natgillin/translations-raw huggingface dataset:
The activities entail close cooperation with the European Parliament and the Council (Budgetary Authority), as well as with the Commission and the Court of Auditors, on matters relating to administration, the budget, personnel, and rules and regulations on finances, audit and accounting.
Te dejavnosti imajo za posledico tesno sodelovanje z Evropskim parlamentom in Svetom (s proračunskim organom) ter Komisijo in Računskim sodiščem pri zadevah, ki se nanašajo na upravljanje, proračun, osebje, ter pri pravilih in predpisih za finance, revizijo in računovodstvo.
Regulatory and procedural guidance
Regulativne in postopkovne smernice
The Council Directive on the conduct of clinical trials on medicinal products for human use came into force on 1 May 2004
Direktiva Sveta o izvajanju kliničnega preizkušanja zdravil za uporabo v humani medicini je začela veljati 1. maja 2004.
The document on frequently asked questions published on the EMEA website has facilitated this task and further steps will be undertaken to maximise the information available.
Dokument o pogosto zastavljenih vprašanjih, objavljen na spletni strani EMEA, je to nalogo olajšal, sprejeti pa bodo nadaljnji ukrepi, da se čim bolj poveča število razpoložljivih informacij.
The new pharmaceutical legislation has given the EMEA and the European network as a whole a wider mandate to increase the transparency of its activities.
Nova farmacevtska zakonodaja je EMEA in Evropski mreži kot celoti podelila širše naloge in pooblastila za povečanje preglednosti njenih dejavnosti.
Support the Commission with the preparation of its five-year report on experience following the implementation of the orphan medicinal products regulation
Podpora Komisiji pri pripravi njenega petletnega poročila o izkušnjah, pridobljenih pri izvajanju uredbe o zdravilih sirotah.
Revision, where necessary, of the Agency's management of minor variations, taking into account the first year's experience of the implementation of new Community legislation
Po potrebi sprememba upravljanja Agencije za manjše spremembe, ob upoštevanju izkušenj, pridobljenih v prvem letu izvajanja nove zakonodaje Skupnosti.
There he was responsible for a number of groups in the technical support division of the Euratom Safeguards Directorate.
Tam je bil odgovoren za številne skupine na oddelku za tehnično podporo Direktorata Euratoma za varnostne ukrepe.
The Committee on Orphan Medicinal Products (COMP) is responsible for making recommendations to the European Commission for the designation of orphan medicinal products for rare diseases.
Odbor za zdravila sirote (COMP) je pristojen za pripravo priporočil Evropski komisiji za določitev zdravil sirot za redke bolezni.
Continuous collaboration with the Directorate-General for Health and Consumer Protection on biological threats and infectious diseases, and establishment of collaboration with the newly created European Centre for Disease Prevention and Control
Stalno sodelovanje z Generalnim direktoratom za zdravje in varstvo potrošnikov glede bioloških nevarnosti in nalezljivih bolezni ter vzpostavitev sodelovanja z na novo ustanovljenim Evropskim centrom za preprečevanje in nadzor bolezni.
Budget process for 2006 budget
Proračunski postopek za leto 2006.
2.8 Scientific committees
2.8 Znanstveni odbori
Increasing technological, industrial and regulatory globalisation, and need for global harmonisation activities
Vse večja tehnološka, industrijska in regulativna globalizacija ter potreba po usklajevanju dejavnosti na svetovni ravni.
Faster release of the summary of opinion after Commission decision through improved consultation with patients' organisations
Hitrejše objavljanje povzetkov mnenj, potem ko se Komisija odloči, po boljšem posvetovanju z organizacijami bolnikov.
Interactions with Canada and Japan and other regulatory authorities will continue through the EMEA visiting experts programme
Vzajemno delovanje s Kanado in Japonsko ter drugimi regulativnimi organi se bo nadaljevalo v okviru programa EMEA za gostujoče strokovnjake.
A Community marketing authorisation is valid throughout the EU and a centrally authorised medicinal product is by definition identical in all Member States.
Dovoljenje Skupnosti za promet z zdravilom velja po vsej EU, centralno odobreno zdravilo pa je po definiciji enako v vseh državah članicah.
The maintenance of six floors at 7 Westferry Circus is highly labour intensive as it includes all the facilities on each of the floors, plus mechanical and engineering services.
Vzdrževanje šestih nadstropij na Westferry Circus 7 zahteva veliko dela, saj vključuje vso infrastrukturo iz vsakega nadstropja ter strojne in tehnične storitve.
Administration Unit
Upravna enota
To take forward Eudra projects in a consistent, well-structured manner, and to put in place the modifications to systems and services necessary to successfully implement the new legislation.
Nadaljevati dosledno in dobro organizirano izvajanje projektov Eudra ter izvesti spremembe sistemov in storitev, potrebnih za uspešno izvajanje nove zakonodaje.
In 2005, particular emphasis will be placed on preparations for the full mandate of the Committee.
Leta 2005 bo poseben poudarek namenjen pripravi na polni mandat odbora.
Provision of guidance to the CVMP on criteria to be considered when deciding whether an application for a product is eligible for the centralised procedure because it is “in the interests of patients and animal health at Community level” (Article 3(2)(b) of Regulation 726/2004)
Zagotavljanje navodil odboru glede meril, ki jih je treba upoštevati pri odločitvi, ali je vloga za izdelek upravičena do centraliziranega postopka, ker je "v interesu bolnikov in zdravja živali na ravni Skupnosti" (člen 3(2)(b) Uredbe 726/2004).
His published works include scores of articles in computer journals during the 1980s and several popular software packages.
Njegova objavljena dela vključujejo članke v računalniških revijah v 80-ih letih in več splošnih programskih paketov.
The CVMP's procedure adopted in October 2004 to facilitate such communication and dialogue (EMEA/CVMP/329/04-Final) will be fully implemented and will progress the following initiatives:
2004, da se omogočita takšno obveščanje in dialog (EMEA/CVMP/329/04-končno), se bo začel v celoti izvajati in bo razvijal naslednje pobude:
The number of arbitrations and referrals under Articles 29 and 30 is expected to increase in 2005 compared to 2004
Število arbitraž in predložitev v skladu s členoma 29 in 30 naj bi se predvidoma leta 2005 v primerjavi z letom 2004 povečalo.
Member State national competent authorities will receive about 30 % of the Agency's total budget in 2005 in return for scientific evaluation and inspection services performed for the EMEA.
Pristojni nacionalni organi držav članic bodo v zameno za storitve znanstvenega vrednotenja in nadzora, ki jih bodo opravili za EMEA, prejeli približno 30 odstotkov skupnega proračuna Agencije za leto 2005.
Contribution to EMEA and HMA activities on follow-up and implementation of revised legislation
Prispevek k dejavnostim EMEA in HMA za spremljanje in izvajanje revidirane zakonodaje
The yearly audit cycle of the Committee for Medicinal Products for Human Use (CHMP) will contribute to the culture of continuous process improvement at CHMP level.
Odbor za zdravila za uporabo v humani medicini Letni revizijski ciklus CHMP bo prispeval h kulturi stalnega procesa izboljševanja na ravni CHMP.
The number of referrals related to pharmacovigilance concerns is expected to remain at the same level compared to 2004, although the impact of the new legislative provisions (e.g. the scope of these referral procedures) needs to be monitored
Število predložitev, povezanih z vprašanji farmakovigilance, naj bi predvidoma ostalo enako kot v letu 2004, čeprav je treba spremljati vpliv določb nove zakonodaje (npr. obseg teh postopkov za predložitev).
Managing the impact of the enlargement on the various services in the area of infrastructure
Obvladovanje vpliva povečanega obsega različnih storitev na področju infrastrukture.
Bringing of EuroPharm into production, including data from as many competent national authorities as wish to contribute
Začetek proizvajanja EuroPharma, vključno s podatki vseh pristojnih nacionalnih organov, ki jih želijo prispevati.
Career to date: Mr Ettore joined the European Commission as conference interpreter in 1976.
Dosedanja poklicna pot: G. Ettore se je Evropski komisiji pridružil kot konferenčni tolmač leta 1976.
To improve business continuity arrangements, i.e. to put in place the necessary infrastructure and processes to guarantee that the Agency's core business will not be interrupted for more than one working day
Izboljšati ureditev za zveznost poslovanja, tj. vzpostavitev potrebne infrastrukture in postopkov, in zagotoviti, da osnovna dejavnost Agencije ne bo motena več kot en delovni dan.
To increase the level of transparency of Agency and European network activities
Zvišati raven preglednosti dejavnosti Agencije in Evropske mreže.
Management and follow-up of approximately 175 annual reports to be submitted in 2005 for designated orphan medicinal products
Vodenje in spremljanje približno 175 letnih poročil, ki jih bo treba leta 2005 predložiti za zdravila, določena za zdravila sirote.
He has held a number of appointments in research and regulatory affairs in multinational companies both in the UK and overseas.
Imel je več delovnih mest na področju raziskav in regulativnih zadev v večnacionalnih družbah v Združenem kraljestvu in v tujini.
In November 2005, the MRFG will be replaced by the coordination group established by the new legislation.
Novembra 2005 bo MRFG nadomestila skupina za usklajevanje, ustanovljena v skladu z novo zakonodajo.
This requires a substantial review of the procedure following the opinion of the CVMP.
To zahteva poglobljen pregled postopka, ki sledi mnenju CVMP.
Initiatives will include the finalisation of the recommendations on provision of information to patients.
Pobude bodo vključevale dokončno oblikovanje priporočil za zagotavljanje informacij bolnikom.
To further implement the EudraVigilance project, including the SUSAR component, in particular as regards the implementation at Member State and pharmaceutical industry level, to achieve a more operational system.
Nadaljevati izvajanje projekta EudraVigilance, vključno z elementom SUSAR, zlasti glede izvajanja na ravni držav članic in farmacevtske industrije, da se doseže bolj operativni sistem.
Full composition of the Management Board will be completed in 2005 with the appointment of four members from civil society representing patients', doctors' and veterinarians' organisations.
Upravni odbor bo dobil svojo popolno sestavo v letu 2005 z imenovanjem štirih članov iz civilne družbe, ki bodo predstavljali organizacije bolnikov, zdravnikov in veterinarjev.
To maintain the accounts, make payments and collect revenue in accordance with the procedures laid down in the financial regulation
Vodenje računov, izvajanje plačil in zbiranje prihodkov v skladu s postopki iz finančne uredbe.
Optimisation of the Agency's core business and existing activities
Optimizacija osnovne dejavnosti Agencije in njenih obstoječih dejavnosti
Interest from around the world in the work of the EMEA and the European system is expected to increase, particularly following enlargement of the system to include 28 EU and EEA-EFTA countries
Zanimanje iz različnih delov sveta za delo EMEA in evropski sistem se bo po pričakovanjih povečalo, zlasti po razširitvi sistema, ko bo vključenih 28 držav članic EU in EGP-EFTA.
Further development of the EMEA website, in particular with regard to improving access to information for the public.
Nadaljnji razvoj spletne strani EMEA, zlasti za lažji dostop javnosti do informacij.
An additional 51,800 ICSRs are expected from outside the EU.
Dodatnih 51.800 ICSR se pričakuje iz držav, ki niso članice
Setting-up of procedures for the assessment and re-evaluation of products five years from designation and/or removal from the Community register
Vzpostavitev postopkov za vrednotenje izdelkov in njihovo ponovno vrednotenje pet let po določitvi in/ali izbrisu iz registra Skupnosti.
In addition to legislative challenges, the Agency is also facing rapid development in the field of science and technology, as well as recent changes in the political environment.
Agencija se srečuje z zakonodajnimi izzivi, pa tudi z naglim razvojem na področju znanosti in tehnologije ter nedavnimi spremembami političnega okolja.
The safety of medicines and improvement of the Agency's core activities will remain priorities in 2005.
Varnost zdravil in izboljšanje osnovnih dejavnosti Agencije bosta še naprej prednostni nalogi tudi v letu 2005.
To be finalised in 2005 after further consultation on related core SPC
Dokončno se oblikuje leta 2005 po nadaljnjem posvetovanju o s tem povezanim osnovnim SPC
100 % of fees for protocol assistance
100 % pristojbin za pomoč pri protokolu,
Products placed on the market in one Member State can be marketed in any other part of the Community by a ‘parallel distributor' independent of the marketing authorisation holder.
Izdelke, dane na trg v eni državi članici, lahko v katerem koli drugem delu Skupnosti trži "vzporedni distributer", neodvisen od imetnika dovoljenja za promet z zdravilom.
He later joined the French Neuromuscular Diseases Association (AFM) as special adviser to its president, to stimulate public health policy on rare diseases and to create the French Alliance Maladies Rares, an umbrella of 134 patients' organisations.
Kasneje se je pridružil Francoskemu združenju za nevromuskularne bolezni (AFM) kot posebni svetovalec njegovega predsednika, da bi spodbudili politiko javnega zdravja za redke bolezni in ustanovili francosko združenje za Maladies Rares, krovno organizacijo za 134 organizacij bolnikov.
A large number of important telematics projects are carried out by the Agency concomitantly.
Agencija hkrati izvaja veliko telematskih projektov.
The new legislation as regards the scientific advice described in section 2.2 of the work programme is equally applicable in both the human and veterinary medicinal product areas Objectives:
Nova zakonodaja za znanstveno svetovanje, opisano v oddelku 2.2 delovnega programa, se uporablja enako na področju zdravil za uporabo v humani medicini kot na področju veterinarskih zdravil.
In order to fully embrace the opportunities presented, the Agency, in addition to implementation of the new legislation, also plans to implement a number of actions originating from the Agency's Road Map to 2010.
Da bi v celoti zajela predstavljene možnosti, načrtuje poleg izvajanja nove zakonodaje tudi izvajanje številnih ukrepov iz usmeritvenega načrta Agencije do leta 2010.
4.5 Sampling and testing
4.5 Vzorčenje in preizkušanje
During implementation of the new EU pharmaceutical legislation, significant emphasis will be made on the preparation of regulatory and procedural guidance, which will complement the ongoing review of the available guidance documents
Med izvajanjem nove farmacevtske zakonodaje EU bo velik poudarek namenjen pripravi regulativnih in postopkovnih smernic, ki bodo dopolnjevale stalno preverjanje razpoložljivih usmeritvenih dokumentov.
Cooperation with other public-health-oriented scientific and regulatory institutions and agencies at European Union level will develop further as a result of the increased responsibilities given to the Agency by the new European pharmaceutical legislation
Sodelovanje z drugimi znanstvenimi in regulativnimi institucijami in agencijami, usmerjenimi v javno zdravje, na ravni Evropske unije se bo razvijalo še naprej kot rezultat povečanih pristojnosti, ki jih je Agenciji dodelila nova evropska farmacevtska zakonodaja.
The European medicines network faces important opportunities as well as challenges stemming from political, institutional, legislative and, particularly, scientific developments, the result of the latter being the advent of new technologies for treatment of diseases
Evropska mreža zdravil se srečuje s pomembnimi priložnostmi in izzivi, ki izhajajo iz političnega, institucionalnega, zakonodajnega in zlasti znanstvenega razvoja, rezultat zadnjega pa je pojav novih tehnologij za zdravljenje bolezni.
Following establishment of a standing scientific advice working party, modification to its structures and administrative procedures will be introduced in 2005.
Po ustanovitvi stalne delovne skupine za znanstveno svetovanje bodo leta 2005 spremenjeni njena organiziranost in upravni postopki.
Contribution to maintenance and guidance on the use of MedDRA at request of EC
Prispevek k vzdrževanju in usmerjanju uporabe MedDRA na zahtevo ES
30 % increase in the number of meetings to be organised due to the additional new committee and related working party meetings, as well as the planned increase in the number of scientific advice oral explanation meetings and meetings with companies
30-odstotno povečanje števila sestankov, ki jih je treba organizirati zaradi dodatnih zasedanj novega odbora in njegovih delovnih skupin, ter načrtovano povečanje števila sestankov za ustno razlago znanstvenega nasveta in sestankov s podjetji.
The use of veterinary medicinal products in food-producing animals may result in the presence of residues in foodstuffs obtained from treated animals.
Uporaba veterinarskih zdravil pri živalih, namenjenih za proizvodnjo hrane, lahko povzroči njihove ostanke v živilih, pridobljenih iz zdravljenih živali.
He moved to the Translation Centre for Bodies of the European Union in 1999 as head of the department for interinstitutional cooperation.
Leta 1999 se je preselil v Prevajalski center za organe Evropske unije kot vodja Oddelka za medinstitucionalno sodelovanje.
Seconded to the European Commission in 1992, she was involved in the implementation of the EU legislation on existing chemicals and coordinated the development of the EU approach on risk assessment for chemicals.
Leta 1992 je bila poslana v Evropsko komisijo, kjer se je ukvarjala z izvajanjem zakonodaje EU za obstoječe kemikalije in usklajevala razvoj pristopa EU do ocene tveganja za kemikalije.
The Committee is expected to visit the EMEA in 2005
Predvidoma bo odbor obiskal EMEA leta 2005.
The CVMP will continue to consider the need, when appropriate, for new guidelines, based on prior consideration of concept papers, subject to the widest consultation.
CVMP bo nadaljeval preučevanje potrebe, če je ustrezno, po novih smernicah na podlagi predhodne obravnave idejnih dokumentov in ob najširšem možnem posvetovanju.
To be incorporated in revised Volume 9 (see above)
Vključi se v revidirani Zvezek 9 (glej zgoraj)
The Agency will maintain its commitment to support the Heads of Medicines Agencies (Veterinary) on strengthening the EU network of veterinary experts and all endeavours undertaken jointly to reinforce regulatory activities in the veterinary sector.
Obveznost Agencije bo še naprej podpirati vodje agencij za zdravila (veterinarska) pri krepitvi mreže EU veterinarskih strokovnjakov ter vsa prizadevanja, ki jih skupaj prevzamejo za krepitev regulativnih dejavnosti v veterinarskem sektorju.
The forecast number of SUSAR reports for 2005 is 8,000
Predvidena številka poročil SUSAR za leto 2005 znaša 8000.
Increased involvement of external experts for both common and rare diseases
Povečano vključevanje zunanjih strokovnjakov za pogoste in redke bolezni.
In 2002, he was appointed director-delegate of international affairs.
Leta 2002 je bil imenovan za direktorja delegata za mednarodne zadeve.
To enhance the efficiency of reimbursement procedures
Povečati učinkovitost postopkov za povračilo stroškov.
Secretarial assistance with preparation of annual reports, assistance with specific activities assigned to the coordination groups under their work programmes, and assistance in providing regulatory and legal support to the group's activities
pisarniško pomoč pri pripravi letnih poročil, pomoč pri posebnih dejavnostih, dodeljenih skupinam za usklajevanje na podlagi njihovih delovnih programov, ter pomoč pri zagotavljanju regulativne in pravne podpore dejavnostim skupine.
Steady increase in number of requests for scientific advice and follow-up requests as sponsors become more aware of its benefits
Stalno povečevanje števila zahtevkov za znanstveno svetovanje in spremljanje, ker se sponzorji vse bolj zavedajo njegovih koristi.
Review and possible revision of core SPC.
Pregled in možna revizija osnovnega SPC.
The Agency therefore establishes maximum safe residue limits for pharmacologically active substances used in veterinary medicinal products in respect of all the various foodstuffs of animal origin, including meat, fish, milk, eggs and honey to provide for safe use of such foodstuffs.
Zato Agencija določa mejne vrednosti ostankov farmakološko zdravilnih učinkovin, ki se uporabljajo v veterinarskih zdravilih, za različna živila živalskega izvora, vključno z mesom, ribami, mlekom, jajci in medom, da se zagotovi varna uporaba takšnih živil.
In 2004, the first part of the new European Union pharmaceutical legislation was introduced, effecting the biggest change in the structure and roles of the Agency since its creation in 1995.
Leta 2004 je bil uveden prvi del nove farmacevtske zakonodaje Evropske unije, kar je povzročilo največjo spremembo v organiziranosti in vlogah Agencije od njene ustanovitve leta 1995.
Implementation of the first modules of Lot 2 of EudraCT
Začeti izvajanje prvih modulov Lota 2 EudraCT.
The Agency will phase in the whole package of new activities and tasks over the course of 2005 and 2006.
Agencija bo celoten paket dejavnosti in nalog uvedla postopoma v letih 2005 in 2006.
The new legislation in the area of evaluation of veterinary medicinal products introduces a number of important changes which have procedural, administrative and resource consequences for the Agency.
Nova zakonodaja na področju ocenjevanja veterinarskih zdravil uvaja številne pomembne spremembe, ki imajo za Agencijo postopkovne in upravne posledice ter posledice na področju virov.
In order to implement European pharmaceutical policy and legislation, the various initiatives aim to increase efficiency and enhance transparency, and support and facilitate the operation of procedures established by legislation.
Za izvajanje evropske farmacevtske politike in zakonodaje so različne pobude usmerjene k povečanju učinkovitosti in preglednosti ter podpori in lažjemu izvajanju postopkov, vzpostavljenih z zakonodajo.
The internal audit capability of the Agency periodically audits key processes, based on the priorities, the level of risk associated with the processes, and the results of previous audits.
Služba Agencije za notranjo revizijo izvaja redne presoje ključnih postopkov na podlagi prednostnih nalog, stopnje nevarnosti, povezane s postopki, ter ugotovitev predhodnih revizij.
Implementation of the new pharmaceutical legislation is among the Agency's key objectives and priorities for 2005.
Izvajanje nove farmacevtske zakonodaje je eden od ključnih ciljev in prednostnih nalog Agencije za leto 2005.
In order to meet expectations from sponsors and patient organisations, and taking into account the level of the orphan drug fund, it is proposed, in line with recommendations of the Committee on Orphan Medicinal Products (COMP), that the level of fee reductions provide a maximum incentive during the development and registration phase, and should cover:
Da se izpolnijo pričakovanja sponzorjev in organizacij bolnikov ter ob upoštevanju višine sklada za zdravila sirote se v skladu s priporočili Odbora za zdravila sirote (Committee for Orphan Medicinal Products, COMP) predlaga, da se z znižanjem pristojbin zagotovi največja možna spodbuda v fazi razvoja in registracije, ki bi morala zajemati:
Specialist in internal medicine.
Specialistka interne medicine.
6.2 Meetings and conferences at the EMEA
6.2 Sestanki in konference v EMEA
The Agency will work to implement the integrated quality management system agreed by the Management Board in 2004.
Agencija si bo prizadevala za izvajanje integriranega sistema vodenja kakovosti, za katerega se je dogovorila z upravnim odborom leta 2004.