natgillin/translations-raw huggingface dataset:
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.
Objectives: 
Cilji:
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
Education: Qualified pharmacist from the University of Uppsala Faculty of Pharmacy. 
Izobrazba: Diplomirani farmacevt s Fakultete za farmacijo Univerze v Uppsali.
Panos Tsintis, Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 18 September 1956, n. British 
Panos Tsintis, vodja Sektorja za farmakovigilanco, varnost in učinkovitost zdravil po izdaji dovoljenja za promet, roj. 18. septembra 1956, po narodnosti Britanec
Special EU contribution for orphan medicinal products Contribution from EEA Contribution from EU programmes p.m. 
Prispevek iz EGP Prispevek iz programov EU
He joined the EMEA in February 1997. 
EMEA se je pridružil februarja 1997.
Parallel distribution notifications received/forecast (Input) 
Število prejetih/predvidenih obvestil o vzporedni distribuciji (Vhodni podatek)
The performance indicator for this objective is the percentage of applications evaluated within the 120-day timeline. 
Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v roku 120-ih dni.
14-17 February 
14.-17. februar
Follow-up on initiatives to improve transparency and provide clear and understandable information to patients, healthcare professionals and the public 
2003 in priporočilom G10; spremljanje pobud za boljšo preglednost in zagotavljanje jasnih in razumljivih informacij bolnikom, zdravstvenim strokovnjakom in javnosti; krepitev mednarodnega sodelovanja Agencije.
CVMP meetings in 2005 
Zasedanja CVMP leta 2005
CVMP member since 1998 and chairman of the CVMP ad hoc group for environmental risk assessment. 
in predsednik njegove ad hoc skupine za oceno tveganja za okolje.
Education: Master of science in economics and bachelor of science in public administration from Trinity College Dublin. 
Izobrazba: Magisterij iz ekonomije in diploma iz javne uprave na Trinity Collegu v Dublinu.
Education: Bachelor of law from the University of Birmingham, qualified as a member of the Institute of Chartered Accountants in England and Wales. 
Izobrazba: Diplomirani pravnik z Univerze v Birminghamu, član Združenja revizorjev v Angliji in
Work to start in 2005 
Delo se začne leta 2005
Education: Bachelor of commerce from University College Dublin. 
Izobrazba: Diplomirani komercialist Univerzitetnega kolidža v Dublinu.
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. 
Doktorat iz fizikalne organske kemije; Magisterij iz fizikalne organske kemije; Diploma iz biokemije.
CHMP Biotechnology Working Party 
Delovna skupina CHMP za biotehnologijo Referenčna številka
12-14 January 
12.-14. januar
Career to date: After 10 years of fundamental prostaglandin research she joined the pharmaceutical industry in 1981 as a clinical research associate. 
Dosedanja poklicna pot: Po desetletnem osnovnem raziskovanju prostaglandina se je leta 1981
Conduct analysis of adverse reaction reports and periodic safety update reports in a timely manner 
Pravočasno analiziranje poročil o neželenih učinkih in periodično dopolnjenih poročil o varnosti Zagotavljanje ustrezne podpore poročevalcem in soporočevalcem.
She joined the EMEA in April 1996. 
EMEA se je pridružila aprila 1996.
E-mail: silvia.domingo@emea.eu.int 
E-naslov: silvia.domingo@emea.eu.int
E-mail: ragini.shivji@emea.eu.int 
E-naslov: ragini.shivji@emea.eu.int
These include implementation of the concept of risk management plans, as well as accelerated assessment, 
Ti vključujejo izvajanje koncepta načrtov za obvladovanje tveganja ter postopke za pospešeno oceno, pogojno izdajo dovoljenja in sočutno uporabo.
To implement the new legislation in the fields of GMP, in particular with respect to active substances 
Izvajati novo zakonodajo na področjihdobre proizvodne prakse, zlasti za zdravilne učinkovine.
Deadline for comments March 
Zadnji rok za pripombe marec 2005
The integration of delegates, staff and experts from the new Member States, and the extension of the Agency's office and conference space to accommodate new staff, delegates and experts following the entry into force of the new legislation 
spremenjeno delovno okolje po pregledu uredbe o ustanovitvi Agencije; izvajanje nove uredbe o pristojbinah; izvajanje novega računovodskega sistema; vključevanje delegatov, osebja in strokovnjakov iz novih držav članic ter povečanje pisarniškega in konferenčnega prostora Agencije za namestitev novega osebja, delegatov in strokovnjakov po začetku veljavnosti nove zakonodaje; izvajanje izboljšane proračunske zbirke podatkov, utemeljene na dejavnostih, in proračunskega načrtovanja;
EU Comments in preparation of VICH Guideline 
Pripombe EU k pripravi smernice VICH
Consultation ended 16 Dec. 04, under revision by PhVWP- V for adoption in 1Q 2005 
2004, pod revizijo PhVWP-V za sprejetje v 1. četrt.
Concept paper for preparation of guideline to be developed 
Idejni dokument, ki se sestavi za pripravo smernice
He has a continuing teaching appointment for pharmacology and toxicology at the University of Würzburg. 
Stalno delovno mesto ima kot predavatelj farmakologije in toksikologije na Univerzi v Wuerzburg.
In 1979 he joined the National Board of Health, where he acted as senior pharmaceutical inspector and head of the pharmaceuticals department. 
Nacionalnemu odboru za zdravje, kjer je bil višji farmacevtski inšpektor in vodja Oddelka za farmacevtske izdelke.
Education: Qualified medical doctor from the University of Würzburg, Germany. 
Izobrazba: Diplomiral iz splošne medicine na Univerzi v Wuerzburgu, Nemčija.
Scientific Advice Requests received/forecast (Input) 
Prejeti/predvideni zahtevki za znanstveno svetovanje (Vhodni podatek)
Preparatory work for the establishment of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products 
Pripravljalno delo za določitev seznama zeliščnih snovi, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zeliščnih zdravilih.
Career to date: After a traineeship with the European Commission, from 1991 to 1992, Martin Harvey Allchurch worked as a European affairs consultant in Brussels, from 1992 to 1995. 
Allchurch delal od 1992 do 1995 kot svetovalec za evropske zadeve v Bruslju.
To conduct quality orphan medicinal product designations and related activities and adhere to regulatory timelines 
Izvajati kakovostno določanje zdravil sirot in s tem povezanih dejavnosti ob upoštevanju predpisanih rokov.