natgillin/translations-raw huggingface dataset:
The objective of the document is to provide a harmonised set of recommendations, to ensure the utmost safety and well-being of trial participants across the EU while preserving the quality of the data generated by the trials.
Cilj smernic je ponuditi usklajen sklop priporočil, da se zagotovita največja možna varnost in dobro počutje udeležencev preskušanj po vsej EU, obenem pa ohrani kakovost podatkov, pridobljenih s preskušanji.
This recommendation takes into account social distancing measures and possible limitations in trial site/hospital resources.
To priporočilo upošteva ukrepe za omejevanje socialnih stikov in morebitne omejitve v zvezi z viri na mestih kliničnih preskušanj ali v bolnišnicah;
Remote source data verification (SDV): the verification of the raw data in hospitals can become extremely difficult during the pandemic due to safety measures, such as social distancing.
preverjanje izvornih podatkov na daljavo: preverjanje neobdelanih podatkov v bolnišnicah je lahko med pandemijo zaradi varnostnih ukrepov, kot je omejevanje socialnih stikov, izjemno oteženo.
Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU
Koronavirus: Komisija objavila smernice za ublažitev motenj pri izvajanju kliničnih preskušanj v EU
The guidance also aims to make sure that clinical trials for other treatments than coronavirus, notably for rare diseases and serious or life-threatening medical conditions with no satisfactory treatment options, are not disrupted by the current crisis.
Poleg tega je namen smernic zagotoviti, da bodo kljub trenutni krizi nemoteno potekala tudi klinična preskušanja v zvezi z zdravljenjem drugih bolezni, ki niso povezane s koronavirusom, zlasti redkih bolezni ter resnih ali življenjsko nevarnih zdravstvenih stanj, za katere ni zadovoljivih možnosti zdravljenja.
Remote SDV to conclude a trial could facilitate the marketing authorisation of coronavirus and life-saving medicines.
Preverjanje izvornih podatkov na daljavo za zaključek preskušanja bi lahko olajšalo izdajanje dovoljenj za promet z zdravili proti koronavirusu in življenjsko pomembnimi zdravili;
Communication to authorities: urgent actions to protect trial participants against any immediate hazard or other changes with an effect on patient safety or data robustness might become necessary to mitigate disruptions during the ongoing public health crisis.
komunikacija z organi: za ublažitev motenj med trenutno krizo v javnem zdravju bo morda treba sprejeti nujne ukrepe za zaščito udeležencev preskušanj pred morebitno neposredno nevarnostjo ali drugimi spremembami, ki bi lahko vplivale na varnost pacientov ali zanesljivost podatkov.
With more than 200 coronavirus clinical trials now registered in the EU database ( EudraCT ), the guidance offers recommendations for simple and flexible measures to respond to the current situation, and to ensure that patients participating in clinical trials across the EU can continue receiving their medicines.
Smernice vsebujejo priporočila za enostavne in prožne ukrepe za odziv na trenutne razmere ter za zagotovitev nadaljnje oskrbe pacientov, ki sodelujejo v kliničnih preskušanjih po vsej EU, z zdravili.
Commissioner Stella Kyriakides, in charge of Health and Food Safety, said: "We are in the midst of the worst pandemic in recent memory and it is absolutely crucial that we show flexibility in our rules to maintain research on critical treatments, including chronic and rare diseases, through clinical trials.
Evropska komisarka za zdravje in varnost hrane Stela Kiriakides je povedala: „Soočamo se z najhujšo pandemijo sodobnega časa.
This is also key to realising their European perspective.
To je ključno tudi za uresničevanje njihove evropske perspektive.
Together we will overcome this crisis and recover.
Skupaj bomo premagali to krizo in okrevali.
The region is also associated to the work of relevant health bodies.
Regija je pridružena tudi na področju dela ustreznih zdravstvenih organov.
Today proposals are the Commission's contribution ahead of this meeting.
Današnji predlogi so predhodni prispevek Komisije.
Looking ahead - an economic and investment plan for recovery
Pogled naprej - gospodarski in naložbeni načrt za okrevanje gospodarstva
It will also include a substantial investment package for the region.
Vključeval bo tudi obsežen naložbeni sveženj za regijo.
In addition to continued economic reforms, this requires a stronger focus on the rule of law, the functioning of democratic institutions and public administration.
Poleg nadaljevanja gospodarskih reform se je treba zato še bolj osredotočiti na pravno državo, delovanje demokratičnih institucij in javno upravo.
The EU is mobilising a substantial financial package, confirming the strong solidarity.
EU je mobilizirala obsežen finančni sveženj in s tem potrdila svojo močno solidarnost.
Investing in clean and digital technologies and capacities, together with a circular economy, will help create jobs and growth.
Naložbe v čiste in digitalne tehnologije in zmogljivosti bodo skupaj s krožnim gospodarstvom prispevale k ustvarjanju delovnih mest in rasti.
The recovery from the current crisis will only work if the partners keep delivering on their reform commitments and produce tangible results in their implementation.
Okrevanje po sedanji krizi bo učinkovito le, če bodo partnerji še naprej uresničevali reformne zaveze in dosegli oprijemljive rezultate pri njihovem izvajanju.
President of the European Commission, Ursula von der Leyen, said: "We have a special responsibility to assist in this pandemic our partners in the Western Balkans, as their future clearly lies in European Union.
Predsednica Evropske komisije Ursula von der Leyen je dejala: „Nosimo posebno odgovornost, da v tej pandemiji pomagamo našim partnerjem na Zahodnem Balkanu, saj je očitno, da je njihova prihodnost v Evropski uniji.
And beyond that, we will continue to support the region, including with the reforms needed on their EU path, as the recovery will only work effectively if the countries keep delivering on their commitments."
Poleg tega bomo regijo še naprej podpirali, tudi pri reformah, ki so potrebne na njeni poti v EU, saj bo okrevanje učinkovito le, če bodo države še naprej izpolnjevale svoje zaveze."
A strong focus will be put on the transport and energy links, which are crucial for the economic development of the region and the EU alike.
Močan poudarek bo na prometu in energetskih povezavah, ki so ključnega pomena za gospodarski razvoj regije in EU.
EU heads of State and Government and those of the Western Balkans will gather on 6 May 2020 for an EU-Western Balkans' leaders meeting to tackle common challenges.
Voditelji in voditeljice držav in vlad EU ter držav Zahodnega Balkana se bodo 6. maja 2020 zbrali na srečanju voditeljev EU in Zahodnega Balkana, namenjenem reševanju skupnih izzivov.
It also includes a proposal for €750 million of Macro-Financial Assistance and a €1.7 billion package of assistance from the European Investment Bank.
Vključuje tudi predlog za makrofinančno pomoč v višini 750 milijonov evrov in sveženj pomoči Evropske investicijske banke v vrednosti 1,7 milijarde evrov.
The EU is also providing immediate humanitarian assistance to vulnerable refugees and migrants amounting to €4.5 million and €8 million to address pressing needs in migrant camps across the region.
EU zagotavlja tudi takojšnjo humanitarno pomoč ranljivim beguncem in migrantom v višini 4,5 milijona evrov in 8 milijonov evrov za obravnavanje nujnih potreb v begunskih taboriščih po vsej regiji.
The EU financial support package of more than €3.3 billion includes reallocations from the Instrument for Pre-Accession Assistance of €38 million of immediate support for the health sector, in particular through delivering essential supplies to save lives, such as personal protective equipment, masks and ventilators; €389 million to address social and economic recovery needs and a €455 million economic reactivation package, in close cooperation with the International Financial Institutions.
Sveženj finančne pomoči EU v vrednosti več kot 3,3 milijarde evrov vključuje prerazporeditve sredstev iz instrumenta za predpristopno pomoč v višini 38 milijonov evrov neposredne podpore za zdravstveni sektor, zlasti z zagotavljanjem osnovnih potrebščin za reševanje življenj, kot so osebna zaščitna oprema, maske in ventilatorji; 389 milijonov evrov za obravnavo socialnih potreb in potreb po gospodarskem okrevanju ter 455 milijonov evrov v svežnju za ponovno oživitev gospodarstva v tesnem sodelovanju z mednarodnimi finančnimi institucijami.
Today, the European Commission is announcing over €3.3 billion of EU financial support mobilised jointly with the European Investment Bank to the benefit of the Western Balkans' citizens.
Evropska komisija je danes napovedala finančno podporo EU v višini več kot 3,3 milijarde evrov, ki bo mobilizirana skupaj z Evropsko investicijsko banko v korist državljanov Zahodnega Balkana.
The EU's global response to the coronavirus pandemic follows a ‘Team Europe' approach; combining resources from the EU, its Member States and financial institutions, in particular the European Investment Bank and the European Bank for Reconstruction and Development.
Odziv EU na pandemijo koronavirusa temelji na pristopu „Ekipa Evropa", ki pomeni združevanje virov iz EU, njenih držav članic in finančnih institucij, zlasti Evropske investicijske banke in Evropske banke za obnovo in razvoj.
The Green transition and the Digital transformation will play a central role in relaunching and modernising the economies of the Western Balkans.
Osrednjo vlogo pri oživitvi in modernizaciji gospodarstev Zahodnega Balkana bosta imela zeleni prehod in digitalna preobrazba.
The Western Balkans will require continued support to address the impact of the pandemic once the immediate crisis is over.
Države Zahodnega Balkana bodo potrebovale nadaljnjo podporo pri odpravljanju posledic pandemije, ko bo pereča kriza minila.
This includes for instance joint procurement of medical equipment, exempting the region from the EU's export authorisation scheme for personal protective equipment, ensuring the fast flow of essential goods across land borders through "green lanes", and the EU supply of testing material to ensure the correct functioning of coronavirus tests in the Western Balkans.
To vključuje na primer skupno naročanje medicinske opreme, izvzetje regije iz programa EU za izvozna dovoljenja za osebno zaščitno opremo, zagotavljanje hitrega pretoka osnovnih dobrin čez kopenske meje prek „zelenih pasov" in dobavo testnega materiala s strani EU, da se zagotovi pravilno delovanje koronavirusnih testov na Zahodnem Balkanu.
For the 2021-2027 period, the Commission has proposed a total envelope for the Pre-Accession Instrument III of €14.5 billion, of which the lion's share is destined for the Western Balkans.
Komisija je za obdobje 2021-2027 predlagala skupna sredstva za predpristopni instrument III v višini 14,5 milijarde evrov, pri čemer je levji delež namenjen državam Zahodnega Balkana.
Support will also be provided to improve the competitiveness of the economies of the Western Balkans, to better connect them within the region and with the EU, and to help make the Western Balkans fit for the digital age.
Zagotovljena bo tudi podpora za izboljšanje konkurenčnosti gospodarstev Zahodnega Balkana, boljše povezovanje teh gospodarstev znotraj regije in z EU ter pomoč državam Zahodnega Balkana, da se pripravijo na digitalno dobo.
Commissioner for Neighbourhood and Enlargement, Olivér Várhelyi, commented: "The European Union acted quickly and comprehensively to support the Western Balkans in addressing the COVID-19 pandemic, with unparalleled financial assistance as well as access to many of the EU's initiatives.
Komisar za sosedstvo in širitev Olivér Várhelyi je dodal: „Evropska unija je hitro in celovito ukrepala v podporo Zahodnemu Balkanu pri obvladovanju pandemije COVID-19, in sicer s finančno pomočjo brez primere ter dostopom do številnih pobud EU.
As a result of the coronavirus outbreak, the Western Balkans have also activated the Union Civil Protection Mechanism (UCPM) and have already started to receive assistance through delivery of equipment and repatriation of citizens from the UCPM Member States and Participating States.
Zaradi izbruha koronavirusa so države Zahodnega Balkana aktivirale tudi mehanizem Unije na področju civilne zaščite in že začele prejemati pomoč v obliki dobave opreme in vračanja državljanov iz držav članic mehanizma in sodelujočih držav.
Initially foreseen as a summit in Zagreb, the meeting will due to the COVID-19 pandemic now take place via videoconference.
Srečanje, ki je bilo načrtovano kot srečanje na vrhu v Zagrebu, bo zaradi pandemije COVID-19 potekalo v obliki videokonference.
Furthermore, given their European perspective, the EU is treating the Western Balkans as privileged partners by granting them access to many initiatives and instruments reserved for EU Member States.
Zaradi njihove evropske perspektive EU poleg tega partnerjem z Zahodnega Balkana namenja prednostno obravnavo in jim omogoča dostop do številnih pobud in instrumentov, ki so sicer namenjeni le državam članicam EU.
This package aims to address the immediate health and resulting humanitarian needs of the COVID-19 pandemic as well as help with the social and economic recovery.
Sveženj obravnava nujne zdravstvene potrebe in humanitarne potrebe v zvezi s pandemijo COVID-19 ter nudi pomoč pri socialnem in gospodarskem okrevanju.
The European Commission will later in the year come forward with an Economic and Investment Plan for the region, to spur the long-term recovery, boost economic growth and support reforms required to move forward on the EU path.
Evropska komisija bo v nadaljevanju leta predstavila gospodarski in naložbeni načrt za regijo, da bi spodbudila dolgoročno okrevanje gospodarstva in gospodarsko rast ter podprla reforme, ki so potrebne za napredek na poti do EU.
The Commission foresees a doubling in the provision of grants through the Western Balkans Investment Framework and substantially increasing the financial guarantees to support public and private investment in the region through a dedicated Guarantee Instrument under the Western Balkans Investment Framework.
Komisija predvideva, da se bodo v okviru naložbenega okvira za Zahodni Balkan podvojila podeljena nepovratna sredstva, poleg tega pa naj bi se znatno povečala finančna jamstva za podporo javnim in zasebnim naložbam v regiji prek namenskega jamstvenega instrumenta v okviru naložbenega okvira za Zahodni Balkan.
Western Balkans' leaders meeting: EU reinforces support to address COVID-19 crisis and outlines proposal for post-pandemic recovery
Srečanje voditeljev držav Zahodnega Balkana: EU krepi podporo pri obvladovanju krize COVID-19 in predstavlja predlog za okrevanje po pandemiji
EU reinforces support to Western Balkans to address COVID-19
EU krepi podporo Zahodnemu Balkanu pri obvladovanju COVID-19
EU support to the Western Balkans in tackling the coronavirus
Podpora EU Zahodnemu Balkanu pri obvladovanju koronavirusa
In addition to the reinforced support, the Commission is in its contribution ahead of the EU-Western Balkans' leaders meeting of 6 May 2020 also outlining the broad parameters of longer-term support to be presented later this year in the form of an Economic and Investment Plan for the region.
Komisija je v svojem prispevku pred srečanjem voditeljev EU in Zahodnega Balkana, ki bo potekalo 6. maja 2020, poleg okrepljene podpore predstavila tudi splošni okvir dolgoročnejše podpore, ki bo letos predstavljena v obliki gospodarskega in naložbenega načrta za regijo.
And our work will continue as we prepare an Economic and Investment Plan for the region, to tackle the hard socio-economic impact of the crisis, to modernise the economies in the region, support the reforms and start closing the development gap, thus bringing concrete benefits to the people faster."
Naše delo se bo nadaljevalo, saj pripravljamo gospodarski in naložbeni načrt za regijo, namenjen odpravljanju težkih socialno-ekonomskih učinkov krize, modernizaciji gospodarstva v regiji, podpori reformam in začetku odpravljanja razvojne vrzeli.
For More Information
Izvajanje temeljnih reform
Together with our partners, we are making sure that the substantial EU funding already allocated to the Western Balkans is targeted to help them address the impact of the pandemic.In parallel, some EU Member States are also providing bilateral support, whether financial or donations of supplies.
Skupaj s partnerji zagotavljamo, da bo znatno financiranje EU, ki je že bilo dodeljeno državam Zahodnega Balkana, usmerjeno v pomoč pri odpravljanju učinkov pandemije.
More deliveries will follow.
Dodatne pošiljke bodo sledile.
The Emergency Response Coordination Centre manages the distribution of the equipment to ensure it goes where it is needed most.
Center za usklajevanje nujnega odziva upravlja razdeljevanje opreme, da se zagotovi, da gre ta tja, kjer se jo najbolj potrebuje.
In this case Spain, Italy and Croatia were selected based on the needs expressed by these countries in their requests for assistance under the European Civil Protection Mechanism.
V tem primeru so bile Španija, Italija in Hrvaška izbrane glede na potrebe, ki so jih te države izrazile v svojih prošnjah za pomoč v okviru evropskega mehanizma na področju civilne zaščite.
How the rescEU capacity works
Delovanje zmogljivosti rescEU
I thank Romania and Germany for being the first Member States to host the rescEU equipment," said Commissioner for Crisis Management, Janez Lenarčič.
„Zahvaljujem se Romuniji in Nemčiji, ki kot prvi državi članici gostita opremo rescEU," je dejal komisar za krizno upravljanje Janez Lenarčič.
The strategic medical capacity is part of the wider rescEU reserve, including other capacities such as aerial firefighting means and medical evacuation capacities.
Strateška zdravstvena zmogljivost je del širše rezerve rescEU, vključno z drugimi zmogljivostmi, kot so zmogljivosti gašenja požarov iz zraka in zmogljivosti za medicinsko evakuacijo.
EU Member States, the UK (during the transition period), Iceland, Norway, Serbia, North Macedonia, Montenegro and Turkey participate in the Union Civil Protection Mechanism.
V mehanizmu Unije na področju civilne zaščite sodelujejo države članice EU, Združeno kraljestvo (v prehodnem obdobju), Islandija, Norveška, Srbija, Severna Makedonija, Črna gora in Turčija.
We have already created a stock of masks.
Uspešno smo ustvarili zalogo mask.
Today's support comes on top of the EU Medical Teams, masks and disinfectant already mobilised via the EU Civil Protection Mechanism as well as bilateral offers from Member States.
Današnja podpora dopolnjuje zdravniške ekipe, maske in razkužila, ki so se že mobilizirali v okviru mehanizma Unije na področju civilne zaščite, in dvostranske ponudbe držav članic.
Romania and Germany are the first Member States to host the rescEU reserve and are therefore responsible for procuring the equipment, while the Commission finances 100% of the assets such as personal protective equipment.
Romunija in Nemčija sta prvi državi članici, ki gostita rezerve rescEU, in sta tako odgovorni za naročanje opreme, Komisija pa pri tem v celoti financira sredstva, kot je osebna zaščitna oprema.
In these first deliveries, already 330,000 masks have now been delivered to Italy, Spain and Croatia.
V teh prvih pošiljkah je bilo Italiji, Španiji in Hrvaški že dobavljenih 330 000 mask.
The rescEU reserve constitutes the last resort layer of the Union Civil Protection Mechanism, which can be activated for all type of natural and man-made hazards.
Rezerva rescEU je možnost v skrajni sili v okviru mehanizma Unije na področju civilne zaščite, ki se lahko aktivira za vse vrste naravnih nesreč in nevarnosti, ki jih povzroči človek.
"We have worked around the clock to build up the rescEU reserve of medical equipment.
„Noč in dan smo si prizadevali za oblikovanje rezerve medicinske opreme rescEU.
Spain, Italy and Croatia will be the first to receive equipment, but more deliveries will follow.
Prve bodo opremo prejele Španija, Italija in Hrvaška, zatem pa bodo sledile dodatne dobave.
Coronavirus: rescEU masks delivered to Spain, Italy and Croatia
Koronavirus: maske rescEU dobavljene Španiji, Italiji in Hrvaški
Following last week's delivery to Italy, more batches of FFP2 protective masks are being distributed this weekend to Spain, Italy and Croatia from rescEU - the first ever common European reserve of medical equipment set up last month to help countries affected by the coronavirus outbreak.
Po dobavi v Italijo, ki je bila opravljena prejšnji teden, bodo ta konec tedna dodatne pošiljke zaščitnih mask FFP2 iz rescEU dobavljene tudi Španiji, Italiji in Hrvaški.
For more information
Sporočilo za medije2.
This proposal needs to be submitted to the Council and the Parliament for approval.
Predlog je treba predložiti Svetu in Parlamentu v odobritev.
Applications to participate in the scheme will open from 7 May 2020.
Prijave za sodelovanje v shemi bo mogoče vložiti od 7. maja 2020.
The exceptional market measures proposed on 22 April and now fully adopted and published include:
Izredni tržni ukrepi, ki so bili predlagani 22. aprila in so zdaj v celoti sprejeti in objavljeni, vključujejo:
In addition, it will allow the reorientation of funding priorities towards crisis management measures.
Poleg tega bo mogoča preusmeritev prednostnih nalog financiranja v ukrepe kriznega upravljanja.
Coronavirus: agri-food sector
Koronavirus: Agroživilski sektor
Some agricultural and food markets have been hit hard by the crisis.
Kriza je nekatere kmetijske in živilske trge močno prizadela.
These measures follow a wide-ranging package of measures adopted earlier on by the Commission.
Ti ukrepi sledijo širokemu svežnju ukrepov, ki jih je Komisija že sprejela .
This should provide immediate relief to those most impacted by the crisis.
S tem bi se zagotovila takojšnja pomoč tistim, ki jih je kriza najbolj prizadela.
However, I am now confident that the adoption of these measures will provide tangible support, send the right signal to markets, and soon provide some stability.
Vendar sem prepričan, da bo sprejetje teh ukrepov zagotovilo konkretno podporo, na trge poslalo pravi signal in kmalu prineslo nekaj stabilnosti.
This measure aims to stabilise the market by temporarily reducing available supply.
Cilj tega ukrepa je stabilizacija trga z začasnim zmanjšanjem razpoložljive ponudbe.
Agriculture and Rural Development Commissioner Janusz Wojciechowski said: "We have acted swiftly to have all necessary measures available as quickly as possible to support farmers and those in need.
Komisar za kmetijstvo in razvoj podeželja Janusz Wojciechowski je povedal: „S hitrim ukrepanjem smo za kmete in tiste, ki to potrebujejo, kar najhitreje sprejeli vse potrebne ukrepe za podporo.
This comes on top of the de-minimis aid for the agricultural sector and the increased state aid ceiling previously adopted.
To dopolnjuje pomoč de minimis za kmetijski sektor in pred tem sprejeto povišano zgornjo mejo državne pomoči.
This measure allows the temporary withdrawal of products from the market for a minimum of 2 to 3 months, and a maximum period of 5 to 6 months.
Ti ukrepi omogočajo začasni umik proizvodov s trga za najmanj 2 do 3 mesece in največ 5 do 6 mesecev.
The Commission adopted such derogations for the milk, flowers and potatoes sectors.
Komisija je takšna odstopanja sprejela za sektorje mleka, cvetja in krompirja.
This flexibility aims to limit available supply in each sector to lead to a rebalancing of markets.
Namen te prožnosti je omejiti razpoložljivo ponudbo v vsakem od sektorjev, da se omogoči ponovno uravnoteženje trgov.
Temporary derogation from EU competition rules: Article 222 of the Common Markets Organisation Regulation (CMO) allows the Commission to adopt temporary derogations from certain EU competition rules in situations of severe market imbalances.
Začasno odstopanje od pravil EU o konkurenci: člen 222 uredbe o skupni ureditvi trgov (SUT) Komisiji omogoča, da v primeru hudih tržnih neravnovesij sprejme začasna odstopanja od nekaterih pravil EU o konkurenci.