FrancophonIA/ELRC3.0 huggingface dataset:
English: Melanie Leivers, Deputy Head of Sector for veterinary marketing authorisation procedures, b. 1 December 1958, n. British
Slovenian: Melanie Leivers, namestnica vodje Sektorja za postopke za izdajo dovoljenja za promet z veterinarskimi zdravili, roj. 1. decembra 1958, po narodnosti Britanka
English: Career to date: From 1984 Professor Vamvakas held positions in the department of pharmacology and toxicology at the University of Würzburg and in the department of pharmacology at the Medical Centre of the University of Rochester NY, USA.
Slovenian: Dosedanja poklicna pot: Od leta 1984 je prof. Vamvakas delal na Oddelku za farmakologijo in toksikologijo Univerze v Wuerzburgu in na Oddelku za farmakologijo v Medicinskem centru Univerze v Rochesterju NY, ZDA.
English: 23-26 May
Slovenian: 23.-26. maj
English: Core SPC for human plasma derived and recombinant coagulation Factor IX products
Slovenian: Core SPC for human plasma derived and recombinant coagulation Factor IX
English: He was appointed head of sector for quality of medicines in January 2001.
Slovenian: 2001 je bil imenovan za vodjo Sektorja za kakovost zdravil.
English: Objectives:
Slovenian: Cilji:
English: David Drakeford, Head of Sector for information technology, b. 4 December 1957, n. Irish
Slovenian: David Drakeford, vodja Sektorja za informacijsko tehnologijo, roj. 4. decembra 1957,
English: Career to date: From 1976 to 1980, Dr Lyngvig was research assistant and lecturer at the Technical University of Denmark.
Slovenian: Dosedanja poklicna pot: Dr. Lyngvigova je bila od leta 1976 do 1980 asistentka raziskovalka in predavateljica na Danski tehnični univerzi.
English: This builds on a previous increase of 20 % relative to the number forecast for 2004.
Slovenian: odstotnem povečanju glede na predvideno število za leto 2004.
English: 4-6 October
Slovenian: 4.-6. oktober
English: The COMP is also responsible for advising the European Commission on the development of an orphan medicinal product policy, and for providing assistance in liaison with international partners and patients' organisations in this respect.
Slovenian: politike za zdravila sirote in za zagotavljanje pomoči pri tem v povezavi z zadevnimi mednarodnimi partnerji in organizacijami bolnikov.
English: Concept paper and recommendations to be developed and completed in 2005
Slovenian: Idejni dokument in priporočila, ki se pripravijo in dokončno oblikujejo leta
English: Integrated quality management IQM adviser
Slovenian: Svetovalec za integrirano upravljanje kakovosti
English: More orphan medicinal products reach the stage of marketing authorisation.
Slovenian: Fazo izdanega dovoljenja za promet dosega več zdravil sirot.
English: 10-13 October
Slovenian: 10.-13. oktober
English: Concept paper to be prepared
Slovenian: Pripravi se idejni dokument
English: Education: PhD in microbiology from the University of Lyon.
Slovenian: Izobrazba: Doktorat iz mikrobiologije na Univerzi v Lyonu.
English: Work with the Agency's traditional partners on the EU-Japan-USA trilateral harmonisation of regulatory requirements for human and veterinary medicines (ICH and VICH)
Slovenian: Sodelovanje s tradicionalnimi partnerji Agencije pri tristranskem usklajevanju EU, Japonske in
English: He is a co-founder of the European Organisation for Rare Diseases (EURORDIS) of which he has been the chief executive officer since 2001.
Slovenian: Je soustanovitelj Evropske organizacije za redke bolezni (EURORDIS), katere generalni izvršni direktor je od leta 2001. Junija 2003 je bil ponovno izvoljen za podpredsednika COMP.
English: Establishment of a dedicated sector for medical information
Slovenian: Vzpostavitev namenskega področja za obveščanje o zdravilih.
English: Jytte Lyngvig, Vice-Chairman of the Management Board, b.13 October 1953, n. Danish
Slovenian: Jytte Lyngvig, podpredsednica upravnega odbora, roj. 13. oktobra 1953, po narodnosti Danka
English: He was re-elected vice-chairman of the CVMP in 2004.
Slovenian: Leta 2004 je bil ponovno izvoljen za podpredsednika CVMP.
English: John Purves, Head of Sector for quality of medicines, b. 22 April 1945, n. British
Slovenian: John Purves, vodja Sektorja za kakovost zdravil, roj. 22. aprila 1945, po narodnosti Britanec
English: He was elected chairman of the board in May 2004.
Slovenian: Maja 2004 je bil izvoljen za njegovega predsednika.
English: Guidance on the development of vaccines against emerging and reemerging diseases such as SARS, pathogens potentially used in bioterrorism, monovalent polio vaccines
Slovenian: pathogens potentially used in bioterrorism, monovalent polio vaccines
English: Joint concept paper adopted by EWP and SWP, under discussion by CVMP
Slovenian: Skupni idejni dokument, ki sta ga sprejeli delovni skupini za učinkovistost in varnost po razpravi s CVMP
English: Johannes Hoogland, Vice-Chairman of the CVMP, b. 22 February 1956, n. Dutch
Slovenian: Johannes Hoogland, podpredsednik CVMP, roj. 22. februarja 1956, po narodnosti
English: New applications for veterinary medicines received/forecast (Input)
Slovenian: Prejete/predvidene nove vloge za veterinarska zdravila (Vhodni podatek)
English: 2-4 March
Slovenian: 2-4. marec
English: 3.4 Post-authorisation activities
Slovenian: 3.4 Dejavnosti po izdaji dovoljenja
English: Efficacy Working Party
Slovenian: Prispevek delovne skupine za učinkovitost
English: 11-13 January
Slovenian: 11.-13. januar
English: He joined the French medicines agency in 1994 as director of pharmacotherapeutic evaluation, a post he holds today.
Slovenian: Leta 1994 se je pridružil francoski agenciji za zdravila kot direktor farmakoterapevtskega ocenjevanja; na tem delovnem mestu je še danes.
English: Key initiatives to meet the objective:
Slovenian: Ključne pobude za izpolnitev cilja:
English: Employed by the Ministry of Agriculture, Nature Management and Fisheries in 1988; from 1988 to 1998 by the State Institute for Quality Control of Agricultural Products (RIKILT-DLO) as an assessor for veterinary medicinal products and feed additives, research on development of analytical methods and development of quality systems for agricultural production; from 1998 to the present by the Bureau Registratie Diergeneesmiddelen (BRD).
Slovenian: Od leta 1988 zaposlen na Ministrstvu za kmetijstvo, upravljanje narave in ribištvo, od 1988 do 1998 na Državnem inštitutu za obvladovanje kakovosti kmetijskih proizvodov (RIKILT-DLO) kot ocenjevalec veterinarskih zdravil in krmnih dodatkov;
English: Protocol assistance and follow-up requests Scientific advice and follow-up requests
Slovenian: Zahtevki za pomoč pri protokolu in spremljanje Zahtevki za znanstveno svetovanje in spremljanje
English: 14-16 June
Slovenian: 14.-16. junij
English: Thomas Lönngren, Executive Director, b. 16 December 1950, n. Swedish
Slovenian: Thomas Lönngren, izvršni direktor, roj. 16. decembra 1950, po narodnosti Šved
English: Arbitration and Community referrals made to EMEA (Input)
Slovenian: Arbitraža in zadeve, ki jih Skupnost predloži EMEA (Vhodni podatek)
English: Note for Guidance on the conduct of pharmacovigilance for medicinal products authorised through mutual recognition
Slovenian: Pharmacovigilance for Medicinal Products Authorised through Mutual Recognition
English: Plasma master files and vaccine antigen master files
Slovenian: Glavni dosje plazme in glavni dosje virusnih antigenov
English: Contribution to development of haemovigilance procedures and mechanisms for interaction between haemovigilance and pharmacovigilance systems if requested
Slovenian: Prispevek k razvoju postopkov hemovigilance in mehanizmov za vzajemno delovanje med sistemi
English: 20-23 June
Slovenian: 20.-23. junij
English: The target is 100 % of applications
Slovenian: Cilj je 100 % vlog.
English: To provide quality scientific advice and protocol assistance to applicants and adhere to the defined timelines
Slovenian: Zagotavljati kakovostno znanstveno svetovanje prosilcem in upoštevati predpisane roke.
English: Operational expenditure Meetings
Slovenian: Odhodki iz poslovanja Sestanki
English: The EMEA will provide more information on medicinal products it authorises and supervises.
Slovenian: informacij o zdravilih, za katera bo izdala dovoljenje za promet in ki jih bo nadzirala.
English: Education: Bachelor of Arts in languages and linguistics at the University of East Anglia and postgraduate degree in librarianship and information science at the University of Wales.
Slovenian: Izobrazba: Diplomantka filozofske fakultete iz jezikov in jezikoslovja na Univerzi v Vzhodni Angliji, podiplomski študij iz knjižničarstva in informatike na Univerzi v Walesu.
English: She joined the EMEA in January 2000 and was appointed head of sector for scientific advice and orphan drugs in December 2001.
Slovenian: EMEA se je pridružila januarja 2000 in bila decembra 2001 imenovana za vodjo Sektorja za znanstveno svetovanje in zdravila sirote.
English: This was followed by positions as a pharmacist.
Slovenian: Nato je službovala kot farmacevtka.
English: Annex 1 EMEA establishment plan 2003-2005
Slovenian: Priloga I Načrt delovnih mest EMEA za obdobje 2003-2005
English: Konstantin Keller, Chairman of the HMPC, b. 19 February 1954, n. German
Slovenian: Konstantin Keller, predsednik HMPC, roj. 19. februarja 1954, po narodnosti Nemec
English: Gérard Moulin, Chairman of the CVMP, b. 18 October 1958, n. French
Slovenian: Gérard Moulin, predsednik CVMP, roj. 18. oktobra 1958, po narodnosti Francoz
English: The ad hoc group of GCP inspection services will meet four times in 2005.
Slovenian: Ad hoc skupina inšpekcijskih služb za dobro klinično prakso se bo leta 2005 sestala štirikrat.
English: But many of the implementation activities will be carried out and finalised in 2005 when the remaining legislative provisions come into force.
Slovenian: 2005, ko bodo začele veljati še preostale zakonske določbe.
English: Sabine Brosch, Deputy Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 17 August 1963, n. Austrian
Slovenian: Sabine Brosch, namestnica vodje Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet, roj. 17. avgusta 1963, po narodnosti Avstrijka
English: Concept paper to be adopted for consultation during 2005
Slovenian: Sprejme se idejni dokument za posvetovanje v letu 2005
English: She joined the EMEA in November 1996 and was appointed deputy head of sector for pharmacovigilance, post-authorisation safety and efficacy of medicines in January 2001.
Slovenian: EMEA se je pridružila novembra 1996 in bila januarja 2001 imenovana za namestnico vodje Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet.
English: Hans-Georg Wagner, Head of Unit, b. 29 November 1948, n. German
Slovenian: Enota za obveščanje in povezovanje v mrežo Hans-Georg Wagner, vodja Enote, roj. 29. novembra 1948, po narodnosti Nemec
English: Progress interactions with the innovative, non-prescription and generic medicines industries
Slovenian: Skupno prizadevanje za napredek z industrijami inovativnih zdravil ter zdravil brez recepta in generičnih zdravil.
English: 22-23 March
Slovenian: 22.-23. marec
English: The area of meeting management and conferences will experience a significant increase in its activities in 2005.
Slovenian: Leta 2005 se bodo zelo povečale njene dejavnosti na področju vodenja sestankov in konferenc.
English: Type I variation applications Type II variation applications Line extension applications
Slovenian: Vloge za spremembo tipa I Vloge za spremembo tipa II Vloge za podaljšanje rokov
English: The initial evaluation phase covers a number of EMEA activities ranging from pre-submission discussions with future applicants, through the evaluation by the Committee for Medicinal Products for Human Use (CHMP), to the granting by the European Commission of the product authorisation.
Slovenian: Faza začetnega vrednotenja zajema številne dejavnosti EMEA, ki segajo od razprav s prihodnjimi vlagatelji pred oddajo vloge, preko ovrednotenja s strani CHMP do dovoljenja za promet z izdelkom, ki ga izda Evropska komisija.
English: 18-20 October
Slovenian: 18.-20. oktober
English: Scientific advice and protocol assistance requests (Input)
Slovenian: Zahtevki za znanstveno svetovanje in pomoč pri protokolu (Vhodni podatek)
English: Education: Graduate in biochemistry and pharmacology from Leeds University.
Slovenian: Izobrazba: Diplomirala iz biokemije in farmakologije na Univerzi v Leedsu.
English: 2.7 Herbal medicinal products
Slovenian: 2.7 Zeliščna zdravila
English: Postgraduate degree in paediatrics and a PhD in nutrition.
Slovenian: Podiplomski študij iz pediatrije in doktorat iz prehrane.
English: Work to be continued in 2005
Slovenian: Delo se nadaljuje leta 2005
English: Requests for GMP re-inspections of manufacturing sites are expected to form a high proportion of GMP requests in 2005, and coordination of responses to quality defects of centrally authorised products is also expected to increase due to the greater number of authorised products and increased awareness of the effects of deviations
Slovenian: predvidoma pa naj bi se povečalo tudi usklajevanje odgovorov na kakovostne pomanjkljivosti centralno odobrenih zdravil zaradi večjega števila izdelkov z izdanim dovoljenjem za promet in večje ozaveščenosti glede učinkov odstopanj.
English: To be released in January 2005 for 3 months' consultation.
Slovenian: Da se v 3-mesečno posvetovanje predvidoma januarja 2005 Dokončno se oblikuje do 3. četrt.
English: Expansion of accommodation for both offices and meetings
Slovenian: Povečanje prostora, namenjenega pisarnam in sestankom.
English: 21 - 22 July
Slovenian: 21.-22. julij
English: Requests for GMP and PMF (plasma master file) inspections are expected to increase by 10 % in 2005.
Slovenian: Trendi: Število zahtevkov za inšpekcijske preglede dobre proizvodne prakse in glavnega dosjeja plazme naj bi se leta 2005 predvidoma povečalo za 10 %.
English: o the format and content of the bibliographic review of safety data and expert report required as part of the documentation supporting an application for registration o the bibliography or expert evidence on the medicinal use throughout a period of at least 30 years (format and type of evidence) to support a registration application o demonstration that the pharmacological effects or the efficacy are made plausible on the basis of long-standing use and experience
Slovenian: o bibliografija ali izvedenski dokaz o zdravilni uporabi v celotnem obdobju najmanj 30 let (oblika in vrsta dokaza), kot podpora vlogi za registracijo;
English: Education: Pharmacist, doctorate in natural sciences (pharmacognosy) from the University of Saarbrücken.
Slovenian: Izobrazba: Farmacevt, doktorat iz naravoslovnih ved (farmakognozija) iz Univerze v Saarbrücknu.
English: The implementation of a new accounting system
Slovenian: Izvajanje računovodskega sistema za zaloge.
English: The Committee on Orphan Medicinal Products
Slovenian: Odbor za zdravila sirote
English: 8-10 February
Slovenian: 8.-10. februar
English: Postgraduate qualifications in paediatrics and methodology.
Slovenian: Podiplomski študij iz pediatrije in metodologije.
English: In 1992 she moved to the pharmacovigilance department at the Austrian Ministry of Health and completed a six-month regulatory traineeship in the pharmaceuticals unit of the European Commission in 1995.
Slovenian: za zdravje in leta 1995 opravila šestmesečno regulativno pripravništvo v Enoti za farmacevtske izdelke Evropske komisije.
English: Education: Professor Wahlroos is a qualified pharmacist (pharmacology) from the University of Helsinki and holds a PhD (SocPharm) from the University of Kuopio.
Slovenian: Izobrazba: Prof. Wahlroos je diplomirani farmacevt (farmakologija) z Univerze v Helsinkih in doktor znanosti (soc.
English: Arbitration procedures (either under Article 29 of Directive 2001/83/EC or Article 6(12) of Commission Regulation (EC) No 1084/2003) are initiated because of disagreement between Member States in the framework of the mutual recognition procedure.
Slovenian: Arbitražni postopki (na podlagi člena 29 Direktive 2001/83/ES ali člena 7(5) Uredbe Komisije (ES) št.
English: The target is 100 % of summaries published at the time of the press release o percentage of MRL summary reports published within 14 days after publication of Community MRLs.
Slovenian: o odstotek zbirnih poročil o MRL, objavljenih v štirinajstih dneh po objavi MRL Skupnosti.
English: The programme for sampling and testing centrally authorised products will continue in 2005, with 37 human and veterinary products to be tested.
Slovenian: Program vzorčenja in preizkušanja centralno odobrenih zdravil se bo leta 2005 izvajal še naprej;
English: EU Comments in preparation of revised VICH Guidelines
Slovenian: Pripombe EU k pripravi revidiranih smernic VICH
English: Education: Qualified medical doctor from the University of Grenoble, France.
Slovenian: Izobrazba: Diplomirala iz splošne medicine na Univerzi v Grenoblu, Francija.
English: He joined the EMEA in May 1995 and was appointed deputy head of sector in July 2003.
Slovenian: se je pridružil maja 1995 in bil julija 2003 imenovan za namestnika vodje Sektorja.
English: Ms Fayl joined the EMEA in April 1995.
Slovenian: Faylova se je EMEA pridružila aprila 1995.
English: Guideline on the investigation of mitochondrial toxicity of HIVtherapeutics in vitro
Slovenian: Guideline on the investigation of mitochondrial toxicity of HIV
English: CHMP Blood Products Working Party
Slovenian: Delovna skupina CHMP za izdelke iz krvi Referenčna številka
English: The target is to publish 80 % of summary reports within the timeline To provide timely information in response to queries from third parties on established MRLs in accordance with agreed timelines
Slovenian: Zagotavljati pravočasne informacije kot odgovor na vprašanja tretjih strani o določenih MRL-jih v skladu z dogovorjenimi roki.
English: 2-4 February
Slovenian: 2.-4. februar
English: Integration into the CVMP assessment procedure of advice and recommendations of the scientific advisory group concerning applications for new antimicrobials
Slovenian: Vključitev nasvetov in priporočil znanstveno svetovalne skupine glede vlog za nova protimikrobna sredstva v ocenjevalni postopek CVMP.
English: Core SPC for human plasma derived and recombinant coagulation Factor VIII products
Slovenian: Core SPC for human plasma derived and recombinant coagulation Factor
English: Status studies in the safety evaluation of new medicinal products in animals
Slovenian: Pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals
English: To be prepared during 2005
Slovenian: Pripravi se v letu 2005
English: Protocol assistance and follow-up finalised Scientific advice and follow-up finalised
Slovenian: Izvedena pomoč pri protokolu in spremljanje Izvedena strokovno svetovanje in spremljanje
English: Daniel Brasseur, Chairman of the CHMP, b. 7 June 1951, n. Belgian
Slovenian: Znanstveni odbori EMEA Daniel Brasseur, predsednik CHMP, roj. 7. junija 1951, po narodnosti Belgijec
English: Early cooperation with regulatory authorities in the accession countries prior to the historic enlargement of the European Union in 2004 contributed greatly to their smooth integration into the European medicines network.
Slovenian: Evropske unije leta 2004 je veliko prispevalo k njihovi nemoteni vključitvi v Evropsko mrežo zdravil.
English: Prepare for the submission of applications for biosimilar, generic and self-medication medicinal products
Slovenian: Priprave na predložitev vlog za biološko podobna in generična zdravila ter zdravila za samozdravljenje.
English: Ad hoc groups of GMP, GCP inspections and joint CHMP/CVMP Quality Working Party
Slovenian: Ad hoc skupine inšpekcijskih služb za dobro proizvodno in klinično prakso ter skupna delovna skupina CHMP/CVMP za kakovost
English: Concept paper to be developed in 2005
Slovenian: Idejni dokument se pripravi v letu 2005
English: Under development by the PhVWP-V
Slovenian: Pripravlja PhVWP-V
English: Education: Qualified pharmacist with a master's degree in pharmaceutical chemistry and a master's degree in business administration (MBA) from Trinity College Dublin.
Slovenian: Izobrazba: Izobrazbo farmacevtke z magisterijem iz farmacevtske kemije in magisterijem iz poslovne administracije (MBA) je pridobila na Trinity Collegu v Dublinu.
English: Revision to be finalised in 2005
Slovenian: Revizija se zaključi leta 2005
English: Career to date: Worked for the food industry (1976-1977), biological laboratory of the Free University of Amsterdam (1977-1978).
Slovenian: Dosedanja poklicna pot: Delal je v živilski industriji (1976-1977), v biološkem laboratoriju na
English: Unit for the Post-authorisation evaluation of medicines for human use
Slovenian: Enota za vrednotenje zdravil za uporabo v humani medicini po izdaji dovoljenja za promet
English: Education: Qualified pharmacist from the University of Uppsala Faculty of Pharmacy.
Slovenian: Izobrazba: Diplomirani farmacevt s Fakultete za farmacijo Univerze v Uppsali.
English: Panos Tsintis, Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 18 September 1956, n. British
Slovenian: Panos Tsintis, vodja Sektorja za farmakovigilanco, varnost in učinkovitost zdravil po izdaji dovoljenja za promet, roj. 18. septembra 1956, po narodnosti Britanec
English: Special EU contribution for orphan medicinal products Contribution from EEA Contribution from EU programmes p.m.
Slovenian: Prispevek iz EGP Prispevek iz programov EU
English: He joined the EMEA in February 1997.
Slovenian: EMEA se je pridružil februarja 1997.
English: Parallel distribution notifications received/forecast (Input)
Slovenian: Število prejetih/predvidenih obvestil o vzporedni distribuciji (Vhodni podatek)
English: The performance indicator for this objective is the percentage of applications evaluated within the 120-day timeline.
Slovenian: Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v roku 120-ih dni.
English: 14-17 February
Slovenian: 14.-17. februar
English: ICH-E2D: Post-Approval Safety Management: Definitions and Standards for Expedited Reporting and Good Case Management Practices
Slovenian: ICH-E2D: Post-Approval Safety
English: Follow-up on initiatives to improve transparency and provide clear and understandable information to patients, healthcare professionals and the public
Slovenian: 2003 in priporočilom G10; spremljanje pobud za boljšo preglednost in zagotavljanje jasnih in razumljivih informacij bolnikom, zdravstvenim strokovnjakom in javnosti; krepitev mednarodnega sodelovanja Agencije.
English: CVMP meetings in 2005
Slovenian: Zasedanja CVMP leta 2005
English: CVMP member since 1998 and chairman of the CVMP ad hoc group for environmental risk assessment.
Slovenian: in predsednik njegove ad hoc skupine za oceno tveganja za okolje.
English: Education: Master of science in economics and bachelor of science in public administration from Trinity College Dublin.
Slovenian: Izobrazba: Magisterij iz ekonomije in diploma iz javne uprave na Trinity Collegu v Dublinu.
English: Education: Bachelor of law from the University of Birmingham, qualified as a member of the Institute of Chartered Accountants in England and Wales.
Slovenian: Izobrazba: Diplomirani pravnik z Univerze v Birminghamu, član Združenja revizorjev v Angliji in
English: Work to start in 2005
Slovenian: Delo se začne leta 2005
English: Education: Bachelor of commerce from University College Dublin.
Slovenian: Izobrazba: Diplomirani komercialist Univerzitetnega kolidža v Dublinu.
English: Education: Doctorate of science in physical sciences; qualification in research management; PhD in physical organic chemistry; master's degree in physical organic chemistry; degree in biochemistry.
Slovenian: Doktorat iz fizikalne organske kemije; Magisterij iz fizikalne organske kemije; Diploma iz biokemije.
English: CHMP Biotechnology Working Party
Slovenian: Delovna skupina CHMP za biotehnologijo Referenčna številka
English: 12-14 January
Slovenian: 12.-14. januar