FrancophonIA/ELRC3.0 huggingface dataset:
English: Continuing responsibility for Veterinary Joint Implementation Group coordination of training and applications for EudraVigilance, as well as data collection, analysis, reporting and communication of electronic adverse reactions received from 1 January 2005
Slovenian: Stalna odgovornost za podporo Veterinarski skupini za skupno izvajanje na področju usklajevanja usposabljanja, vlog za EudraVigilance, zbiranja podatkov, analiziranja, sporočanja in obveščanja o neželenih učinkih, prejetih v elektronski obliki po 1. januarju 2005.
English: Frances Nuttall, Head of Sector for personnel and budget, b. 11 November 1958, n. Irish
Slovenian: Frances Nuttall, vodja Sektorja za osebje in proračun, roj. 11. novembra 1958, po narodnosti Irka
English: Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisations.
Slovenian: Dejavnosti po izdaji dovoljenja se nanašajo na spremembe, podaljšanje rokov in prenose dovoljenj za promet z zdravilom.
English: Inspections
Slovenian: Inšpekcijski nadzor
English: Emer Cooke, Head of Sector for inspections, b. 9 April 1961, n. Irish
Slovenian: Emer Cooke, vodja Sektorja za inšpekcijske preglede, roj. 9. aprila 1961, po narodnosti Irka
English: The target is 90 % of summaries published at the time of the press release o percentage of European public assessment reports published within two weeks after Commission decision.
Slovenian: Cilj je 90 % povzetkov, objavljenih hkrati s sporočilom za javnost; o odstotek evropskih javnih poročil o oceni, objavljen v dveh tednih po odločitvi
English: Noël Wathion, Head of Unit, b. 11 September 1956, n. Belgian
Slovenian: Noël Wathion, vodja enote, roj. 11. septembra 1956, po narodnosti Belgijec
English: These initiatives include implementation of the concept of risk management plans, expansion of the scope of medicines to be authorised through the centralised procedure, establishment of the accelerated assessment, conditional authorisation and compassionate use procedures, as well as procedures for authorisation of biosimilar and generic products, and support to small and medium-sized enterprises 9 High importance will be attributed to initiatives aimed at increased communication and provision of information to patients, healthcare professionals and the general public
Slovenian: Te pobude vključujejo izvajanje koncepta načrtov za obvladovanje tveganja, razširitev obsega tistih zdravil, katerim se izda dovoljenje za promet po centraliziranem postopku, vzpostavitev postopkov za pospešeno oceno, izdajo pogojnega dovoljenja in sočutno uporabo ter postopkov za izdajo dovoljenja za promet z biološko podobnimi in generičnimi izdelki ter podporo majhnim in srednje velikim podjetjem.
English: Performance indicators for this objective are: o percentage of summaries of opinion published at the time of publication of the press release following the CVMP meeting.
Slovenian: Kazalnika uspešnosti za ta cilj sta: o odstotek povzetkov mnenj, objavljenih hkrati z objavo sporočila za javnost, ki sledi zasedanju CVMP.
English: Plasma master files (PMFs) and vaccine antigen master files (VAMFs) are separate documents from the dossier for a marketing authorisation.
Slovenian: Glavni dosje plazme (PMF) in glavni dosje virusnih antigenov (VAMF) sta dokumenta, ločena od dokumentacije za izdajo dovoljenja za promet z zdravilom.
English: These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports).
Slovenian: Sem spadajo dejavnosti, ki se nanašajo na informacije o farmakovigilanci (poročila o neželenih učinkih zdravil (ADR) in periodiočno dopolnjena poročila o varnosti (PSUR)).
English: Opinions adopted (Output)
Slovenian: Sprejeta mnenja (Izhodni podatek)
English: She acted as scientific secretary of the Biotechnology Working Party until December 2000.
Slovenian: je bila znanstvena sekretarka Delovne skupine za biotehnologijo.
English: Revision expected to be released by mid 2005
Slovenian: Revizija se sprosti predvidoma do sredine leta 2005
English: Career to date: From 1977 to 1986, Dr Le Courtois worked as a general practitioner and as director of a medical centre in Paris.
Slovenian: Dosedanja poklicna pot: Od 1977 do 1986 je dr. Le Courtois delal kot splošni zdravnik in direktor zdravstvenega centra v Parizu.
English: Work on Concept paper to be continued in 2005
Slovenian: Delo na idejnem dokumentu se nadaljuje leta 2005
English: The target is to publish 80 % of EPARs within the timeline
Slovenian: Cilj je v roku objaviti 80 % EPAR-ov.
English: Education: Qualified as a pharmacist from Heriot-Watt University, Edinburgh.
Slovenian: Izobrazba: Diplomirani farmacevt z Univerze Heriot-Watt v Edinburghu.
English: Career to date: From 1976 to 1986, Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Slovenian: Dosedanja poklicna pot: Od leta 1976 do 1986 je dr. Brasseur delal kot pediater v Univerzitetni bolnišnici Sint Pieter v Bruslju.
English: He worked also as research assistant in international law at the University of Pavia from 1992 to 1999, as associate professor of international law at the University of Insubria (Varese) from 1999 to 2003, and as chair professor of international law at the same University since 2004.
Slovenian: Delal je tudi kot asistent raziskovalec na področju mednarodnega prava na Univerzi v Pavii od 1992 do 1999, izredni profesor mednarodnega prava na Univerzi v
English: Kornelia Grein, Head of Sector for safety of veterinary medicines, b. 24 July 1952, n. German
Slovenian: Kornelia Grein, vodja Sektorja za varnost veterinarskih zdravil, roj. 24. julija 1952, po narodnosti Nemka
English: Safety Working Party
Slovenian: Prispevek delovne skupine za varnost
English: To be finalised following end of public consultation
Slovenian: Dokončno se oblikuje po zaključenem javnem posvetovanju
English: The legislation provides for compliance with GMP requirements by manufacturers of active substances and for the establishment of a database containing information on GMP certificates and on manufacturing authorisations.
Slovenian: Zakonodaja predpisuje, da morajo izdelovalci zdravilnih učinkovin upoštevati zahteve zadobro proizvodno prakso, ter vzpostavitev zbirke podatkov, ki bo vsebovala informacije o potrdilih dobre proizvodne prakse in dovoljenjih za izdelavo.
English: Requests should be sent in writing to the EMEA or to
Slovenian: Pisni zahtevki se pošljejo EMEA
English: Education: Business studies and languages at Loughborough Polytechnic Career to date: From 1975 to 1990, Mrs Mendosa held a number of posts at the European Commission in Luxembourg, including the Conference Service, the Office for Official Publications and the Statistical Office.
Slovenian: Dosedanja poklicna pot: Od 1975 do 1990 je ga. Mendosa opravljala različne službe v Evropski komisiji v Luksemburgu, med drugim v konferenčni službi, Uradu za javne objave in v Statističnem uradu.
English: Hannes Wahlroos, Chairman of the Management Board, b. 7 July 1952, n. Finnish
Slovenian: Hannes Wahlroos, predsednik upravnega odbora, roj. 7. julija 1952, po narodnosti Finec
English: Career to date: From 1976 to 1978, lecturer at the University of Uppsala.
Slovenian: Dosedanja poklicna pot: Od leta 1976 do 1978 predavatelj na Univerzi v Uppsali.
English: 6.3 EMEA document management and publishing
Slovenian: 6.3 Vodenje in objavljanje dokumentacije EMEA
English: She was appointed head of sector for safety and efficacy of medicines in January 2001.
Slovenian: Januarja 2001 je bila imenovana za vodjo Sektorja za varnost in učinkovitost zdravil.
English: He joined the EMEA in May 1996 and was appointed head of sector for regulatory affairs and operational support in January 2001.
Slovenian: EMEA se je pridružil maja 1996 in bil januarja 2001 imenovan za vodjo Sektorja za regulativne zadeve in operativno podporo.
English: The performance indicator for this objective is the percentage of products evaluated within the regulatory timeline of 210 days.
Slovenian: Kazalnik uspešnosti za ta cilj je odstotek izdelkov, ovrednotenih v predpisanem roku 210 dni.
English: Gerard O'Malley, Head of Sector for accounting, b. 14 October 1950, n. Irish
Slovenian: Gerard O'Malley, vodja računovodskega sektorja, roj. 14. oktobra 1950, po narodnosti
English: 60 % increase in the reimbursement of meeting expenses to delegates, national authorities and suppliers
Slovenian: 60-odstotno povečanje pri povračilu stroškov, ki so ji imeli v zvezi s sestankom delegati,
English: Revenue and expenditure overview 2003-2005 Guidelines and working documents in 2005 EMEA contact points
Slovenian: Načrt delovnih mest EMEA za obdobje 2003-2005 Pregled prihodkov in odhodkov v obdobju 2003-2005 Smernice in delovni dokumenti za leto 2005 Kontaktne osebe EMEA
English: CVMP Pharmacovigilance Working Party (PhVWP-V)
Slovenian: Delovna skupina CVMP za farmakovigilanco (PhVWP-V) Referenčna številka
English: If revision is needed, revision expected to be released for consultation in 2005 and finalised in 2006
Slovenian: Če se zahteva revizija, se da v posvetovanje predvidoma leta 2005 in zaključi 2006
English: Career to date: Since qualifying in 1983, Mr Humphreys has worked in the area of development pharmaceutics for a national branded generics manufacturer and an international research and development company.
Slovenian: Dosedanja poklicna pot: Po končanem šolanju leta 1983 je g. Humphreys delal na področju razvoja farmacevtike za izdelovalca generičnih zdravil z nacionalno blagovno znamko ter mednarodno raziskovalno in razvojno družbo.
English: Provision of accurate and timely financial information to management Implementation of inventory accounting system
Slovenian: Zagotavljanje točnih in pravočasnih finančnih informacij vodstvu.
English: Preparation of transparency and communication strategies and related policies that set out what, how and when information will be published
Slovenian: Priprava strategij preglednosti in obveščanja ter s tem povezanih politik, v katerih bo določeno,
English: She participated as UK CVMP member from 1996 until joining the EMEA in July
Slovenian: Bila je predstavnica Združenega kraljestva v CVMP od 1996 do svoje pridružitve EMEA julija 1997.
English: To be revised as per PhVWP-V work programme for 2005 (VEDDRA subgroup to meet May 05, adoption by PhVWP July 05 & CVMP Sept. 05)
Slovenian: Revidira se v skladu z delovnim programom PhVWP-V za leto 2005 (podskupina VEEDRA, ki naj bi se sestala maja 2005, sprejme pa ga
English: Communication and action by Member States in response to suspected quality defects relating to centrally authorised medicines are also coordinated by the EMEA.
Slovenian: EMEA usklajuje tudi obveščanje in ukrepanje držav članic kot odgovor na domnevne kakovostne pomanjkljivosti centralno odobrenih zdravil.
English: PhD in pharmaceutical microbiology from the University of Strathclyde, Glasgow.
Slovenian: Doktoriral je iz farmacevtske mikrobiologije na Univerzi Strathclyde v Glasgowu.
English: Further to the restructuring of the Human Medicines Evaluation Unit in 2001, he was appointed head of unit for the pre-authorisation evaluation of medicines for human use, in March
Slovenian: Po preoblikovanju Enote za vrednotenje zdravil za ljudi leta 2001 je bil marca 2001 imenovan za vodjo Enote za vrednotenje zdravil za uporabo v humani medicini pred izdajo dovoljenja za promet.
English: Other documents on working practices and work-sharing as well as new document management and communication/information exchange/tracking tools, in particular
Slovenian: Other documents on working practices and work-sharing as well as new document management and communication/information exchange/tracking tools, in particular with view to implementing the EU Risk Management Strategy and the revised PhVWP Mandate of September 2003
English: The initial evaluation phase covers a number of EMEA activities ranging from pre-submission discussions with future applicants, through the evaluation by the CVMP, to the granting by the European Commission of the product marketing authorisation.
Slovenian: Faza začetne ocene zajema številne dejavnosti EMEA, ki segajo od razprav z bodočimi vlagatelji pred oddajo vloge, ovrednotenja s strani CVMP do dovoljenja za promet z izdelkom, ki ga izda Evropska komisija.
English: The Management Board will meet four times in 2005:
Slovenian: Upravni odbor se bo leta 2005 sestal štirikrat: Zasedanja upravnega odbora leta 2005
English: A pilot implementation of the data warehouse and business intelligence applications for EudraVigilance
Slovenian: Pilotsko izvajanje podatkovnega skladišča in vloge poslovne inteligence za EudraVigilance.
English: The implementation of a new competence-development policy
Slovenian: izvajanje politike za razvoj novih pristojnosti.
English: She joined the EMEA as head of sector for inspections in July 2002.
Slovenian: EMEA se je pridružila julija 2002 kot vodja Sektorja za inšpekcijske preglede.
English: Yann Le Cam, Vice-Chairman of the COMP, b. 15 July 1961, n. French
Slovenian: Yann Le Cam, podpredsednik COMP, roj. 15. julija 1961, po narodnosti Francoz
English: In 1998 he was coordinator-director for the creation of the Spanish Medicines Agency and executive director of the Spanish Medicines Agency from 1999 to 2000.
Slovenian: Leta 1998 je bil direktor koordinator za ustanovitev španske Agencije za zdravila, od
English: Career to date: From 1988 to 1992, Dr Brosch worked as an assistant professor at the department of pharmacology and toxicology at the University of Vienna, where she specialised in electrophysiology.
Slovenian: Dosedanja poklicna pot: Od leta 1988 do 1992 je dr. Broscheva delala kot profesorica asistentka na Oddelku za farmakologijo in toksikologijo Univerze na Dunaju, kjer je specializirala iz elektrofiziologije.
English: Jill Ashley-Smith, Head of Sector for veterinary marketing authorisation procedures, b. 18 December 1962, n. British
Slovenian: Jill Ashley-Smith, vodja Sektorja za postopke za izdajo dovoljenja za promet z veterinarskimi zdravili, roj. 18. decembra 1962, po narodnosti Britanka
English: To provide high-quality service, including extended helpdesk facilities, of EU telematics to the EMEA's partners on an ongoing basis.
Slovenian: Stalno zagotavljati visoko kakovostno storitev telematike EU partnerjem EMEA, vključno s povečanimi zmogljivostmi za pomoč uporabnikom.
English: Eric Abadie, Vice-Chairman of the CHMP, b. 14 July 1950, n. French
Slovenian: Eric Abadie, podpredsednik CHMP, roj. 14. julij 1950, po narodnosti Francoz
English: 27-28 January
Slovenian: 27.-28. januar
English: Increase in workload as a result of the EU enlargement (handling of product information in 20 EU languages and possibility for additional referral procedures) and Commission decisions which involve specific commitments (pre-clinical trials, clinical trials, PSURs, post-marketing studies, registries) that need adequate follow-up
Slovenian: EU in možnost dodatnih postopkov za predložitev) in sklepov Komisije, ki vključujejo posebne zahteve (predklinično preizkušanje, klinično preizkušanje, PSUR-i, študije po izdaji dovoljenja za promet, registri), ki jih je treba spremljati.
English: Board-certified specialist in pharmacology and toxicology (Bavarian Chamber of Physicians).
Slovenian: Specialist s certifikatom iz farmakologije in toksikologije (Bavarska zdravniška zbornica).
English: CVMP Scientific Advisory Group on Antimicrobials
Slovenian: Znanstveno svetovalna skupina CVMP za protimikrobna sredstva Referenčna številka
English: The EMEA publishes a European public assessment report (EPAR) once the Commission decision has been taken.
Slovenian: Ko Komisija sprejme svojo odločitev, EMEA objavi evropsko javno poročilo o oceni zdravila (EPAR).
English: Sylvie Bénéfice, Head of Sector for meeting management and conferences, b. 28 December 1954, n. French
Slovenian: Sylvie Bénéfice, vodja Sektorja za vodenje sestankov in konferenc, roj. 28. decembra 1954, po narodnosti Francozinja
English: Adopted by EWP in October 04, under discussion at CVMP
Slovenian: Sprejel jo je EWP oktobra 2004 po razpravi v CVMP
English: Vincenzo Salvatore, Head of Legal Sector, b. 8 August 1963, n. Italian
Slovenian: Vincenzo Salvatore, vodja Pravnega sektorja, roj. 8. avgusta 1963, po narodnosti
English: Key initiatives to meet the objectives:
Slovenian: Ključne pobude za izpolnitev ciljev:
English: 17-20 January
Slovenian: 17.-20. januar
English: Riccardo Ettore, Deputy Head of Sector for information technology, b. 8 April 1953, n. Italian
Slovenian: Riccardo Ettore, namestnik vodje Sektorja za informacijsko tehnologijo, roj. 8. aprila 1953, po narodnosti Italijan
English: 3.2 Initial evaluation
Slovenian: 3.2 Začetna ocena
English: Agnès Saint Raymond, Head of Sector for orphan drugs and scientific advice and Acting Head of Sector for safety & efficacy of medicines, b. 7 September 1956, n. French
Slovenian: Agnès Saint Raymond, vodja Sektorja za zdravila sirote in znanstveno svetovanje ter vršilka dolžnosti vodje Sektorja za varnost in učinkovitost zdravil, roj. 7. septembra 1956, po narodnosti Francozinja
English: He joined the EMEA in September 1997 where he was appointed head of sector for new chemical substances in June 1998 and head of sector for orphan drugs and scientific advice in January 2001.
Slovenian: EMEA se je pridružil septembra 1997, junija 1998 je bil imenovan za vodjo Sektorja za nove kemične snovi, januarja 2001 pa za vodjo Sektorja za zdravila sirote in znanstveno svetovanje.
English: Spiros Vamvakas, Acting Deputy Head of Sector for orphan drugs and scientific advice, b. 4 September 1960, n. German/Greek
Slovenian: Spiros Vamvakas, vršilec dolžnosti namestnika vodje Sektorja za zdravila sirote in znanstveno svetovanje, roj. 4. septembra 1960, po narodnosti Nemec/Grk
English: Andreas Pott, Head of Unit, b. 14 April 1949, n. German
Slovenian: Andreas Pott, vodja Enote, roj. 14. aprila 1949, po narodnosti Nemec
English: Post-authorisation activities on initial certification of plasma master files and vaccine antigen master files will develop
Slovenian: Razvijale se bodo dejavnosti po izdaji dovoljenja v zvezi z začetnim certificiranjem glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov.
English: Career to date: From 1972 to 1989, Mr Pott held a number of teaching and research posts, including a research fellowship at the Institute of Peace Research and Security Policy, University of Hamburg.
Slovenian: Dosedanja poklicna pot: Od 1972 do 1989 je bil g. Pott predavatelj in raziskovalec na različnih delovnih mestih, med drugim je bil raziskovalni sodelavec na Inštitutu za mirovne raziskave in varnostno politiko Univerze v Hamburgu.
English: Career to date: From 1978 to 1982, Dr Keller worked as a research and teaching assistant at the Institute for Pharmacognosy and Analytical Phytochemistry of the University of Saarbrücken.
Slovenian: Dosedanja poklicna pot: Od 1978 do 1982 je dr. Keller delal kot asistent raziskovalec in predavatelj na Inštitutu za farmakognozijo in analitično fitokemijo Univerze v Saarbrücknu.
English: Proposal of meeting agendas, preparation and distribution of documents, provision of lists of positions taken on similar issues and follow-up to the meetings, including the preparation of monthly statistics related to the mutual recognition and decentralised procedures
Slovenian: predloge dnevnih redov zasedanj, pripravo in razdeljevanje gradiva, zagotavljanje seznamov stališč glede podobnih vprašanj in naloge po zasedanjih, vključno s pripravo mesečnih statističnih podatkov o medsebojnem priznavanju in decentraliziranih postopkih; postopno uvajanje in vzdrževanje pomnilnika regulativnih in znanstvenih sporazumov ter izidov razprav o posebnem medsebojnem priznavanju ali decentraliziranem postopku;
English: To conduct quality assessments of MRL applications and related activities, and adhere to regulatory timelines
Slovenian: Kakovostno ocenjevati vloge za MRL in s tem povezane dejavnosti ter upoštevati predpisane roke.
English: Sara Mendosa, Head of Sector for infrastructure services, b. 23 January 1950, n. British
Slovenian: Sara Mendosa, vodja Sektorja za infrastrukturne storitve, roj. 23. januarja 1950, po narodnosti Britanka
English: Beatrice Fayl, Head of Sector for document management and publishing, b. 9 October 1959, n. Danish
Slovenian: Beatrice Fayl, vodja Sektorja za vodenje in objavljanje dokumentacije, roj. 9. oktobra 1959, po narodnosti Danka
English: Guideline to be prepared
Slovenian: Pripravi se smernica
English: CPMP Note for Guidance on the rapid alert system and non-urgent information system in pharmacovigilance
Slovenian: Alert System and Non-Urgent Information System in Pharmacovigilance
English: Veterinary medicines
Slovenian: veterinarska zdravila
English: To consolidate operational aspects of the respective MRAs (all agreements, with the exception of that with the US, are fully operational at least within the old Member States) To complete inclusion of the new Member State authorities in the MRAs (EC-Canada) To expand the scope of the EC-Japan agreement
Slovenian: Združiti operativne vidike zadevnih sporazumov o vzajemnem priznavanju (vsi sporazumi, razen sporazuma z ZDA, so v celoti pripravljeni za izvajanje vsaj v starih državah članicah).
English: Isabelle Moulon, Head of Sector for medical information, b. 9 March 1958, n. French
Slovenian: Isabelle Moulon, vodja Sektorja za informacije o zdravilih, roj. 9. marca 1958, po narodnosti Francozinja
English: 10-12 May
Slovenian: 10.-12. maj
English: Good Pharmacovigilance Practice (GVP)
Slovenian: Good Pharmacovigilance Practice
English: Coordinate and manage effectively the requests for GMP, GCP, pharmacovigilance and GLP inspections relating to applications for products through the centralised procedure within the timeframe laid down in Community law and to the standards required by the Agency's quality management system
Slovenian: Usklajevanje in učinkovito obravnavanje zahtevkov za inšpekcijske preglede dobre proizvodne prakse, dobre klinične prakse, farmakovigilance in dobre laboratorijske prakse, ki se nanašajo na vloge za izdelke, odobrene po centraliziranem postopku, v roku iz zakonodaje Skupnosti in po standardih, ki jih zahteva sistem Agencije za upravljanje kakovosti.
English: To be finalised following end of consultation
Slovenian: Dokončno se oblikuje po zaključenem posvetovanju
English: To implement EudraVigilance Veterinary effectively on 1 January 2005 for the competent authorities and by November 2005 for the Veterinary pharmaceutical industry
Slovenian: Začeti učinkovito izvajanje EudraVigilance za veterino 1. januarja 2005 za pristojne organe,
English: Tim Buxton, Head of Sector for project management, b. 27 February 1959, n. British
Slovenian: Tim Buxton, vodja Sektorja za vodenje projektov, roj. 27. februarja 1959, po narodnosti
English: 17-19 May
Slovenian: 17.-19. maj
English: The focus of its work will be on the continued harmonisation of inspection procedures and GMP interpretation, as well as on GMP implications of the new Community blood and GCP directives.
Slovenian: Njeno delo bo usmerjeno k stalnemu usklajevanju inšpekcijskih postopkov in razlag dobre proizvodne prakse ter k posledicam, ki jih imajo nove direktive Skupnosti o krvi in dobri klinični praksi na dobro proizvodno prakso.
English: Marisa Papaluca Amati, Deputy Head of Sector for safety and efficacy of medicines, b. 12 October 1954, n. Italian
Slovenian: Marisa Papaluca Amati, vršilka dolžnosti vodje Sektorja za varnost in učinkovitost zdravil, roj. 12. oktobra 1954, po narodnosti Italijanka
English: The Committee will be asked to act upon such referrals to harmonise summaries (Article 34 referral) once the Agency and Commission have agreed on finalisation of the list and timing of actions required.
Slovenian: Odbor se bo zaprosilo, da po takšnih predložitvah ukrepa, da se uskladijo povzetki (predložitev iz člena 34), potem ko se
English: Fellow of the Institute of Chartered Accountants in Ireland.
Slovenian: Član Združenja revizorjev iz Irske.