains slow).
Slovenian: • predlog o obveščanju bolnikov (določbe v zvezi z zakonodajo o farmakovigilanci so zdaj ločene od predloga o obveščanju bolnikov; napredek v zvezi z zadnjim predlogom je še vedno počasen);
English: • Substances of human origin (the Commission will establish an information system on the substances; the Agency and ECDC will have an advisory role within their areas of competence).
Slovenian: • snovi človeškega izvora (Komisija bo vzpostavila informacijski sistem o teh snoveh; agencija in center ECDC bosta imela svetovalno vlogo v okviru svojih pristojnosti).
English: Effort will also be made to enhance the coordination of the scientific committees in light of the increasing complexity of interaction following the establishment of the seventh committee, which will deal with pharmacovigilance topics.
Slovenian: Prizadevajo si tudi za okrepitev usklajevanja dela znanstvenih odborov ob upoštevanju vse večje zapletenosti sodelovanja po ustanovitvi sedmega odbora, ki se bo ukvarjal s temami v zvezi s farmakovigilanco.
English: In addition to his responsibilities as Deputy Executive Director, Andreas will continue in his position as Head of Administration Unit.
Slovenian: Poleg odgovornosti namestnika izvršnega direktorja bo še naprej opravljal funkcijo vodje enote za administrativne zadeve.
English: With regard to this particular concern, the meeting was reminded that the issue was discussed when preparing the experts' policy.
Slovenian: V zvezi s tem posebnim pomislekom so bili udeleženci seje opozorjeni, da se je o tem vprašanju razpravljalo pri pripravi politike za strokovnjake.
English: Interaction between the Agency and healthcare professionals a.) Framework for interaction between the Agency and healthcare professionals, and b.) Criteria to be fulfilled by healthcare professionals' organisations involved in Agency activities
Slovenian: Sodelovanje agencije in zdravstvenih delavcev a) Okvir za sodelovanje agencije in zdravstvenih delavcev b) Merila, ki jih morajo izpolnjevati organizacije zdravstvenih delavcev, ki so vključene v dejavnosti agencije
English: Vote on the adoption of agenda item 7bis - Personnel matter
Slovenian: Glasovanje o sprejetju točke 7a dnevnega reda - Kadrovska zadeva
English: The Board therefore asked to consider expanding this approach to veterinary medicines.
Slovenian: Upravni odbor je zato pozval k razmisleku o razširitvi tega pristopa na zdravila za uporabo v veterinarski medicini.
English: The Management Board discussed at length the implementation of the provision on public hearings in the context of the revised urgent Union procedure.
Slovenian: Upravni odbor je obširno razpravljal o izvajanju določbe o javnih obravnavah v okviru spremenjenega nujnega postopka Unije.
English: The Board discussed the proposal to introduce restrictions in certain cases where potential conflicts of interests can be perceived.
Slovenian: Upravni odbor je razpravljal o predlogu za uvedbo omejitev v nekaterih primerih, v katerih je mogoče zaznati morebitna navzkrižja interesov.
English: The decision was taken following a long period of discussions between the Commission, the European
Slovenian: Ta odločitev je bila sprejeta po dolgotrajnih razpravah med Komisijo, Evropsko agencijo za zdravila in
English: A new member of the Committee is introduced to represent the business activities of the Agency.
Slovenian: Predstavljen je bil nov član odbora za zastopanje poslovnih interesov agencije.
English: This improved response time reflects stronger collaboration between the Agency secretariat and the CHMP and its Pharmacovigilance Working Party, especially in terms of increased awareness of the current signal management process.
Slovenian: Ta izboljšani odzivni čas je plod tesnejšega sodelovanja med sekretariatom agencije in odborom CHMP (Odborom za zdravila za uporabo v humani medicini) ter njegovo delovno skupino za farmakovigilanco, zlasti v smislu večje ozaveščenosti o sedanjem postopku obvladovanja znakov.
English: • The cross-border directive (progress has been achieved in setting up a voluntary cooperation structure with Member States in the area of health technology assessment; a network of Member States in the e-health area was established; a new proposal on cross-border health threats was adopted).
Slovenian: • direktiva o čezmejnem zdravstvenem varstvu (dosežen je bil napredek z vzpostavitvijo strukture za prostovoljno sodelovanje z državami članicami na področju ocenjevanja zdravstvene tehnologije; oblikovana je bila mreža držav članic na področju e-zdravja; sprejet je bil nov predlog o čezmejnih nevarnostih za zdravje);
English: Nomination to the new Pharmacovigilance Risk Assessment Committee (PRAC)
Slovenian: Imenovanja v novi Odbor za ocenjevanje tveganja na področju farmakovigilance (Pharmacovigilance Risk Assessment Committee, PRAC)
English: The mandates of the current civil society members of the Board expire on 4 March 2012.
Slovenian: Mandati sedanjih članov upravnega odbora, ki so predstavniki civilne družbe, se iztečejo 4. marca 2012.
English: The meeting also stressed that a mechanism to effectively address unethical behaviour should be put in place and would be an important instrument to ensure compliance with the requirements.
Slovenian: Udeleženci seje so polega tega poudarili, da je treba vzpostaviti mehanizem za učinkovito obravnavo neetičnega vedenja, ki bi bil pomemben instrument za zagotavljanje skladnosti z zahtevami.
English: The European Parliament granted the discharge for the implementation of the Agency's 2009 budget on 25 October 2011.
Slovenian: Evropski parlament je 25. oktobra 2011 podelil razrešnico za izvrševanje proračuna agencije za leto 2009.
English: The European Commission reminded the Board of the fact that the EU contribution to the Agency's budget is a balancing contribution.
Slovenian: Evropska komisija je upravni odbor opozorila na dejstvo, da je prispevek EU v proračun agencije izravnalni prispevek.
English: The meeting discussed that the Agency has to continue to review the scope of its activities and, when relevant, to reallocate resources from activities that are not strictly required by legislation.
Slovenian: Udeleženci seje so razpravljali, da mora agencija še naprej pregledovati obseg svojih dejavnosti in po potrebi prerazporediti sredstva iz dejavnosti, ki jih zakonodaja ne zahteva izrecno.
English: The Board agreed to discuss a first draft proposal on public hearings at the next meeting.
Slovenian: Upravni odbor se je strinjal, da bo o prvem osnutku predloga o javnih obravnavah razpravljal na naslednji seji.
English: List of written procedures during the period from 15 September 2011 to 30 November 2011
Slovenian: Seznam pisnih postopkov v obdobju od 15. septembra 2011 do 30. novembra 2011
English: With regard to communication, the Board was informed that the Agency plans to reassess and further improve its communication activities with a view to providing the Agency's stakeholders with information about how the Agency and EU institutions contribute to public health.
Slovenian: V zvezi s komuniciranjem je bil upravni odbor obveščen, da agencija namerava ponovno oceniti in dodatno izboljšati svoje komunikacijske dejavnosti, da bo zainteresiranim stranem agencije zagotavljala informacije, kako agencija in institucije EU prispevajo k javnemu zdravju.
English: Draft agenda for 15 December 2011 meeting
Slovenian: Osnutek dnevnega reda za sejo dne 15. decembra 2011
English: The meeting was also informed that the Agency is preparing further guidance to experts about its policies on conflicts of interests.
Slovenian: Udeleženci seje so bili tudi obveščeni, da agencija pripravlja dodatne smernice za strokovnjake o svojih politikah o navzkrižjih interesov.
English: The Chair informed the Board that he had examined declarations of interests of members together with the Vice-chair and the secretariat, and concluded that there were no conflicts of interest that could interfere with the topics of the meeting.
Slovenian: Predsednik je upravni odbor obvestil, da je pregledal izjave o interesih članov, podpredsednika in sekretariata, in ugotovil, da ni navzkrižij interesov, ki bi posegala v teme seje.
English: The Executive Director briefed the Board about a range of topics discussed at the meeting, among which were the communication strategy of the Agency and the implementation of the pharmacovigilance legislation.
Slovenian: Izvršni direktor je upravnemu odboru poročal o različnih temah, o katerih se je razpravljajo na srečanju, med drugim o komunikacijski strategiji agencije in izvajanju zakonodaje o farmakovigilanci.
English: The Management Board welcomed the Agency's efforts in this domain and recognised the contribution of staff in establishing fruitful and exemplary cooperation with its stakeholders.
Slovenian: Upravni odbor je pozdravil prizadevanja agencije na tem področju in izrekel priznanje za prispevek osebja pri vzpostavitvi uspešnega in vzornega sodelovanja z zainteresiranimi stranmi agencije.
English: This was the last Management Board meeting for Hans-Georg Wagner, Head of Information and Communications Technology (ICT) Unit, who was shortly to retire after serving with the Agency since May 2002.
Slovenian: To je bila zadnja seja upravnega odbora za Hansa-Georga Wagnerja, vodjo enote za informacijsko in komunikacijsko tehnologijo, ki se bo kmalu upokojil, delo pri agenciji pa je nastopil maja 2002.
English: Members welcomed Guido Rasi, the Executive Director of the Agency, for whom this was the first Management Board meeting in this capacity.
Slovenian: Člani so pozdravili Guida Rasija, izvršnega direktorja agencije, ki se je seje upravnega odbora prvič udeležil v tej funkciji.