FrancophonIA/ELRC3.0 huggingface dataset:
English: Career to date: From 1978 to 1982, Dr Keller worked as a research and teaching assistant at the Institute for Pharmacognosy and Analytical Phytochemistry of the University of Saarbrücken.
Danish: Karriereforløb: 1978 til 1982 ansat som forsknings- og undervisningsassistent ved institut for farmakognosi og analytisk fytokemi ved Saarbrückens universitet.
English: Revision 3 expected in 1Q 2005
Danish: Revision 3 forventes i 1. kv.
English: Plasma master files and vaccine antigen master files
Danish: Masterfiler vedrørende plasma og vaccineantigener
English: The target is 90 % of summaries published at the time of the press release o percentage of European public assessment reports published within two weeks after Commission decision.
Danish: Målet er, at 90 % af resuméerne skal være offentliggjort på tidspunktet for pressemeddelelsen o antal procent af europæiske offentlige evalueringsrapporter, der er offentliggjort inden for to uger efter kommissionsafgørelsen.
English: Joint concept paper adopted by EWP and SWP, under discussion by CVMP
Danish: EWP og SWP, under diskussion i CVMP
English: 8-10 February
Danish: 8.-10. februar
English: Administration Unit
Danish: Administrationsafdelingen
English: Preparation of transparency and communication strategies and related policies that set out what, how and when information will be published
Danish: Nedsættelse af en arbejdsgruppe med lægemiddelstyrelsescheferne for spørgsmål vedrørende gennemsigtighed og informationsformidling i netværket Udarbejdelse af strategier for gennemsigtighed og informationsformidling samt politikker i forbindelse hermed, som definerer, hvordan, hvorledes og hvilken information, der skal offentliggøres
English: Education: Graduate in biochemistry and pharmacology from Leeds University.
Danish: Uddannelse: Uddannet i biokemi og farmakologi ved Leeds universitet.
English: He joined the EMEA in May 1995 and was appointed deputy head of sector in July 2003.
Danish: Han blev ansat i EMEA i maj 1995 og blev udnævnt til viceleder af sektionen i juli 2003.
English: He co-founded the International Alliance of Patient Organisations (IAPO) based in London, and served as vice-chairman from 1997 to 2000.
Danish: IAPO (International Alliance of Patients Organisations), som har hjemsted i London.
English: 2-4 March
Danish: 2.-4. marts
English: 2-4 February
Danish: 2.-4. februar
English: Entry into force of the new legislation, requiring considerable effort to set up structures, processes and tools for the changed regulatory environment
Danish: Ikrafttrædelse af den nye lovgivning, hvilket kræver en betydelig indsats for at etablere strukturer,
English: 20-23 June
Danish: 20.-23. juni
English: Policy for the transmission of PhVWP Recommendations and Assessment Reports for mutually recognised and purely nationally authorised products to marketing authorisation holders
Danish: Reports for mutually recognised and purely nationally authorised products to marketing authorisation holders fortsætter i 2005
English: More biosimilar products are anticipated in 2005 compared to 2004
Danish: 2005, hvilket vil medføre en minimal stigning i antallet af ansøgninger Der forventes flere bioækvivalente produkter i 2005 sammenholdt med 2004
English: He joined the EMEA in February 1997.
Danish: Ansat i EMEA i februar 1997.
English: Follow-up on initiatives to improve transparency and provide clear and understandable information to patients, healthcare professionals and the public
Danish: Der vil blive lagt vægt på initiativer rettet mod forbedret kommunikation og information til patienter, ansatte i sundhedssektoren og offentligheden.
English: Revision 2 expected in 1Q 2005
Danish: Revision 2 forventes i 1. kv.
English: 3.6 Arbitration and Community referrals
Danish: 3.6 Voldgifter og henvisninger af sager til Fællesskabet
English: She was appointed head of sector for safety and efficacy of medicines in January 2001.
Danish: Udnævnt til leder af sektionen for lægemidlers sikkerhed og virkninger i januar 2001.
English: CVMP working parties and ad hoc groups in 2005 Number of meetings Immunologicals Working Party
Danish: CVMP arbejdsgrupper og ad hoc-grupper i 2005
English: Education: Qualified medical doctor from the University of Grenoble, France.
Danish: Uddannelse: Uddannet i medicin ved Grenobles universitet i Frankrig.
English: Revision to be considered in 2005
Danish: Revision overvejes i 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.
Danish: Påbegyndte sit virke i EMEA i november 1996 og blev udnævnt til viceleder af sektionen for lægemiddelovervågning og tilsyn med lægemidlers sikkerhed og virkninger efter godkendelse i januar 2001.
English: Guideline on the investigation of mitochondrial toxicity of HIVtherapeutics in vitro
Danish: Guideline on the investigation of mitochondrial toxicity of HIV
English: Education: Degree in analytical chemistry from the University of Amsterdam, 1984, followed by a PhD in biochemistry from the University of Amsterdam, 1988.
Danish: Uddannelse: Universitetseksamen i analytisk kemi fra Amsterdams universitet 1984, efterfulgt af en
English: Education: Qualified chemist and pharmacist from the Free University of Berlin.
Danish: Uddannelse: Uddannet som kemiker og farmaceut ved Freie Universität Berlin.
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.
Danish: og uddannet i forskningsstyring, PhD i fysisk organisk kemi og mastergrad i fysisk organisk kemi, universitetseksamen i biokemi.
English: Core SPC for human plasma derived and recombinant coagulation Factor VIII products
Danish: Core SPC for human plasma derived and recombinant coagulation Factor
English: Career to date: Ms Fayl held various positions as a documentalist in several European countries, the latest from 1988 to 1995, setting up and running the documentation service at the European Commission Delegation in Norway.
Danish: Karriereforløb: Forskellige stillinger som dokumentalist i flere lande i Europa, senest 1988-1995,
English: Consultation ended 17 Sept. 04, under revision by PhVWP- V for adoption in 1Q 2005
Danish: Høring sluttede den 17. sept. 04, under revision i PhVWP-V til vedtagelse i 1. kv.
English: The target is 90 % of summaries published at the time of the press release o percentage of European public assessment reports published within 14 days after Commission decision.
Danish: Målet er, at 90 % af resuméerne skal være offentliggjort på tidspunktet for pressemeddelelsen o Antal procent af europæiske offentlige evalueringsrapporter, der er offentliggjort inden for 14 dage efter kommissionsafgørelsen.
English: Dr Pittner was also a CPMP delegate from 1995 to 1997 and from 2001 until April 2004; since May 2004 Dr Pittner has been a CHMP delegate.
Danish: Fra 1995 til 1997 og fra 2001 til april 2004 medlem af CPMP.
English: 14-16 June
Danish: 14.-16. juni
English: Status studies in the safety evaluation of new medicinal products in animals
Danish: Pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals
English: Beatrice Fayl, Head of Sector for document management and publishing, b. 9 October 1959, n. Danish
Danish: Beatrice Fayl, leder af sektionen for Dokumentstyring og offentliggørelse, født 9.
English: Implementation of Directive 2001/20/EC and of the new legislation will add to demands on community inspection resources
Danish: Gennemførelse af direktiv 2001/20/EF og af den nye lovgivning vil ligeledes få antallet af anmodninger om EU-inspektioner til at stige Virkninger af procesanalyseteknologier på kvalitetsaspekter af vurdering og inspektion
English: In 1998 he was coordinator-director for the creation of the Spanish Medicines Agency and executive director of the Spanish Medicines Agency from 1999 to 2000.
Danish: I 1998 varetog han hvervet som ledende koordinator i forbindelse med oprettelsen af den spanske lægemiddelstyrelse.
English: She joined the EMEA in January 2000 and was appointed head of sector for scientific advice and orphan drugs in December 2001.
Danish: Hun blev ansat i EMEA i januar 2000 og udnævnt til leder af sektionen for videnskabelig rådgivning og lægemidler til sjældne sygdomme i december 2001.
English: Further to the restructuring of the Human Medicines Evaluation Unit in 2001, he was appointed head of unit for the pre-authorisation evaluation of medicines for human use, in March
Danish: I forlængelse af omstruktureringen af afdelingen for vurdering af humanmedicinske lægemidler i 2001 blev han udnævnt til leder af afdelingen for vurdering af humanmedicinske lægemidler efter godkendelse i marts 2001.
English: There is only limited market growth foreseen in the veterinary pharmaceutical sector as a result of a reduction in the number of companies and industry's claims that investment in new products is being diverted into defensive research and development
Danish: Tendensen for ansøgninger gennem den centraliserede procedure fortsætter, hvilket sikrer et løbende udbud af nye og innovative lægemidler for dyrlæger og af dyreejere i hele Fællesskabet Der forventes kun en begrænset vækst på markedet for farmaceutiske veterinærlægemidler, hvilket skyldes et mindre antal virksomheder samt branchens påstand om, at investeringer i nye lægemidler omlægges til defensiv forskning og udvikling
English: Education: Qualified medical doctor from the University of Graz.
Danish: Uddannelse: Uddannet som læge ved universitet i Graz.
English: Progress interactions with the innovative, non-prescription and generic medicines industries
Danish: Status for samarbejdet med de innovative industrier for håndkøbsmedicin og generiske lægemidler
English: He joined the EMEA as head of the legal sector in November 2004.
Danish: Ansat ved EMEA som leder af den juridiske sektion siden november 2004.
English: Education: Qualified as a pharmacist, BSc (Pharm) and was granted a master's degree in pharmaceutics in the research area of microencapsulation from Trinity College Dublin.
Danish: Uddannelse: Bachelorgrad i farmaci (BSc) og mastergrad i farmaci inden for forskning i mikroindkapsling fra Trinity College i Dublin.
English: To provide timely and understandable product information to patients and healthcare professionals
Danish: At behandle specifikke behov for nye teknologier At yde rettidig og forståelig produktinformation til patienter og ansatte i sundhedssektoren
English: 2.6 Arbitration and Community referrals
Danish: 2.6 Voldgifter og henvisninger af sager til Fællesskabet
English: To provide high-quality service, including extended helpdesk facilities, of EU telematics to the EMEA's partners on an ongoing basis.
Danish: Opnåelsen af disse målsætninger vil blive målt på levering af systemerne til tiden, inden for budgettet, og i henhold til specifikationerne Løbende at levere kvalitetstjenester, herunder udvidede helpdesk-faciliteter, inden for EU's telematikstrategi til EMEA's partnere.
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
Danish: Målet er, at 80 % af sammenfatningerne skal være offentliggjort inden for denne frist At tilvejebringe rettidig information efter henvendelser fra tredjeparter om fastsatte maksimale grænseværdier i overensstemmelse med aftalte frister Præstationsindikatoren for denne målsætning er procenten af svar, der afgives inden for 14 dage.
English: Revision expected to be released by mid 2005
Danish: Revision forventes sendt til høring medio 2005
English: Some reasons for this:
Danish: Hertil hører:
English: 14-17 February
Danish: 14.-17. februar
English: Salaries
Danish: Lønudbetalinger
English: Education: Qualified pharmacist from the University of Uppsala Faculty of Pharmacy.
Danish: Uddannelse: Uddannet farmaceut ved fakultetet for farmaci, Uppsalas universitet.
English: Joint CHMP/CVMP Quality Working Party
Danish: Den fælles CHMP/CVMP-arbejdsgruppe vedrørende kvalitet
English: If revision is required, expected to be released for consultation in 2005 and finalised in 2006
Danish: Hvis det er nødvendigt med en revision, forventes den sendt til høring i 2005 og færdigudarbejdet i
English: Work to be considered in 2005
Danish: Arbejdet overvejes i 2005
English: 2.5 Pharmacovigilance and maintenance activities 2.6 Arbitration and Community referrals 2.7 Herbal medicinal products
Danish: 2.4 Aktiviteter efter godkendelse 2.5 Lægemiddelovervågning og ajourføringsaktiviteter 2.6 Voldgifter og henvisninger af sager til Fællesskabet
English: CHMP Vaccine Working Party
Danish: CHMP-arbejdsgruppen vedrørende vacciner
English: Increasing technological, industrial and regulatory globalisation, and need for global harmonisation activities
Danish: Forventet udvidelse af Den Europæiske Union i 2007 Stigende globalisering på det teknologiske, industrielle og regulerende område, og behov for globale harmoniseringsaktiviteter Interessen fra resten af verden i EMEA's arbejde og det europæiske system forventes at vokse,
English: Revision to be finalised in 2005
Danish: Revision afsluttes i 2005
English: He has a continuing teaching appointment for pharmacology and toxicology at the University of Würzburg.
Danish: Beklæder fortsat en stilling inden for farmakologi og toksikologi ved universitetet i Wuerzburg.
English: The summarised comparative budget statements for 2003 to 2005 are as follows: (Amounts expressed in euro)
Danish: Sammendrag af de komparative budgetoversigter for 2003-2005:
English: Specialist in endocrinology and metabolic diseases.
Danish: Specialisering inden for endokrinologi.
English: 1 EMEA IN THE EUROPEAN SYSTEM 1.1 Management Board
Danish: Indledning ved den administrerende direktør 1 EMEA I DET EUROPÆISKE SYSTEM
English: From 1984 to 1994, as medical director at the pharmaceutical department of the Italian Ministry of Health, she was in charge of the Operative Centre for Community Procedures, was the Italian member of the former Committee for Proprietary Medicinal Products (CPMP), and was also involved in ICH activities.
Danish: 1984-1994 var hun som leder af Lægemiddelkontoret i Italiens sundhedsministerium, hun var ansvarlig for Det Operative
English: ICH-E2D: Post-Approval Safety Management: Definitions and Standards for Expedited Reporting and Good Case Management Practices
Danish: ICH-E2D: Post-Approval Safety
English: To provide timely and quality opinions arising from arbitration and referral procedures
Danish: At afgive kvalitetsudtalelser hidrørende fra voldgifter og indbringelsesprocedurer inden for fristerne
English: • by writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB UK
Danish: Canary Wharf London E14 4HB UK
English: CHMP Blood Products Working Party
Danish: CHMP-arbejdsgruppen vedrørende blodpræparater
English: 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.
Danish: Karriereforløb: Efter et praktikophold i Europa-Kommissionen i 1991-92 arbejdede Martin Harvey
English: 12-14 January
Danish: 12.-14. januar
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.
Danish: Målet er, at 100 % af resuméerne skal være offentliggjort på tidspunktet for pressemeddelelsen o antal procent af sammenfatninger af maksimalgrænseværdier, der er offentliggjort inden for 14 dage efter offentliggørelse af Fællesskabets maksimale grænseværdier.
English: Career to date: Mr Salvatore acted as a private practice lawyer from 1991 to 2004, dealing with arbitration and litigation cases mainly in the fields of public procurement, competition, international trade and contracts.
Danish: Uddannelse: Juridisk embedseksamen fra Pavia universitetet i Italien, PhD i europæisk fællesskabsret fra det europæiske universitetsinstitut i Firenze, Italien, Avvocato, professor i international ret. Karriereforløb: arbejdede som privatpraktiserende advokat fra 1991 til 2004 med voldgifts- og retssager, navnlig inden for offentlige indkøb, konkurrence, international handel og aftaler.
English: Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to human medicines
Danish: At iværksætte den indledende fase af gennemførelsesplanen for EMEA's “køreplan” frem til
English: Category & Grade
Danish: Kategori og løntrin
English: Revision to start in 2005
Danish: Revision indledes i 2005
English: Following graduation with an MBA degree in 1991, she joined EFPIA, the European pharmaceutical industry association, as manager of scientific and regulatory affairs.
Danish: Efter erhvervelsen af en MBA-grad i 1991 blev hun ansat i EFPIA, Den Europæiske Sammenslutning af
English: The target is to have 90 % of applications evaluated within these timelines
Danish: Målet er, at 90 % af ansøgningerne skal være evalueret inden for denne frist
English: Consultation ended 16 Dec. 04, under revision by PhVWP- V for adoption in 1Q 2005
Danish: Høring sluttede den 16. dec. 04, under revision i PhVWP-V til vedtagelse i 1. kv.
English: Direct telephone: (44-20) 75 23 71 47 Fax: (44-20) 74 18 85 45
Danish: Tlf.: (direkte nummer): (44-20) 75 23 71 47 Fax: (44-20) 74 18 85 45
English: He joined the EMEA in May 1996 and was appointed head of sector for regulatory affairs and operational support in January 2001.
Danish: EMEA i maj 1996 og udnævnt til leder af sektionen for retsforskrifter og organisatorisk støtte i januar
English: Career to date: From 1973 to 1979, Professor Wahlroos served as a pharmacist and a researcher in several pharmacies, at the University of Helsinki and in the pharmaceutical industry.
Danish: Karriereforløb: Fra 1973 til 1979 arbejdede prof. Wahlroos på adskillige apoteker, ved universitetet i
English: The target is to publish 80 % of EPARs within the timeline
Danish: Målet er, at 80 % af EPAR'ene skal være offentliggjort inden for denne frist
English: Bringing of EuroPharm into production, including data from as many competent national authorities as wish to contribute
Danish: EudraVigilance, EudraCT, EuroPharm og e-Submission Sætte EuroPharm i produktion, herunder data fra alle de kompetente nationale myndigheder, der ønsker at bidrage
English: Education: Law degree from the University of Dundee, UK. Master's degree in European and international law from the Free University of Brussels, Belgium.
Danish: Mastergrad i europæisk og international ret fra Vrije Universiteit i Bruxelles, Belgien.
English: Paediatric Working Party Vaccine Working Party
Danish: Arbejdsgruppen for pædiatriske lægemidler Arbejdsgruppen vedrørende vacciner
English: Press office Press officer
Danish: Pressesekretær
English: Following this she worked on a short-term contract at the European Commission (DG XI) and then in industry at Pfizer (formerly SmithKline Beecham Animal Health) as a regulatory affairs manager.
Danish: Kommissionen (GD XI) og efterfølgende inden for lægemiddelindustrien hos Pfizer (tidligere
English: Direct telephone: (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
Danish: Tlf.: (direkte nummer): (44-20) 74 18 85 52 Fax: (44-20) 74 18 85 45
English: Accounts
Danish: Bogholderi
English: Agnès Saint Raymond, Head of Sector for orphan drugs and scientific advice and Acting Head of Sector for safety & efficacy of medicines, b. 7 September 1956, n. French
Danish: Agnès Saint Raymond, leder af sektionen for lægemidler til sjældne sygdomme og videnskabelig rådgivning, født 7. september 1956, fransk statsborger
English: Career to date: From 1976 to 1981, Dr Grein held a position at the Free University of Berlin in Germany teaching and conducting research.
Danish: Karriereforløb: 1976-1981 var dr. Grein ansat som forsker og underviser ved Freie Universität Berlin.
English: CHMP Safety Working Party
Danish: CHMP-arbejdsgruppen vedrørende sikkerhed
English: Coordinate and manage effectively the requests for GMP, GCP, pharmacovigilance and GLP inspections relating to applications for products through the centralised procedure within the timeframe laid down in Community law and to the standards required by the Agency's quality management system
Danish: Færdiggørelse af det interne vurderingsarbejde med nye medlemsstater inden for rammerne af den gensidige anerkendelsesaftale med Canada At koordinere og effektivt styre anmodningerne om GMP, GCP, lægemiddelovervågning og GLP-inspektioner vedrørende ansøgninger om produkttilladelser gennem den centraliserede procedure inden for den af fællesskabslovgivningen fastsatte frist og i overensstemmelse med de standarder, der kræves af agenturets kvalitetsstyringssystem Gennemførelse af en handlingsplan, i samarbejde med EDQM, for revision af programmet for stikprøveudtagning og afprøvning for centralt godkendte produkter, der tager sigte på at effektivisere aktiviteter og målrette ressourcer med udgangspunkt i en risikobaseret strategi.
English: Increased electronic reporting both for ICSRs (individual case safety reports) and SUSARs (suspected unexpected serious adverse reactions) into the EudraVigilance database for all medicinal products, irrespective of the licensing route
Danish: (formodede uventede og alvorlige bivirkninger) til EudraVigilance-databasen for alle lægemidler, uanset hvordan godkendelsen foretages
English: To be finalised in 2005
Danish: Afsluttes i 2005
English: To conduct quality orphan medicinal product designations and related activities and adhere to regulatory timelines
Danish: At udføre kvalitetsudpegelser af lægemidler til sjældne sygdomme og aktiviteter i forbindelse hermed og overholde forskriftsmæssige frister
English: Preparatory work for the establishment of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
Danish: Centrale initiativer: Indledende arbejde i forbindelse med oprettelsen af listen over plantelægemidler, præparater og blandinger heraf til brug i traditionelle plantelægemidler
English: From 1990 to 1994, he was technical counsellor in clinical evaluation and pharmacology at the Spanish Ministry of Health, a member of the CPMP Efficacy Working Party and involved in the Efficacy Group of the ICH.
Danish: 1990-1994 var han teknisk rådgiver inden for klinisk vurdering og farmakologi i det spanske sundhedsministerium,
English: COMP meetings in 2005
Danish: Møder i COMP i 2005
English: The target is to have 100 % of applications evaluated within this timeline
Danish: Målet er, at 100 % af ansøgningerne skal være evalueret inden for denne frist
English: CVMP meetings in 2005
Danish: Møder i CVMP i 2005
English: She joined the EMEA in October 1994.
Danish: Ansat i EMEA i oktober 1994.
English: He joined the EMEA in May 2000.
Danish: Ansat i EMEA i maj 2000.
English: Education: Qualified medical doctor from the University of Paris.
Danish: Uddannelse: Uddannet som læge ved Paris' universitet.
English: Career to date: From 1987 to 1994, Dr Ashley-Smith was employed in the veterinary pharmaceutical industry, first as a technical adviser and subsequently as a registration manager.
Danish: Karriereforløb: 1987-1994 var Ashley-Smith ansat inden for den veterinære lægemiddelindustri,
English: Kornelia Grein, Head of Sector for safety of veterinary medicines, b. 24 July 1952, n. German
Danish: Kornelia Grein, leder af sektionen for veterinærlægemidlers sikkerhed,
English: Scientific Advice Requests received/forecast (Input)
Danish: Modtagne/skønnede anmodninger om videnskabelig rådgivning (input)
English: Payments received Payments made
Danish: Indbetalinger Udbetalinger
English: This includes making multilingual navigation possible and improving presentation, user friendliness and search tools
Danish: Bl.a. skal der kunne navigeres på flere forskellige sprog, og præsentation,