natgillin/translations-raw huggingface dataset:
The area of infrastructure services at the EMEA covers a wide range of services, including security, telecommunications, reception, switchboard, archiving, mail, reprographics, technical assistance to meeting rooms, confidential waste, health & safety, fire and emergency plans, business continuity planning, inventory, office equipment and supplies, maintenance, refurbishment and fitting out, and management of the catering facilities. 
Področje infrastrukturnih storitev v EMEA zajema širok razpon storitev, vključno z varnostjo, telekomunikacijami, sprejemanjem, posredovalnim mestom, arhiviranjem, pošto, reprografiko, tehnično pomočjo za sejne sobe, posebnimi odpadki, zdravjem in varnostjo, načrtom gašenja in ukrepov v sili, načrtovanjem zveznosti poslovanja, zalogami, pisarniško opremo in materialom, vzdrževanjem, obnavljanjem in opremljanjem ter upravljanjem zmogljivosti za pripravo in dostavo hrane.
Clarification of applicability to welldefined active substances 
Pojasni se uporabnost za točno določene aktivne snovi
Certificat de Hautes Etudes Européennes (economics) from the College of Europe, Bruges. 
Certificat de Hautes Etudes Européennes (ekonomija) Evropskega kolidža v Brugesu.
This harmonisation work will include the development of GMP guidelines on products used as gene and cell therapies. 
To usklajevalno delo bo vključevalo razvoj smernic dobre proizvodne prakse za izdelke, ki se uporabljajo za gensko in celično zdravljenje.
Preparation of communication strategy, including annual report on pharmacovigilance for centralised products, for release to the Commission and Member States 
Priprava strategije sporočanja, vključno z letnim poročilom o farmakovigilanci za centralizirane izdelke, zato da se sporoči Komisiji in državam članicam.
To handle effectively and in a timely manner adverse reaction reports and PSURs for centralised products, in conjunction with rapporteur and co-rapporteur, for review by the CVMP, and to communicate information to the Commission, the Member States and the general public 
Učinkovito in pravočasno obravnavati poročila o neželenih učinkih in PSUR-je za centralizirane izdelke v povezavi s poročevalcem in soporočevalcem, da jih pregleda CVMP in da se informacije sporočijo Komisiji, državam članicam in javnosti.
Endorse the EMEA transparency and communication strategies and related policies 
Odobril strategiji EMEA o preglednosti in obveščanju ter s tem povezane politike.
To implement the EU review of pharmaceutical legislation, in particular as regards the reinforced coordinating role for the EMEA in the area of pharmacovigilance and provision of information on safety aspects 
V EU izvesti pregled farmacevtske zakonodaje, zlasti glede okrepljene usklajevalne vloge EMEA na področju farmakovigilance in zagotavljanja informacij o varnostnih vidikih.
The consequences of the new pharmaceutical legislation: 
Posledice nove farmacevtske zakonodaje:
The new legislation, in addition, introduces requirements to provide information on withdrawals of applications by applicants prior to opinion and on refusals of marketing authorisations, to prepare summaries of European public assessment reports in a manner that is understandable to the public, and to distribute appropriate pharmacovigilance information. 
Nova zakonodaja uvaja tudi zahteve za zagotavljanje informacij o umiku vlog s strani vlagateljev pred izdajo mnenja ter o zavrnitvah izdaje dovoljenja za promet, da se pripravi povzetke evropskih javnih poročil o oceni na način, ki je razumljiv javnosti, in širi ustrezne informacije o farmakovigilanci.
Such increase will be influenced by the revised classification of variations and the status of implementation of new Community legislation on certification of plasma master files and vaccine antigen master files 
Na takšno povečanje bodo vplivali revidirana razvrstitev sprememb in status izvajanja nove zakonodaje Skupnosti o certificiranju glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov.
The biggest impact on future workload estimated for 2005 will be the implementation and management of new invoicing and financial accounting systems. 
Predvidoma bo na prihodnjo delovno obremenitev v letu 2005 najbolj vplivalo izvajanje in upravljanje novih računovodskih sistemov za izdajanje računov in finance.
She was appointed deputy head of sector for safety and efficacy of medicines in January 2001, and since then has been in charge of EMEA activities in the field of innovation, emerging therapies & technologies, and the coordination of scientific training. 
Januarja 2001 je bila imenovana za vršilko dolžnosti vodje Sektorja za varnost in učinkovitost zdravil in od takrat naprej je odgovorna za dejavnosti EMEA na področju inovacij, novih oblik zdravljenja in tehnologij ter za usklajevanje znanstvenega usposabljanja.
These projects have been agreed as being EudraNet, EudraVigilance, the EuroPharm database, electronic submissions, implementation of the Clinical Trials Directive and the good manufacturing practice database. 
Dogovorjeno je bilo, da so to projekti EudraNet, EudraVigilance, zbirka podatkov EuroPharm, elektronsko pošiljanje, izvajanje direktive o kliničnem preizkušanju in zbirka podatkov o dobri proizvodni praksi.
Development and implementation of methodologies and tools for data analysis supporting signal detection; provision of adequate training to all users of the EudraVigilance system, including the new SUSAR component 
Razvijanje in izvajanje metodologij in orodij za analiziranje podatkov v podporo odkrivanju signalov, zagotavljanje ustreznega usposabljanja za vse uporabnike sistema EudraVigilance, vključno z novim elementom SUSAR.
He was later appointed to the Pharmaceutical Inspectorate (Ministry of Social Affairs and Public Health) in Brussels as a chief inspector, acting as the secretary of the Belgian Medicines Commission. 
Nato je bil dodeljen farmacevtskemu inšpektoratu (Ministrstvo za socialne zadeve in javno zdravje) v Bruslju kot glavni inšpektor, ki je deloval kot sekretar Belgijske komisije za zdravila.
Establish scientific advisory groups, in particular for mandatory therapeutic fields of the centralised procedure 
Ustanovitev znanstveno svetovalnih skupin, zlasti za obvezna terapevtska področja centraliziranega postopka.
She worked at the Danish Environment Ministry from 1979 to 1985, first as a consultant and later as an official, before moving to the City of Copenhagen Environment Protection Agency until 1988. 
Od leta 1979 do 1985 je delala na danskem Ministrstvu za okolje, najprej kot svetovalka in kasneje kot njegova uslužbenka, preden se je do leta 1988 preselila v Kopenhagen na Agencijo za varstvo okolja.
4.2 Implementation of the Clinical Trials Directive 
4.2 Izvajanje direktive o kliničnem preizkušanju
Implementation of the early information function and cooperation with the European Directorate for the Quality of Medicines on the sampling and testing programme for centrally authorised products 
Izvajanje naloge zgodnjega obveščanja in sodelovanje z Evropskim direktoratom za kakovost zdravil pri programu vzorčenja in preizkušanja centralno odobrenih zdravil.
In addition, EU regulators will have instant access to information about ongoing clinical trials in Europe and information about the status of GMP certificates and manufacturing authorisations. 
Poleg tega bodo imeli zakonodajalci EU takojšen dostop do informacij o kliničnih preizkušanjih, ki potekajo v Evropi, ter informacij o statusu potrdil o dobri proizvodni praksi in dovoljenj za izdelavo.
Scientific advice is a priority area for the EMEA and is provided on any aspect of research and development relating to quality, safety or efficacy of medicinal products. 
Znanstveno svetovanje je za EMEA prednostno področje in se zagotavlja za vse vidike raziskav in razvoja, povezane s kakovostjo, varnostjo ali učinkovitostjo zdravil.
Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to human medicines 
Uvedba prve faze izvedbenega načrta za usmeritveni načrt EMEA do 2010 za zdravila za ljudi.
Development and implementation of document management, records management and mail registration policies will be undertaken in 2005. 
Leto 2005 se bo začelo z razvojem in izvajanjem vodenja dokumentacije, vodenja poročil in politik registriranja pošte.
Career to date: Six years of clinical experience in UK hospitals, five years as director of pharmacovigilance and regulatory affairs at Astra Pharmaceuticals in the UK and a total of seven years at the UK Medicines Control Agency. 
Dosedanja poklicna pot: Šest let kliničnih izkušenj v angleških bolnišnicah, pet let kot direktor za farmakovigilanco in regulativne zadeve pri Astra Pharmaceuticals v Združenem kraljestvu in skupaj sedem let pri angleški Agenciji za nadzorovanje zdravil.
To provide timely and understandable product information to users and interested parties 
Zagotavljati pravočasne in razumljive informacije o izdelkih uporabnikom in zainteresiranim stranem.
Applications are expected in the context of cooperation with the WHO where the EMEA may be asked to provide an opinion on medicinal products intended exclusively for markets outside the Community. 
Pričakujejo se vloge v okviru sodelovanja s Svetovno znanstveno organizacijo, kjer se EMEA lahko zaprosi za mnenje o zdravilih, namenjenih izključno trgom zunaj Skupnosti.
9 In 2005 the Agency will focus on preparation for the full entry into force of the new legislation in the last part of the year 
Leta 2005 se bo Agencija usmerila k pripravi na začetek popolne veljavnosti nove zakonodaje v zadnji polovici leta.
She was appointed integrated quality management adviser in January 2004. 
Januarja 2004 je bila imenovana za svetovalko za integrirano upravljanje kakovosti.
Establish procedures and a dedicated structure to provide support for small and medium-sized enterprises 
Vzpostavitev postopkov in namenske organiziranosti za zagotavljanje podpore majhnim in srednje velikim podjetjem.
Enhancement of the activity-based budgeting system 
Povečanje proračunskega sistema, utemeljenega na dejavnostih.
To implement the new legislative requirements in the area of scientific advice 
Izvajati nove zakonske zahteve na področju znanstvenega svetovanja.
The operation of the Mutual Recognition Facilitation Group (MRFG) will continue to be supported by the EMEA at its monthly meetings. 
Recognition facilitation Group, MRFG) na njenih mesečnih zasedanjih.
To prepare for provision of incentives to small and medium-sized enterprises 
Pripraviti se na zagotavljanje spodbud za majhna in srednje velika podjetja.
Implementation of transparency initiatives in the designation procedure in liaison with patients' organisations 
Izvajanje pobud za preglednost postopka za določitev v povezavi z organizacijami bolnikov.
Activities in relation to plasma and vaccine antigen master files and to medical devices containing biotechnology and blood-derived medicinal products will develop further 
Dejavnosti, povezane z glavnima dosjejema plazme in virusnih antigenov ter medicinskimi pripomočki, ki vsebujejo biotehnološka zdravila in zdravila iz krvi, se bodo razvijale še naprej.
Develop procedures for more systematic and repeated use of scientific advice and protocol assistance during the development of products, particularly for rare diseases and new therapies 
Razvoj postopkov za bolj sistematično in večkratno uporabo znanstvenega svetovanja in pomoč pri protokolu med razvojem zdravil, zlasti za redke bolezni in nove terapije.
Delivery of first production versions of the EuroPharm medicines information system, the EudraVigilance data warehouse and pharmacointelligence tools, and the product information management system (PIM), plus completion of phase 2a of the European Clinical Trials registration database system (EudraCT). 
Dostaviti prve proizvodne različice informativnega sistema EuroPharm za zdravila, podatkovnega skladišča EudraVigilance in orodij farmakointeligence in sistema upravljanja informacij o izdelkih, ter zaključiti fazo 2a sistema zbirke podatkov o registraciji evropskih kliničnih preizkušanj (EudraCT).
Interaction with the US Food and Drug Administration will be further developed through enhanced cooperation in the context of the confidentiality arrangements, e.g. in the fields of orphan medicinal products, scientific advice requests, new applications, pharmacovigilance, development of guidelines and the exchange of trainees and experts 
Vzajemno delovanje z Upravo za hrano in zdravila ZDA se bo še naprej razvijalo z okrepljenim sodelovanjem v okviru dogovorov o zaupnosti, npr. na področju zdravil sirot, zahtevkov za znanstveno svetovanje, novih vlog, farmakovigilance, pripravi smernic ter izmenjavi udeležencev usposabljanja in strokovnjakov.
Line extensions are likely to increase, with eight applications foreseen for 2005. 
Število vlog za podaljšanje rokov bo verjetno naraščalo, za leto 2005 se predvideva osem vlog.
He currently holds the positions of director and professor at the Federal Institute for Drugs and Medical Devices. 
Trenutno je direktor in profesor na Zveznem inštitutu za zdravila in medicinske pripomočke.
2.12 Coordination group 
2.12 Skupina za usklajevanje
She was editor for the ICH GCP guideline from February 1992 until its adoption in May 1996. 
Bila je urednica smernice ICH za dobro klinično prakso od februarja 1992 do njenega sprejetja maja 1996.
Invitation by the CVMP, its working parties or scientific advisory groups to interested parties on specific technical/scientific issues 
povabilo CVMP, njegovih delovnih ali znanstveno svetovalnih skupin zainteresiranih strani k skupnemu reševanju posebnih tehničnih/znanstvenih vprašanj;
This includes the organisation of meetings, travel and hotel arrangements for delegates and hosts, reception of visitors, the reimbursement of delegates' expenses, and the payment of suppliers' invoices, as well as the preparation and follow-up of meeting room facilities. 
Sem spadajo organiziranje sestankov in potovanj ter hotelske nastanitve delegatov in gostov, sprejem obiskovalcev, vračilo stroškov delegatom, plačilo računov dobaviteljev ter priprava in spremljanje naprav v sejnih sobah.
The trend in the number of generic applications which began in 2004 is anticipated to continue in 
Trend glede števila generičnih vlog, ki se je začel leta 2004, se bo leta 2005 predvidoma nadaljeval.
To improve the availability of information in relation to Community referral procedures 
Izboljšati dostopnost informacij o postopkih za predložitev Skupnosti.
Establish new procedures necessary to implement the new pharmaceutical legislation (conditional approval, accelerated assessment, compassionate use, opinions for medicinal products not marketed in the EU (in collaboration with the WHO), scientific advisory groups, extended scope of the centralised procedure, etc.) 
Vzpostavitev novih postopkov, potrebnih za izvajanje nove farmacevtske zakonodaje (pogojna odobritev, pospešena ocena, sočutna uporaba, mnenja o zdravilih, ki se v EU ne tržijo (v sodelovanju s Svetovno zdravstveno organizacijo), znanstveno svetovalne skupine, razširjeno področje uporabe centraliziranega postopka itd.).
Monitor use of resources by the Agency as well as implementation of EU telematics and other information technology initiatives 
Spremljal, kako Agencija uporablja vire ter izvaja telematske in druge pobude EU na področju informacijske tehnologije.
The working party on Environmental Risk Assessment will advise the CVMP on implementation of specific requirements in the new legislation concerning any risk of undesirable effects on the environment resulting from the use of veterinary medicinal products. 
Delovna skupina za oceno tveganja za okolje bo CVMP seznanila z izvajanjem posebnih zahtev iz nove zakonodaje, ki se nanašajo na kakršno koli nevarnost neželenih učinkov na okolje, ki bi bila
Need for comments in the light of experience to be considered in 2005 
Potrebne so pripombe glede na izkušnje, ki se preučijo leta 2005
Service quality will be measured by a number of performance indicators, such as systems availability, helpdesk response times and problem resolution times 
Kakovost storitve se bo merila s številnimi kazalniki uspešnosti, kot so dostopnost sistemov, odzivni čas pomoči za uporabnike in porabljeni čas za rešitev težave.
Continuous improvement of the designation procedure 
Stalno izboljševanje postopka za določitev.
The activities in the administration area relate to a number of functions, which include managing revenue, expenditure and accounts according to existing rules and regulations, conducting recruitment procedures, and managing and administering staff and seconded personnel, as well as providing and running the necessary infrastructure services for effective functioning of the Agency. 
Dejavnosti na področju upravljanja se nanašajo na številne naloge, ki vključujejo vodenje prihodkov in odhodkov ter računov v skladu z veljavnimi pravili in predpisi, vodenje zaposlitvenih postopkov, vodenje in upravljanje zaposlenega in začasno dodeljenega osebja ter zagotavljanje in vodenje potrebnih infrastrukturnih storitev za učinkovito delovanje Agencije.
3.7 Regulatory activities 
3.7 Regulativne dejavnosti
The Committee on Herbal Medicinal Products The Committee on Herbal Medicinal Products (HMPC) will meet six times in 2005. 
Odbor za zeliščna zdravila (Committe on Herbal Medicinal Poducts, HMPC) se bo leta 2005 sestal šestkrat.
Contribution to the activities initiated by the Directorate-General for Research relating to emerging therapies and medicinal products for rare diseases and for developing countries 
Prispevek k dejavnostim, ki jih je uvedel Generalni direktorat za raziskave in se nanašajo na nove terapije in zdravila za redke bolezni ter za države v razvoju.
Further strengthening and maintenance of the quality assurance system in relation to the management of procedures and CHMP activities 
Nadaljnja krepitev in vzdrževanje sistema zagotavljanja kakovosti za vodenje postopkov in dejavnosti CHMP.
Key initiatives in this area: 
Ključne pobude na tem področju:
The Agency is in the process of revising its practices to make such information more understandable and accessible for both patients and healthcare professionals. 
Agencija izvaja revizijo svojih postopkov, da bi bile takšne informacije razumljivejše ter dostopnejše bolnikom in zdravstvenim strokovnjakom.
Dr Brasseur has held a number of teaching posts and is currently professor of nutrition and nutrition-related diseases at the Free University of Brussels. 
Dr. Brasseur je tudi veliko poučeval in je trenutno profesor prehrane in z njo povezanih bolezni na Neodvisni univerzi v Bruslju.
Implementation of the guideline on the provision of scientific opinions in the context of cooperation with the WHO 
Izvajanje smernic za zagotavljanje znanstvenih mnenj v okviru sodelovanja s Svetovno zdravstveno organizacijo.
He co-founded the International Alliance of Patient Organisations (IAPO) based in London, and served as vice-chairman from 1997 to 2000. 
Bil je soustanovitelj Mednarodne zveze organizacij bolnikov (IAPO) s sedežem v Londonu in bil od leta 1997 do 2000 njen podpredsednik.
This relates to the provision of scientific advice to sponsors during the research and development of medicinal products. 
To se nanaša na zagotavljanje znanstvenega svetovanja sponzorjem med raziskavami in razvojem zdravil.
Requests for GCP and pharmacovigilance inspections are not expected to increase from their 2004 level as the rise in number for that year was already significant 
Število zahtevkov za inšpekcijske preglede dobre klinične prakse in farmakovigilance se predvidoma ne bo povečalo ter bo ostalo na ravni iz leta 2004, saj se je že v tem letu zelo povečalo.
To improve scientific and regulatory consistency of opinions, adhere to regulatory timelines, and continue strengthening the operation of the initial evaluation procedure 
Izboljšati znanstveno in regulativno skladnost mnenj, ob upoštevanju predpisanih rokov, in nadaljevati s krepitvijo delovanja postopka začetnega vrednotenja.
Further develop the EMEA risk management strategy, in particular as regards the concept of risk management plans and further implementation of the EudraVigilance project, including the reporting of adverse drug reactions in clinical trials 
Nadaljnji razvoj strategije EMEA za obvladovanje tveganja, zlasti v zvezi s konceptom načrtov obvladovanja tveganja in nadaljnjim izvajanjem projekta EudraVigilance, vključno s poročanjem o neželenih učinkih zdravila med kliničnim preizkušanjem.
Preparatory work to provide access to dedicated information contained in the EudraVigilance database to healthcare professionals, marketing authorisation holders and the public. 
Pripravljalno delo, ki naj zagotovi dostop do namenskih informacij iz zbirke podatkov EudraVigilance zdravstvenim strokovnjakom, imetnikom dovoljenja za promet z zdravilom in javnosti.
To further implement the EMEA risk management strategy, as part of the EU risk management strategy 
Nadaljevati izvajanje strategije EMEA za obvladovanje tveganja kot sestavnega dela strategije
Guidelines for consultation on the possible adaptation of data requirements for testing medicinal products for minor uses and minor species to facilitate their further authorisation will be drafted 
Pripravili se bodo osnutki smernic za posvetovanje o možni prilagoditvi podatkovnih zahtev za preizkušanje zdravil za manjše uporabe in manj pomembne vrste, da se omogoči nadaljnje izdajanje dovoljenj.
Impact of new approach to WHO cooperation in the context of the certification scheme 
Vpliv novega pristopa k sodelovanju s Svetovno zdravstveno organizacijo v okviru certifikacijskega sistema.
50 % of fees for post-authorisation applications and annual fees 
50 % pristojbin za vloge po izdaji dovoljenja za promet in letne pristojbine.
In 1992, he became professor of clinical pharmacology and therapeutics and director of the masters/diploma course on European registration of medicinal products (UAB). 
Leta 1992 je postal profesor klinične farmakologije in terapevtike ter direktor magistrskega/diplomskega študija Evropska registracija zdravil (UAB).
To consider new and innovative ways of applying technological solutions to conducting meetings, including promoting greater use of videoconferencing and web streaming 
Preučiti nove in inovativne načine uporabe tehnoloških rešitev pri vodenju sestankov, vključno s spodbujanjem večje uporabe prenašanja prek videokonference in neprekinjenega pretoka po spletu.
50 % of fees for initial applications for marketing authorisations and inspections 
50 % pristojbin za začetne vloge za izdajo dovoljenja za promet in nadzor,
Emphasis is put on transparency, communication and information on pharmacovigilance issues. 
Poudarjeni so preglednost, sporočanje in obveščanje o vprašanjih farmakovigilance.
Establishment of a working party with the Heads of Medicines Agencies to address transparency and communication policy issues of the network 
Ustanovitev delovne skupine iz vodij agencij za zdravila, ki bo obravnavala vprašanja, povezana s politiko preglednosti in obveščanja v mreži.
In 1984, he joined the Veterinary Medicines Laboratory in Fougères where he was assessor and rapporteur for marketing authorisation dossiers. 
Leta 1984 se je pridružil Laboratoriju za veterinarska zdravila v Fougèresu, kjer je bil ocenjevalec in poročevalec za dokumentacijo za izdajo dovoljenja za promet z zdravilom.
To process parallel distribution notifications in accordance with the EMEA procedure and adhering to regulatory timelines 
Obravnavati obvestila o vzporedni distribuciji v skladu s postopkom EMEA in ob upoštevanju predpisanih rokov.
The goal is to shorten the procedure time for safety referrals 
Cilj je skrajšati čas postopka za predložitve v zvezi z varnostnimi vprašanji.
Considerations of the Scientific group to be prepared during 2005 
Premisleki Znanstvene skupine se pripravijo v letu 2005
Reporting and feedback on pharmacovigilance issues relating to centralised procedures to the Member States, interested parties and the public 
Poročanje in povratne informacije o vprašanjih farmakovigilance, ki se nanašajo na centralizirane postopke, za države članice, zainteresirane skupine in javnost.