natgillin/translations-raw huggingface dataset:
Common systems need to be developed for proactive release of information.
Oblikovati je treba skupne sisteme za proaktivno objavo informacij.
Ombudsman and access to EMA documents
Varuh človekovih pravic in dostop do dokumentov agencije EMA
Alternates and other participants
Nadomestni člani in drugi udeleženci
The dates for 2011 are as follows: 16-17 March, 9 June, 6 October and 15 December.
Datumi za leto 2011 so: 16. in 17. marec, 9. junij, 6. oktober in 15. december.
The whole report can be found on the website of the Commission: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf
Celotno poročilo je na voljo na spletni strani Komisije na naslovu: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf.
The lease of the Agency's premises expiries in 2014.
Najem prostorov agencije se bo iztekel leta 2014.
Contractual arrangements: monitoring of key performance indicators
Pogodbene ureditve: spremljanje ključnih kazalnikov uspešnosti
Currently, the Agency uses teleconferencing for meetings involving small numbers of participants.
Agencija zdaj uporablja telekonference za sestanke z manjšim številom udeležencev.
European Commission initiative on vigilance system for substances of human origin: cells, tissues, blood
Pobuda Evropske komisije o sistemu stalnega nadzora za snovi človeškega izvora: celice, tkiva in kri
In total there were 32 votes cast.
Oddanih je bilo skupaj 32 glasov.
The experience was largely welcomed by the committee Chair and members.
Predsednik in člani odbora so to izkušnjo večinoma pozdravili.
The proposals coming from the discussions will be classified into those requiring legislative changes and those that can be implemented without changing the legislation.
Predlogi iz razprav bodo razvrščeni med predloge, ki zahtevajo zakonodajne spremembe, in predloge, ki jih je mogoče izvajati brez spremembe zakonodaje.
Activities related to referrals increased since the 2004 review of legislation.
Količina dejavnosti v zvezi z napotitvami se je od pregleda zakonodaje iz leta 2004 povečala.
4 August 2010 EMA/MB/404038/2010
4. avgust 2010 EMA/MB/404038/2010
• The political agreement on cross-border healthcare directive.
• političnim sporazumom o direktivi o čezmejnem zdravstvenem varstvu;
New appointments
Nova imenovanja
Amongst other measures to increase transparency, all declarations of interests submitted by the experts will be systematically published on the website.
V okviru drugih ukrepov za izboljšanje preglednosti bodo na spletni strani sistematično objavljene vse izjave o interesih, ki jih predložijo strokovnjaki.
The system is complex and therefore requires simplification, while assuring sustainability and providing needed flexibility.
Ker je zapleten, ga je treba poenostaviti, obenem pa zagotoviti trajnost in potrebno prožnost.
This item was considered at the beginning of the meeting by the Vice-Chair.
Podpredsednica je to točko obravnavala na začetku seje.
The procedure for the appointment of the Executive Director will be discussed in October.
O postopku imenovanja izvršnega direktorja se bo razpravljalo oktobra.
Declaration of conflict of interests
Izjava o navzkrižju interesov
No conflicts of interests were declared.
Nihče ni izrazil navzkrižja interesov.
Observers from Liechtenstein and Norway were appointed as tellers.
Opazovalca iz Lihtenštajna in Norveške sta bila imenovana za preštevalca glasov.
The decision on the option may need to be taken this year to allow adequate time to involve relevant EU institutions and to prepare the Agency for changes, if necessary.
Odločitev o najprimernejši možnosti bo morda treba sprejeti še letos, da bo na voljo dovolj časa za vključitev ustreznih institucij EU in da se bo po potrebi agencija pripravila na spremembe.
• Progress on legislative proposals on pharmacovigilance, falsified medicines and information to patients.
• napredkom pri zakonodajnih predlogih o farmakovigilanci, ponarejenih zdravilih in informacijah za bolnike;
A new legislative proposal may be adopted by Autumn 2011.
Nov zakonodajni predlog bo morda sprejet do jeseni 2011.
Key principles of a revised policy and procedure for the handling of conflicts of interest
Ključna načela revidirane politike in postopek za obravnavo navzkrižja interesov
The Board recognised that the arrangements on handing of conflicts of interest differ in different Member States and this needs to be reflected in the memorandum.
Priznal je, da se ureditve za obravnavo navzkrižij interesov po državah članicah razlikujejo in da je na to treba opozoriti v memorandumu.
The Management Board telematics committee will prepare an overview of available options.
Odbor upravnega odbora za telematiko bo pripravil pregled razpoložljivih možnosti.
In case an Executive Director cannot be appointed by the end of 2010 or is unable to start office from 1 January 2011, the Board asked the Executive Director to inform the Board about the arrangements to appoint an interim director for discussion at the October meeting.
Če izvršnega direktorja ne bo mogoče imenovati do konca leta 2010 ali če ta ne bo mogel nastopiti mandata 1. januarja 2011, je upravni odbor pozval izvršnega direktorja, naj ga obvesti o ureditvi za imenovanje začasnega direktorja, o kateri se bo razpravljalo na oktobrski seji.
The Board was advised of the list of scientific, international and national publications in which the announcement is to be placed.
Upravni odbor je prejel nasvete o seznamu znanstvenih, mednarodnih in nacionalnih publikacij, v katerih je treba objaviti obvestilo.
Following this, the Council will give its advice on whether the Fee Regulation needs to be reviewed.
Svet bo zatem svetoval, ali je treba uredbo pregledati.
Providing such access demands significant resources for the Agency.
Agencija za zagotavljanje takega dostopa potrebuje precejšnje vire.
The number of indictors will be expanded in future, once experience with the agreed indicators is gained and systems for reporting on other indicators are established.
Število kazalnikov se bo v prihodnosti povečalo po prvih izkušnjah z dogovorjenimi kazalniki in vzpostavitvi sistemov poročanja o drugih kazalnikih.
Draft agenda for 10 June 2010 meeting
Osnutek dnevnega reda za sejo dne 10. junija 2010
Following the adoption, the Board's opinion and the final accounts will be sent to the relevant EU institutions.
Ko bodo mnenje upravnega odbora in končni računovodski izkazi sprejeti, bodo poslani ustreznim institucijam EU.
However, an agreement on what information should be considered confidential is pending.
Vendar še vedno ni bil dosežen sporazum, katere informacije je treba šteti za zaupne.
A workshop will be organised on 6-7 September 2010 as part of the consultation process, to which a wide range of EU and third-country regulators and stakeholders will be invited.
V okviru posvetovanja bo 6. in 7. septembra 2010 organizirana delavnica, na katero bodo povabljeni številni regulativni organi in zainteresirane strani iz EU in tretjih držav.
However, the European Commission representative stated that the Commission will be unable to allocate additional resources and the tasks will have to be accommodated within the existing human and financial resources at either Agency.
Vendar je predstavnik Evropske komisije povedal, da Komisija ne more dodeliti dodatnih virov in da bo treba naloge opraviti z obstoječimi človeškimi in finančnimi viri teh dveh agencij.
The Board also asked the European Commission to assure timely communication with the Board at the highest level.
Upravni odbor je poleg tega Evropsko komisijo pozval, naj poskrbi za pravočasno komuniciranje z upravnim odborom na najvišji ravni.
7. Review of fees payable to the EMA (Fee Regulation)
Pregled pristojbin, ki se plačujejo agenciji EMA (uredba o pristojbinah)
The number of data fields to be removed varies in different cases.
Število podatkovnih polj, ki jih je treba odstraniti, se po posameznih primerih razlikuje.
Apologies
Opravičilo
The Board also considered the analysis of the impact of proposed changes on the current membership of the committees and scientific advisory groups.
Poleg tega je obravnaval analizo učinka predlaganih sprememb na sedanje članstvo v odborih in znanstvenih svetovalnih skupinah.
The conclusions of the evaluation are positive and highlight the effectiveness and the efficiency of the Agency, as part of the network, as well as recognising its contribution to EU policies.
Sklepne ugotovitve ocene so pozitivne ter poudarjajo učinkovitost in uspešnost agencije kot dela mreže, poleg tega pa je v njih priznan tudi njen prispevek k politikam EU.
• A strategic discussion on the benefits of e-readiness and the different systems being used by medicines agencies to work in an electronic-only environment.
• strateško razpravo o koristih e-pripravljenosti in različnih sistemih, ki jih agencije za zdravila uporabljajo pri delu v izključno elektronskem okolju;
The report contains information for 2009 on what action has been taken by the rapporteur and the regulatory outcome, where relevant.
Poročilo vsebuje informacije za leto 2009 o ukrepih, ki jih je sprejel poročevalec, in njihovem zakonodajnem učinku, če je to primerno.
• Overview of the allowable conflicts of interests for the various EMA activities.
• Pregled dovoljenih navzkrižij interesov za različne dejavnosti agencije EMA.
When deciding where to allocate the responsibilities for the new task, the European Commission may consider whether to combine the capacities and experience of collaboration of the two agencies (EMA and ECDC).
Evropska komisija lahko med odločanjem, komu naj podeli pristojnosti za to novo nalogo, prouči, ali naj združi zmogljivosti in izkušnje s sodelovanjem dveh agencij (EMA in ECDC).
32 votes cast
32 oddanih glasov
The Agency works to address the issues and will adopt the same approach to data released reactively and proactively.
Agencija si prizadeva obravnavati ta vprašanja in bo sprejela en sam pristop za podatke, ki so objavljeni reaktivno in proaktivno.
The Executive Director's report covers the achievements in key policy areas as well as describes the management system to provide reasonable assurance on the effective and efficient use of resources to achieve the policy objectives.
Poročilo izvršnega direktorja zajema dosežke na ključnih področjih politike in opis sistema upravljanja za predložitev razumnega zagotovila o učinkoviti in smotrni uporabi virov za doseganje ciljev politike.
• Presentation on key principles of a revised policy and procedures on the handling of conflicts of interests of scientific committees' members and experts: Impact analysis and proposed way forward.
• Predstavitev ključnih načel revidirane politike in postopkov za obravnavo navzkrižij interesov članov in strokovnjakov znanstvenih odborov: analiza učinka in predlagani prihodnji ukrepi.
The final adoption of an updated policy is expected in October 2010.
Končno sprejetje posodobljene politike je načrtovano za oktober 2010.
The proposals will be implemented in a stepwise approach.
Predlogi se bodo izvajali postopoma.
The Agency started work to identify and review options for future accommodation taking into account financial and functional requirements, including accessibility of the Agency by experts.
Agencija je začela izvajati dejavnosti za opredelitev in proučitev možnosti za prihodnje prostore ob upoštevanju finančnih in funkcionalnih zahtev, vključno z dostopnostjo agencije za strokovnjake.
Tabled documents
Predloženi dokumenti
The activity of the newly proposed member in his capacity of a surgeon is only very marginally linked with the objectives of the CHMP.
Dejavnost novega predlaganega člana v funkciji kirurga je le zelo bežno povezana s cilji odbora CHMP.
The newly proposed member never worked as a member of the CHMP and has no specific experience as an employee at the National Medicines Agency.
Predlagani član ni bil nikoli član odbora CHMP in nima izkušenj z delom v nacionalni agenciji za zdravila.
The reflection paper has been released for public consultation until 30 September 2010.
Študija je bila objavljena za javno posvetovanje, ki bo potekalo do 30. septembra 2010.
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.
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.
The European Commission and the Agency will organise a conference on 30 June 2010 to discuss the outcomes of the evaluation with stakeholders.
Evropska komisija in agencija bosta 30. junija 2010 organizirali konferenco, na kateri bosta z zainteresiranimi stranmi razpravljali o izidih ocene.
EudraVigilance status report 2009
Poročilo o stanju sistema EudraVigilance za leto 2009
Written comments were invited within 2 weeks after the meeting.
Člani so bili pozvani, naj pisne pripombe predložijo najpozneje dva tedna po seji.
The topic will also be addressed in the EC/EMA conference on the outcomes of the evaluation of the Agency.
Ta tema bo obravnavana tudi na konferenci Evropske komisije in agencije EMA o izidih ocene agencije.
• The ongoing work with a view to reviewing the Clinical Trials Directive.
• sedanjim delom za pregled direktive o kliničnih preskušanjih.
The Board noted the proposed agenda of the workshop.
Upravni odbor se je seznanil s predlaganim dnevnim redom delavnice.
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.
Skupina tematskih koordinatorjev upravnega odbora (Avstrija, Francija, Danska in predsednik) bo v sodelovanju z osebjem agencije preučila predlog.
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.
Vendar bi uporaba drugih tehnologij za sestanke v kombinaciji s sestanki znanstvenih odborov v živo povečala učinkovitost uporabe znanstvenih virov.
The report contains the Executive Director's declaration of assurance.
Poročilo vključuje tudi izjavo izvršnega direktorja o zanesljivosti.
The Board recognised that practices adopted at the EMA will impact on the arrangements put in place at the national level.
Upravni odbor je priznal, da bodo prakse, ki jih sprejme agencija EMA, vplivale na ureditve na nacionalni ravni.
The re-opening of the vacancy will be announced by 26 June with a four-week deadline for applications.
Vnovična objava prostega delovnega mesta bo napovedana do 26. junija s štiritedenskim rokom za oddajo prijav.
Lessons learned during the volcanic eruption
Poudarki Spoznanja, pridobljena med izbruhom vulkana
The Board gave a positive assessment of the Agency's performance on a broad range of issues in 2009.
Uspešnost agencije je pozitivno ocenil pri zelo različnih številnih vprašanjih v letu 2009.
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.
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.
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.
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.
The Management Board endorsed the subset of key performance indicators which will be monitored and reported upon.
Potrdil je podskupino ključnih kazalnikov uspešnosti, ki se bodo spremljali in o katerih se bo poročalo.
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.
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.
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.
Poročila o neželenih učinkih zdravil vključujejo številna podatkovna polja, ki jih je treba pregledati za varstvo identitete osebe pri dodelitvi dostopa do poročila.
Analysis and assessment of the Executive Director's annual activity report 2009
Analiza in ocena letnega poročila o dejavnostih izvršnega direktorja za leto 2009
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.
V poročilu, ki vključuje informacije, ki so se zagotavljale že prej, se zdaj proučuje prispevek sistema EudraVigilance k izvajanju farmakovigilance v EU.
The European Commission will contact the candidates and those applicants who were late to send their applications to explain the procedure.
Evropska komisija bo navezala stik s kandidati in tistimi vlagatelji, ki so se prijavili prepozno, ter jim pojasnila postopek.
• Discharge from the European Parliament on the EMA final accounts for the financial year 2008.
• Razrešnica Evropskega parlamenta o končnih računovodskih izkazih agencije EMA za proračunsko leto 2008.
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.
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.
The Vice-Chair continued to chair the meeting during the election process of the Management Board Chair.
Podpredsednica je predsedovala seji tudi med postopkom izvolitve predsednika upravnega odbora.
Update on future accommodation of the Agency
Posodobljene informacije o prihodnjih prostorih agencije
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.
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.
Therefore for all the aforementioned reasons, Prof. Nisticò does not endorse the nomination of the new nominee from Poland as CHMP member".
Prof. Nisticò zato ne podpira imenovanja novega kandidata s Poljske za člana odbora CHMP.“
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.
Evropska komisija bo do novembra 2010 proučila poročilo v okviru priprave poročila Komisije Svetu o izvajanju uredbe o pristojbinah.
CHMP and CVMP meetings are already broadcast internally and now the technical facilities are available to broadcast to national competent authorities.
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.
Nominations to CVMP and CHMP under consultation
Imenovanja v odbora CHMP in CVMP, o katerih potekajo posvetovanja
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.”
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.“
Referrals to CVMP of veterinary medicinal products: a report from the Agency
Napotitve zdravil za uporabo v veterinarski medicini Odboru za zdravila za uporabo v veterinarski medicini (CVMP): poročilo agencije
Management Board meeting dates 2011
Datumi sej upravnega odbora v letu 2011
The Management Board noted the outcomes of the evaluation of the Agency which was conducted in 2009 at the request of the European Commission.
Upravni odbor se je seznanil z izidi ocene agencije, ki je bila na zahtevo Evropske komisije opravljena leta 2009.
Preparation for a written procedure on adoption of the Agency's final accounts for the year ending 31 December 2009
Priprava na pisni postopek za sprejetje končnih računovodskih izkazov agencije za leto, ki se je končalo 31. decembra 2009
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.
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.
10bis Appointment of Accounting Officer ad interim
10a Imenovanje začasnega računovodje
London, 10 June 2010
V Londonu, 10. junija 2010
Procedure for the appointment of the Executive Director
Postopek imenovanja izvršnega direktorja
The Management Board re-elected Pat O'Mahony as its Chair for a new three-year term, by unanimous vote.
Upravni odbor je Pata O'Mahonyja znova soglasno izvolil za predsednika za nov triletni mandat.
Outcome of the evaluation of the Agency
Izid ocene agencije
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.
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.
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.
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.