natgillin/translations-raw huggingface dataset:
The Board expressed its support for the vaccination strategies adapted by Member States in the wake of a potentially severe pandemic threat.
Odbor je izrazil podporo strategijam cepljenja, ki so jih prilagodile države članice zaradi morebitne hude nevarnosti pandemije.
The Commissioner was satisfied with the work of the Agency, including achievements in the area of communication and the involvement of patients and healthcare professionals.
Komisar je bil zadovoljen z delom agencije, vključno z dosežki na področju komunikacij ter sodelovanjem bolnikov in zdravstvenih delavcev.
The PDB includes an increase of 48 posts in the establishment plan, to a maximum number of 615 temporary agents.
PDB vključuje povečanje za 48 delovnih mest, določeno v kadrovskem načrtu, pri čemer naj bi bilo največje število začasnih uslužbencev 615.
The operations of the Agency and its work programme are shaped by various trends in the scientific and business environment of the Agency, including globalisation, scientific progress, and growing demand for openness and communication with stakeholders.
Dejavnosti agencije in njen delovni program oblikujejo različne težnje v znanstvenem in poslovnem okolju agencije, vključno z globalizacijo, znanstvenim napredkom in čedalje večjo potrebo po odprtosti in komunikaciji z zainteresiranimi stranmi.
The Board noted that a number of non-EU countries used EU authorisation to grant authorisation of pandemic vaccines in their own countries.
Odbor je opozoril, da so številne države nečlanice EU uporabile dovoljenje EU za izdajo dovoljenja za pandemska cepiva v svojih državah.
This is particularly true for areas where targets are self-set, as for example in the area of European public assessment reports (EPARs), where a number of self-set targets are not achieved due to circumstances outside of the Agency's reach.
To še zlasti velja za področja, na katerih so cilji samozastavljeni, kot na primer na področju evropskih javnih poročil o oceni zdravila (EPAR), pri katerih številni samozastavljeni cilji niso doseženi zaradi okoliščin, na katere agencija ne more vplivati.
The Executive Director and the Board thanked the staff of the Agency and the national authorities for their deep commitment and highly effective performance in the face of this public-health threat.
Izvršni direktor in Odbor sta se zahvalila osebju agencije in nacionalnim organom za njihovo globoko predanost in zelo učinkovito delovanje ob tej nevarnosti za javno zdravje.
In the meantime, the network needs to continue developing a coherent approach to the provision of information to patients and healthcare professionals across the EU.
Medtem mora mreža še naprej razvijati jasen pristop za zagotavljanje informacij bolnikom in zdravstvenim delavcem v EU.
The impact of the recent legislation on variations should be seen in 2010 and will need to be taken into account in 2011.
Vpliv nedavno sprejete zakonodaje o spremembah bi moral biti opazen v letu 2010 in ga bo treba upoštevati leta 2011.
• progress with the HMA/EMA training strategy;
• napredkom pri strategiji usposabljanja HMA/EMA;
• Agenda point 8bis_Amendment of the reimbursement rules for delegates.
• Točka 8a dnevnega reda Sprememba pravil o nadomestilih za delegate.
The Board suggested looking at the adequacy of some of the key performance indicators.
Odbor je predlagal, naj se preveri, ali so nekateri ključni kazalniki uspešnosti ustrezni.
Specifically, the sessions presented how to extend human capabilities in decision making and also demonstrated case studies where models were applied to extend and improve human judgement.
Še zlasti je bilo na predavanjih predstavljeno, kako razširiti človeške sposobnosti pri sprejemanju odločitev, predstavljene pa so bile tudi študije primerov, pri katerih so bili uporabljeni modeli za razširitev in izboljšanje človeške presoje.
The first meeting of chairs of the management boards of EU agencies took place to share best practices and discuss common issues and challenges.
Namen prvega sestanka predsednikov upravnih odborov agencij EU je bil izmenjati najboljšo prakso ter razpravljati o skupnih vprašanjih in izzivih.
• Creation of a task force on corporate social responsibility of the pharmaceutical industry.
• oblikovanjem projektne skupine za družbeno odgovornost podjetij v farmacevtski industriji.
Concern was expressed that the decision was taken prematurely, without due examination of the issue and discussion with all stakeholders.
Odločitev je bila po njihovem mnenju sprejeta prezgodaj, brez potrebne presoje vprašanja in razprave z vsemi zainteresiranimi stranmi.
Draft agenda for 18 March 2010 meeting
Osnutek dnevnega reda za sejo dne 18. marca 2010
The Agency will now work to identify lessons learned from the pandemic situation to identify improvements for future situations of this nature.
Agencija se bo zdaj lotila opredeljevanja lekcij, naučenih na podlagi pandemije, da bi opredelila izboljšanja za take primere v prihodnosti.
Expiry of the building lease in 2014
Iztek najemne pogodbe za zgradbo leta 2014
The new website of the Agency, which is under development, was demonstrated to the Management Board.
Nova spletna stran agencije, ki še nastaja, je bila predstavljena upravnemu odboru.
With regard to output of the Committee, the members also regretted that Member States do not have adequate resources to allow additional support for the work of the Committee.
Člani so glede učinka Odbora obžalovali tudi, da države članice nimajo ustreznih sredstev, da bi omogočile dodatno podporo njegovemu delu.
Following the discussion of the Management Board at the December meeting about the gap between workload and the number of temporary agents, the Agency requested 34 posts to replace existing contract agent positions with temporary agent positions.
Agencija je po razpravi upravnega odbora na decembrski seji o razliki med delovno obremenitvijo in številom začasnih uslužbencev zahtevala 34 delovnih mest, s katerimi bi nadomestila zdajšnja delovna mesta za pogodbene uslužbence z delovnimi mesti za začasne uslužbence.
If needed, the Court of Auditors will be contacted for further clarification.
Po potrebi bo za dodatna pojasnila navezala stik z njim.
Annual report 2009
Letno poročilo za leto 2009
The Agency began to identify options for a future location of the Agency in London, once its current lease expires in 2014.
Agencija je začela iskati možnosti za svoj prihodnji sedež v Londonu, ko se ji bo leta 2014 iztekla zdajšnja najemna pogodba.
The priorities for 2011 are consistent with previous years and the Road Map to 2010.
Prednostne naloge za leto 2011 so enake kot prejšnja leta in skladne s časovnim načrtom do leta 2010.
The Board was concerned that few applications are submitted to national competent authorities in many Member States in light of the approaching deadline for registration of herbal medicinal products in Member States (April 2011)1.
Odbor je bil zaskrbljen, ker je bilo nacionalnim pristojnim organom v številnih državah članicah glede na bližajoči se rok za registracijo zdravil rastlinskega izvora v državah članicah (april 2011)1 predloženih malo vlog.
A number of additional changes were made to the minutes as part of the written procedure which preceded this adoption.
V pisnem postopku pred tem sprejetjem so bile opravljene številne dodatne spremembe zapisnika.
The Board also stressed that the Agency's guidance relating to new and emerging therapies is highly important in the light of scientific development.
Odbor je še poudaril, da so navodila agencije glede novih in nastajajočih zdravljenj zelo pomembna glede na znanstveni razvoj.
• The move of the Pharmaceutical Unit F2 (and Unit F3, cosmetics and medical devices) to DG
• prehodom farmacevtskih enot F2 in F3 (kozmetični izdelki in medicinski pripomočki) pod GD
The report shows that the Agency's performance with regard to the growing core business remained at a high standard, despite the fact that significant resources were dedicated to pandemic work throughout the year.
Składno s poročilom je uspešnost agencije, kar zadeva razvijajočo se osnovno dejavnost, ostala na visoki ravni, čeprav so bila med letom precejšnja sredstva namenjena delu v zvezi s pandemijo.
Prof. Lawrence Phillips of the London School of Economics led the sessions.
Predaval je prof. Lawrence Phillips z London School of Economics.
Mr Dalli had extensive meetings with key staff of the Agency, and also outlined his priorities and replied to the questions of staff members.
Imel je izčrpne sestanke s ključnim osebjem agencije, na kratko je tudi predstavil svoje prednostne naloge in odgovoril na vprašanja osebja.
There is also a correlation between compliance with scientific advice and positive outcomes.
Obstaja tudi povezava med upoštevanjem znanstvenih nasvetov in ugodno rešenimi vlogami.
• Capabilities & limitations of human judgement presentation.
• Predstavitev sposobnosti in omejitev človeške presoje.
Board members raised concerns about the process by which DG Sanco has apparently decided to give the mandate for vigilance of cells and tissues to ECDC.
Člani odbora so izrazili zaskrbljenost glede postopka, s katerim se je GD SANCO menda odločil, da bo mandat za stalni nadzor celic in tkiv podelil ECDC.
Revised Management Board consultation procedure for CHMP and CVMP nominations
Spremenjeni posvetovalni postopek upravnega odbora za imenovanje v CHMP in CVMP
The Commission also stated that any deficit in the EU contribution compared to the request should not lead to cuts in the telematics expenditure intended for the implementation of the proposed legislation.
Komisija je še navedla, da prispevek EU, ki je manjši od zahtevanega, ne sme biti vzrok za zmanjšanje izdatkov za telematiko, namenjenih za izvajanje predlagane zakonodaje.
The Chair invited members to volunteer as topic coordinators for the assessment of the Executive Director's annual activity report 2009.
Predsednik je pozval člane, naj se prostovoljno javijo za tematske koordinatorje za oceno letnega poročila o dejavnostih izvršnega direktorja za leto 2009.
The Commission will write to the Chair to confirm specific dates for the shortlist of candidates to enable the Board to plan for an extraordinary meeting.
Komisija bo pisala predsedniku, naj potrdi posebne datume za ožji seznam kandidatov, da bo Odbor lahko načrtoval izredno sejo.
This topic links to the Agency's work on the methodology for the assessment of benefit/risk balance of medicinal products.
Ta tema je povezana z delom agencije na področju metodologije za oceno razmerja med koristmi in tveganji pri zdravilih.
The conference will address the topics raised in the evaluation and will also be an opportunity to discuss key issues proposed in the Agency's draft road map to 2015.
Na konferenci se bodo obravnavale teme iz ocene, razpravljalo se bo lahko tudi o ključnih vprašanjih, predlaganih v osnutku časovnega načrta agencije do leta 2015.
Committee on Herbal Medicinal Products: update from the Chair
Odbor za zdravila rastlinskega izvora: najnovejše informacije od predsednika
The Board also requested that the Agency send for information copies of scientific articles that are written by the Agency's staff.
Odbor je še zahteval, naj agencija naroči informativne izvode znanstvenih člankov, ki jih piše njeno osebje.
The adequacy of available genotoxicity data should be judged on a case-by-case basis and the request for new data should be made when there is a specific concern for safety.
Ustreznost dostopnih podatkov o genotoksičnosti je treba presojati za vsak primer posebej, v primeru posebne zaskrbljenosti zaradi varnosti pa je treba zahtevati nove podatke.
For new active substances the negative outcome rate last year was 40%.
Pri novih zdravilnih učinkovinah je bilo lansko leto zavrnjenih 40 % vlog.
The Board also noted that issues exist in the area of the registration of traditional herbal medicinal products which can lead to products being marketed under another classification, e.g. food supplements.
Odbor je še opozoril na težave na področju registracije tradicionalnih zdravil rastlinskega izvora, zaradi katerih se lahko zdravila dajo v promet v okviru druge klasifikacije, npr. prehranskih dopolnil.
The Board proposed to develop a harmonised approach for use by all Member States after the expiry of the transitional period.
Predlagal je, naj vse države članice po izteku prehodnega obdobja pripravijo usklajen pristop za uporabo.
The draft budget also includes resource needs for the implementation of the future pharmacovigilance and counterfeit medicines legislation, which were challenged by the Commission as being higher than estimated.
Predlog proračuna vključuje tudi potrebna sredstva za izvajanje prihodnje zakonodaje o farmakovigilanci in ponarejenih zdravilih, ki jim je Komisija nasprotovala, ker da so višja od ocenjenih.
A number of issues were raised, relating to the availability of genotoxicity data by Member States, distribution of rapporteurships among Member States, and the impact of the strict requirements of the conflicts-of-interest policy on the availability of scientific expertise.
Obravnavana so bila mnoga vprašanja, npr. glede dostopnosti podatkov o genotoksičnosti držav članic, razdelitve poročanja med države članice in vpliva strogih zahtev politike za obvladovanje navzkrižij interesov, ki velja za dostopnost znanstvenega strokovnega znanja.
The adopted preliminary work programme will be further modified in the course of 2010 to take into account the outcome of the evaluation of the Agency and its Road Map to 2015.
Sprejet predhodni delovni program bo še spremenjen v letu 2010, pri čemer bosta upoštevana izid ocene agencije in njen časovni načrt do leta 2015.
The amendments may concern the reduction of fee income due to revised inflation rate, possible use of part of the surplus from 2008, increase in orphan medicinal products budget, financing ICT expenditure, and consultancy services aimed to identify options for future accommodation for the Agency.
Spremembe se bodo lahko nanašale na zmanjšanje dohodka od pristojbin zaradi popravljene stopnje inflacije, mogočo uporabo dela presežka iz leta 2008, povečanje proračuna za zdravila za sirote, financiranje izdatkov za IKT in svetovalne storitve za opredelitev možnosti za prihodnji sedež agencije.
The Board also commented that the quality of dossiers may be a significant factor, and it is likely that a number of the products that received a negative opinion could have been approved if the dossiers had been of a higher standard.
Odbor je še pripomnil, da je lahko pomemben dejavnik kakovost vlog in da je verjetno, da bi bila lahko številna zdravila, za katera je bilo sprejeto negativno mnenje, odobrena, če bi bile vloge kakovostnejše.
The Board discussed the need to enhance the number of list entries, but noted the hurdles posed by the unavailability of genotoxicity data.
Odbor je razpravljal o potrebnem povečanju števila vnosov na seznamu, vendar je opozoril na ovire zaradi nedostopnosti podatkov o genotoksičnosti.
With regard to EPARs, the Board suggested that work should continue to promote them in the medical and scientific community, as these documents contain very valuable information about the evaluation of medicines and the decision-making process.
Odbor je glede EPAR predlagal, naj se nadaljuje njihovo promoviranje v zdravniški in znanstveni skupnosti, saj vsebujejo zelo dragocene informacije o oceni zdravil in postopku sprejemanja odločitev.
[EMA/MB/3790/2010] The agenda was adopted.
[EMA/MB/3790/2010] Dnevni red je bil sprejet.
European Commission Isabel de la Mata Georgette Lalis
Isabel de la Mata, Georgette Lalis
• Extending & improving judgement presentation.
• Predstavitev o širjenju in izboljšanju presoje.
The Management Board welcomed the presentation of the Chair of the Committee on Herbal Medicinal Products.
Upravni odbor je pozdravil predstavitev predsednika Odbora za zdravila rastlinskega izvora.
The revised implementing rules will enter into force on 1 April 2010.
Spremenjena izvedbena pravila bodo začela veljati 1. aprila 2010.
Meeting of the chairs of the management boards of EU agencies
Sestanek predsednikov upravnih odborov agencij EU
The Committee watched presentations by the chairs of the telematics implementation groups.
Odbor je gledal predstavitve predsednikov izvedbenih skupin za telematiko.
The Executive Director will write to members of the Board before June concerning the appointment of a Chair.
Izvršni direktor bo članom Odbora glede imenovanja predsednika pisal pred junijem.
The revised rules will enter into force on 1 April 2010.
Spremenjena pravila bodo začela veljati 1. aprila 2010.
[EMA/MB/183091/2010] The Management Board adopted the amendments to the reimbursement rules for delegates, whereby an allowance, corresponding to 35% of the maximum cost of a hotel night (€60 for London), is introduced to provide financial support to delegates where no accommodation invoices can be provided.
[EMA/MB/183091/2010] Upravni odbor je sprejel spremembe pravil o nadomestilih za delegate, pri čemer se uvaja nadomestilo v višini 35 % najvišjih stroškov za prenočitev v hotelu (60 EUR za London), da se zagotovi finančna podpora delegatom, če ne morejo predložiti računa o nastanitvi.
− [EMA/78873/2010] Survey 2009 for medicinal products for human use;
[EMA/78873/2010] Raziskava o zdravilih za uporabo v humani medicini za leto 2009;
The Management Board supported the conversion of these contract agent posts to temporary agent posts as essential in the Agency's efforts to recruit and retain scientific and highly specialised expertise.
Upravni odbor je podprl pretvorbo delovnih mest za pogodbene uslužbence v delovna mesta za začasne uslužbence kot ključni ukrep pri prizadevanjih agencije za zaposlovanje in ohranitev osebja z znanstvenim in visokospecializiranim strokovnim znanjem.
The Board also stressed that Member States continued to have reservations as to the ability to record time on an ongoing basis.
Odbor je še poudaril, da imajo države članice še vedno dvome glede tega, ali lahko vsakič evidentirajo porabljeni čas.
Held in London on 17-18 March 2010
V Londonu, 17. in 18. marca 2010
The Committee discussed the overall governance arrangements of the telematics programme.
Razpravljal je o splošni ureditvi vodenja programa telematike.
Draft work programme and budget 2011
Predlog delovnega programa in proračuna za leto 2011
The Board had an opportunity to test the website during the break.
Odbor jo je med odmorom lahko preskusil.
The Chair also informed the Board that the Chair of the Audit Advisory Committee is preparing a reflection paper for the Board, which will set out options for the future of the Committee.
Predsednik je Odbor obvestil tudi o tem, da predsednik Odbora za presojo in svetovanje pripravlja študijo za Odbor, v kateri bodo predstavljene možnosti za prihodnost Odbora za presojo in svetovanje.
The amendments concern the adjustment of fees to inflation (increase by 1%), establishing reduced fees for applications for marketing authorisation for multi-strain dossiers, adapting the fees for extensions of marketing authorisations and clarifying reporting requirements for national competent authorities.
Spremembe zadevajo prilagoditev pristojbin inflaciji (povečanje za 1 %), določitev znižanih pristojbin za vloge za pridobitev dovoljenja za promet z zdravilom za vloge za več sevov, prilagoditev pristojbin za razširitve dovoljenj za promet z zdravilom in pojasnitev zahtev za poročanje nacionalnim pristojnim organom.
Minutes of the 66th meeting of the Management Board
Zapisnik 66. seje upravnega odbora
Preliminary draft budget 2011 (PDB)
Predhodni predlog proračuna za leto 2011 (PDB)
Rannveig Gunnarsdóttir (Iceland)
Rannveig Gunnarsdóttir (Islandija),
[EMA/MB/806136/2009] The Management Board adopted the minutes with the following changes under point 12 (payment system to Member States): The Board clarified that only those countries which participated in the pilot demonstrated ability to identify hourly rates for services provided and to record time spent on centralised applications.
[EMA/MB/806136/2009] Upravni odbor je sprejel zapisnik z naslednjimi spremembami pod točko 12 (sistem plačil državam članicam): Odbor je pojasnil, da so samo države, ki so sodelovale v poskusnem projektu, pokazale, da lahko opredelijo urne postavke za opravljene storitve in evidentirajo čas, porabljen za vloge za pridobitev dovoljenja za promet z zdravilom po centraliziranem postopku.
[EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] The Management Board adopted the preliminary work programme, preliminary draft budget (PDB) and draft staff policy plan for 2011.
[EMA/MB/6505/2010; EMA/MB/68936/201; EMA/MB/125880/2010] Upravni odbor je sprejel predhodni delovni program, predhodni predlog proračuna (PDB) in predlog načrta kadrovske politike za leto 2011.
It was emphasised that there should be the right balance between the interests of patients and of industry.
Poudaril je še, da morajo biti interesi bolnikov in industrije v pravilnem ravnotežju.
Evaluation of the Agency by the European Commission
Ocena agencije, ki jo je naročila Evropska komisija
Preliminary work programme 2011
Predhodni delovni program za leto 2011
26 April 2010 EMA/MB/194352/2010
26. aprila 2010 EMA/440615/2011
a) Update
a) Najnovejše informacije
The change took place on 1 March 2010.
SANCO; sprememba se je zgodila 1. marca 2010;
Minutes from the 65th meeting, held on 10 December 2009
Zapisnik s 65. seje, ki je potekala 10. decembra 2009
Revised delegate reimbursement rules
Spremenjena pravila o nadomestilih za delegate
• Action plan for herbal medicines 2010-2011 presentation.
• Predstavitev Akcijskega načrta za zdravila rastlinskega izvora za leti 2010 in 2011.
The following colleagues put their names forward to assist in this task: Chair, Austria, Estonia, Ireland,
Naslednji kolegi so se javili, da bodo pomagali pri tej nalogi: predsednik, Avstrija, Estonija, Irska, Nemčija, Španija, Nizozemska in Mike O'Donovan.
[EMA/MB/75924/2010] A written procedure will be launched in April or May to amend the budget 2010.
[EMA/MB/75924/2010] Aprila ali maja se bo začel pisni postopek za spremembo proračuna za leto 2010.
• [EMA/MB/84539/2010] Outcome of written procedures during the period from 21 November 2009
• [EMA/MB/84539/2010] Rezultat pisnih postopkov v obdobju od 21. novembra 2009 do
[EMA/MB/142837/2010] The Management Board endorsed an action plan for herbal medicinal products.
[EMA/MB/142837/2010] Upravni odbor je potrdil akcijski načrt za zdravila rastlinskega izvora.
• [EMA/61092/2010] Update report on the Agency's implementation of the EU telematics strategy.
• [EMA/61092/2010] Dopolnjeno poročilo o telematski strategiji EU, ki jo izvaja agencija.
Action plan for herbal medicines for 2010-2011
Akcijski načrt za zdravila rastlinskega izvora za leti 2010 in 2011
The Commission representative stated that the Agency's justification for the request to convert these posts was inappropriate, taking into account the Staff Regulations.
Predstavnik Komisije je navedel, da agencija glede na kadrovske predpise ni ustrezno utemeljila zahteve za pretvorbo teh delovnih mest.
b) Terms of reference
b) Poslovnik
Data indicate that small companies suffer higher rates of negative outcomes.
Podatki kažejo, da se zavrne več vlog malih podjetij.
[EMA/MB/818152/2009] The Management Board adopted the amendments to the Fee Regulation implementing rules.
[EMA/MB/818152/2009] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah.
[EMA/MB/69923/2010] The Management Board adopted the Agency's annual report 2009.
[EMA/MB/69923/2010] Upravni odbor je sprejel letno poročilo agencije za leto 2009.
Timely engagement between regulators and industry is needed to assure that more products pass the regulatory assessment.
Za zagotovitev, da bo več zdravil odobrenih na podlagi ocene regulativnih organov, je potrebno pravočasno sodelovanje regulativnih organov in industrije.
European Food Safety Agency (EFSA) in the area of health claims for food containing herbal ingredients.
• odzvati se na vse zahteve Komisije po okrepljenem sodelovanju med agencijo EMA in Evropsko agencijo za varnost hrane (EFSA) na področju zdravstvenih trditev za hrano, ki vsebuje rastlinske sestavine.