natgillin/translations-raw huggingface dataset:
2010, for så vidt angår veterinærlægemidler, med særlig vægt på risikostyring af antimikrobiel resistens, som kan skyldes brugen af antimikrobielle stoffer i dyr, og på sikring af en tilstrækkelig miljømæssig risikovurdering i overensstemmelse med den nye EU-lovgivning 
Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to veterinary medicines, with particular emphasis on risk management of antimicrobial resistance, which may result from use of antimicrobials in animals, and on ensuring the adequacy of the environmental risk assessment in accordance with new EU legislation
Driftsudgifter Møder 
Operational expenditure Meetings
Core SPC sendt til videre høring i 2004 og færdigudarbejdes i 2005 
Core SPC released for further consultation in 2004 and to be finalised in 2005
Uddannelse: Uddannet i farmaci, medicin og kirurgi ved Barcelonas universitet og har desuden taget kurser efter kandidateksamen i farmakologi og toksikologi, folkesundhed og europæiske institutioner. 
Education: Qualified pharmacist and degree in medicine and surgery from the University of Barcelona, as well as postgraduate courses in pharmacology and toxicology, public health and European institutions.
Doktorgrad i klinisk farmakologi ved Barcelonas Autonome Universitet (UAB). 
Doctorate in clinical pharmacology from the Autonomous University of Barcelona (UAB).
25.-28. juli 
25-28 July
Karriereforløb: 1972-1989 beklædte Andreas Pott en række undervisnings- og forskningsstillinger, bl.a. som forskningsstipendiat ved Instituttet for Fredsforskning og Sikkerhedspolitik ved Hamborgs universitet. 
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.
Arbejdet med konceptdokumentet fortsætter i 2005 
Work on Concept paper to be continued in 2005
Sylvie Bénéfice, leder af sektionen for mødestyring og konferencer, født 28. december 1954, fransk statsborger 
Sylvie Bénéfice, Head of Sector for meeting management and conferences, b. 28 December 1954, n. French
I 1992 blev hun udstationeret ved Europa-kommissionen, hvor hun deltog i gennemførelsen af EU's lovgivning om eksisterende kemikalier og koordinerede udarbejdelsen af 
Seconded to the European Commission in 1992, she was involved in the implementation of the EU legislation on existing chemicals and coordinated the development of the EU approach on risk assessment for chemicals.
Guideline on the non-clinical documentation for mixed marketing 
Guideline on the non-clinical documentation for mixed marketing authorisation applications
Prioriterede opgaver for veterinærlægemidler i 2005 
Priorities for veterinary medicines in 2005:
Type II ændring ansøgninger Type I ændring ansøgninger 
Type I variation applications Type II variation applications Line extension applications
Anmodninger om nye GMP-inspektioner af produktionsanlæg forventes at udgøre en stor andel af GMP-anmodningerne i 2005, og tilsvarende forventes koordineringen af svar på kvalitetsfejl på centralt godkendte produkter ligeledes at stige som følge af det større antal tilladte produkter og stigende bevidsthed om virkningerne af afvigelser Anmodninger om GCP- og lægemiddelovervågningsinspektioner forventes ikke at stige i forhold til niveauet for 2004, idet stigningen i antallet for det pågældende år allerede var stort 
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
Agenturet planlægger at omstrukturere sine procedurer for mødestyring. 
The Agency plans to re-engineer and reinforce its processes related to meeting management.
Marisa Papaluca Amati, viceleder af sektionen for lægemidlers sikkerhed og virkninger, født 12. oktober 1954, italiensk statsborger 
Marisa Papaluca Amati, Deputy Head of Sector for safety and efficacy of medicines, b. 12 October 1954, n. Italian
At forbedre kvaliteten og den forskriftsmæssige og videnskabelige konsistens i vurderingen af ansøgninger om produktserieudvidelser, ændringer i og overførsler af markedsføringstilladelser, 
To increase the quality and the regulatory and scientific consistency of the evaluation of applications for line extensions, variations to and transfers of marketing authorisations, and adhere to regulatory timelines
Karriereforløb: 1977-1986 arbejdede Le Courtois som praktiserende læge og som direktør for et sundhedscenter i Paris. 
Career to date: From 1977 to 1986, Dr Le Courtois worked as a general practitioner and as director of a medical centre in Paris.
Ansat i EMEA i august 1996 som leder af sektionen for bioteknologi og biologiske lægemidler. 
He joined the EMEA in August 1996 as head of sector for biotechnology and biologicals.
Prioriteter for humanmedicinske lægemidler i 2005 
Priorities for medicines for human use in 2005:
GMP-inspektionstjenesternes ad hoc-gruppe vil mødes fire gange i 2005. 
The ad hoc group of GMP inspection services will meet four times in 2005.
Retningslinjer og arbejdsdokumenter i 2005 EMEA's kontaktpunkter 
Revenue and expenditure overview 2003-2005 Guidelines and working documents in 2005 EMEA contact points
PhD i organisk kemi fra Freie Universität Berlin. 
PhD in organic chemistry from the Free University of Berlin.
Peter Jones, afdelingsleder, født 9. august 1947, britisk statsborger 
Peter Jones, Head of Unit, b. 9 August 1947, n. British
Hans-Georg Wagner, afdelingsleder, født 29. november 1948, tysk nationalitet 
Hans-Georg Wagner, Head of Unit, b. 29 November 1948, n. German
Patrick Le Courtois, afdelingsleder, født 9. august 1950, fransk statsborger 
Patrick Le Courtois, Head of Unit, b. 9 August 1950, n. French
Gennemførelse af en ny gebyrforordning 
The implementation of a new fee regulation
Støtte til Kommissionen med hensyn til forberedelse af dens femårsrapport om erfaringerne efter gennemførelsen af forordningen om lægemidler til sjældne sygdomme Gennemførelse af initiativer for gennemsigtighed inden for udpegelsesproceduren i samarbejde med patientorganisationer 
Support the Commission with the preparation of its five-year report on experience following the implementation of the orphan medicinal products regulation
fortsætter stigningen i antallet af bivirkningsrapporter og periodisk opdaterede sikkerhedsindberetninger, og tallet for 2005 skønnes til ca. 400 bivirkningsrapporter og over 50 
With the steady increase in products being authorised through the centralised procedure, the rise in adverse reaction reports and periodic safety update reports continues, with approximately 400 of the former and over 50 of the latter forecast for 2005
Eric Abadie, næstformand i CPMP, født 14. juli 1950, fransk statsborger 
Eric Abadie, Vice-Chairman of the CHMP, b. 14 July 1950, n. French
EMEA lægemiddelovervågningsinspektioner, som er bestilt af de videnskabelige udvalg og inspektioner af blodbanker inden for rammerne af certificeringen af masterfiler vedrørende plasma 
Similarly, the EMEA coordinates pharmacovigilance inspections requested by the scientific committees and inspections of blood establishments within the Plasma Master File (PMF) certification framework.
Efterfølgende beklædte hun flere stillinger som farmaceut. 
This was followed by positions as a pharmacist.
Bilag 5 Profiler af EMEA's ledende medarbejdere 
Annex 5 Profiles of EMEA personalities
Stigning i antallet af anmodninger om protokolbistand, der svarer til stigningen i antallet af udpegede lægemidler til sjældne sygdomme, og på basis af anbefalingen søgning af protokolbistand fra COMP på udpegelsestidspunktet Den samlede arbejdsbyrde forventes at stige i forhold til 2004 
Increase in number of requests for protocol assistance in line with an increase in the number of designated orphan medicinal products and on the basis of the recommendation to seek protocol assistance made by the COMP at the time of designation
Tony Humphreys, viceleder af sektionen for retsforskrifter og organisatorisk støtte, født 12. december 1961, irsk statsborger 
Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b. 12 December 1961, n. Irish
1978-1990 ansat i den svenske sundhedsstyrelse, hvor han var ansvarlig for urtemedicin, kosmetik, medicinsk udstyr, narkotika og antikonception. 
Mr Lönngren was with the National Board of Health and Welfare, Sweden, from 1978 to 1990, during which time he was responsible for herbal medicines, cosmetics, medical devices, narcotics and contraceptives.
Forslag til mødedagsordener, udarbejdelse og distribution af dokumenter, udarbejdelse af lister over holdninger til tilsvarende spørgsmål og opfølgning på møderne, herunder udarbejdelse af månedsstatistikker vedrørende gensidig anerkendelse og decentraliserede procedurer Gradvis indførelse og vedligeholdelse af en hukommelse for forskriftsmæssige og videnskabelige aftaler og for resultatet af diskussioner vedrørende en specifik gensidig anerkendelse eller decentraliseret procedure 
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
Genvalgt som formand for Udvalget for Lægemidler til Sjældne Sygdomme i maj 2003. 
He was reelected chairman of the Committee on Orphan Medicinal Products in May 2003.
Uddannelse: Uddannet kemiingeniør fra Danmarks Tekniske Universitet. 
Education: Graduate in chemical engineering from the Technical University of Denmark.
Fra november 2000 generaldirektør for Centret for Sundheds- og Biovidenskabelige Uddannelser, Dr. Rober 
In November 2000, he became director-general of the Advanced Centre of Services and Training for Health and Life Sciences, Dr Rober Foundation (UAB).
Direktoratet for Farmaci i Frankrigs sundhedsministerium og i 1993 i det franske Lægemiddelagentur som CPMP-rapportør, afdelingsleder for Europæiske Procedurer og fra januar 1995 som fransk 
In 1990 he joined the pharmacy directorate of the French Ministry of Health and in 1993 joined the French Medicines Agency as CPMP rapporteur, was head of unit for European procedures and from January 1995 was a French CPMP delegate.
Jytte Lyngvig, næstformand i bestyrelsen, født 13. oktober 1953, dansk statsborger 
Jytte Lyngvig, Vice-Chairman of the Management Board, b.13 October 1953, n. Danish
1.6 EU-institutioner, agenturer og internationale partnere 1.7 Virksomhedsledelse - Integreret styringssystem2 HUMANMEDICINSKE LÆGEMIDLER 2.1 Lægemidler til sjældne sygdomme 2.2 Videnskabelig rådgivning og protokolbistand 2.3 Indledende vurdering 
1.4 European medicines network 1.5 Transparency and communication in the European network 1.6 EU institutions, agencies and international partners 1.7 Corporate governance - Integrated management system2 MEDICINES FOR HUMAN USE 2.1 Orphan medicinal products
som kemiker-kontaktperson i 5 år, inden hun blev udnævnt til underdirektør for MMB/Federation of Agricultural Cooperatives kontor i Bruxelles, der repræsenterer alle områder af landbrugssamarbejdet over for Europa-Kommissionen. 
Career to date: Miss Leivers worked for the Milk Marketing Board for England and Wales (MMB) as a liaison chemist for five years, prior to being appointed assistant director of the MMB/Federation of Agricultural Cooperatives office in Brussels, representing all sectors of agricultural cooperation to the European institutions.
Genvalgt som næstformand for COMP i juni 2003. 
He was re-elected vice-chairman of the COMP in June 2003.
Karriereforløb: 1977-1990 arbejdede prof. Torrent i Farnell inden for intern medicin og klinisk farmakologi i Spanien og var desuden ansat som docent i farmakologi ved UAB. 
Career to date: From 1977 to 1990, Professor Torrent i Farnell worked in internal medicine and clinical pharmacology in Spain and was assistant professor of pharmacology at the UAB.
Emer Cooke, leder af sektionen for tilsyn, født 9. april 1961, irsk statsborger 
Emer Cooke, Head of Sector for inspections, b. 9 April 1961, n. Irish
Har desuden en MBA fra Centre de Perfectionnement aux Affaires, Groupe HEC-CPA, 2000, Jouy-en-Josas i 
Executive master of business administration from the Centre de Perfectionnement aux Affaires at HEC-CPA, in Jouy-en-Josas, France, in 2000.
Karriereforløb: 1976-1986 arbejdede dr. Brasseur som pædiater ved universitetshospitalet Sint Pieter i Bruxelles. 
Career to date: From 1976 to 1986, Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Bestyrelsesmøder i 2005 
Management Board meetings in 2005
2.7 Plantelægemidler 
2.7 Herbal medicinal products
Jill Ashley-Smith, leder af sektionen for veterinærmedicinske markedsføringstilladelser, født 18. december 1962, britisk statsborger 
Jill Ashley-Smith, Head of Sector for veterinary marketing authorisation procedures, b. 18 December 1962, n. British
Udnævnt til medlem af CPMP i 1997. 
He was appointed a member of the CHMP in 1997.
sprog og mulighed for yderligere henvisningsprocedurer) og Kommissionens afgørelser, som involverer specifikke forpligtelser (prækliniske forsøg, kliniske forsøg, PSUR, undersøgelser efter markedsføring, registre), som kræver relevant opfølgning Målsætninger: 
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
I 1995 blev hun ansat i det franske lægemiddelagentur som leder af afdelingen for klinisk vurdering af farmakologisk toksicitet. 
In 1995 she joined the French Medicines Agency as head of unit for pharmaco-toxico-clinical assessment.
Thomas Lönngren, administrerende direktør, født 16. december 1950, svensk statsborger 
Thomas Lönngren, Executive Director, b. 16 December 1950, n. Swedish
Karriereforløb: Fra 1976 til 1980 var Dr. Lyngvig forskningsassistent og underviser ved Danmarks Tekniske Universitet. 
Career to date: From 1976 to 1980, Dr Lyngvig was research assistant and lecturer at the Technical University of Denmark.
ansøgninger 
applications
Hertil hører aktiviteter vedrørende oplysninger om lægemiddelovervågning (indberetninger af bivirkninger (ADR) og periodisk opdaterede sikkerhedsindberetninger (PSUR). 
These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports).
Målet er, at 95 % af svarene skal være afgivet inden for denne frist 
The target is to provide 95 % of responses within the timeline
Noël Wathion, afdelingsleder, født 11. september 1956, belgisk statsborger 
Noël Wathion, Head of Unit, b. 11 September 1956, n. Belgian
Europa-Kommissionen (GD XII) med ansvar for koordinering af forskningsnetværk og organisering af videnskabelige konferencer og workshopper i Europa. 
From 1993 to 1997, she was seconded to the European Commission (DG XII) as scientific secretary for COST actions in the field of chemistry, with responsibility for coordination of research networks and organisation of scientific conferences and workshops in Europe.
Frances Nuttall, leder af sektionen for personale og budget, født 11. november 1958, 
Frances Nuttall, Head of Sector for personnel and budget, b. 11 November 1958, n. Irish
Karriereforløb: 1978-1983 arbejdede dr. Papaluca som forskningsstipendiat ved Roms universitet med projekter inden for klinisk immunologi, onkologi og celleimmunologi. 
Career to date: From 1978 to 1983, research fellow at the State University of Rome on projects in the area of clinical immunology, oncology and cellular immunology.
Karriereforløb: Forskellige stillinger inden for den offentlige forvaltning i Irland, med tjeneste i sundheds- og finansministeriet og Kontoret for Offentlige Arbejder. 
Career to date: Ms Nuttall held several posts in the Irish Civil Service, serving in the Departments of Health, Finance and the Office of Public Works.
CHMP-arbejdsgruppen vedrørende bioteknologi 
CHMP Biotechnology Working Party
Til de initiativer, der skal tages, hører implementering af konceptet med risikohåndteringsplaner, udvidelse af anvendelsesområdet for lægemidler, der skal godkendes gennem den centraliserede procedure, etablering af den fremskyndede vurdering, betinget godkendelse og procedurer for lægemidler med særlig udleveringstilladelse (compassionate use), procedurer for godkendelse af bioækvivalente og generiske produkter, samt støtte til små og mellemstore virksomheder. 
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
CVMP's gruppe vedrørende videnskabelig rådgivning om antimikrobielle stoffer 
CVMP Scientific Advisory Group on Antimicrobials
At forberede iværksættelse af tiltag over for små og mellemstore virksomheder 
To prepare for provision of incentives to small and medium-sized enterprises
(‘lægemiddelovervågning') er en vigtig del af de nationale kompetente myndigheders og EMEA's arbejde. 
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance') is an important part of the work of the national competent authorities and the EMEA.
US Food and Drug Administration og overvågning af dens effektivitet Fortsat overvågning af virkningerne af videnskabelig rådgivning på resultatet af ansøgningerne om markedsføringstilladelser og analyse som del af databaserne for videnskabelig hukommelse og videnskabelig rådgivning Arbejdsgruppen vedrørende videnskabelig rådgivning 
Continuous monitoring of the impact of scientific advice on the outcome of applications for marketing authorisations and analysis as part of the scientific memory and scientific advice databases
Det forventes, at der vil blive modtaget ca. 1 700 ICSR fra EU elektronisk gennem 
It is forecast that there will be some 1,700 ICSRs from the EU received electronically through the EudraVigilance post-authorisation module in 2005.
BILAG 1 EMEA's stillingsfortegnelse for 2003-2005 
Annex 1 EMEA establishment plan 2003-2005
Ad hoc-grupper om GMP-, GCP-inspektioner og den fælles CHMP/CVMP 
Ad hoc groups of GMP, GCP inspections and joint CHMP/CVMP Quality Working Party
Gennemførelse af en ny politik for kompetenceudvikling Personale og budget 
The implementation of a new competence-development policy
Profiler af EMEA's ledende medarbejdere 
Profiles of EMEA personalities
17.-20. januar 
17-20 January
EMEA forventer, at interessen for at søge sådan rådgivning vil fortsætte og stige i kraft af nedsættelsen af en ny arbejdsgruppe for videnskabelig rådgivning vedrørende veterinærlægemidler Der forventes ni ansøgninger om videnskabelig rådgivning i år 
The EMEA anticipates that interest in seeking such advice will continue and grow with the establishment of a new Scientific Advice Working Party for veterinary medicines Nine applications for scientific advice are expected this year Only a few applications for free scientific advice for products intended for minor uses/minor species have been received - for food animals
Han blev ansat i EMEA i august 1996 som leder af sektionen for retsforskrifter og lægemiddelovervågning og blev i september 2000 udnævnt til leder af afdelingen for vurdering af humanmedicinske lægemidler. 
He joined the EMEA in August 1996 as head of sector for regulatory affairs and pharmacovigilance and was appointed head of the Human Medicines Evaluation Unit in September 2000.
Gérard Moulin, formand for CVMP, født 18. oktober 1958, fransk statsborger 
Gérard Moulin, Chairman of the CVMP, b. 18 October 1958, n. French
Udvikling af en database over fremstillingsgodkendelser og GMP-certifikater 
Development of the database on manufacturing authorisations and GMP certificates
Videnskabelig Forskning (CNRS), hvor hun i 1991 udnævntes til ansvarlig for europæiske anliggender. 
In 1986 she joined the French National Scientific Research Centre (CNRS) as Chargé de recherche 1ère classe and became officer for European affairs in 1991.
2010 i relation til humanmedicinske lægemidler Videreudvikling af EMEA's risikostyringsstrategi, navnlig med hensyn til risikostyringsplaner og yderligere gennemførelse af EudraVigilance-projektet, herunder indberetning af bivirkninger ved kliniske forsøg 
Further develop the EMEA risk management strategy, in particular as regards the concept of risk management plans and further implementation of the EudraVigilance project, including the reporting of adverse drug reactions in clinical trials
Konceptdokument udvikles i 2005 
Concept paper to be developed in 2005
Uddannet som veterinærkirurg på Royal Veterinary College ved Londons universitet. 
Qualified as a veterinary surgeon from the Royal Veterinary College, University of London.
Drift, vedligeholdelse, support og videreudvikling af fem EU-telematikprojekter: EudraNet, 
Operation, maintenance, support and further development of five EU telematics projects: EudraNet, EudraVigilance, EudraCT, EuroPharm and e-Submission
Agenturet gå videre med en kraftig udvidelse af det oprindelige anvendelsesområde for EuroPharm-databasen for information om alle EU-godkendte lægemidler. 
As part of this plan: 9 The Agency will carry out additional work to considerably widen the original scope of the EuroPharm database of information on all medicines authorised in the EU.
Valgt som formand for CVMP i januar 2003 og genvalgt som formand i 2004. 
He was first elected chairman of the CVMP in January 2003 and was re-elected in 2004.
Studier efter kandidateksamen inden for kardiologi og endokrinologi. 
Postgraduate studies in cardiology and endocrinology.
Der vil den 1. januar 2005 blive iværksat elektronisk indberetning af bivirkninger for alle veterinærlægemidler under EudraVigilance Veterinary At etablere en database for videnskabelig hukommelse for centralt godkendte lægemidler med det formål at understøtte kvaliteten og konsekvensen af videnskabelig vurdering inden for CVMP, hvorved risk/benefit-analysen forud for tilladelsen til nye veterinærmedicinske lægemidler styrkes 
Establish a scientific memory database for centrally authorised medicinal products to underpin the quality and consistency of scientific assessment within the CVMP, thereby reinforcing the risk/benefit analysis prior to authorisation of new veterinary medicines
At konsolidere operationelle aspekter af de respektive gensidige anerkendelsesaftaler (MRA) (alle aftaler, med undtagelse af aftalen med USA, er fuldt operationelle i hvert fald i de gamle medlemsstater) 
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
Uddannelse: Farmaceut, doktorgrad i naturvidenskab (farmakognosi ) fra universitetet i Saarbrücken. 
Education: Pharmacist, doctorate in natural sciences (pharmacognosy) from the University of Saarbrücken.
Codex Alimentarius, og agenturet og CVMP vil fortsat være repræsenteret i andre internationale fora, 
There will be continued technical support to the Commission in its membership of Codex Alimentarius, and the Agency and CVMP will continue their representation at other international forums, including the WHO, OIE and FAO.