natgillin/translations-raw huggingface dataset:
To increase the quality and the regulatory and scientific consistency of the evaluation of applications for line extensions, variations to and transfers of marketing authorisations, and adhere to regulatory timelines 
Izboljšati kakovost ter regulativno in znanstveno doslednost pri presojanju vlog za podaljšanje rokov, spremembe in prenose dovoljenj za promet z zdravilom ter upoštevati predpisane roke.
Career to date: Dr Saint Raymond held a position as paediatrician in a teaching paediatric hospital in Paris, followed by a number of years working for a number of pharmaceutical companies. 
Dosedanja poklicna pot: Dr. Saint Raymondova je bila pediatrinja v pediatrični poučevalni bolnišnici v Parizu, nato pa je več let delala za številne farmacevtske družbe.
He was first elected chairman of the CVMP in January 2003 and was re-elected in 2004. 
Za predsednika CVMP je bil prvič izvoljen januarja 2003, leta 2004 pa je bil izvoljen ponovno.
The legislation also requires the Agency to provide information on withdrawal of an application by an applicant prior to opinion, and on refusal of marketing authorisation. 
Zakonodaja od Agencije tudi zahteva, da zagotavlja informacije o umiku vloge s strani vlagatelja pred izdajo mnenja in o zavrnitvi izdaje dovoljenja za promet z zdravilom.
Career to date: From 1981 to 1984, Dr Moulin worked in the Bovine Pathology Laboratory in Lyon. 
Dosedanja poklicna pot: Dr. Moulin je od leta 1981 do 1984 delal v patološkem laboratoriju za govedo v Lyonu.
Technical Requirements for Blood and Blood Components (including those used for medicinal products derived from human blood and plasma) 
Blood Components (including those used for medicinal products derived
Nine applications for renewal of marketing authorisation are forecast for 2005 
Za leto 2005 se predvideva devet vlog za obnovo dovoljenja za promet z zdravilom.
To increase the quality, as well as the regulatory and scientific consistency, of the outcome of the scientific review. 
Izboljšati kakovost ter regulativno in znanstveno doslednost ugotovitev strokovne presoje.
Continuous collaboration with the Directorate-General for Enterprise on development of legislation relating to paediatric medicines, tissue engineering and the provision of information to the public 
Stalno sodelovanje z Generalnim direktoratom za gospodarstvo pri razvoju zakonodaje za zdravila za otroke in inženiring tkiv ter obveščanju javnosti.
Education: Qualified in medicine from Sheffield University in 1983. 
Izobrazba: Diplomiral iz medicine na Univerzi v Sheffieldu leta 1983.
Preparation of draft Community herbal monographs for herbal medicinal products with a wellestablished use 
Priprava osnutkov zeliščnih monografij Skupnosti za zeliščna zdravila z dobro uveljavljeno uporabo.
The performance indicator for this objective is the percentage of responses provided within 14 days. 
Kazalnik uspešnosti za ta cilj je odstotek odgovorov, zagotovljenih v štirinajstih dneh.
The new legislation sets forth provisions for the implementation of a risk management system as well as the possibility to set up a system of permanent follow-up of the risk/benefit balance. 
V novi zakonodaji so navedene določbe za izvajanje sistema obvladovanja tveganja in za možnost vzpostavitve sistema stalnega spremljanja razmerja med tveganji in koristmi.
Priorities for inspections in 2005: 
Prednostne naloge inšpekcijskega nadzora v letu 2005:
A*16 A*15 A*14 A*13 A*12 A*11 A*10 A*9 A*8 A*7 A*6 A*5 Total grade A B*11 B*10 B*9 B*8 B*7 B*6 B*5 B*4 B*3 Total grade B C*7 C*6 C*5 C*4 C*3 C*2 C*1 Total grade C D*5 D*4 D*3 D*2 Total grade D Total Staff 
A*16 A*15 A*14 A*13 A*12 A*11 A*10
Reimbursed meetings Videoconferences 
Sestanki s povrnjenimi stroški Videoconference
To improve transparency and provision of designation-related information to patients and other interested parties 
Izboljšati preglednost in zagotavljanje informacij o določitvi bolnikom in drugim zainteresiranim stranem.
3.3 Establishment of maximum residue limits 
3.3 Določitev mejne vrednosti ostankov (MRL)
MSc in social and regulatory pharmacy. 
Magisterij iz socialne in regulativne farmacije.
In 1994, she joined the UK Veterinary Medicines Directorate as senior veterinary assessor in the pharmaceuticals and feed additives team. 
Leta 1994 se je pridružila Direktoratu Združenega kraljestva za veterinarska zdravila kot višja veterinarska ocenjevalka v skupini za farmacevtske izdelke in krmne dodatke.
The EMEA and the CVMP will play an important part in contributing to the drafting of a new regulation and subsequent guidelines on residue control of veterinary medicines in food animals to succeed Council Regulation 2377/90 
EMEA in CVMP bosta imela pomembno vlogo pri pripravi osnutka nove uredbe o nadzorovanju ostankov veterinarskih zdravil v živalih za prehrano ter nadaljnjih smernic, ki bodo nasledile Uredbo
Education: Law degree from the University of Pavia, Italy; PhD in European Law from the European University Institute of Florence, Italy; Avvocato, chair professor of international law. 
Izobrazba: Diploma iz prava na Univerzi v Pavii, Italija, doktorat iz evropskega prava na Evropskem univerzitetnem inštitutu v Firencah, Italija, Avvocato, redni profesor mednarodnega prava.
Professor Wahlroos had a central role in the pharmaceutical sector in the preparations for the accession of Finland to the EU in 1995. 
Prof. Wahlroos je imel osrednjo vlogo na farmacevtskem področju v pripravah na pristop
Professor Wahlroos was appointed director-general of the National Agency for Medicines (NAM) in 1993. 
Leta 1993 je bil prof. Wahlroos imenovan za generalnega direktorja Nacionalne agencije za zdravila.
He has been executive director of the EMEA since January 2001. 
Izvršni direktor EMEA je od januarja 2001.
Adopt rules for the implementation of the staff regulations 
Sprejel pravila za izvajanje kadrovskih predpisov.
To implement the new legislative requirements and increase the quality of assessment of such applications and adhere to regulatory timelines 
Izvajati zahteve nove zakonodaje in izboljšati kakovost ocen takšnih vlog ter upoštevati predpisane roke.
Preparation for progressive submission of applications for emerging therapies and new technologies, and for applications for self-medication and generic products 
Priprava na postopno predlaganje vlog za nove terapije in tehnologije ter vlog za samozdravljenje in generične izdelke.
Education: Master's degree in political science, history and English from the University of Hamburg. 
Izobrazba: Magisterij iz političnih znanosti, zgodovine in angleščine na Univerzi v Hamburgu.
Career to date: Ms Nuttall held several posts in the Irish Civil Service, serving in the Departments of Health, Finance and the Office of Public Works. 
Nuttallova je imela več služb v irski državni upravi, delala je na Oddelku za zdravje, finance in v Uradu za javna dela.
The goal is to encourage all applicants in the field of new technologies and therapies to receive scientific advice 
Cilj je spodbujati vse vlagatelje k iskanju znanstvenega svetovanja na področju novih tehnologij in terapij.
Establishment of processes for preparation of summaries of EPARs written in a manner that is understandable to the public 
Vzpostavitev postopkov za pripravo povzetkov EPAR-ov, napisanih tako, da so razumljivi javnosti.
Career to date: From 1981 to 1983, Dr Abadie held a number of clinical and laboratory positions, before joining the pharmaceutical industry in 1983. 
Dosedanja poklicna pot: Dr. Abadie je od 1981 do 1983 delal na različnih delovnih mestih na klinikah in v laboratorijih, preden se je leta 1983 pridružil farmacevtski industriji.
Preparation for inclusion of new mandatory therapeutic areas within the scope of the centralised procedure 
Priprava na vključitev novih obveznih terapevtskih področij v obseg uporabe centraliziranega postopka.
Career to date: Dr Pittner worked in the pharmaceutical industry from 1972 to 1985 where he discovered the pharmacological properties of the beta 1 - adrenoceptor antagonist celiprolol. 
Dosedanja poklicna pot: Od 1972 do 1985 je dr. Pittner delal v farmacevtski industriji, kjer je odkril farmakološke značilnosti beta 1 - adrenoceptorja antagonista celiprolola.
This relates to the provision of scientific advice and protocol assistance to sponsors during the research and development of medicinal products. 
To se nanaša na zagotavljanje znanstvenega svetovanja in pomoči pri protokolu sponzorjem med raziskavami in razvojem zdravil.
He joined the EMEA in 1995 as principal scientific administrator and from 1996 to 1998 he was head of sector for new chemical substances. 
1995 kot odgovorni znanstveni administrator, od leta 1996 do 1998 pa je bil vodja sektorja za nove kemične snovi.
Organisation of a dedicated workshop in the field of human medicines to discuss information and communication issues with healthcare professionals 
Organiziranje namenske delavnice na področju zdravil za ljudi, da se z zdravstvenimi strokovnjaki obravnavajo vprašanja obveščanja in sporočanja.
Postgraduate degrees in tropical medicine, clinical research and epidemiology. 
Podiplomski študij iz tropske medicine, kliničnih raziskav in epidemiologije.
Invented Name Review Group 
Skupina za presojo izmišljenih imen
Electronic reporting of adverse reactions in the veterinary sector will begin in January 2005 for the competent authorities, which will see a growth in development of electronic reporting by marketing authorisation holders as well 
Januarja 2005 bodo pristojni organi začeli izvajati elektronsko poročanje o neželenih učinkih v veterinarskem sektorju, povečal se bo tudi obseg elektronskega poročanja imetnikov dovoljenj za promet z zdravilom.
Consolidation of the new Staff Regulations 
Utrditev novih kadrovskih predpisov.
TEMPORARY POSTS 
ZAČASNA DELOVNA MESTA
Type I variations continue to grow in line with total marketing authorisations, with 25 anticipated for 2005. 
Število vlog za spremembe tipa I še naprej narašča v skladu s skupnim številom izdanih dovoljenj, za leto 2005 se jih pričakuje 25.
Education: Degree in analytical chemistry from the University of Amsterdam, 1984, followed by a PhD in biochemistry from the University of Amsterdam, 1988. 
Izobrazba: Diplomiral iz analitične kemije na Univerzi v Amsterdamu leta 1984, sledil je doktorat iz biokemije na Univerzi v Amsterdamu leta 1988
Postgraduate qualifications in internal medicine, endocrinology, diabetology and cardiology. 
Podiplomsko usposabljanje iz interne medicine, endokrinologije, diabetologije in kardiologije.
He was director of medical affairs of the French pharmaceutical trade association from 1985 to 1993 and returned to industry until 1994. 
Od 1985 do 1993 je bil direktor za zdravstvene zadeve francoskega farmacevtskega panožnega združenja, nato pa se je do leta 1994 vrnil v farmacevtsko industrijo.
Internal guideline to be developed 
Pripravi se notranja smernica
Finalisation of recommendations under development by the EMEA/CHMP Working Party with Patients' Organisations 
Dokončno oblikovanje priporočil, ki jih razvija Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov.
To provide support to the implementation of the clinical trials legislation, in particular with respect to GCP inspection 
Zagotavljati podporo izvajanju zakonodaje o kliničnem preizkušanju, zlasti v zvezi z inšpekcijskimi pregledi dobre klinične prakse.
To prepare for provision of specialised support to small and medium-sized companies 
Pripraviti se na zagotavljanje posebne podpore majhnim in srednje velikim podjetjem.
The continuing responsibility for the organisation and support of the Veterinary Joint Implementation Group, the coordination of training, and the management of registration applications for access to EudraVigilance, as well as data collection, analysis, reporting and communication of electronic adverse reactions received from 1 January 2005, will place significant burdens on the small pharmacovigilance group in the veterinary sector. 
Stalna odgovornost za organiziranje in podporo veterinarski skupini za skupno izvajanje, usklajevanje usposabljanja, obravnavanje vlog za registracijo za dostop do EudraVigilance, zbiranje podatkov, analiziranje ter poročanje in obveščanje o neželenih učinkih, prejetih v elektronski obliki po 1. januarju 2005, bo precej obremenila majhno skupino za farmakovigilanco
Work programme for the European Medicines Agency 
Delovni program Evropske agencije za zdravila
He joined the EMEA in August 1996 as head of sector for biotechnology and biologicals. 
EMEA se je pridružil avgusta 1996 kot vodja Sektorja za biotehnološke in biološke izdelke.
Education: Graduate in chemical engineering from the Technical University of Denmark. 
Izobrazba: Diplomirala je iz kemijskega inženiringa na Tehnični univerzi na Danskem.
26 May 
26. maj
Member of the UK Royal College of Veterinary Surgeons. 
Članica Kraljevske akadenmije veterinarjev v Združenem kraljestvu.
3.5 Pharmacovigilance and maintenance activities 
3.5 Farmakovigilanca in vzdrževalne dejavnosti
Therefore, there will be increased follow-up and assessment of designation criteria at the time of marketing authorisation 
Zato se bo med izdajanjem dovoljenja za promet bolj spremljalo in ocenjevalo merila za določitev.
Marijke Korteweg, Integrated quality management adviser, b. 29 May 1947, n. Belgian 
Marijke Korteweg, svetovalka za integrirano upravljanje kakovosti, roj. 29. maja 1947,
Annex 5 Profiles of EMEA personalities 
Priloga 5 Osnovni podatki o osebju EMEA
Career to date: Tim Buxton completed articles with Touche Ross & Co. in London in 1987. 
Dosedanja poklicna pot: Tim Buxton je leta 1987 opravil pripravništvo pri Touche Ross & Co v
He is a former Belgian member of both the CPMP and CVMP and representative on the Pharmaceutical Committee, Standing Committee and Notice to Applicants working group. 
CPMP in CVMP in predstavnik v Farmacevtskem odboru, Stalnem odboru in Delovni skupini za obvestila vlagateljem.
To be finalised (with SWP) following end of public consultation 
Dokončno se oblikuje (skupaj z delovno skupino za varnost) po zaključenem javnem posvetovanju
Core SPC released for further consultation in 2004 and to be finalised in 2005 
Osnovni SPC sproščen za nadaljnje posvetovanje leta 2004 in predvidoma dokončno oblikovan leta 2005
Dr Tsintis joined the EMEA as head of sector, pharmacovigilance and post-authorisation safety and efficacy of medicines in March 
Dr. Tsintis se je EMEA pridružil kot vodja Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet marca 2002.
6.1 Administration 
6.1 Upravljanje
He was appointed a member of the CHMP in 1997. 
Leta 1997 je bil imenovan za člana CPMP.
As part of this plan: 9 The Agency will carry out additional work to considerably widen the original scope of the EuroPharm database of information on all medicines authorised in the EU. 
Agencija bo opravila dodatno delo za precejšnjo razširitev prvotnega obsega zbirke podatkov EuroPharm o informacijah o vseh zdravilih v EU z dovoljenjem za promet.
The certification of these Master Files in a system analogous to the centralised procedure leads to the issuance by the EMEA of a certificate of compliance with Community legislation that is valid throughout the European Community. 
Certificiranje teh glavnih dosjejev v sistem, podoben centraliziranemu postopku, vodi k izdaji potrdila o skladnosti z zakonodajo
PhD in public health from the University of Bordeaux. 
Doktoriral iz javnega zdravja na Univerzi v Bordeauxu.
Guideline on the clinical requirements for locally applied, locally acting products containing known constituents 
Guideline on the clinical requirements for locally applied, locally acting
Key initiatives: 
Ključne pobude:
Career to date: From 1973 to 1979, Professor Wahlroos served as a pharmacist and a researcher in several pharmacies, at the University of Helsinki and in the pharmaceutical industry. 
Dosedanja poklicna pot: Od 1973 do 1979 je prof. Wahlroos delal kot farmacevt in raziskovalec v več lekarnah, na Univerzi v Helsinkih in farmacevtski industriji.
In anticipation of the EU legislation on paediatric medicines, which could be adopted in 2006, the Agency will continue to support the Paediatric Working Party in its work with individual companies to discuss the development of paediatric formulations and its work on the availability of information on medicines for use in children 
Agencija bo v pričakovanju zakonodaje EU za otroška zdravila, ki bi bila lahko sprejeta leta 2006, še naprej podpirala Pediatrično delovno skupino in njeno delo s posameznimi podjetji zaradi
Under discussion in view of revised pharmaceutical legislation 
V razpravi zaradi spremenjene farmacevtske zakonodaje
Special EU contribution for IT Telematics strategy 
Splošni prispevek EU Posebni prispevek EU za IT in telematsko strategijo
Education: Master's degree in business administration from the Institut Superieur de Gestion in Paris. 
Izobrazba: Magisterij iz poslovne administracije na Inštitutu Superieur de Gestion v Parizu.
He joined the EMEA in August 1996 as head of sector for regulatory affairs and pharmacovigilance and was appointed head of the Human Medicines Evaluation Unit in September 2000. 
EMEA se je pridružil avgusta 1996 kot vodja Sektorja za regulativne zadeve in farmakovigilanco, septembra 2000 pa je bil imenovan za vodjo Enote za vrednotenje zdravil za ljudi.
The number of initial applications for a marketing authorisation is expected to stabilise in 2005. 
Število začetnih vlog za izdajo dovoljenja za promet z zdravilom se bo predvidoma v letu 2005 ustalilo.
Postgraduate diploma in European Community law from King's College London. 
Dokončala podiplomski študij iz zakonodaje Evropske skupnosti na Kraljevem kolidžu v Londonu.
9 To provide for safe use of medicinal products, the Agency will reinforce its activities in the area of pharmacovigilance, in particular the EudraVigilance database and the implementation of the EMEA risk management strategy for medicines for human use. 
Agencija bo za zagotovitev varne uporabe zdravil okrepila svoje dejavnosti na področju farmakovigilance, zlasti pri zbirki podatkov EudraVigilance in izvajanju strategije obvladovanja tveganja pri zdravilih za uporabo v humani medicini.
He was appointed acting deputy head of sector for scientific advice and orphan drugs in October 2004. 
Oktobra 2004 je bil imenovan za vršilca dolžnosti namestnika vodje Sektorja za znanstveno svetovanje in zdravila sirote.
Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b. 12 December 1961, n. Irish 
Tony Humphreys, vodja Sektorja za regulativne zadeve in organizacijsko podporo, roj. 12. decembra 1961, po narodnosti Irec
Implementation of the EU risk management strategy 
Izvajanje strategije EU za obvladovanje tveganja.
The achievement of these objectives will be monitored through key performance indicators, such as systems availability, response times and on-time delivery, within budget and to specifications, for new or improved information systems 
Doseganje teh ciljev bodo pri novih ali izboljšanih informacijskih sistemih spremljali ključni kazalniki uspeha, kot so dostopnost sistemov, odzivni čas in pravočasna dostava v okviru proračuna in po specifikacijah.
The legislative basis of pharmacovigilance inspections is now provided. 
Zakonska podlaga inšpekcijskih pregledov farmakovigilance je zdaj zagotovljena.
Career to date: Ms Cooke worked in a number of positions within the Irish pharmaceutical industry before joining the Irish Medicines Board as a pharmaceutical assessor in 1988. 
Cooke je imela več služb v irski farmacevtski industriji, preden se je 1988 pridružila Irskemu odboru za zdravila kot ocenjevalka farmacevtskih izdelkov.
From 1990 to 1994, he was technical counsellor in clinical evaluation and pharmacology at the Spanish Ministry of Health, a member of the CPMP Efficacy Working Party and involved in the Efficacy Group of the ICH. 
do 1994 je bil tehnični svetovalec za klinično ocenjevanje in farmakologijo pri španskem Ministrstvu za zdravje, član Delovne skupine CPMP za učinkovitost, sodeloval je tudi pri Skupini ICH za učinkovitost.
Priorities for medicines for human use in 2005: 
Prednostne naloge zdravil za uporabo v humani medicini v letu 2005:
Category & Grade 
Skupina in stopnja
Education: Qualified pharmacist and degree in medicine and surgery from the University of Barcelona, as well as postgraduate courses in pharmacology and toxicology, public health and European institutions. 
Izobrazba: Diplomiral iz farmacije ter medicine in kirurgije na Univerzi v Barceloni, podiplomski študij iz farmakologije in toksikologije, javnega zdravja in evropskih institucij.
The legislative basis for pharmacovigilance inspections is now provided. 
Zakonska podlaga za inšpekcijske preglede farmakovigilance je zdaj zagotovljena.
Dr Pittner joined the Herbal Medicinal Products Working Party (HMPWP) in 1999 and was vice-chairman of the HMPWP from 2002 until 2004. 
1999 pridružil Delovni skupini za zeliščna zdravila (HMPWP) in bil od 2002 do 2004 njen podpredsednik.
The performance indicator for this objective is the percentage of applications evaluated within the 30, 60 or 90-day timeline (depending on the procedure). 
Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v 30-, 60- ali 90-dnevnem roku (odvisno od postopka).
Josep Torrent i Farnell, Chairman of the COMP, b. 2 May 1954, n. Spanish 
Josep Torrent i Farnell, predsednik COMP, roj. 2. maja 1954, po narodnosti Španec
Education: Qualified as a medical doctor in Rome in July 1978. 
Izobrazba: Diplomirala iz splošne medicine julija 1978 v Rimu.
To provide timely and understandable product information to patients and healthcare professionals 
Zagotavljati pravočasne in razumljive informacije o izdelkih bolnikom in zdravstvenim strokovnjakom.
Miss Leivers joined the EMEA in February 1996 and was appointed deputy head of sector in June 2001. 
Gospodična Leiversova se je EMEA pridružila februarja 1996 in bila junija 2001 imenovana za namestnico vodje Sektorja.
Enhancement of liaison with working parties of CHMP and scientific advisory groups 
Okrepitev povezovanja z delovnimi skupinami CHMP in znanstveno svetovalnimi skupinami.
He has been a CVMP member since 1997; he was elected vice-chairman of the CVMP in 2001. 
Član CVMP je od leta 1997, leta 2001 je bil izvoljen za njegovega podpredsednika.
He moved briefly to the pharmaceutical industry from 1986 to 1987, before returning to clinical work at the Queen Fabiola Children's University Hospital in Brussels as head of the nutrition and pharmacodynamics unit, a post he continues to hold today. 
preden se je vrnil h kliničnemu delu v Univerzitetni otroški bolnišnici kraljice Fabiole v Bruslju kot vodja enote za prehrano in farmakodinamiko; na tem delovnem mestu je še danes.
To be finalised following end of consultation, the revision and update of 3AQ10a 
Dokončno se oblikuje po zaključenem posvetovanju, revizija in posodobitev
As a result of the initiatives in the area of transparency and communication, patients, healthcare professionals, academia, learned societies, the pharmaceutical industry and other stakeholders will have faster, easier access to a wider range of information regarding the activities of the Agency and the network. 
akademski sveti, poklicna združenja, farmacevtska industrija in druge zainteresirane strani hitrejši in enostavnejši dostop do večjega obsega informacij o dejavnostih Agencije in mreži.
He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997. 
Leta 1997 se je pridružil farmacevtskemu inšpektoratu belgijskega ministrstva za javno zdravje kot vodja ocenjevalcev zdravil.
25-28 July 
25.-28. julij
Publication of summaries of opinion at the time of adoption by the CVMP Regular updating of EPARs in the post-authorisation phase for procedural and scientific aspects 
Redno posodabljanje poročil EPAR v fazi po izdaji dovoljenja zaradi postopkovnih in znanstvenih vidikov.
He joined the EMEA as head of the legal sector in November 2004. 
EMEA se je pridružil novembra 2004 kot vodja Pravnega sektorja.