natgillin/translations-raw huggingface dataset:
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.
Dr Keller is a member of the American Society of Pharmacognosy and of the International Society for Medicinal Plant Research. 
Dr. Keller je član Ameriškega društva za farmakognozijo in Mednarodnega društva za raziskave zdravilnih rastlin.
To this end, the Agency will prepare to implement provisions regarding reduction in fees, deferment of the payment of fees, support for the translation of medical information, and administrative assistance to these enterprises. 
V ta namen se bo Agencija pripravila na izvajanje določb o znižanju pristojbin, odlogu njihovega plačila, podpori pri prevajanju zdravstvenih informacij in administrativni pomoči tem podjetjem.
There will also be further development of the interaction between the inspection and assessment functions so that best use can be made of the inspection resource available in the Community. 
Nadaljevalo se bo tudi razvijanje vzajemnega delovanja inšpekcijskih in ocenjevalnih nalog, da se tako lahko najbolje izkoristijo viri, ki so v Skupnosti na voljo za izvajanje inšpekcijskih pregledov.
Some 18,800 adverse drug reaction (ADR) reports for centrally authorised medicines are expected to be received by paper mail for EU cases, with an additional 3,390 ADR reports from outside the EU 
Po pošti naj bi prispelo približno 18.800 poročil o neželenih učinkih zdravil (adverse drug reaction, ADR) za centralno odobrena zdravila za primere iz EU, dodatnih 3390 poročil o ADR pa za primere zunaj EU.
Payments received Payments made 
Prejeta plačila Izvedena plačila
1.2 Implementation of the new pharmaceutical legislation 
1.2 Izvajanje nove farmacevtske zakonodaje
Professional training management directed towards a continuous system of competence development, taking account of the enhanced scientific role of the Agency 
Vodenje strokovnega usposabljanja, usmerjenega k neprekinjenemu sistemu razvijanja pristojnosti, ter upoštevanje povečane znanstvene vloge Agencije.
Member of the Pharmaceutical Society of Ireland. 
Članica Irskega farmacevtskega društva.
The EMEA will provide support to workshops with stakeholders, in particular with academic research organisations, organised at the initiative of the COMP and CHMP, on new scientific and methodological aspects. 
EMEA bo podpirala delavnice z zainteresiranimi stranmi, zlasti z akademskimi raziskovalnimi organizacijami, organiziranimi na pobudo COMP in CHMP, o novih znanstvenih in metodoloških vidikih.
Dr Abadie has been a consultant in cardiology and diabetology since 1984. 
Dr. Abadie je bil od leta 1984 svetovalec na področju kardiologije in diabetologije.
Contribution to draft prepared by EudraVigilance Working Groups 
Prispevek k osnutku, ki so ga pripravile delovne skupine za EudraVigilance
The CVMP will meet 11 times during the year. 
CVMP se bo med letom sestal enajstkrat.
Career to date: David Drakeford worked with Telecom Eireann where he managed the implementation of a national data communication network. 
Dosedanja poklicna pot: David Drakeford je delal za Telecom Eireann, kjer je vodil izvajanje nacionalne mreže sporočanja podatkov.
The European public assessment reports will have to contain summaries written in a manner that is understandable to the public. 
Evropska javna poročila o oceni bodo morala vsebovati povzetke, napisane tako, da bodo razumljivi javnosti.
Since October 2004 she has been in charge of establishing the new sector for medical information. 
Od oktobra 2004 je odgovorna za ustanovitev novega Sektorja za informacije o zdravilih.
Implementation of Lot 2A of EudraCT as a production version 
Izvajanje lota 2A Eudra CT kot proizvodne različice.
In 1991 he joined the International Regulatory Affairs Division of Glaxo Group Research Limited where he was responsible for the development and submission of a series of international registration applications in a number of therapeutic areas. 
Leta 1991 se je pridružil Mednarodni diviziji za regulativne zadeve Glaxo Group Research Limited, kjer je bil odgovoren za razvoj in predložitev vrste vlog za mednarodno registracijo na številnih terapevtskih področjih.
A significant impact on the activities of the Agency in 2005 is the introduction of new procedures which reinforce the safety of medicines and facilitate access to new medicines. 
Na dejavnosti Agencije v letu 2005 bo močno vplivala uvedba novih postopkov, ki bodo povečali varnost zdravil in olajšali dostop do novih zdravil.
Adopt rules for the implementation of the new regulation on fees payable to the EMEA 
Sprejel pravila za izvajanje nove uredbe o pristojbinah, ki se plačujejo EMEA.
To be finalised following revision of Annex I of Directive 2001/82/EC 
Dokončno se oblikuje po reviziji Priloge I k Direktivi 2001/82/ES
She has led the Agency's integrated quality management system and internal audit system since November 1999. 
Od novembra 1999 vodi sistem integriranega upravljanja kakovosti in sistem notranjih revizij.
The legislation provides for a more active role of the Agency in different international forums concerned with regulatory harmonisation. 
Zakonodaja predvideva dejavnejšo vlogo Agencije v različnih mednarodnih forumih, ki se ukvarjajo z usklajevanjem zakonov in predpisov.
Setting up a ‘visitors' centre' on the EMEA website, including information such as the Delegate manual 
Vzpostaviti "center za obiskovalce" na spletni strani EMEA, ki bo vključeval informacije, kot je priročnik za delegate.
Her responsibilities there included coordination of regulatory aspects of European procedures and International Conference on Harmonisation (ICH) activities. 
Njene tamkajšnje odgovornosti so vključevale usklajevanje regulativnih vidikov evropskih postopkov in dejavnosti v zvezi z Mednarodno konferenco o usklajevanju (ICH).
There is only limited market growth foreseen in the veterinary pharmaceutical sector as a result of a reduction in the number of companies and industry's claims that investment in new products is being diverted into defensive research and development 
V veterinarskem farmacevtskem sektorju se predvideva samo omejena tržna rast, zaradi manjšega števila zahtev podjetij in industrije, da se naložbe v nove izdelke preusmerijo v netvegane raziskave in razvoj.
Encourage development of medicines for minor uses and minor species through implementation of the recommendations of the strategic action plan presented in the Committee for Medicinal Products for Veterinary Use (CVMP) Position Paper regarding Availability of Medicinal Products for Minor Uses and Minor Species, adopted in July 2004. 
Spodbujanje razvoja zdravil za manjše uporabe in manj pomembne vrste na podlagi izvajanja priporočil strateškega akcijskega načrta, ki je bil predstavljen v Dokumentu o stališču Odbora za zdravila za uporabo v veterinarski medicini (Committee for Medicinal Products for Veterinary Use, CVMP glede razpoložljivosti zdravil za manjše uporabe in manj pomembne vrste, sprejetem julija 2004.
Continued organisation of Infodays, focus groups and bilateral meetings 
stalno organiziranje informativnih dnevov, osredotočenih skupin in dvostranskih srečanj.
The development of guidelines and procedures resulting from the GMP impact of the review of legislation will form a significant part of the work plan in 2005. 
Razvoj smernic in postopkov, ki so posledica vpliva dobre proizvodne prakse iz pregleda zakonodaje, bo zajemal pomemben del delovnega načrta za leto 2005.