natgillin/translations-raw huggingface dataset:
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
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
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.
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.
Spiros Vamvakas, Acting Deputy Head of Sector for orphan drugs and scientific advice, b. 4 September 1960, n. German/Greek
Spiros Vamvakas, vršilec dolžnosti namestnika vodje Sektorja za zdravila sirote in znanstveno svetovanje, roj. 4. septembra 1960, po narodnosti Nemec/Grk
Andreas Pott, Head of Unit, b. 14 April 1949, n. German
Andreas Pott, vodja Enote, roj. 14. aprila 1949, po narodnosti Nemec
Post-authorisation activities on initial certification of plasma master files and vaccine antigen master files will develop
Razvijale se bodo dejavnosti po izdaji dovoljenja v zvezi z začetnim certificiranjem glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov.
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.
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.
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.
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.
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
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;
To conduct quality assessments of MRL applications and related activities, and adhere to regulatory timelines
Kakovostno ocenjevati vloge za MRL in s tem povezane dejavnosti ter upoštevati predpisane roke.
Sara Mendosa, Head of Sector for infrastructure services, b. 23 January 1950, n. British
Sara Mendosa, vodja Sektorja za infrastrukturne storitve, roj. 23. januarja 1950, po narodnosti Britanka
Beatrice Fayl, Head of Sector for document management and publishing, b. 9 October 1959, n. Danish
Beatrice Fayl, vodja Sektorja za vodenje in objavljanje dokumentacije, roj. 9. oktobra 1959, po narodnosti Danka
Guideline to be prepared
Pripravi se smernica
Veterinary medicines
veterinarska zdravila
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
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).
Isabelle Moulon, Head of Sector for medical information, b. 9 March 1958, n. French
Isabelle Moulon, vodja Sektorja za informacije o zdravilih, roj. 9. marca 1958, po narodnosti Francozinja
10-12 May
10.-12. maj
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
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.
To be finalised following end of consultation
Dokončno se oblikuje po zaključenem posvetovanju
To implement EudraVigilance Veterinary effectively on 1 January 2005 for the competent authorities and by November 2005 for the Veterinary pharmaceutical industry
Začeti učinkovito izvajanje EudraVigilance za veterino 1. januarja 2005 za pristojne organe,
Tim Buxton, Head of Sector for project management, b. 27 February 1959, n. British
Tim Buxton, vodja Sektorja za vodenje projektov, roj. 27. februarja 1959, po narodnosti
17-19 May
17.-19. maj
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.
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.
Marisa Papaluca Amati, Deputy Head of Sector for safety and efficacy of medicines, b. 12 October 1954, n. Italian
Marisa Papaluca Amati, vršilka dolžnosti vodje Sektorja za varnost in učinkovitost zdravil, roj. 12. oktobra 1954, po narodnosti Italijanka
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.
Odbor se bo zaprosilo, da po takšnih predložitvah ukrepa, da se uskladijo povzetki (predložitev iz člena 34), potem ko se
Fellow of the Institute of Chartered Accountants in Ireland.
Član Združenja revizorjev iz Irske.
Melanie Leivers, Deputy Head of Sector for veterinary marketing authorisation procedures, b. 1 December 1958, n. British
Melanie Leivers, namestnica vodje Sektorja za postopke za izdajo dovoljenja za promet z veterinarskimi zdravili, roj. 1. decembra 1958, po narodnosti Britanka
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.
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.
23-26 May
23.-26. maj
He was appointed head of sector for quality of medicines in January 2001.
2001 je bil imenovan za vodjo Sektorja za kakovost zdravil.
David Drakeford, Head of Sector for information technology, b. 4 December 1957, n. Irish
David Drakeford, vodja Sektorja za informacijsko tehnologijo, roj. 4. decembra 1957,
Career to date: From 1976 to 1980, Dr Lyngvig was research assistant and lecturer at the Technical University of Denmark.
Dosedanja poklicna pot: Dr. Lyngvigova je bila od leta 1976 do 1980 asistentka raziskovalka in predavateljica na Danski tehnični univerzi.
This builds on a previous increase of 20 % relative to the number forecast for 2004.
odstotnem povečanju glede na predvideno število za leto 2004.
4-6 October
4.-6. oktober
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.
politike za zdravila sirote in za zagotavljanje pomoči pri tem v povezavi z zadevnimi mednarodnimi partnerji in organizacijami bolnikov.
Concept paper and recommendations to be developed and completed in 2005
Idejni dokument in priporočila, ki se pripravijo in dokončno oblikujejo leta
Integrated quality management IQM adviser
Svetovalec za integrirano upravljanje kakovosti
More orphan medicinal products reach the stage of marketing authorisation.
Fazo izdanega dovoljenja za promet dosega več zdravil sirot.
10-13 October
10.-13. oktober
Concept paper to be prepared
Pripravi se idejni dokument
Education: PhD in microbiology from the University of Lyon.
Izobrazba: Doktorat iz mikrobiologije na Univerzi v Lyonu.
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)
Sodelovanje s tradicionalnimi partnerji Agencije pri tristranskem usklajevanju EU, Japonske in
He is a co-founder of the European Organisation for Rare Diseases (EURORDIS) of which he has been the chief executive officer since 2001.
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.
Establishment of a dedicated sector for medical information
Vzpostavitev namenskega področja za obveščanje o zdravilih.
Jytte Lyngvig, Vice-Chairman of the Management Board, b.13 October 1953, n. Danish
Jytte Lyngvig, podpredsednica upravnega odbora, roj. 13. oktobra 1953, po narodnosti Danka
He was re-elected vice-chairman of the CVMP in 2004.
Leta 2004 je bil ponovno izvoljen za podpredsednika CVMP.
John Purves, Head of Sector for quality of medicines, b. 22 April 1945, n. British
John Purves, vodja Sektorja za kakovost zdravil, roj. 22. aprila 1945, po narodnosti Britanec
He was elected chairman of the board in May 2004.
Maja 2004 je bil izvoljen za njegovega predsednika.
Joint concept paper adopted by EWP and SWP, under discussion by CVMP
Skupni idejni dokument, ki sta ga sprejeli delovni skupini za učinkovistost in varnost po razpravi s CVMP
Johannes Hoogland, Vice-Chairman of the CVMP, b. 22 February 1956, n. Dutch
Johannes Hoogland, podpredsednik CVMP, roj. 22. februarja 1956, po narodnosti
New applications for veterinary medicines received/forecast (Input)
Prejete/predvidene nove vloge za veterinarska zdravila (Vhodni podatek)
2-4 March
2-4. marec
3.4 Post-authorisation activities
3.4 Dejavnosti po izdaji dovoljenja
Efficacy Working Party
Prispevek delovne skupine za učinkovitost
11-13 January
11.-13. januar
He joined the French medicines agency in 1994 as director of pharmacotherapeutic evaluation, a post he holds today.
Leta 1994 se je pridružil francoski agenciji za zdravila kot direktor farmakoterapevtskega ocenjevanja; na tem delovnem mestu je še danes.
Key initiatives to meet the objective:
Ključne pobude za izpolnitev cilja:
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).
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;
Protocol assistance and follow-up requests Scientific advice and follow-up requests
Zahtevki za pomoč pri protokolu in spremljanje Zahtevki za znanstveno svetovanje in spremljanje
14-16 June
14.-16. junij
Thomas Lönngren, Executive Director, b. 16 December 1950, n. Swedish
Thomas Lönngren, izvršni direktor, roj. 16. decembra 1950, po narodnosti Šved
Arbitration and Community referrals made to EMEA (Input)
Arbitraža in zadeve, ki jih Skupnost predloži EMEA (Vhodni podatek)
Plasma master files and vaccine antigen master files
Glavni dosje plazme in glavni dosje virusnih antigenov
Contribution to development of haemovigilance procedures and mechanisms for interaction between haemovigilance and pharmacovigilance systems if requested
Prispevek k razvoju postopkov hemovigilance in mehanizmov za vzajemno delovanje med sistemi
20-23 June
20.-23. junij
The target is 100 % of applications
Cilj je 100 % vlog.
To provide quality scientific advice and protocol assistance to applicants and adhere to the defined timelines
Zagotavljati kakovostno znanstveno svetovanje prosilcem in upoštevati predpisane roke.
Operational expenditure Meetings
Odhodki iz poslovanja Sestanki
The EMEA will provide more information on medicinal products it authorises and supervises.
informacij o zdravilih, za katera bo izdala dovoljenje za promet in ki jih bo nadzirala.
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.
Izobrazba: Diplomantka filozofske fakultete iz jezikov in jezikoslovja na Univerzi v Vzhodni Angliji, podiplomski študij iz knjižničarstva in informatike na Univerzi v Walesu.
She joined the EMEA in January 2000 and was appointed head of sector for scientific advice and orphan drugs in December 2001.
EMEA se je pridružila januarja 2000 in bila decembra 2001 imenovana za vodjo Sektorja za znanstveno svetovanje in zdravila sirote.
This was followed by positions as a pharmacist.
Nato je službovala kot farmacevtka.
Annex 1 EMEA establishment plan 2003-2005
Priloga I Načrt delovnih mest EMEA za obdobje 2003-2005
Konstantin Keller, Chairman of the HMPC, b. 19 February 1954, n. German
Konstantin Keller, predsednik HMPC, roj. 19. februarja 1954, po narodnosti Nemec
Gérard Moulin, Chairman of the CVMP, b. 18 October 1958, n. French
Gérard Moulin, predsednik CVMP, roj. 18. oktobra 1958, po narodnosti Francoz
The ad hoc group of GCP inspection services will meet four times in 2005.
Ad hoc skupina inšpekcijskih služb za dobro klinično prakso se bo leta 2005 sestala štirikrat.
But many of the implementation activities will be carried out and finalised in 2005 when the remaining legislative provisions come into force.
2005, ko bodo začele veljati še preostale zakonske določbe.
Sabine Brosch, Deputy Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 17 August 1963, n. Austrian
Sabine Brosch, namestnica vodje Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet, roj. 17. avgusta 1963, po narodnosti Avstrijka
Concept paper to be adopted for consultation during 2005
Sprejme se idejni dokument za posvetovanje v letu 2005
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.
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.
Hans-Georg Wagner, Head of Unit, b. 29 November 1948, n. German
Enota za obveščanje in povezovanje v mrežo Hans-Georg Wagner, vodja Enote, roj. 29. novembra 1948, po narodnosti Nemec
Progress interactions with the innovative, non-prescription and generic medicines industries
Skupno prizadevanje za napredek z industrijami inovativnih zdravil ter zdravil brez recepta in generičnih zdravil.
22-23 March
22.-23. marec
The area of meeting management and conferences will experience a significant increase in its activities in 2005.
Leta 2005 se bodo zelo povečale njene dejavnosti na področju vodenja sestankov in konferenc.
Type I variation applications Type II variation applications Line extension applications
Vloge za spremembo tipa I Vloge za spremembo tipa II Vloge za podaljšanje rokov
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.
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.
18-20 October
18.-20. oktober
Scientific advice and protocol assistance requests (Input)
Zahtevki za znanstveno svetovanje in pomoč pri protokolu (Vhodni podatek)
Education: Graduate in biochemistry and pharmacology from Leeds University.
Izobrazba: Diplomirala iz biokemije in farmakologije na Univerzi v Leedsu.
2.7 Herbal medicinal products
2.7 Zeliščna zdravila
Postgraduate degree in paediatrics and a PhD in nutrition.
Podiplomski študij iz pediatrije in doktorat iz prehrane.
Work to be continued in 2005
Delo se nadaljuje leta 2005
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
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.
To be released in January 2005 for 3 months' consultation.
Da se v 3-mesečno posvetovanje predvidoma januarja 2005 Dokončno se oblikuje do 3. četrt.
Expansion of accommodation for both offices and meetings
Povečanje prostora, namenjenega pisarnam in sestankom.
21 - 22 July
21.-22. julij
Requests for GMP and PMF (plasma master file) inspections are expected to increase by 10 % in 2005.
Trendi: Število zahtevkov za inšpekcijske preglede dobre proizvodne prakse in glavnega dosjeja plazme naj bi se leta 2005 predvidoma povečalo za 10 %.
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
o bibliografija ali izvedenski dokaz o zdravilni uporabi v celotnem obdobju najmanj 30 let (oblika in vrsta dokaza), kot podpora vlogi za registracijo;
Education: Pharmacist, doctorate in natural sciences (pharmacognosy) from the University of Saarbrücken.
Izobrazba: Farmacevt, doktorat iz naravoslovnih ved (farmakognozija) iz Univerze v Saarbrücknu.
The implementation of a new accounting system
Izvajanje računovodskega sistema za zaloge.
The Committee on Orphan Medicinal Products
Odbor za zdravila sirote
8-10 February
8.-10. februar
Postgraduate qualifications in paediatrics and methodology.
Podiplomski študij iz pediatrije in metodologije.
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.
za zdravje in leta 1995 opravila šestmesečno regulativno pripravništvo v Enoti za farmacevtske izdelke Evropske komisije.
Education: Professor Wahlroos is a qualified pharmacist (pharmacology) from the University of Helsinki and holds a PhD (SocPharm) from the University of Kuopio.
Izobrazba: Prof. Wahlroos je diplomirani farmacevt (farmakologija) z Univerze v Helsinkih in doktor znanosti (soc.
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.
Arbitražni postopki (na podlagi člena 29 Direktive 2001/83/ES ali člena 7(5) Uredbe Komisije (ES) št.
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.
o odstotek zbirnih poročil o MRL, objavljenih v štirinajstih dneh po objavi MRL Skupnosti.
The programme for sampling and testing centrally authorised products will continue in 2005, with 37 human and veterinary products to be tested.
Program vzorčenja in preizkušanja centralno odobrenih zdravil se bo leta 2005 izvajal še naprej;
EU Comments in preparation of revised VICH Guidelines
Pripombe EU k pripravi revidiranih smernic VICH
Education: Qualified medical doctor from the University of Grenoble, France.
Izobrazba: Diplomirala iz splošne medicine na Univerzi v Grenoblu, Francija.
He joined the EMEA in May 1995 and was appointed deputy head of sector in July 2003.
se je pridružil maja 1995 in bil julija 2003 imenovan za namestnika vodje Sektorja.
Ms Fayl joined the EMEA in April 1995.
Faylova se je EMEA pridružila aprila 1995.
CHMP Blood Products Working Party
Delovna skupina CHMP za izdelke iz krvi Referenčna številka
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
Zagotavljati pravočasne informacije kot odgovor na vprašanja tretjih strani o določenih MRL-jih v skladu z dogovorjenimi roki.
2-4 February
2.-4. februar
Integration into the CVMP assessment procedure of advice and recommendations of the scientific advisory group concerning applications for new antimicrobials
Vključitev nasvetov in priporočil znanstveno svetovalne skupine glede vlog za nova protimikrobna sredstva v ocenjevalni postopek CVMP.
To be prepared during 2005
Pripravi se v letu 2005
Protocol assistance and follow-up finalised Scientific advice and follow-up finalised
Izvedena pomoč pri protokolu in spremljanje Izvedena strokovno svetovanje in spremljanje
Daniel Brasseur, Chairman of the CHMP, b. 7 June 1951, n. Belgian
Znanstveni odbori EMEA Daniel Brasseur, predsednik CHMP, roj. 7. junija 1951, po narodnosti Belgijec
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.
Evropske unije leta 2004 je veliko prispevalo k njihovi nemoteni vključitvi v Evropsko mrežo zdravil.
Prepare for the submission of applications for biosimilar, generic and self-medication medicinal products
Priprave na predložitev vlog za biološko podobna in generična zdravila ter zdravila za samozdravljenje.
Ad hoc groups of GMP, GCP inspections and joint CHMP/CVMP Quality Working Party
Ad hoc skupine inšpekcijskih služb za dobro proizvodno in klinično prakso ter skupna delovna skupina CHMP/CVMP za kakovost
Concept paper to be developed in 2005
Idejni dokument se pripravi v letu 2005
Under development by the PhVWP-V
Pripravlja PhVWP-V
Education: Qualified pharmacist with a master's degree in pharmaceutical chemistry and a master's degree in business administration (MBA) from Trinity College Dublin.
Izobrazba: Izobrazbo farmacevtke z magisterijem iz farmacevtske kemije in magisterijem iz poslovne administracije (MBA) je pridobila na Trinity Collegu v Dublinu.
Revision to be finalised in 2005
Revizija se zaključi leta 2005
Career to date: Worked for the food industry (1976-1977), biological laboratory of the Free University of Amsterdam (1977-1978).
Dosedanja poklicna pot: Delal je v živilski industriji (1976-1977), v biološkem laboratoriju na
Unit for the Post-authorisation evaluation of medicines for human use
Enota za vrednotenje zdravil za uporabo v humani medicini po izdaji dovoljenja za promet