FrancophonIA/ELRC3.0 huggingface dataset:
English: To implement the new legislative requirements and increase the quality of assessment of such applications and adhere to regulatory timelines
Slovenian: Izvajati zahteve nove zakonodaje in izboljšati kakovost ocen takšnih vlog ter upoštevati predpisane roke.
English: Preparation for progressive submission of applications for emerging therapies and new technologies, and for applications for self-medication and generic products
Slovenian: Priprava na postopno predlaganje vlog za nove terapije in tehnologije ter vlog za samozdravljenje in generične izdelke.
English: Education: Master's degree in political science, history and English from the University of Hamburg.
Slovenian: Izobrazba: Magisterij iz političnih znanosti, zgodovine in angleščine na Univerzi v Hamburgu.
English: 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.
Slovenian: Nuttallova je imela več služb v irski državni upravi, delala je na Oddelku za zdravje, finance in v Uradu za javna dela.
English: The goal is to encourage all applicants in the field of new technologies and therapies to receive scientific advice
Slovenian: Cilj je spodbujati vse vlagatelje k iskanju znanstvenega svetovanja na področju novih tehnologij in terapij.
English: Establishment of processes for preparation of summaries of EPARs written in a manner that is understandable to the public
Slovenian: Vzpostavitev postopkov za pripravo povzetkov EPAR-ov, napisanih tako, da so razumljivi javnosti.
English: Career to date: From 1981 to 1983, Dr Abadie held a number of clinical and laboratory positions, before joining the pharmaceutical industry in 1983.
Slovenian: 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.
English: Preparation for inclusion of new mandatory therapeutic areas within the scope of the centralised procedure
Slovenian: Priprava na vključitev novih obveznih terapevtskih področij v obseg uporabe centraliziranega postopka.
English: 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.
Slovenian: Dosedanja poklicna pot: Od 1972 do 1985 je dr. Pittner delal v farmacevtski industriji, kjer je odkril farmakološke značilnosti beta 1 - adrenoceptorja antagonista celiprolola.
English: This relates to the provision of scientific advice and protocol assistance to sponsors during the research and development of medicinal products.
Slovenian: To se nanaša na zagotavljanje znanstvenega svetovanja in pomoči pri protokolu sponzorjem med raziskavami in razvojem zdravil.
English: He joined the EMEA in 1995 as principal scientific administrator and from 1996 to 1998 he was head of sector for new chemical substances.
Slovenian: 1995 kot odgovorni znanstveni administrator, od leta 1996 do 1998 pa je bil vodja sektorja za nove kemične snovi.
English: Organisation of a dedicated workshop in the field of human medicines to discuss information and communication issues with healthcare professionals
Slovenian: Organiziranje namenske delavnice na področju zdravil za ljudi, da se z zdravstvenimi strokovnjaki obravnavajo vprašanja obveščanja in sporočanja.
English: Postgraduate degrees in tropical medicine, clinical research and epidemiology.
Slovenian: Podiplomski študij iz tropske medicine, kliničnih raziskav in epidemiologije.
English: Invented Name Review Group
Slovenian: Skupina za presojo izmišljenih imen
English: 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
Slovenian: 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.
English: Consolidation of the new Staff Regulations
Slovenian: Utrditev novih kadrovskih predpisov.
English: TEMPORARY POSTS
Slovenian: ZAČASNA DELOVNA MESTA
English: Type I variations continue to grow in line with total marketing authorisations, with 25 anticipated for 2005.
Slovenian: Število vlog za spremembe tipa I še naprej narašča v skladu s skupnim številom izdanih dovoljenj, za leto 2005 se jih pričakuje 25.
English: Education: Degree in analytical chemistry from the University of Amsterdam, 1984, followed by a PhD in biochemistry from the University of Amsterdam, 1988.
Slovenian: Izobrazba: Diplomiral iz analitične kemije na Univerzi v Amsterdamu leta 1984, sledil je doktorat iz biokemije na Univerzi v Amsterdamu leta 1988
English: Postgraduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Slovenian: Podiplomsko usposabljanje iz interne medicine, endokrinologije, diabetologije in kardiologije.
English: He was director of medical affairs of the French pharmaceutical trade association from 1985 to 1993 and returned to industry until 1994.
Slovenian: 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.
English: Internal guideline to be developed
Slovenian: Pripravi se notranja smernica
English: Finalisation of recommendations under development by the EMEA/CHMP Working Party with Patients' Organisations
Slovenian: Dokončno oblikovanje priporočil, ki jih razvija Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.eu.int http://www.emea.eu.int
Slovenian: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 09
English: To provide support to the implementation of the clinical trials legislation, in particular with respect to GCP inspection
Slovenian: Zagotavljati podporo izvajanju zakonodaje o kliničnem preizkušanju, zlasti v zvezi z inšpekcijskimi pregledi dobre klinične prakse.
English: To prepare for provision of specialised support to small and medium-sized companies
Slovenian: Pripraviti se na zagotavljanje posebne podpore majhnim in srednje velikim podjetjem.
English: 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.
Slovenian: 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
English: Work programme for the European Medicines Agency
Slovenian: Delovni program Evropske agencije za zdravila
English: He joined the EMEA in August 1996 as head of sector for biotechnology and biologicals.
Slovenian: EMEA se je pridružil avgusta 1996 kot vodja Sektorja za biotehnološke in biološke izdelke.
English: Note for Guidance on Quality, Preclinical and Clinical Aspects of Gene Transfer Medicines - Lentiviral Vectors
Slovenian: Note for Guidance on Quality, Pre clinical and Clinical Aspects of Gene Transfer Medicines - Lentiviral
English: Education: Graduate in chemical engineering from the Technical University of Denmark.
Slovenian: Izobrazba: Diplomirala je iz kemijskega inženiringa na Tehnični univerzi na Danskem.
English: 26 May
Slovenian: 26. maj
English: Member of the UK Royal College of Veterinary Surgeons.
Slovenian: Članica Kraljevske akadenmije veterinarjev v Združenem kraljestvu.
English: 3.5 Pharmacovigilance and maintenance activities
Slovenian: 3.5 Farmakovigilanca in vzdrževalne dejavnosti
English: Therefore, there will be increased follow-up and assessment of designation criteria at the time of marketing authorisation
Slovenian: Zato se bo med izdajanjem dovoljenja za promet bolj spremljalo in ocenjevalo merila za določitev.
English: Marijke Korteweg, Integrated quality management adviser, b. 29 May 1947, n. Belgian
Slovenian: Marijke Korteweg, svetovalka za integrirano upravljanje kakovosti, roj. 29. maja 1947,
English: Annex 5 Profiles of EMEA personalities
Slovenian: Priloga 5 Osnovni podatki o osebju EMEA
English: Career to date: Tim Buxton completed articles with Touche Ross & Co. in London in 1987.
Slovenian: Dosedanja poklicna pot: Tim Buxton je leta 1987 opravil pripravništvo pri Touche Ross & Co v
English: 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.
Slovenian: CPMP in CVMP in predstavnik v Farmacevtskem odboru, Stalnem odboru in Delovni skupini za obvestila vlagateljem.
English: To be finalised (with SWP) following end of public consultation
Slovenian: Dokončno se oblikuje (skupaj z delovno skupino za varnost) po zaključenem javnem posvetovanju
English: Core SPC released for further consultation in 2004 and to be finalised in 2005
Slovenian: Osnovni SPC sproščen za nadaljnje posvetovanje leta 2004 in predvidoma dokončno oblikovan leta 2005
English: Dr Tsintis joined the EMEA as head of sector, pharmacovigilance and post-authorisation safety and efficacy of medicines in March
Slovenian: Dr. Tsintis se je EMEA pridružil kot vodja Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet marca 2002.
English: 6.1 Administration
Slovenian: 6.1 Upravljanje
English: He was appointed a member of the CHMP in 1997.
Slovenian: Leta 1997 je bil imenovan za člana CPMP.
English: 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.
Slovenian: Agencija bo opravila dodatno delo za precejšnjo razširitev prvotnega obsega zbirke podatkov EuroPharm o informacijah o vseh zdravilih v EU z dovoljenjem za promet.
English: 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.
Slovenian: Certificiranje teh glavnih dosjejev v sistem, podoben centraliziranemu postopku, vodi k izdaji potrdila o skladnosti z zakonodajo
English: PhD in public health from the University of Bordeaux.
Slovenian: Doktoriral iz javnega zdravja na Univerzi v Bordeauxu.
English: Guideline on the clinical requirements for locally applied, locally acting products containing known constituents
Slovenian: Guideline on the clinical requirements for locally applied, locally acting
English: Key initiatives:
Slovenian: Ključne pobude:
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: Under discussion in view of revised pharmaceutical legislation
Slovenian: V razpravi zaradi spremenjene farmacevtske zakonodaje
English: Special EU contribution for IT Telematics strategy
Slovenian: Splošni prispevek EU Posebni prispevek EU za IT in telematsko strategijo
English: Education: Master's degree in business administration from the Institut Superieur de Gestion in Paris.
Slovenian: Izobrazba: Magisterij iz poslovne administracije na Inštitutu Superieur de Gestion v Parizu.
English: 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.
Slovenian: 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.
English: The number of initial applications for a marketing authorisation is expected to stabilise in 2005.
Slovenian: Število začetnih vlog za izdajo dovoljenja za promet z zdravilom se bo predvidoma v letu 2005 ustalilo.
English: Postgraduate diploma in European Community law from King's College London.
Slovenian: Dokončala podiplomski študij iz zakonodaje Evropske skupnosti na Kraljevem kolidžu v Londonu.
English: 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.
Slovenian: 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.
English: He was appointed acting deputy head of sector for scientific advice and orphan drugs in October 2004.
Slovenian: Oktobra 2004 je bil imenovan za vršilca dolžnosti namestnika vodje Sektorja za znanstveno svetovanje in zdravila sirote.
English: Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b. 12 December 1961, n. Irish
Slovenian: Tony Humphreys, vodja Sektorja za regulativne zadeve in organizacijsko podporo, roj. 12. decembra 1961, po narodnosti Irec
English: Implementation of the EU risk management strategy
Slovenian: Izvajanje strategije EU za obvladovanje tveganja.
English: 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
Slovenian: 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.
English: Biostatistical/methodological issues arising from CHMP discussion on marketing authorisation applications: Choice of non-inferiority margin
Slovenian: Biostatistical/methodological issues arising from CHMP discussion on marketing authorisation applications:
English: The legislative basis of pharmacovigilance inspections is now provided.
Slovenian: Zakonska podlaga inšpekcijskih pregledov farmakovigilance je zdaj zagotovljena.
English: 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.
Slovenian: Cooke je imela več služb v irski farmacevtski industriji, preden se je 1988 pridružila Irskemu odboru za zdravila kot ocenjevalka farmacevtskih izdelkov.
English: 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.
Slovenian: 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.
English: Priorities for medicines for human use in 2005:
Slovenian: Prednostne naloge zdravil za uporabo v humani medicini v letu 2005:
English: Category & Grade
Slovenian: Skupina in stopnja
English: Revised guideline on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
Slovenian: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
English: 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.
Slovenian: Izobrazba: Diplomiral iz farmacije ter medicine in kirurgije na Univerzi v Barceloni, podiplomski študij iz farmakologije in toksikologije, javnega zdravja in evropskih institucij.
English: The legislative basis for pharmacovigilance inspections is now provided.
Slovenian: Zakonska podlaga za inšpekcijske preglede farmakovigilance je zdaj zagotovljena.
English: Dr Pittner joined the Herbal Medicinal Products Working Party (HMPWP) in 1999 and was vice-chairman of the HMPWP from 2002 until 2004.
Slovenian: 1999 pridružil Delovni skupini za zeliščna zdravila (HMPWP) in bil od 2002 do 2004 njen podpredsednik.
English: The performance indicator for this objective is the percentage of applications evaluated within the 30, 60 or 90-day timeline (depending on the procedure).
Slovenian: Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v 30-, 60- ali 90-dnevnem roku (odvisno od postopka).
English: Policy for the transmission of PhVWP Recommendations and Assessment Reports for mutually recognised and purely nationally authorised products to marketing authorisation holders
Slovenian: Reports for mutually recognised and purely nationally authorised products to marketing authorisation holders
English: Josep Torrent i Farnell, Chairman of the COMP, b. 2 May 1954, n. Spanish
Slovenian: Josep Torrent i Farnell, predsednik COMP, roj. 2. maja 1954, po narodnosti Španec
English: Education: Qualified as a medical doctor in Rome in July 1978.
Slovenian: Izobrazba: Diplomirala iz splošne medicine julija 1978 v Rimu.
English: To provide timely and understandable product information to patients and healthcare professionals
Slovenian: Zagotavljati pravočasne in razumljive informacije o izdelkih bolnikom in zdravstvenim strokovnjakom.
English: Miss Leivers joined the EMEA in February 1996 and was appointed deputy head of sector in June 2001.
Slovenian: Gospodična Leiversova se je EMEA pridružila februarja 1996 in bila junija 2001 imenovana za namestnico vodje Sektorja.
English: Enhancement of liaison with working parties of CHMP and scientific advisory groups
Slovenian: Okrepitev povezovanja z delovnimi skupinami CHMP in znanstveno svetovalnimi skupinami.
English: He has been a CVMP member since 1997; he was elected vice-chairman of the CVMP in 2001.
Slovenian: Član CVMP je od leta 1997, leta 2001 je bil izvoljen za njegovega podpredsednika.
English: 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.
Slovenian: 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.
English: To be finalised following end of consultation, the revision and update of 3AQ10a
Slovenian: Dokončno se oblikuje po zaključenem posvetovanju, revizija in posodobitev
English: 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.
Slovenian: akademski sveti, poklicna združenja, farmacevtska industrija in druge zainteresirane strani hitrejši in enostavnejši dostop do večjega obsega informacij o dejavnostih Agencije in mreži.
English: He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Slovenian: Leta 1997 se je pridružil farmacevtskemu inšpektoratu belgijskega ministrstva za javno zdravje kot vodja ocenjevalcev zdravil.
English: 25-28 July
Slovenian: 25.-28. julij
English: 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
Slovenian: Redno posodabljanje poročil EPAR v fazi po izdaji dovoljenja zaradi postopkovnih in znanstvenih vidikov.
English: He joined the EMEA as head of the legal sector in November 2004.
Slovenian: EMEA se je pridružil novembra 2004 kot vodja Pravnega sektorja.
English: Martin Harvey Allchurch, Head of Executive Support, b. 20 October 1966, n. British
Slovenian: Martin Harvey Allchurch, vodja izvršne podpore, roj. 20. oktobra 1966, po narodnosti Britanec
English: In addition to general harmonisation work on approaches to GCP inspection, focus will be on consolidation of procedures to support the implementation of the Clinical Trials Directive and the Commission directive on GCP.
Slovenian: Osrednja pozornost bo usmerjena k splošnemu usklajevalnemu delu pri pristopih inšpekcije za dobro klinično prakso in h konsolidaciji postopkov, da se podpre izvajanje direktive o kliničnem preizkušanju in direktive Komisije odobri klinični praksi.
English: Core SPC released for 6 months' consultation in 2003 and to be finalised in early 2005
Slovenian: Osnovni SPC dan v 6-mesečno posvetovanje leta 2003 in dokončno oblikovan predvidoma na začetku leta
English: 3.6 Arbitration and Community referrals
Slovenian: 3.6 Arbitraža in predložitve Skupnosti
English: Education: Graduated in veterinary medicine from the faculty of veterinary science at Liverpool University and is a member of the Royal College of Veterinary Surgeons of the United Kingdom.
Slovenian: Izobrazba: Diplomiral iz veterinarske medicine na Veterinarski fakulteti Univerze v Liverpoolu, je član Kraljevske akademije veterinarjev Združenega kraljestva.
English: Variations to marketing authorisations can be either minor (type I) or major (type II) changes.
Slovenian: Spremembe dovoljenj za promet z zdravilom so lahko manjše (tipa I) ali večje
English: He served on the management board of the French National Agency for Health Evaluation and Hospital Accreditation (ANAES) from 2000 to 2004, and on its executive committee from 2002 to 2004.
Slovenian: Med letoma 2000 in 2004 je bil član upravnega odbora francoske Nacionalne agencije za vrednotenje zdravil in bolnišnično akreditacijo (ANAES), od 2002 do 2004 pa je bil tudi v njenem izvršnem odboru.
English: Postgraduate studies in cardiology and endocrinology.
Slovenian: Podiplomski študij iz kardiologije in endokrinologije.
English: Peter Jones, Head of Unit, b. 9 August 1947, n. British
Slovenian: Peter Jones, vodja enote, roj. 9. avgusta 1947, po narodnosti Britanec
English: The summarised comparative budget statements for 2003 to 2005 are as follows: (Amounts expressed in euro)
Slovenian: Povzetek primerjalnih proračunskih poročil za obdobje 2003-2005 je, kot sledi:
English: Position paper on the non-clinical safety studies to support clinical trials, with a single low dose of a compound
Slovenian: Position paper on the non-clinical safety studies to support clinical trials,
English: Career to date: From 1977 to 1990, Professor Torrent i Farnell worked in internal medicine and clinical pharmacology in Spain and was assistant professor of pharmacology at the UAB.
Slovenian: Dosedanja poklicna pot: Prof. Torrent i Farnell je od leta 1977 do 1990 delal na področju interne medicine in klinične farmakologije v Španiji in bil profesor asistent farmakologije na UAB.