natgillin/translations-raw huggingface dataset:
Overall, the new system has streamlined activities and improved resource use in the concerned areas.
Novi sistem je na splošno racionaliziral dejavnosti in izboljšal uporabo virov na zadevnih področjih.
Fourth report on progress of the interaction with patients
Četrto poročilo o napredku pri sodelovanju z bolniki
The first meeting is scheduled for 27 October 2011.
Prva seja je predvidena 27. oktobra 2011.
The Mediator case also contributed to a larger number of referrals, since the environment has become more risk averse.
Primer Mediator je prispeval tudi k velikemu številu napotitev, saj se je okolje bolj skušalo izogibati tveganjem.
• The next stage of the Benchmarking of European Medicines Agencies initiative.
• naslednjo fazo primerjalne analize pobude Evropske agencije za zdravila.
These savings are needed for the implementation of pharmacovigilance legislation and to finance the move to the new premises.
Ti prihranki so potrebni za izvajanje zakonodaje o farmakovigilanci in financiranje selitve v nove prostore.
The future revised framework will focus on the role of patients in the scientific committees, the involvement of patients in benefit/risk evaluation and the implementation of a strategy for training and support.
Prihodnji spremenjeni okvir se bo osredotočal na vlogo bolnikov v znanstvenih odborih, vključevanje bolnikov v ocenjevanje razmerja med koristmi in tveganji ter izvajanje strategije za usposabljanje in podporo.
• leave;
• dopust;
Such a vote will be open and meeting minutes will indicate members who voted in favour, against or abstained.
Takšno glasovanje bo odprto glasovanje, v zapisniku seje pa bodo navedeni člani, ki so glasovali za, tisti, ki so glasovali proti, oziroma tisti, ki so se vzdržali glasovanja.
The implementation progresses according to plan.
Izvajanje poteka v skladu z načrti.
The meetings which cannot be cancelled or postponed during the peak Olympic period in the months of July and August 2012 will be hosted at other locations.
Seje, predvidene med glavnim dogajanjem na olimpijskih igrah v mesecih juliju in avgustu 2012, ki jih ni mogoče preklicati ali preložiti, bodo potekale na drugih lokacijah.
Such members, however, will have to make a considered choice in light of the current policy.
Takšni strokovnjaki bodo morali ob upoštevanju sedanje politike sprejeti premišljeno odločitev.
Revised criteria to be fulfilled by patients' and consumers' organisations involved in EMA activities
Spremenjena merila, ki jih morajo izpolnjevati organizacije bolnikov in potrošnikov, vključene v dejavnosti agencije EMA
• European networks of reference for rare diseases (setting the criteria to identify networks, their financing, functioning).
• evropske referenčne mreže za redke bolezni (določanje meril za opredelitev mrež, njihovega financiranja, delovanja).
The Committee on Budgetary Control of the European Parliament has made a proposal to grant the discharge to the Executive Director of the Agency for the budget year 2009.
Odbor za proračunski nadzor Evropskega parlamenta je predložil predlog za podelitev razrešnice izvršnemu direktorju agencije za proračunsko leto 2009.
The updated document will be published on the website following the meeting.
Posodobljeni dokument bo po sej objavljen na spletni strani.
The format of the report has been changed at the request of the Management Board Telematics Committee.
Oblika poročila je bila na zahtevo Odbora upravnega odbora za telematiko spremenjena.
Now a new human resource module of the system has been launched, which replaced a further three databases.
Nedavno se je začel uporabljati nov modul sistema za človeške vire, ki je nadomestil dodatne tri podatkovne zbirke.
• Written procedure for adoption of the Agency's Final Accounts for the financial year 2010, adopted on 28 June 2011.
• Pisni postopek za sprejetje zaključnih računov agencije za proračunsko leto 2010, ki je bil sprejet 28. junija 2011.
As a consequence, the implementation has been reprioritised in the following way: activities contributing to public health were given the highest priority, followed by activities increasing transparency and improving communication, followed by simplification measures.
Posledično se je prednostni seznam izvajanja spremenil na naslednji način: dejavnosti, ki prispevajo k javnemu zdravju, imajo največjo prednost, sledijo jim dejavnosti, ki povečujejo preglednost in izboljšujejo komunikacijo, za njimi pa so ukrepi za poenostavitev.
This required reviewing options for the implementation of the legislation.
Zato je bilo treba proučiti možnosti za izvajanje zakonodaje.
Draft agenda for 6 October 2011 meeting
Osnutek dnevnega reda za sejo dne 6. oktobra 2011
The Management Board will review in greater detail ongoing activities in the area of transparency at the next meeting.
Upravni odbor bo na naslednji seji podrobneje pregledal sedanje dejavnosti na področju preglednosti.
The Agency will draw on this multiannual implementation plan to prepare its annual work programmes, at which point final decisions will be taken as to which activities will be taken forward in line with resources available.
Agencija se bo na večletni izvedbeni načrt opirala pri pripravi letnih delovnih načrtov, kjer bodo sprejete končne odločitve glede tega, katere dejavnosti se bodo nadaljevale v skladu z razpoložljivimi viri.
• The implementation of the cross-border health care directive (implementation by October 2013, a number of implementing measures will need to be adopted).
• izvajanje direktive o čezmejnem zdravstvenem varstvu (izvajanje do oktobra 2013, sprejeti bo treba več izvedbenih ukrepov);
The Agency is reviewing working parties in order to further streamline their activities and participation.
Agencija opravlja pregled delovnih skupin, da bi še bolj racionalizirala njihove dejavnosti in sodelovanje.
The Board therefore has adopted the decision to delegate to the Chair the power to sign such implementing rules on behalf of the Board without presenting them at the plenary meetings.
Odbor je zato sprejel odločitev, da predsednika pooblasti za podpisovanje takšnih izvedbenih pravil v imenu odbora, ne da bi jih moral predstaviti na plenarnih sejah.
Those experts who work with the EMA but have not yet updated their declaration of interests in line with the new policy were reminded that they will not receive documents and/or invitations to the October meetings of scientific committees unless a signed declaration of interests is received.
Strokovnjaki, ki sodelujejo z agencijo EMA, vendar še niso posodobili svojih izjav o interesih v skladu z novo politiko, so bili opozorjeni, da ne bodo prejemali dokumentov in/ali vabil na oktobrske seje znanstvenih odborov, dokler ne bodo predložili podpisanih izjav o interesih.
The Committee on Environment, Public Health and Food Safety gave a positive opinion after the hearing of Mr Rasi on 13 July 2011, following which the Conference of Presidents of the European Parliament took the decision on 7 September 2011 to endorse the nomination of Mr Rasi for the position of Executive Director of the Agency.
Odbor za okolje, javno zdravje in varnost hrane je po zaslišanju Guida Rasija 13. julija 2011 podal pozitivno mnenje, nato pa je konferenca predsednikov Evropskega parlamenta 7. septembra 2011 sprejela sklep v podporo imenovanju g. Rasija za izvršnega direktorja agencije.
The Board was informed that the Agency has signed a contract for lease of a new building.
Odbor je bil obveščen, da je agencija podpisala pogodbo za najem nove stavbe.
• A call for expressions of interest for membership of some EMA committees and of its Management Board (published on 30 September 2011; the call is open till the beginning of December 2011).
• razpis za prijavo interesa za članstvo v nekaterih odborih agencije EMA in v njenem upravnem odboru (objavljen 30. septembra 2011; razpis je odprt do začetka decembra 2011);
The Management Board noted the oral report by the Chair on the progress made following the last meeting.
Upravni odbor se je seznanil z ustnim poročilom predsednika o doseženem napredku po zadnji seji.
The rules were sent to the European Commission for approval and the dialogue is ongoing.
Pravilnik je bil predložen Evropski komisiji v potrditev, pogovori pa se nadaljujejo.
Experts who need to contribute only during a part of a meeting should be given the possibility to participate through audio-visual means.
Strokovnjakom, ki morajo sodelovati samo del seje, bi bilo treba dati možnost za sodelovanje z avdiovizualnimi sredstvi.
At the time of the report, 2,600 of 5,000 experts who are included in the database had signed their declarations of interest.
V času izdaje poročila je izjave o interesih podpisalo 2 600 od 5 000 strokovnjakov, ki so vključeni v podatkovno zbirko.
The delegation visited the Agency in June 2011 to discuss the operations of the Agency and the environment impacting on the work of the Agency.
Delegacija je agencijo obiskala junija 2011, da bi razpravljali o delovanju agencije in okoljskih vprašanjih, ki vplivajo na njeno delo.
The group will aim to clarify any concerns raised by the management boards of the two bodies and the needs and expectations of national competent authorities.
Skupina bo skušala razjasniti morebitne pomisleke, ki jih bosta izpostavila upravna odbora obeh organov, ter potrebe in pričakovanja nacionalnih pristojnih organov.
The policy was seen as another good example of how joint activities between the national agencies and the EMA contribute to bringing to the market products whose development could otherwise be discontinued.
Politika se je štela za še en dober primer tega, kako skupne dejavnosti med nacionalnimi agencijami in agencijo EMA prispevajo k dajanju zdravil, katerih razvoj bi se drugače opustil, na trg.
The Board provided final comments about the Agency's role in the area of clinical trials and in responding to European health threats.
Odbor je predložil končne pripombe o vlogi agencije na področju kliničnih preskušanj in pri odzivanju na nevarnosti za zdravje v Evropi.
Best practices among the audited agencies will be identified.
Pri tem bodo izbrane najboljše prakse med agencijami, v katerih potekajo revizije.
The aim of the policy is to increase availability of veterinary medicines by stimulating applications for minor uses and minor species.
Cilj politike je povečati dostopnost zdravil za uporabo v veterinarski medicini s spodbujanjem vlog za manjšo uporabo in manj pomembne vrste.
The Board thanked him for the excellent results achieved during his time in this role, and fruitful cooperation with the Board, national competent authorities and the European Commission, and wished him well in continuing in his position as Head of the Administration Unit.
Odbor se mu je zahvalil za odlične rezultate, ki jih je dosegel med opravljanjem te funkcije, in plodno sodelovanje z odborom, nacionalnimi pristojnimi organi in Evropsko komisijo ter mu zaželel vse najboljše pri nadaljnjem delu, to je opravljanju funkcije vodje administracije.
• eHealth (legal basis to establish a voluntary network of Member States which can adopt guidelines; work is taking place in areas of patient registries, interoperability of national systems).
• e-zdravje (pravna podlaga za ustanovitev prostovoljne mreže držav članic, ki lahko sprejema smernice; delo poteka na področjih registrov bolnikov, interoperabilnosti nacionalnih sistemov);
Regarding the frequency of preparation of these reports, the Board considered that the reports should remain annual; however, members would be content to receive a lighter version of such reports.
V zvezi s pogostostjo priprave teh poročil je odbor menil, da bi se poročila morala še naprej izdajati enkrat letno, vendar bi si člani želeli dobiti skrajšano različico takšnih poročil.
The Board also noted the proposed meeting dates in 2013.
Odbor se je seznanil tudi s predlaganimi datumi sej v letu 2013.
The revised criteria, among other changes, broaden the involvement of the organisations and revise the transparency criterion regarding the provision of information about funding sources.
Spremenjena merila so poleg drugih sprememb razširila vključevanje organizacij in spremenila merilo za preglednost v zvezi z zagotavljanjem informacij o virih financiranja.
The report concludes that there was a significant increase in the interactions between the Agency and patients' and consumers' organisations.
Poročilo ugotavlja, da se je sodelovanje med agencijo ter organizacijami bolnikov in potrošnikov znatno povečalo.
However, members recognised that it may be disadvantageous for experts specialising in a narrow scientific area to discontinue their involvement, since stepping down from some of their activities may affect their level of expertise long term.
Vendar so člani priznali, da bi lahko bila odločitev strokovnjakov, ki so se specializirali za ozko znanstveno področje, o prenehanju sodelovanja neugodna, ker bi lahko nenavzočnost pri nekaterih dejavnostih dolgoročno vplivala na njihovo strokovno znanje.
The revised rules of procedure will be submitted for adoption at the December meeting.
Spremenjen poslovnik bo predložen v sprejetje na decembrski seji.
It must be noted that the majority of experts who have not submitted their declaration of interests are not involved in EMA activities.
Opozoriti je treba, da večina strokovnjakov, ki niso predložili izjav o interesih, ni vključena v dejavnosti agencije EMA.
More specifically, in five Member States responsibility for SoHO is given to NCAs responsible for medicinal products, in a further ten some of the responsibility in the field is given to NCAs responsible for medicinal products, while in twelve Member States responsibility for SoHO is given to NCAs that are not responsible for medicinal products.
Natančneje, v petih državah članicah je odgovornost za snovi človeškega izvora dodeljena nacionalnim pristojnim organom, ki so odgovorni za zdravila, v desetih državah se nacionalnim pristojnim organom, odgovornim za zdravila, dodeli samo nekaj odgovornosti na tem področju, v dvanajsti državah članicah pa se odgovornost za snovi človeškega izvora dodeli nacionalnim pristojnim organom, ki niso odgovorni za zdravila.
The Agency is implementing the so-called OpEx programme that aims, amongt other objectives, to further increase efficiency of processes through their redesign.
Agencija uvaja tako imenovani program OpEx, katerega cilj je med drugim nadalje izboljšati učinkovitost postopkov z njihovim preoblikovanjem.
The parties involved recognise that the area of conflicts of interests is complex, and requires managing a variety of scenarios as well as public perception of ‘factual' and ‘perceived' conflicts of interests.
Vključene stranke priznavajo, da je področje navzkrižij interesov zapleteno ter zahteva upravljanje najrazličnejših scenarijev in javnega mnenja o „dejanskih“ in „zaznanih“ navzkrižjih interesov.
The meeting noted that the budgetary situation has evolved since the March 2011 Management Board meeting when the preliminary draft budget 2012 was adopted.
Na seji je bilo ugotovljeno, da so se od seje upravnega odbora marca 2011, ko je bil sprejet predhodni osnutek proračuna za leto 2012, proračunske razmere izboljšale.
Implementation of the pharmacovigilance legislation
Izvajanje zakonodaje o farmakovigilanci
• A proposal on health security to better protect citizens against serious cross-border threats to public health (the European Commission expects the adoption of the proposal in July 2012).
• predlog o zdravstveni varnosti za boljše varovanje državljanov pred resno čezmejno ogroženostjo zdravja (Evropska komisija pričakuje, da bo predlog sprejet julija 2012);
The Acting Executive Director stressed the need to increase the use of virtual meeting technologies.
Vršilec dolžnosti izvršnega direktorja je poudaril potrebo po pogostejši uporabi tehnologij za virtualne seje.
Members discussed that for the majority of experts who had direct interests, it was not an issue to discontinue those interests.
Člani so razpravljali o tem, da za večino strokovnjakov, ki imajo neposredne interese, opustitev teh interesov ne predstavlja težave.
With regard to herbal products, the Board raised the issue that genotoxicity data remain inaccessible to the HMPC, which impedes the work of the Committee.
V zvezi z zdravili rastlinskega izvora je odbor izpostavil, da podatki o genotoksičnosti še vedno niso dostopni odboru HMPC, kar ovira njegovo delo.
With regard to initiatives in the field of transparency, it was reiterated that the Agency will aim to implement a policy for proactive release of milestone documents emanating from the opinion-making process.
V zvezi s pobudami na področju preglednosti je bilo večkrat omenjeno, da si bo agencija prizadevala za izvajanje politike za proaktivno objavljanje ključnih dokumentov, ki izhajajo iz postopka sprejemanja mnenj.
The Board was informed that OLAF will visit the Agency as part of its investigation into the Agency's role in the medicinal product ‘Mediator'.
Odbor je bil obveščen, da bo urad OLAF obiskal agencijo v okviru preiskave v zvezi z njeno vlogo pri zdravilu „Mediator“.
Held in London on 6 October 2011
V Londonu, 6. oktobra 2011
List of written procedures during the period from 17 May 2011 to 14 September 2011
Seznam pisnih postopkov v obdobju od 17. maja 2011 do 14. septembra 2011
• Establishment and functioning of health technology assessment bodies and arrangements to grant financial support to HTA activities.
• ustanovitev in delovanje organov za oceno zdravstvene tehnologije in ureditve za dodelitev finančne podpore dejavnostim ocenjevanja zdravstvene tehnologije.
The Board decided to clarify this point in the rules of procedure, stating that in situations where there is absence of obvious consensus, the Chair will ask members whether they wish to vote following the closure of a debate.
Odbor se je odločil, da bo to točko razjasnil v poslovniku, zato je navedel, da predsednik v razmerah, kadar ni mogoče doseči očitnega soglasja, vpraša člane, ali želijo glasovati po zaključku razprave.
With regard to the request to open the group to a larger number of representatives from Member States, the European Commission confirmed that the steering group should remain small, representing the three settings EMA, ECDC and NCAs for tissues and cells, considering also that this group is doing the preparatory work.
V zvezi z zahtevo, da bi bila skupina odprta za večje število predstavnikov iz držav članic, je Evropska komisija potrdila, da bi morala usmerjevalna skupina ostati majhna in predstavljati agencijo EMA, center ECDC in nacionalne pristojne organe za tkiva in celice, če upoštevamo še dejstvo, da ta skupina opravlja tudi pripravljalna dela.
The European Commission provided an update on a number of items, including the following.
Evropska komisija je predstavila posodobljene informacije o več temah, vključno z naslednjim:
The Management Board noted the presentation summarising the discussions on the implementation of the pharmacovigilance legislation which were held during the meeting of the Heads of Medicines Agencies on 5 October 2011.
Upravni odbor se je seznanil s predstavitvijo, ki povzema razprave o izvajanju zakonodaje o farmakovigilanci, ki so potekale 5. oktobra 2011 med sejo vodij agencij za zdravila.
The Agency hosted visits of many interested parties, including the French Senate, The French National Assembly and the IGAS inspectorate, and responded to enquires of committees conducting investigations into the circumstances surrounding the product, as well as to enquiries from the media.
Agencija je gostila obiske številnih zainteresiranih strani, vključno s francoskim senatom, francoskim državnim zborom in inšpektoratom IGAS (Inspection générale des affaires sociales), ter odgovarjala na poizvedbe odborov, ki so opravljali preiskave v zvezi z okoliščinami zdravila, in na vprašanja medijev.
In cases where discussions are controversial, meeting minutes shall provide further details of the discussion and shall record dissenting opinions.
Kadar so razprave sporne, bodo v zapisniku navedene dodatne podrobnosti o razpravi in odklonilna mnenja.
Reinstatement of the Accounting officer
Vrnitev računovodje na delovno mesto
First update on the implementation of conflicts of interests policy for experts and staff
Prve novice o izvajanju politike o navzkrižju interesov za strokovnjake in osebje
The Board was informed that the European Court of Auditors is conducting an audit on systems and policies for managing conflicts of interest in several EU agencies.
Odbor je bil obveščen, da Evropsko računsko sodišče opravlja revizijo sistemov in politik za upravljanje navzkrižij interesov v več agencijah EU.
[EMA/MB/650168/2011] The agenda was adopted.
[EMA/MB/650168/2011] Dnevni red je bil sprejet.
Jytte Lyngvig, the chair of the group, informed the Board that the work takes place in the areas of negotiated procedures, centralised oversight of tendering and use of exceptions.
Jytte Lyngvig, predsednica skupine, je odbor obvestila, da se ukvarjajo s področji, kot so postopki s pogajanji, centralizirani pregled zbiranja ponudb in uporaba izjem.
New premises for the Agency
Novi prostori agencije
• Falsified medicines directive (the date of implementation is January 2013; the three areas of activity for implementing measures are the implementation of the safety feature, control of import of active pharmaceutical ingredients and preparing a logo for online pharmacies).
• direktiva o ponarejenih zdravilih (datum začetka izvajanja je januar 2013; tri področja dejavnosti za izvedbene ukrepe so izvajanje zaščitnega elementa, nadzor nad uvozom aktivnih farmacevtskih učinkovin ter priprava logotipa za spletne lekarne);
A parallel project is ongoing to organise the work of staff.
Sočasno se izvaja projekt organizacije dela osebja.
Following the appointment, Guido Rasi joined the meeting of the Management Board.
Po imenovanju se je Guido Rasi pridružil seji upravnega odbora.
Apart from elections, the Board generally only votes in exceptional situations.
Odbor običajno glasuje samo v izjemnih primerih, razen pri volitvah.
The group aims to provide its recommendations for the December Management Board meeting.
Cilj skupine je predložiti priporočila za decembrsko sejo upravnega odbora.
• The Commission is preparing an impact assessment for the revision of the legislation on clinical trials (the aim is to prepare a proposal in the third quarter of 2012).
• Komisija pripravlja oceno učinka za spremembo zakonodaje o kliničnem preskušanju (cilj je pripraviti predlog v tretjem četrtletju leta 2012);
Processes that are subject to this approach are Type I variations, validation, management of requests to access documents and information.
Postopki, pri katerih se uporablja ta pristop, so spremembe tipa I, potrjevanje, upravljanje zahtev za dostop do dokumentov in obveščanje.
The Board was reminded that the group on procurement is reviewing the Agency's procedures and will make recommendations to reinforce procurement practices at the Agency.
Odbor je bil opomnjen, da skupina za javna naročila pregleduje postopke agencije in da bo predložila priporočila za okrepitev praks za javna naročila v agenciji.
The Chair informed the Board that he had reviewed declarations of interests of Board members and alternates and will send a number of letters to clarify certain issues.
Predsednik je odbor obvestil, da je pregledal izjave o interesih članov odbora in namestnikov ter da bo poslal več dopisov za pojasnitev nekaterih vprašanj.
It was agreed that the website information on this topic would be made more specific to explicitly confirm that any experts who have not submitted a valid, signed declaration will not be involved in any EMA activities.
Dogovorjeno je bilo, da bodo na spletni strani posredovane natančnejše informacije o tej temi, tako da bo iz njih jasno razvidno, da strokovnjaki, ki niso predložili veljavne, podpisane izjave, ne bodo sodelovali pri nobenih dejavnostih agencije EMA.
Implementing rules for Staff Regulations
Izvedbena pravila za kadrovske predpise