FrancophonIA/ELRC3.0 huggingface dataset:
English: The reflection paper has been released for public consultation until 30 September 2010.
Slovenian: Študija je bila objavljena za javno posvetovanje, ki bo potekalo do 30. septembra 2010.
English: The Vice-Chair, Lisette Tiddens-Engwirda, opened the meeting by welcoming meeting participants and by asking Members to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Slovenian: Podpredsednica Lisette Tiddens-Engwirda je odprla sestanek, pozdravila udeležence seje in člane pozvala, naj se izrečejo o kakršnih koli posebnih interesih v zvezi s katero koli točko dnevnega reda, ki bi lahko vplivali na njihovo neodvisnost.
English: The European Commission and the Agency will organise a conference on 30 June 2010 to discuss the outcomes of the evaluation with stakeholders.
Slovenian: Evropska komisija in agencija bosta 30. junija 2010 organizirali konferenco, na kateri bosta z zainteresiranimi stranmi razpravljali o izidih ocene.
English: EudraVigilance status report 2009
Slovenian: Poročilo o stanju sistema EudraVigilance za leto 2009
English: Written comments were invited within 2 weeks after the meeting.
Slovenian: Člani so bili pozvani, naj pisne pripombe predložijo najpozneje dva tedna po seji.
English: The topic will also be addressed in the EC/EMA conference on the outcomes of the evaluation of the Agency.
Slovenian: Ta tema bo obravnavana tudi na konferenci Evropske komisije in agencije EMA o izidih ocene agencije.
English: • The ongoing work with a view to reviewing the Clinical Trials Directive.
Slovenian: • sedanjim delom za pregled direktive o kliničnih preskušanjih.
English: The Board noted the proposed agenda of the workshop.
Slovenian: Upravni odbor se je seznanil s predlaganim dnevnim redom delavnice.
English: A group of the Board's topic coordinators (Austria, France, Denmark and the Chair) together with the Agency's staff will reflect on the proposal.
Slovenian: Skupina tematskih koordinatorjev upravnega odbora (Avstrija, Francija, Danska in predsednik) bo v sodelovanju z osebjem agencije preučila predlog.
English: However, if combined with physical meetings of the scientific committees, the use of other meeting technologies would increase the efficiency of the use of scientific resources.
Slovenian: Vendar bi uporaba drugih tehnologij za sestanke v kombinaciji s sestanki znanstvenih odborov v živo povečala učinkovitost uporabe znanstvenih virov.
English: The report contains the Executive Director's declaration of assurance.
Slovenian: Poročilo vključuje tudi izjavo izvršnega direktorja o zanesljivosti.
English: The Board recognised that practices adopted at the EMA will impact on the arrangements put in place at the national level.
Slovenian: Upravni odbor je priznal, da bodo prakse, ki jih sprejme agencija EMA, vplivale na ureditve na nacionalni ravni.
English: The re-opening of the vacancy will be announced by 26 June with a four-week deadline for applications.
Slovenian: Vnovična objava prostega delovnega mesta bo napovedana do 26. junija s štiritedenskim rokom za oddajo prijav.
English: Lessons learned during the volcanic eruption
Slovenian: Poudarki Spoznanja, pridobljena med izbruhom vulkana
English: The Board gave a positive assessment of the Agency's performance on a broad range of issues in 2009.
Slovenian: Uspešnost agencije je pozitivno ocenil pri zelo različnih številnih vprašanjih v letu 2009.
English: Therefore, the right balance between restricting the involvement of experts with conflicting interests in the Agency's activities and ensuring the availability of the best scientific expertise to support the Agency's scientific opinions should be ensured.
Slovenian: Zato je treba zagotoviti ustrezno ravnotežje med omejitvijo vključevanja strokovnjakov, pri katerih se ugotovi navzkrižje interesov v zvezi v dejavnostmi agencije, in razpoložljivostjo najboljšega znanstvenega strokovnega znanja v podporo znanstvenim mnenjem agencije.
English: Further reflection may be needed at the HMA level as to whether it would be useful to agree on a minimum set of standards with regards to handling of conflicts of interest which could be used in the national arrangements.
Slovenian: Na ravni vodij agencij za zdravila bo morda potreben nadaljnji razmislek, ali bi se bilo koristno dogovoriti o minimalnem sklopu standardov v zvezi z obravnavo navzkrižij interesov, ki bi jih bilo mogoče uporabiti v nacionalnih ureditvah.
English: The Management Board endorsed the subset of key performance indicators which will be monitored and reported upon.
Slovenian: Potrdil je podskupino ključnih kazalnikov uspešnosti, ki se bodo spremljali in o katerih se bo poročalo.
English: The Management Board asked the European Commission to provide the aforementioned study before it can respond about the Agency's ability to take on the new responsibility.
Slovenian: Upravni odbor je Evropsko komisijo pozval, naj mu zagotovi zgoraj navedeno študijo, da se bo lahko odzval na trditev o sposobnosti agencije za prevzem nove pristojnosti.
English: Adverse drug reaction reports contain a large number of fields which need to be reviewed to protect the identity of a person when granting access to the report.
Slovenian: Poročila o neželenih učinkih zdravil vključujejo številna podatkovna polja, ki jih je treba pregledati za varstvo identitete osebe pri dodelitvi dostopa do poročila.
English: Analysis and assessment of the Executive Director's annual activity report 2009
Slovenian: Analiza in ocena letnega poročila o dejavnostih izvršnega direktorja za leto 2009
English: In addition to information that used to be provided previously, the report now elaborates on how EudraVigilance contributes to the conduct of pharmacovigilance in the EU.
Slovenian: V poročilu, ki vključuje informacije, ki so se zagotavljale že prej, se zdaj proučuje prispevek sistema EudraVigilance k izvajanju farmakovigilance v EU.
English: The European Commission will contact the candidates and those applicants who were late to send their applications to explain the procedure.
Slovenian: Evropska komisija bo navezala stik s kandidati in tistimi vlagatelji, ki so se prijavili prepozno, ter jim pojasnila postopek.
English: • Discharge from the European Parliament on the EMA final accounts for the financial year 2008.
Slovenian: • Razrešnica Evropskega parlamenta o končnih računovodskih izkazih agencije EMA za proračunsko leto 2008.
English: The Board discussed the possibility of publishing, in future, information on Member States' compliance with the legal timeframe of 15 days for transmission of individual case safety reports (ICSRs) to the Agency.
Slovenian: Upravni odbor je razpravljal o možnosti prihodnjega objavljanja informacij o skladnosti držav članic s pravnim časovnim okvirom za posredovanje varnostnih poročil o posameznih primerih (ICSR) agenciji, ki je 15 dni.
English: The Vice-Chair continued to chair the meeting during the election process of the Management Board Chair.
Slovenian: Podpredsednica je predsedovala seji tudi med postopkom izvolitve predsednika upravnega odbora.
English: Update on future accommodation of the Agency
Slovenian: Posodobljene informacije o prihodnjih prostorih agencije
English: In accordance with Management Board Rules of procedure there are 35 voting members in the Management Board, 28 members were present at the time of the election and 4 proxies were received: from the Czech Republic to Denmark, DG Enterprise to DG Sanco, Greece to Italy and Sweden to Slovenia.
Slovenian: V skladu s poslovnikom upravnega odbora ima glasovalno pravico 35 članov upravnega odbora, od tega jih je bilo ob izvolitvi navzočih 28, prejeta pa so bila štiri pooblastila za zastopanje, in sicer pooblastila Češke republike Danski, GD za podjetništvo in industrijo GD za zdravje in potrošnike, Grčije Italiji in Švedske Sloveniji.
English: Therefore for all the aforementioned reasons, Prof. Nisticò does not endorse the nomination of the new nominee from Poland as CHMP member".
Slovenian: Prof. Nisticò zato ne podpira imenovanja novega kandidata s Poljske za člana odbora CHMP.“
English: The report will be reviewed by the European Commission in preparation of the Commission's report to the Council on the implementation of the Fee Regulation by November 2010.
Slovenian: Evropska komisija bo do novembra 2010 proučila poročilo v okviru priprave poročila Komisije Svetu o izvajanju uredbe o pristojbinah.
English: CHMP and CVMP meetings are already broadcast internally and now the technical facilities are available to broadcast to national competent authorities.
Slovenian: Sestanki odborov CHMP in CVMP (Odbor za zdravila za uporabo v veterinarski medicini) se že predvajajo interno, zdaj pa so na voljo tudi tehnične zmogljivosti za predvajanje nacionalnim pristojnim organom.
English: Nominations to CVMP and CHMP under consultation
Slovenian: Imenovanja v odbora CHMP in CVMP, o katerih potekajo posvetovanja
English: In response to this observation, the Polish representative to the Board emphasised that: “The decision to nominate a candidate to the CHMP is a sovereign decision of a Member State and Poland based its decision on the candidate's scientific background and professional experience.”
Slovenian: Poljski predstavnik v upravnem odboru je v odgovoru na to pripombo poudaril: „Odločitev o imenovanju kandidata v odbor CHMP je suverena odločitev države članice, Poljska pa jo je sprejela na podlagi kandidatovega strokovnega znanja in delovnih izkušenj.“
English: Referrals to CVMP of veterinary medicinal products: a report from the Agency
Slovenian: Napotitve zdravil za uporabo v veterinarski medicini Odboru za zdravila za uporabo v veterinarski medicini (CVMP): poročilo agencije
English: Management Board meeting dates 2011
Slovenian: Datumi sej upravnega odbora v letu 2011
English: The Management Board noted the outcomes of the evaluation of the Agency which was conducted in 2009 at the request of the European Commission.
Slovenian: Upravni odbor se je seznanil z izidi ocene agencije, ki je bila na zahtevo Evropske komisije opravljena leta 2009.
English: Preparation for a written procedure on adoption of the Agency's final accounts for the year ending 31 December 2009
Slovenian: Priprava na pisni postopek za sprejetje končnih računovodskih izkazov agencije za leto, ki se je končalo 31. decembra 2009
English: The actions encompass EMA processes having an impact on clinical trials carried out at different stages of the lifecycle of medicinal products and the relationship with regulators in all parts of the world, with a view to achieving a robust framework for the oversight and conduct of clinical trials.
Slovenian: Ukrepi zajemajo postopke agencije EMA, ki vplivajo na klinična preskušanja, ki se izvajajo v različnih fazah življenjskega ciklusa zdravil, in odnose z regulativnimi organi v vseh delih sveta za oblikovanje trdnega okvira za nadzor in izvajanje kliničnih preskušanj.
English: 10bis Appointment of Accounting Officer ad interim
Slovenian: 10a Imenovanje začasnega računovodje
English: London, 10 June 2010
Slovenian: V Londonu, 10. junija 2010
English: Procedure for the appointment of the Executive Director
Slovenian: Postopek imenovanja izvršnega direktorja
English: The Management Board re-elected Pat O'Mahony as its Chair for a new three-year term, by unanimous vote.
Slovenian: Upravni odbor je Pata O'Mahonyja znova soglasno izvolil za predsednika za nov triletni mandat.
English: Outcome of the evaluation of the Agency
Slovenian: Izid ocene agencije
English: The Board was informed that the CVMP established a Task Force on referrals which will review strategic options for the harmonisation of products, develop a methodology for prioritisation of issues for referral and will develop proposals in relation to future legislation concerning veterinary medicinal products on issues related to referrals.
Slovenian: Upravni odbor je bil obveščen, da je odbor CVMP ustanovil projektno skupino o napotitvah, ki bo pregledala strateške možnosti za usklajevanje zdravil, razvila metodologijo za prednostno razvrščanje vprašanj za napotitev in oblikovala predloge v zvezi s prihodnjo zakonodajo o zdravilih za uporabo v veterinarski medicini v zvezi z vprašanji, ki se nanašajo na napotitve.
English: Due to the disruption of travel following the volcanic eruption in Iceland, the Agency's Committee for Medicinal Products for Human Use worked extensively using teleconferencing tools.
Slovenian: Zaradi oteženih potovanj po izbruhu vulkana na Islandiji je bilo veliko dela v Odboru za zdravila za uporabo v humani medicini (CHMP) agencije EMA opravljenega s telekonferenčnimi orodji.
English: During the discussion, the Management Board considered both nominations in their wider context of the workings of the Committees and reflected favourably on both of the nominees' background and professional experience, with the exception of the European Parliament representative, Prof. Giuseppe Nisticò, who asked that his specific remarks be included in the minutes: “The previous Polish CHMP member's curriculum, who was considered in the CHMP as the reference member for assessment of drug treatment in respiratory diseases, is much more specific and appropriate in terms of regulatory and clinical competence, as opposed to that of the newly proposed member.
Slovenian: Med razpravo je obravnaval obe imenovanji v širšem okviru delovanja odborov ter pozitivno ocenil poklicne in delovne izkušnje kandidatov, le predstavnik Evropskega parlamenta, prof. Giuseppe Nisticò, je zahteval, naj se v zapisnik vključijo njegove posebne pripombe: „Življenjepis prejšnjega poljskega člana odbora CHMP, ki je v odboru CHMP veljal za referenčnega člana za ocenjevanje zdravil za zdravljenje bolezni dihal, je precej podrobnejši in ustreznejši v smislu regulativne in klinične usposobljenosti v primerjavi z življenjepisom novega predlaganega člana.
English: During its discussion, the Board reflected on the issue that a significant amount of work done by the national competent authorities is not compensated in the current fee system.
Slovenian: Upravni odbor je med razpravo o sistemu opozoril, da v sedanjem sistemu pristojbin veliko dela, ki ga opravijo nacionalni pristojni organi, ni plačanega.
English: • Agenda point 10_Advertisement of the vacancy notice for the recruitment of the Executive Director for the EMA.
Slovenian: • Točka 10 dnevnega reda - Naznanilo obvestila o prostem delovnem mestu za zaposlitev izvršnega direktorja agencije EMA.
English: In the context of the two appeals, the European Ombudsman concluded that the Agency has to grant access to adverse drug reaction reports and clinical trial data.
Slovenian: Varuh človekovih pravic je v zvezi z dvema pritožbama ugotovil, da mora agencija dodeliti dostop do poročil o neželenih učinkih zdravil in podatkov o kliničnih preskušanjih.
English: Observers
Slovenian: Opazovalci
English: • [EMEA/221701/2010] Update report on the Agency's implementation of the EU telematics strategy.
Slovenian: • [EMEA/221701/2010] Dopolnjeno poročilo o telematski strategiji EU, ki jo izvaja agencija.
English: The members noted the update report from the European Commission on a range of topics, including the following:
Slovenian: Člani odbora so se seznanili s posodobljenim poročilom Evropske komisije v zvezi z več temami, vključno s/z:
English: The Executive Director announced the appointment of Jean-Claude Brival as head of the newly created Product Data Management Sector in Veterinary Medicines and Product Data Management Unit and Alexis Nolte as head of the Sector for Quality of Medicines.
Slovenian: Izvršni direktor je napovedal imenovanje Jeana-Clauda Brivala za vodjo novega oddelka za upravljanje podatkov o proizvodih v enoti za zdravila za uporabo v veterinarski medicini in upravljanje podatkov o proizvodih, ter Alexisa Nolteja za vodjo oddelka za kakovost zdravil.
English: The Board thanked the topic coordinators - Jytte Lyngvig, Pat O'Mahony and Kristin Raudsepp - for preparing a comprehensive draft analysis and assessment of the report.
Slovenian: Upravni odbor se je tematskim koordinatorjem - Jytte Lyngvig, Patu O'Mahonyju in Kristin Raudseppzahvalil za pripravo celovitega osnutka analize in ocene poročila.
English: HMA supported the constitution of a permanent group of medical devices competent authorities.
Slovenian: Vodje agencij za zdravila so podprli oblikovanje stalne skupine pristojnih organov za medicinske pripomočke.
English: Legislation on access to documents requires making documents held by the Agency public, while the requirements to safeguard commercially confidential information and personal data restrict access.
Slovenian: Čeprav zakonodaja o dostopu do dokumentov določa, da so dokumenti, ki jih hrani agencija, javni, pa dostop omejujejo zahteve za varstvo komercialno zaupnih informacij in osebnih podatkov.
English: The Board stressed that it is of utmost importance to guarantee the involvement of best scientific expertise to ensure assessments of the highest quality.
Slovenian: Poudaril je, da je za zagotavljanje visokokakovostnih ocen bistveno zagotoviti vključenost najboljših znanstvenih strokovnjakov.
English: While the number of referrals for arbitrations arising from consideration of applications by CMDv eased, the referrals taking up increasingly resources of the Committee and the Agency secretariat relate particularly to harmonisation and ‘Community interest' referrals which set precedents and practice that will be followed in subsequent, similar cases.
Slovenian: Medtem ko se je število napotitev za arbitražo, ki izhajajo iz obravnave vlog, ki jo izvaja Koordinacijska skupina za postopek medsebojnega priznavanja in decentralizirani postopek (veterina) (CMDv), nekoliko zmanjšalo, pa zahtevajo čedalje več virov Odbora in sekretariata agencije napotitve, ki se nanašajo zlasti na usklajevalne napotitve in napotitve v zvezi z „interesom Skupnosti“, ki določajo precedense in prakso, ki se bodo upoštevali v poznejših podobnih primerih.
English: The Board made a general scrutiny reservation about the report.
Slovenian: Upravni odbor je v zvezi s poročilom podal splošni proučitveni pridržek.
English: Memorandum of understanding between the EMA and the NCAs on the monitoring of the scientific level and independence of evaluations
Slovenian: Memorandum o soglasju, sklenjen med agencijo EMA in nacionalnimi pristojnimi organi o spremljanju znanstvene ravni in neodvisnosti vrednotenja
English: The Board thanked the topic coordinators -Jean Marimbert and Lisette Tiddens - for their contribution to this work.
Slovenian: Upravni odbor se je zahvalil tematskima koordinatorjema Jeanu Marimbertu in Lisette Tiddens za njun prispevek k temu delu.
English: A further update will be provided in October.
Slovenian: Nove posodobljene informacije bodo predložene oktobra.
English: Chairs of management boards of EU agencies
Slovenian: Predsedniki upravnih odborov agencij EU
English: Fourteen agencies participated and elected Pat O'Mahony as the chair of the group.
Slovenian: Udeležili so se ga predstavniki 14 agencij, ki so Pata O'Mahonyja izvolili za predsednika skupine.
English: Following the discussion at the March 2010 meeting about the allocation of responsibility within the EU on a vigilance system for substances of human origin, the Executive Director wrote a letter to the European Commission that was followed by a discussion between DG Sanco and EMA staff.
Slovenian: Izvršni direktor je po razpravi o podelitvi pristojnosti za sistem stalnega nadzora za snovi človeškega izvora v EU, ki je potekala na seji marca 2010, Evropski komisiji poslal dopis, temu pa je sledila razprava med GD za zdravje in potrošnike ter osebjem agencije EMA.
English: The report will now be presented to the HMA in July and published on the Agency's website.
Slovenian: Poročilo bo julija predstavljeno vodjem agencij za zdravila (HMA) in objavljeno na spletni strani agencije.
English: The updated document will be presented at the HMA meeting in July and submitted to the Management Board for adoption by written procedure.
Slovenian: Posodobljeni dokument bo predstavljen na julijskem sestanku vodij agencij za zdravila (HMA) in predložen upravnemu odboru v sprejetje s pisnim postopkom.
English: • Improving linkage between HMA and medical devices competent authorities.
Slovenian: • izboljšanjem povezav med vodjami agencij za zdravila in pristojnimi organi za medicinske pripomočke.
English: Einar Magnússon (Iceland) Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Slovenian: Einar Magnússon (Islandija) Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška)
English: A detailed report on lessons learned will be provided for the October meeting.
Slovenian: Podrobno poročilo o spoznanjih bo predloženo na oktobrski seji.
English: [EMA/MB/210895/2010] The agenda was adopted with amendments to agenda item 14.
Slovenian: [EMA/MB/210895/2010] Dnevni red je bil sprejet s spremembami točke 14. 2.
English: The Board stressed that it is essential for the national competent authorities to recover the costs fully.
Slovenian: Poudaril je, da je za te bistveno, da v celoti izterjajo stroške.
English: Members suggested that a questionnaire be prepared to gather and share information on what practices are put in place in NCAs with regards to the handing of conflicts of interest.
Slovenian: Člani so predlagali oblikovanje vprašalnika za zbiranje in izmenjavo informacij o praksah nacionalnih pristojnih organov za obravnavo primerov navzkrižja interesov.
English: The group met with a Commission representative to discuss the findings of the evaluation of the EU agencies carried out by the European Commission in
Slovenian: Skupina se je sestala s predstavnikom Komisije in z njim razpravljala o ugotovitvah ocenjevanja agencij EU, ki ga je Evropska komisija izvedla leta 2009.
English: In the meantime, the Agency will present its proposals for the policy on access to documents, which will also address the release of clinical trials data following completion of procedures, at the July meeting of the Heads of Medicines Agencies.
Slovenian: Agencija bo medtem na julijskem sestanku vodij agencij za zdravila predstavila predloge za politiko o dostopu do dokumentov, v kateri bo obravnavano tudi objavljanje podatkov iz kliničnih preskušanj po dokončanju postopkov.
English: [EMA/MB/289198/2010] Pending the receipt of the opinion of the Court of Auditors on provisional accounts, a written procedure will be launched shortly to adopt the Management Board opinion on the Agency's annual accounts for the year ended 31 December 2009.
Slovenian: [EMA/MB/289198/2010] V pričakovanju mnenja Računskega sodišča o začasnih računovodskih izkazih se bo kmalu začel pisni postopek za sprejetje mnenja upravnega odbora o končnih računovodskih izkazih agencije za leto, ki se je končalo 31. decembra 2009.
English: A high-level update on the outcomes of the workshop will be provided to the Management Board in October.
Slovenian: Upravnemu odboru bodo oktobra predložene posodobljene informacije na visoki ravni o izidih delavnice.
English: Report from the European Commission
Slovenian: Poročilo Evropske komisije
English: Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA
Slovenian: Osnutek študije o etičnem vidiku in vidiku dobre klinične prakse glede kliničnih preskušanj zdravil za uporabo v humani medicini, ki se izvajajo v tretjih državah in so agenciji EMA predložena kot del vloge za pridobitev dovoljenja za promet
English: • [EMEA/MB/298753/2010] Summary of transfers of appropriations in the budget 2010.
Slovenian: • [EMEA/MB/298753/2010] Povzetek prerazporeditve sredstev v proračunu za leto 2010.
English: The HMA aims to complete the paper by the end of this year.
Slovenian: Vodje agencij za zdravila ga nameravajo dokončati do konca tega leta;
English: • [EMA/MB/281850/2010] Outcome of written procedures during the period from 26 February 2010 to 2 June 2010.
Slovenian: • [EMA/MB/281850/2010] Rezultat pisnih postopkov v obdobju od 26. februarja 2010 do