natgillin/translations-raw huggingface dataset:
Specialist in endocrinology and metabolic diseases. 
Specialistka za endokrinologijo in metabolične bolezni.
The Agency plans to re-engineer and reinforce its processes related to meeting management. 
Agencija namerava preoblikovati in okrepiti svoj postopek vodenja sestankov.
Prior to his appointment as unit manager in pharmacovigilance, he held a number of positions in both pre- and post-authorisation areas, and was also the UK delegate to the CPMP Pharmacovigilance Working Party. 
Pred imenovanjem za vodjo Enote za farmakovigilanco je opravljal več služb na področju dejavnosti pred in po izdaji dovoljenja za promet z zdravilom ter bil tudi delegat Združenega kraljestva v Delovni skupini CPMP za farmakovigilanco.
Career to date: From 1987 to 1994, Dr Ashley-Smith was employed in the veterinary pharmaceutical industry, first as a technical adviser and subsequently as a registration manager. 
Dosedanja poklicna pot: Od leta 1987 do 1994 je bila dr. Ashley-Smithova zaposlena v farmacevtski industriji veterinarskih zdravil, najprej kot tehnična svetovalka in nato kot vodja registracije.
Possible revision in 2005 
Možna revizija v letu 2005
Interaction between the CHMP and healthcare professionals and learned societies will be further developed. 
Vzajemno delovanje med CHMP ter zdravstvenimi strokovnjaki in znanstvenimi združenji se bo še naprej razvijalo.
EU telematics strategy and information technology 
Telematska strategija EU in informacijska tehnologija
The further development and implementation of EudraVigilance will relate to appropriate methodologies for data analysis, including data warehousing and data mining supporting signal detection, as well as the coordination and provision of training to the EMEA's business partners 
Nadaljnji razvoj in izvajanje EudraVigilance se bosta nanašala na razvoj ustreznih metodologij za analizo podatkov, tudi podatkov, ki se shranijo, in podatkov, ki zavirajo odkrivanje podpornega signala, ter na usklajevanje in zagotavljanje usposabljanja za poslovne partnerje EMEA.
Following the implementation of the confidentiality arrangements with the US Food and Drug Administration, discussions will continue with the FDA regarding specific issues on the development of medicinal products 
Po začetku izvajanja dogovorov o zaupnosti, sklenjenih z Upravo za hrano in zdravila ZDA, se bodo z njo nadaljevale razprave v zvezi s posebnimi vprašanji glede razvoja zdravil.
He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994. 
Od leta 1982 do 1994 je bil višji farmacevtski svetovalec za švedski program zdravstvenega sodelovanja v Vietnamu.
The new scope encompasses medicines intended for self-medication, generic products of centrally authorised medicinal products, and biosimilar medicinal products. 
Nov obseg zajema zdravila, namenjena za samozdravljenje, generična zdravila, odobrena po centraliziranem postopku, in biološko podobna zdravila.
Introduction of the following new procedures foreseen in the new legislation: conditional marketing authorisation, accelerated assessment and compassionate use 
Uvedba naslednjih novih postopkov, ki jih predvideva nova zakonodaja: pogojna izdaja dovoljenja za promet z zdravilom, pospešena ocena in sočutna uporaba.
Career to date: From 1971 to 1974, Mr O'Malley completed articles in Dublin. 
Dosedanja poklicna pot: Od 1971 do 1974 je g. O'Malley opravljal pripravništvo v Dublinu.
Postgraduate qualifications in internal medicine (FRCP) and pharmaceutical medicine (FFPM). 
Podiplomski študij iz interne medicine (FRCP) in farmacevtske medicine (FFPM).
From 1984 to 1994, as medical director at the pharmaceutical department of the Italian Ministry of Health, she was in charge of the Operative Centre for Community Procedures, was the Italian member of the former Committee for Proprietary Medicinal Products (CPMP), and was also involved in ICH activities. 
Od 1984 do 1994 je bila kot zdravstvena direktorica na farmacevtskem oddelku italijanskega Ministrstva za zdravje odgovorna za Operativni center za postopke Skupnosti in je kot italijanska članica bivšega Odbora za lastniška zdravila sodelovala tudi pri dejavnostih ICH.
Preparation of EPAR summaries that are written so they are understandable to the public, and coordination with applicants to ensure package leaflets are similarly written in a manner comprehensible to the lay person 
Priprava povzetkov EPAR, napisanih tako, da so razumljivi javnosti, ter usklajevanje z vlagatelji, da se zagotovi, da so tudi navodila za uporabo napisana tako, da jih razumejo tudi nestrokovnjaki.
1.3 EMEA Road Map to 2010 
1.3 Usmeritveni načrt ("Road Map") EMEA do 2010
He joined the Swedish Medicinal Products Agency in 1990, serving as director of operations and later as deputy director-general. 
Leta 1990 se je pridružil švedski Agenciji za zdravila, kjer je bil poslovni direktor in kasneje namestnik generalnega direktorja.
Consequently, growing demands from the public and interested parties for access to the documents held by the Agency will have procedural and resource implications. 
Zato bo povečano povpraševanje javnosti in zainteresiranih strani po dostopu do dokumentov, ki jih ima Agencija, vplivalo na postopke in vire.
Revision to be released for public consultation by April 2005 
Revizija se da v javno posvetovanje do aprila 2005
Establishment of a dedicated forum which would include the EMEA and Member State competent authorities, as well as the Agency's stakeholders, to discuss and propose the optimal way forward in providing information to patients and healthcare professionals from the European medicines network 
Vzpostavitev namenskega pristojnega mesta, ki bi vključeval EMEA in pristojne organe držav članic ter zainteresirane strani Agencije, za razpravljanje in predlaganje najboljšega možnega prihodnjega načina za zagotavljanje informacij bolnikom in zdravstvenim strokovnjakom prek Evropske mreže zdravil.
Postgraduate studies in nutrition, statistics and methodology. 
Podiplomski študij iz prehrane, statistike in metodologije.
He is the head of the ‘Particular therapies' division, which is in charge of the pharmaceutical und clinical assessment of herbal, homeopathic and anthroposophic products. 
"posebne oblike zdravljenja", ki je pristojen za farmacevtsko in klinično ocenjevanje zeliščnih, homeopatskih in antropozofskih izdelkov.
The new requirements include the establishment of procedures for conditional marketing authorisations, accelerated assessment, compassionate use and for opinions on medicinal products intended for markets exclusively outside the EU (in collaboration with the WHO). 
Nove zahteve vključujejo vzpostavitev postopkov za izdajo pogojnih dovoljenj za promet z zdravili, pospešene ocene, sočutne uporabe ter za mnenja o zdravilih, namenjenih izključno trgom zunaj EU (v sodelovanju s Svetovno zdravstveno organizacijo).
Revision of the safety referral process in order to shorten the timeframe for finalisation of safety referral procedures 
Revizija postopka za predložitev v zvezi z varnostnimi vprašanji, da se skrajša časovni okvir za dokončanje postopkov za predložitev v zvezi z varnostnimi vprašanji.
2.9 Regulatory activities 
2.9 Regulativne dejavnosti
He has three daughters, the eldest of whom is affected by cystic fibrosis. 
najstarejša ima cistično fibrozo.
Dr Korteweg joined the EMEA in August 1997 and has acted as EMEA quality manager since July 1998. 
Dr. Kortewegova se je EMEA pridružila avgusta 1997 in je od julija 1998 njena direktorica za kakovost.
The amount of work in post-authorisation activities such as variations and line extensions will increase steadily in line with the total number of marketing authorisations. 
Obseg dela na področju dejavnosti po izdaji dovoljenja za promet z zdravilom, kot so spremembe in podaljšanje rokov, bo stalno naraščal v skladu s skupnim številom izdanih dovoljenj.
For enquiries concerning VAMF certificates 
Za vprašanja o potrdilih VAMF
The trend in applications through the centralised procedure continues, ensuring a steady supply of new and innovative medicines for veterinarians and animal owners throughout the Community 
Trendi: Pri vlogah se nadaljuje trend po centraliziranem postopku, kar zagotavlja stalno oskrbo veterinarjev in lastnikov živali z novimi in inovativnimi zdravili po vsej Skupnosti.
Career to date: Ms Fayl held various positions as a documentalist in several European countries, the latest from 1988 to 1995, setting up and running the documentation service at the European Commission Delegation in Norway. 
Faylova je imela več služb kot dokumentalistka v več evropskih državah, zadnjo od leta 1988 do 1995, ko je vzpostavila in vodila dokumentacijsko službo delegacije
Implementation of a first production version of the PIM system for 21 November 2005 
Začetek izvajanja prve proizvodne različice sistema upravljanja informacij o izdelkih 21. novembra 2005.
2.11 International activities 
2.11 Mednarodne dejavnosti
The Veterinary Unit will liaise closely with the Center for Veterinary Medicines (CVM) in the US Food and Drug Administration and with the United States Department of Agriculture to implement practical arrangements for advancing the Confidentiality Arrangements for exchange of information and documents agreed between the US and EU in late 2004. 
Veterinarska enota se bo tesno povezala s Centrom za veterinarska zdravila pri Upravi za hrano in zdravila ZDA ter z ameriškim ministrstvom za kmetijstvo pri izvajanju praktičnih rešitev za napredovanje pri dogovorih o zaupnosti za izmenjavo informacij in dokumentov, ki sta jih sklenili
Overall workload to increase compared to 2004 
Povečanje celotne delovne obremenitve v primerjavi z letom 2004.
She joined the EMEA Management Board in the same year, was elected vice-chairman in 2003 and re-elected vice-chairman following the EU enlargement in 2004. 
V istem letu se je pridružila upravnemu odboru EMEA in bila leta 2003 izvoljena za podpredsednico, leta 2004 po širitvi pa ponovno izvoljena za podpredsednico.
The increase is due in part to inspections in the context of plasma master file and vaccine antigen master file certification, but also to the effect of an increase in applications at the end of 2004 
Razlog za povečanje so deloma inšpekcijski pregledi v okviru certificiranja glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov, deloma pa povečanje števila vlog konec leta 2004.
The performance indicator for this activity is the mean time between the start of the procedure and adoption of the advice letter. 
Kazalnik uspešnosti za to dejavnost je povprečni čas, ki poteče od začetka postopka do prejema obvestila o svetovanju.
Increase in the number of travel and hotel booking requests to manage 
Povečanje števila zahtev za organiziranje potovanj in hotelske rezervacije.
Identification of areas for further improvement and implementation of necessary corrective actions 
Določiti področja, na katerih je treba nadaljevati izboljšave in začeti izvajati potrebne popravne ukrepe.
Numbers of certificate requests are expected to continue to increase as the pool of centrally authorised products is growing. 
Število zahtevkov za izdajo potrdil se bo predvidoma še naprej povečevalo, hkrati s povečevanjem števila centralno odobrenih izdelkov.
To provide support for the integration of new Member States in the GMP, GCP and GLP work of the Agency and to contribute to international cooperation and harmonisation activities 
Zagotavljati podporo pri vključevanju novih držav članic v delo Agencije na področju dobre proizvodne, klinične in laboraorijske prakse ter prispevati k mednarodnemu sodelovanju in dejavnostim usklajevanja.
The new legislation sets out the legal basis and enhanced responsibilities for the Agency in the area of scientific advice. 
Nova zakonodaja določa pravno podlago znanstvenemu svetovanju in večje pristojnosti Agencije na tem področju.
The main objective for 2005 is to manage the increased workload and issue certificates according to required timelines. 
Glavni cilj za leto 2005 je obvladovati povečano delovno obremenitev in izdajati potrdila v predpisanih rokih.
To perform high-quality activities in the field of pharmacovigilance and adhere to required timelines 
Izvajati visoko kakovostne dejavnosti na področju farmakovigilance in upoštevati zahtevane roke.
Requirement to produce financial accounts based on generally accepted accounting principles by 
Zahteva, da se z letom 2005 začnejo pripravljati finančna poročila na podlagi splošno sprejetih računovodskih načel.
Authorised for 2004 Requested for 2005 
Odobreno za 2004 Zahteve za 2005
Completion of the construction of an EU telematics data centre with high availability, high scalability and good performance 
Dokončna izgradnja telematskega podatkovnega centra EU z visoko stopnjo razpoložljivosti,
Interaction and participation through scientific meetings and training with the WHO 
Vzajemno delovanje in udeležba v Svetovni zdravstveni organizaciji prek znanstvenih srečanj in usposabljanja.
Support the implementation activities relating to GCP inspections under the Clinical Trials Directive 2001/20/EC for human medicines and the directive on GCP, in particular the implementation of the second phase of the EudraCT database 
Podpora izvedbenim dejavnostim, povezanim z inšpekcijskimi pregledi dobre klinične prakse, v skladu z Direktivo 2001/20/ES o kliničnem preizkušanju zdravil za ljudi ter direktivo o dobri klinični praksi, in zlasti izvajanju druge faze zbirke podatkov EudraCT.
Education: Diploma in conference interpretation and translation from Scuola Superiore per Interpreti, Milan. 
Izobrazba: Diplomiral iz konferenčnega tolmačenja in prevajanja na Scuoli Superiore per Interpreti v Milanu.
Career to date: From 1972 to 1974, Dr Purves worked in the pharmaceutical industry. 
Dosedanja poklicna pot: Od 1972 do 1974 je dr. Purves delal v farmacevtski industriji.
The CHMP will meet 11 times in 2005. 
CHMP bo leta 2005 zasedal enajstkrat.
Reinforcement of the scientific advice procedure to better address post-authorisation safetyrelated aspects 
Krepitev znanstveno svetovalnega postopka za boljše obravnavanje varnostnih vidikov po izdaji dovoljenja.
Establishment of a database to facilitate scientific memory analysis for all centralised applications submitted in the past 10 years, and for future applications, to allow for greater integrity, scientific quality and consistency of CVMP assessment reports 
Vzpostavitev zbirke podatkov zaradi lažjega analiziranja znanstvenega pomnilnika za vse vloge, predložene po centraliziranem postopku v zadnjih desetih letih, in za prihodnje vloge, da se omogoči večja celovitost, znanstvena kakovost in skladnost poročil CVMP o oceni zdravila.
Contribute to EU public health strategies, including those relating to influenza pandemics, tissueengineered products and paediatric medicines 
Prispevanje k strategijam EU za javno zdravje, vključno s strategijami za epidemije gripe, izdelke inženiringa tkiv in zdravila za otroke.
Following graduation with an MBA degree in 1991, she joined EFPIA, the European pharmaceutical industry association, as manager of scientific and regulatory affairs. 
MBA leta 1991 se je pridružila EFPIA, združenju evropske farmacevtske industrije kot vodja znanstvenih in regulativnih zadev.
In 1995 she joined the French Medicines Agency as head of unit for pharmaco-toxico-clinical assessment. 
Leta 1995 se je pridružila francoski Agenciji za zdravila kot vodja Enote za farmako-toksiko-klinično ocenjevanje.
The legislation places emphasis on transparency, communication and provision of information on pharmacovigilance issues. 
V zakonodaji so poudarjeni preglednost, sporočanje in obveščanje o vprašanjih farmakovigilance.
The working parties of the EMEA scientific committees responsible for medicinal products for human use are involved in the development and revision of guidelines, in the provision of recommendations and advice on medicinal products for which applications are made, and in marketing authorisation or post-authorisation activities, according to the specific area of responsibility of each group. 
Delovne skupine znanstvenih odborov EMEA, pristojne za zdravila za uporabo v humani medicini, so vključene v pripravo in revizijo smernic, zagotavljanje priporočil in nasvetov glede zdravil, za katera so oddane vloge, dejavnosti med pridobivanjem dovoljenja za promet in dejavnosti po izdaji tega dovoljenja, v skladu s posebnim področjem pristojnosti posameznih skupin.
Career to date: From 1978 to 1983, research fellow at the State University of Rome on projects in the area of clinical immunology, oncology and cellular immunology. 
Dosedanja poklicna pot: Od leta 1978 do 1983 znanstvena sodelavka na Državni univerzi v Rimu pri projektih s področja klinične imunologije, onkologije in celične imunologije.
Publication of summaries of opinion for those post-authorisation activities which have an important impact on the use of the medicinal product; regular updating of European public assessment reports and publication of press releases regarding major post-authorisation activities 
Objava povzetkov mnenj o tistih dejavnostih po izdaji dovoljenja, ki pomembno vplivajo na uporabo zdravila, sprotno dopolnjevanje evropskih javnih poročil o oceni ter objava sporočil za javnost o pomembnih dejavnostih po izdaji dovoljenja.
Achievement of consensus with the Agency's partners and stakeholders on the most adequate way to provide information on medicines to patients and healthcare professionals 
Dosega soglasja s partnerji Agencije in zainteresiranimi stranmi glede najustreznejšega načina zagotavljanja informacij o zdravilih bolnikom in zdravstvenim strokovnjakom.
Establishment of scientific advisory groups in the new mandatory therapeutic areas 
Ustanovitev znanstveno svetovalnih skupin na novih obveznih terapevtskih področjih.
To provide targeted, useful and accessible information to patients and healthcare professionals about the medicine-related aspects of the work of the Agency 
Zagotavljati bolnikom in zdravstvenim strokovnjakom ciljno naravnane, uporabne in dostopne informacije o vidikih dela Agencije, povezanih z zdravili.
Other TOTAL REVENUE 
Drugo PRIHODKI SKUPAJ
The EMEA coordinates the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the European Community, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation. 
EMEA usklajuje preverjanje skladnosti z načeli dobre proizvodne prakse, dobre klinične prakse in dobre laboratorijske prakse ter z določenimi vidiki nadzorovanja zdravil, za katera je bilo izdano dovoljenje za promet in se uporabljajo v Evropski skupnosti, z inšpekcijskimi pregledi, ki jih zahtevata CHMP ali CVMP v zvezi z oceno vlog za izdajo dovoljenja za promet in/ali oceno zadev, ki so bile tema odboroma predložene v skladu z zakonodajo Skupnosti.
The major priority for 2005 will be to prepare for the implementation of the pharmaceutical legislative review, in particular the new requirements for GMP for starting materials and the setting-up of a database on manufacturing authorisations and GMP certificates 
Najpomembnejša prednostna naloga za leto 2005 bo priprava na izvajanje farmacevtskega zakonodajnega pregleda, zlasti novih zahtev za dobro proizvodno prakso za vhodne snovi ter vzpostavitev zbirke podatkov o dovoljenjih za izdelavo in potrdilih odobri proizvodni praksi.
Postgraduate studies in pharmacology at the Universities of Melbourne and Auckland. 
Podiplomski študij iz farmakologije na Univerzi v Melbournu in Aucklandu.
Unit for Veterinary medicines and inspections 
Enota za veterinarska zdravila in inšpekcijske preglede
Postgraduate studies in management, leadership and administration. 
Podiplomski študij iz managementa, vodenja in upravljanja.
Establishment of a procedure for publication of information on withdrawal of applications and refusal of Community marketing authorisations 
Vzpostavitev postopka za objavljanje informacij o umiku vlog in zavrnitvi izdaje dovoljenja Skupnosti za promet z zdravilom.
Priorities for veterinary medicines in 2005: 
Prednostne naloge za veterinarska zdravila v letu 2005:
Main CHMP standing and temporary working parties in 2005 
Glavne stalne in začasne delovne skupine CHMP v letu 2005
Applications received (non-orphan medicines) Applications received (orphan medicines) 
Prejete vloge (za zdravila, ki niso zdravila sirote) Prejete vloge (za zdravila sirote)
Guideline to be developed after consultation of concept paper 
Smernica se pripravi po posvetovanju o idejnem dokumentu
Expenditure on data processing Other capital expenditure Postage and communications Other administrative expenditure 
Objekti/oprema Najemnina/odhodek Odhodki za obdelavo podatkov Drugi odhodki za naložbe Poštnine in obveščanje Drugi odhodki za poslovanje
Cooperation on the ICH/FDA initiative on quality systems/GMP is expected to build on the need for interaction between GMP inspectors and quality assessors 
Sodelovanje pri pobudi ICH/FDA za sisteme kakovosti/dobro proizvodno prakso naj bi predvidoma temeljilo na potrebi po medsebojnem delovanju inšpektorjev za dobro proizvodno prakso in ocenjevalcev kakovosti.
These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports), follow-up measures, specific obligations, annual reassessments and renewal applications. 
Sem spadajo dejavnosti, povezane z obveščanjem o farmakovigilanci (poročila o neželenih učinkih zdravil in periodično dopolnjena poročila o njihovi varnosti), nadaljnji ukrepi, posebne obveznosti, vloge za vsakoletno ponovno oceno in podaljšanje.
Postgraduate studies in management and health economics. 
Podiplomski študij iz managementa in zdravstvene ekonomike.
The Committee will implement its newly adopted procedure intended to facilitate communication and dialogue between the Committee and interested parties, to fulfil obligations set out in the new legislation by putting in place the necessary arrangements to organise such exchanges and improve transparency as appropriate. 
namenjen lažjemu sporazumevanju in dogovarjanju med odborom in zainteresiranimi stranmi, da bo izpolnil obveznosti iz nove zakonodaje s sprejetjem potrebnih dogovorov za organiziranje takšnih izmenjav in ustrezno izboljšanje preglednosti.
Discussion of comments received on revision to be released for public consultation in 2005 
Obravnavanje pripomb, prejetih v zvezi z revizijo, ki se da v javno posvetovanje leta 2005
Specialist in internal medicine and clinical pharmacology. 
Specialist interne medicine in klinične farmakologije.
Objectives and key initiatives: 
Cilji in ključne pobude:
Continuous monitoring of the impact of scientific advice on the outcome of applications for marketing authorisations and analysis as part of the scientific memory and scientific advice databases 
Stalno spremljanje vpliva znanstvenega svetovanja na rešitev vlog za izdajo dovoljenja za promet in analiziranje v okviru zbirk podatkov znanstvenega pomnilnika in znanstvenega svetovanja.
From 1993 to 1994 he acted as the vice-chairman of the EFTA Expert Group on Pharmaceuticals and from 1994 to 1995 as the chairman of the Nordic Council on Medicines. 
Od leta 1993 do 1994 je bil podpredsednik Izvedenske skupine EFTE za farmacevtske izdelke, od leta 1994 do 1995 pa predsednik Nordijskega sveta za zdravila.
Her responsibilities there included coordination of ICH activities, relations with the FDA, pharmaceutical aspects of mutual recognition agreements, GMP and inspection-related matters, orphan medicinal products, preparatory work on a regulation on paediatric medicinal products and issues relating to EU enlargement. 
Njene tamkajšnje odgovornosti so vključevale usklajevanje dejavnosti za ICH, odnose s FDA, farmacevtske vidike sporazumov o medsebojnem priznavanju, dobro proizvodno prakso in zadeve, povezane z inšekcijskimi pregledi, zdravila sirote, pripravljalno delo za pravno ureditev zdravil za otroke ter vprašanja v zvezi s širitvijo