FrancophonIA/ELRC3.0 huggingface dataset:
English: Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolism in nonsurgical patients
Danish: Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolism in non surgical patients
English: Education: Bachelor of commerce from University College Dublin.
Danish: Uddannelse: Bachelor i handel fra University College i Dublin.
English: Increasing bilateral cooperation with the US Food and Drug Administration following the signing of confidentiality arrangements in September 2003 and the similar agreement proposed with the US Department of Agriculture for certain classes of veterinary medicines
Danish: navnlig som følge af udvidelsen af systemet til at omfatte 28 EU- og EØS-EFTA-lande Stigende bilateralt samarbejde med US Food and Drug Administration efter indgåelsen af fortrolighedsaftaler i september 2003 og den tilsvarende aftale, der er foreslået indgået med det amerikanske landbrugsministerium (Department of Agriculture) for visse klasser af veterinærlægemidler
English: Under development by the PhVWP-V
Danish: Under udvikling i PhVWP-V
English: Education: Qualified in medicine from Sheffield University in 1983.
Danish: Uddannelse: Uddannet læge på Sheffields universitet i 1983.
English: Career to date: From 1971 to 1974, Mr O'Malley completed articles in Dublin.
Danish: Karriereforløb: 1971-1974 færdiggjorde O'Malley sin revisoruddannelse i Dublin.
English: Introduction of the following new procedures foreseen in the new legislation: conditional marketing authorisation, accelerated assessment and compassionate use
Danish: Indførelse af følgende nye procedurer som foreskrevet i den nye lovgivning: Betinget markedsføringstilladelse, fremskyndet vurdering og lægemidler med særlig udleveringstilladelse
English: Other staff-related expenditure
Danish: Andre personalerelaterede udgifter
English: Employed by the Ministry of Agriculture, Nature Management and Fisheries in 1988; from 1988 to 1998 by the State Institute for Quality Control of Agricultural Products (RIKILT-DLO) as an assessor for veterinary medicinal products and feed additives, research on development of analytical methods and development of quality systems for agricultural production; from 1998 to the present by the Bureau Registratie Diergeneesmiddelen (BRD).
Danish: Fra 1988 ansat i Landbrugs-, Naturforvaltnings- og Fiskeriministeriet, fra 1988 til 1998 i Det Statslige Institut for Kvalitetskontrol af Landbrugsprodukter (REKILT-DLO) som bedømmer af veterinærlægemidler og tilsætningsstoffer til foderstoffer, forskning i udvikling af analytiske metoder og udvikling af kvalitetssystemer for landbrugsproduktion.
English: He has been a CVMP member since 1997; he was elected vice-chairman of the CVMP in 2001.
Danish: Medlem af CVMP siden 1997 og valgt til næstformand for CVMP i 2001.
English: As a result of the initiatives in the area of transparency and communication, patients, healthcare professionals, academia, learned societies, the pharmaceutical industry and other stakeholders will have faster, easier access to a wider range of information regarding the activities of the Agency and the network.
Danish: ansatte i sundhedssektoren, forskere, ekspertforeninger, lægemiddelindustrien og andre interessenter have hurtigere og lettere adgang til en bredere palet af information om agenturets og netværkets aktiviteter.
English: Career to date: From 1972 to 1974, Dr Purves worked in the pharmaceutical industry.
Danish: Karriereforløb: 1972-1974 arbejdede dr. Purves inden for medicinalindustrien.
English: 6.2 Meetings and conferences at the EMEA 6.3 EMEA document management and publishing
Danish: 6.2 Møder og konferencer i EMEA 6.3 Styring og offentliggørelse af EMEA-dokumenter
English: Career to date: Worked as a clinical endocrinologist in a French hospital until 1987 and then joined the directorate of pharmacy at the French Ministry of Health.
Danish: Karriereforløb: Arbejdede som klinisk endokrinolog på et fransk hospital indtil 1987, hvor hun blev ansat i Direktoratet for Farmaci i Frankrigs sundhedsministerium.
English: Scientific Advice Working Party
Danish: Arbejdsgruppen vedrørende videnskabelig rådgivning
English: Annex 2 Revenue and expenditure overview 2003-2005
Danish: BILAG 2 OVERSIGT OVER UDGIFTER OG INDTÆGTER FOR 2003-2005
English: Emphasis is put on transparency, communication and information on pharmacovigilance issues.
Danish: Der lægges vægt på gennemsigtighed, informationsformidling og information om spørgsmål, der vedrører lægemiddelovervågning.
English: Discussion of interested parties with working parties and/or ad hoc groups on specific technical/scientific issues
Danish: Udveksling af synspunkter mellem interesserede parter om retningslinjer Drøftelse mellem interesserede parter og arbejdsgrupper og/eller ad hoc-grupper vedrørende specifikke tekniske/videnskabelige spørgsmål
English: Education: Graduated in veterinary medicine from the faculty of veterinary science at Liverpool University and is a member of the Royal College of Veterinary Surgeons of the United Kingdom.
Danish: Uddannelse: Uddannet i veterinærmedicin ved Det Veterinærvidenskabelige Fakultet ved Liverpools universitet og medlem af det britiske Royal College of Veterinary Surgeons.
English: Josep Torrent i Farnell, Chairman of the COMP, b. 2 May 1954, n. Spanish
Danish: Josep Torrent i Farnell, formand for COMP, født 2. maj 1954, spansk statsborger
English: EU telematics strategy and information technology
Danish: EU's telematikstrategi og informationsteknologi
English: Career to date: Mr Ettore joined the European Commission as conference interpreter in 1976.
Danish: Karriereforløb: Riccardo Ettore blev ansat ved Europa-Kommissionen som konferencetolk i 1976.
English: The operation of the Mutual Recognition Facilitation Group (MRFG) will continue to be supported by the EMEA at its monthly meetings.
Danish: EMEA vil på sine månedlige møder fortsat yde støtte til aktiviteterne i gruppen for fremme af gensidig anerkendelse (MRFG).
English: Preparatory work in the area of procedures to be established in relation to the provision to Member States and European institutions of the best scientific opinion on questions related to herbal medicinal products, as well as to the adoption of opinions at the request of the Committee for Medicinal Products for Human Use
Danish: Indledende arbejde i forbindelse med fastlæggelse af procedurer for udarbejdelse af de bedste videnskabelige udtalelser over for medlemsstater og europæiske institutioner i spørgsmål, der vedrører plantelægemidler, og afgivelse af udtalelser efter anmodning fra Udvalget for Humanmedicinske Lægemidler
English: The amount of work in post-authorisation activities such as variations and line extensions will increase steadily in line with the total number of marketing authorisations.
Danish: Det arbejde, der skal udføres i forbindelse med aktiviteter efter tilladelsen, såsom ændringer og produktserieudvidelser, vil stige støt i takt med det samlede antal markedsføringstilladelser.
English: To perform high-quality activities in the field of pharmacovigilance and adhere to required timelines
Danish: At gennemføre aktiviteter af høj kvalitet på området for lægemiddelovervågning og overholde påbudte frister
English: Career to date: Six years of clinical experience in UK hospitals, five years as director of pharmacovigilance and regulatory affairs at Astra Pharmaceuticals in the UK and a total of seven years at the UK Medicines Control Agency.
Danish: Karriereforløb: 6 års klinisk erfaring fra britiske hospitaler, 5 år som direktør for lægemiddelovervågning og forskriftsmæssige anliggender ved Astra Pharmaceuticals i Det Forenede
English: Possible revision in 2005
Danish: Eventuel revision i 2005
English: The new legislation sets forth provisions for the implementation of a risk management system as well as the possibility to set up a system of permanent follow-up of the risk/benefit balance.
Danish: Den nye lovgivning fastsætter bestemmelser for gennemførelsen af risikostyringssystemet samt muligheden for at etablere et permanent opfølgningssystem for afvejning af fordele og risici.
English: After serving as a pharmacist (Captain) in a pharmaceutical control laboratory of the German Army, he joined the former German Federal Health Office in 1983.
Danish: Har beklædt en stilling som farmaceut (kaptajn) ved et lægemiddelkontrollaboratorium i den tyske hær og var i 1983 ansat i den tyske sundhedsstyrelse .
English: Board-certified specialist in pharmacology and toxicology (Bavarian Chamber of Physicians).
Danish: Certificeret specialist i farmakologi og toksikologi (Bavarian Chamber of Physicians).
English: The new requirements include the establishment of procedures for conditional marketing authorisations, accelerated assessment, compassionate use and for opinions on medicinal products intended for markets exclusively outside the EU (in collaboration with the WHO).
Danish: De nye krav omfatter fastlæggelse af procedurer for betingede markedsføringstilladelser, fremskyndet vurdering, procedurer for lægemidler med særlig udleveringstilladelse og for udtalelser om lægemidler, der udelukkende er bestemt til markeder uden for EU (i samarbejde med WHO).
English: Postgraduate studies in pharmacology at the Universities of Melbourne and Auckland.
Danish: Studier efter kandidateksamen inden for farmakologi ved Melbournes og Aucklands universitet.
English: Work with the Agency's traditional partners on the EU-Japan-USA trilateral harmonisation of regulatory requirements for human and veterinary medicines (ICH and VICH)
Danish: Direktorat for Lægemiddelkvalitet om programmet for stikprøveudtagning og afprøvning vedrørende centralt godkendte lægemidler Arbejde med agenturets traditionelle samarbejdspartnere om harmoniseringen af forskrifter mellem EU-Japan-USA vedrørende human- og veterinærmedicinske lægemidler (ICH og VICH)
English: Fellow of the Institute of Chartered Accountants in Ireland.
Danish: Statsautoriserede Revisorer i Irland.
English: Professional training management directed towards a continuous system of competence development, taking account of the enhanced scientific role of the Agency
Danish: Forbedring af det aktivitetsbaserede budgetplanlægningssystem Styring af videreuddannelse med henblik på løbende kompetenceudvikling og under hensyntagen til agenturets udvidede rolle på det videnskabelige område
English: Postgraduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Danish: Uddannelse efter kandidateksamen inden for intern medicin, endokrinologi, diabetologi og kardiologi.
English: Postgraduate degree in paediatrics and a PhD in nutrition.
Danish: Universitetsgrad efter kandidateksamen i pædiatri og en PhD i ernæring.
English: He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Danish: Ansat i Lægemiddelinspektoratet i Belgiens sundhedsministerium som leder af gruppen af medicinske rådgivere i 1997.
English: Education: Master's degree in political science, history and English from the University of Hamburg.
Danish: Uddannelse: Mastergrad i statskundskab, historie og engelsk fra Hamborgs universitet.
English: Regulatory and procedural guidance
Danish: Vejledning vedrørende lovregler og procedurer
English: Note for Guidance on Quality, Preclinical and Clinical Aspects of Gene Transfer Medicines - Lentiviral Vectors
Danish: Note for Guidance on Quality, Pre clinical and Clinical Aspects of Gene Transfer Medicines - Lentiviral
English: Plasma master files (PMFs) and vaccine antigen master files (VAMFs) are separate documents from the dossier for a marketing authorisation.
Danish: Masterfiler vedrørende plasma (PMF) og vaccineantigener (VAMF) er dokumenter, der er adskilt fra dokumentationen i ansøgningen for en markedsføringstilladelse.
English: She participated as UK CVMP member from 1996 until joining the EMEA in July
Danish: Hun var britisk medlem af CVMP fra 1996, indtil hun i juli 1997
English: Conduct analysis of adverse reaction reports and periodic safety update reports in a timely manner
Danish: Analyse af bivirkningsrapporter og periodisk opdaterede sikkerhedsindberetninger inden for fristerne
English: Career to date: From 1981 to 1983, Dr Abadie held a number of clinical and laboratory positions, before joining the pharmaceutical industry in 1983.
Danish: Karriereforløb: 1981-1983 beklædte dr. Abadie en række kliniske stillinger og arbejdede i forskellige laboratorier, indtil han blev ansat inden for medicinalindustrien i 1983.
English: 26 May
Danish: 26. maj
English: Processing the delegates' expenses reimbursement within two weeks after the meeting ends
Danish: Afvikling af de delegeredes udgiftsgodtgørelser inden for to uger efter, at mødet er afsluttet Udvikling af et mødestyringssystem til automatisering af mødestyringsprocessen
English: Education: Doctorate in natural sciences (applied physics and materials science) from Saarbrücken University; diploma in physics from Tübingen University; master of arts (mathematics) from the University of Cambridge, UK.
Danish: Uddannelse: Doktorgrad i naturvidenskab (anvendt fysik og materialevidenskab) fra Saarbrückens universitet, diplom i fysik fra Tübingens universitet, Master of Arts (matematik) fra Cambridge universitet, Det Forenede Kongerige.
English: To provide timely and understandable product information to users and interested parties
Danish: Målet er 100 % af ansøgningerne At tilvejebringe rettidig og forståelig produktinformation til brugere og interesserede parter
English: PhD in pharmaceutical microbiology from the University of Strathclyde, Glasgow.
Danish: PhD i farmaceutisk mikrobiologi fra Strathclydes universitet i Glasgow.
English: Postgraduate studies in management and health economics.
Danish: Studier efter kandidateksamen i forvaltning og økonomi inden for sundhedssektoren.
English: Biostatistical/methodological issues arising from CHMP discussion on marketing authorisation applications: Choice of non-inferiority margin
Danish: Biostatistical/methodological issues arising from CHMP discussion on marketing authorisation applications:
English: However, it should be noted that the implementation of the new Community legislation could result in a significant increase if parallel distributors were to systematically use the new legal provision.
Danish: Der forventes en beskeden stigning i antallet af anmeldelser om paralleldistribution i forhold til 2004 Det skal imidlertid bemærkes, at gennemførelsen af den nye EU-lovgivning vil kunne få tallet til at stige mærkbart, såfremt paralleldistributører systematisk skulle gøre brug af de nye retsregler.
English: Renewal of efforts to ensure availability of the best scientific expertise for evaluation of medicinal products, taking steps to reinforce areas where expertise is insufficient, especially with regard to future technologies, thus strengthening the European medicines network and increasing the overall quality and efficiency of its operation
Danish: kvalitetssikring og forøget videnskabelig bistand fra agenturet Styrkelse af agenturets rolle omkring lægemiddelovervågning og -sikkerhed Fornyet indsats for at sikre adgang til den bedste videnskabelige sagkundskab for vurdering af lægemidler, idet der samtidig tages skridt til at styrke områder, hvor der ikke er tilstrækkelig sagkundskab, navnlig med hensyn til fremtidige teknologier, hvilket styrker det europæiske lægemiddelnetværk og forbedrer den samlede kvalitet og effektivitet af dets virksomhed
English: Professor Wahlroos was appointed director-general of the National Agency for Medicines (NAM) in 1993.
Danish: Prof. Wahlroos blev udnævnt til generaldirektør for den finske lægemiddelstyrelse i 1993.
English: Career to date: Since qualifying in 1983, Mr Humphreys has worked in the area of development pharmaceutics for a national branded generics manufacturer and an international research and development company.
Danish: Karriereforløb: Siden sin afgangseksamen i 1983 har Tony Humphreys arbejdet med udvikling af lægemidler for en national producent af mærkebeskyttede generiske lægemidler og en international forsknings- og udviklingsvirksomhed.
English: Adopted by EWP in October 04, under discussion at CVMP
Danish: Vedtaget af EWP i oktober 04, under diskussion i CVMP
English: The performance indicator for this objective is the percentage of applications evaluated within the 30, 60 or 90-day timeline (depending on the procedure).
Danish: Præstationsindikatoren for denne målsætning er procenten af ansøgninger, der evalueres inden for 30-, 60- eller 90-dages fristen (afhængigt af proceduren).
English: The further development and implementation of EudraVigilance will relate to appropriate methodologies for data analysis, including data warehousing and data mining supporting signal detection, as well as the coordination and provision of training to the EMEA's business partners
Danish: Den videre udvikling og gennemførelse af EudraVigilance vil omfatte passende metoder til dataanalyse, herunder datawarehousing og datamining, der understøtter signaldetektering, samt koordinering og tilvejebringelse af uddannelse til EMEA's forretningspartnere Konsekvenserne af den nye lægemiddellovgivning:
English: In 2004, the first part of the new European Union pharmaceutical legislation was introduced, effecting the biggest change in the structure and roles of the Agency since its creation in 1995.
Danish: resulterende i den største ændring af agenturets struktur og rolle siden dets oprettelse i 1995.
English: Yann Le Cam, Vice-Chairman of the COMP, b. 15 July 1961, n. French
Danish: Yann Le Cam, næstformand i COMP, født 15. juli 1961, fransk statsborger
English: Core SPC released for 6 months' consultation in 2003 and to be finalised in early 2005
Danish: Core SPC sendt til høring i 6 måneder i 2003 og færdigudarbejdes primo 2005
English: Vincenzo Salvatore, Head of Legal Sector, b. 8 August 1963, n. Italian
Danish: Vincenzo Salvatore, chef for den juridiske sektion, født 8. august 1963, italiensk statsborger
English: The legislative basis for pharmacovigilance inspections is now provided.
Danish: Retsgrundlaget for lægemiddelovervågningsinspektioner er nu tilvejebragt.
English: The new legislation sets forth provisions for the implementation of a risk management system, as well as for the possibility to set up a system for permanent follow-up of risk/benefit balance.
Danish: Den nye lovgivning fastsætter bestemmelser for gennemførelsen af risikostyringssystemet samt for muligheden for at etablere et system for løbende vurdering af fordele og risici.
English: Finalisation of recommendations under development by the EMEA/CHMP Working Party with Patients' Organisations
Danish: Færdiggørelse af anbefalinger, der er påbegyndt af EMEA/CHMP-arbejdsgruppen med deltagelse af patientorganisationer
English: He was appointed head of sector for quality of medicines in January 2001.
Danish: Han blev udnævnt til leder af sektionen for lægemiddelkvalitet i januar 2001.
English: Contribution to the activities of the European Monitoring Centre for Drugs and Drug Addiction through extended contribution to EU joint actions
Danish: Bidrag til aktiviteterne i Det Europæiske Overvågningscenter for Narkotika og Narkotikamisbrug gennem et udvidet bidrag til EU's fælles indsatsområder Gennemførelse af funktionen med tidlig information og samarbejde med Det Europæiske
English: In 1979 he joined the National Board of Health, where he acted as senior pharmaceutical inspector and head of the pharmaceuticals department.
Danish: I 1979 blev han ansat ved den finske sundhedsstyrelse, hvor han fungerede som ledende lægemiddelinspektør og chef for afdelingen for lægemidler.
English: GMP inspection requests GCP inspection requests GLP inspection requests
Danish: GLP inspektionsanmodninger GCP inspektionsanmodninger GMP inspektionsanmodninger
English: Johannes Hoogland, Vice-Chairman of the CVMP, b. 22 February 1956, n. Dutch
Danish: Johannes Hoogland, næstformand for CVMP, født 22. februar 1956, nederlandsk statsborger
English: He was director of medical affairs of the French pharmaceutical trade association from 1985 to 1993 and returned to industry until 1994.
Danish: 1985-1993 var han direktør for medicinske anliggender i den franske farmaceutiske brancheforening og arbejdede derefter igen inden for medicinalindustrien indtil 1994.
English: CVMP Pharmacovigilance Working Party (PhVWP-V)
Danish: CVMP's arbejdsgruppe vedrørende lægemiddelovervågning (PhVWP-V)
English: Postgraduate studies in nutrition, statistics and methodology.
Danish: Studier efter kandidateksamen inden for statistik, metodologi og ernæring.
English: To handle effectively and in a timely manner adverse reaction reports and PSURs for centralised products, in conjunction with rapporteur and co-rapporteur, for review by the CVMP, and to communicate information to the Commission, the Member States and the general public
Danish: I samarbejde med rapportøren og medrapportøren at håndtere bivirkningsrapporter og PSUR for centraliserede produkter, der skal gennemgås af CVMP, effektivt og inden for fristerne, og at formidle information til Kommissionen, medlemsstaterne og offentligheden.
English: Revision to be released for public consultation by April 2005
Danish: Revision sendes til offentlig høring i april 2005
English: In 1992 she moved to the pharmacovigilance department at the Austrian Ministry of Health and completed a six-month regulatory traineeship in the pharmaceuticals unit of the European Commission in 1995.
Danish: I 1992 fik hun ansættelse i Afdelingen for Lægemiddelovervågning i Østrigs sundhedsministerium og arbejdede et halvt år som praktikant i Europa-Kommissionens afdeling for farmaceutiske produkter i 1995.
English: This relates to the provision of scientific advice and protocol assistance to sponsors during the research and development of medicinal products.
Danish: Der er tale om at give videnskabelig rådgivning og yde protokolbistand til sponsorer i forbindelse med forskning og udvikling af lægemidler.
English: Protocol assistance and follow-up requests Scientific advice and follow-up requests
Danish: Protokolbistand og opfølgningsanmodninger Videnskabelig rådgivning og opfølgningsanmodninger
English: 6.3 EMEA document management and publishing
Danish: 6.3 EMEA dokumentstyring og offentliggørelse
English: Guideline to be prepared
Danish: Retningslinje forberedes
English: Key initiatives:
Danish: Centrale initiativer:
English: Priorities for inspections in 2005:
Danish: Inspektioner Prioriterede opgaver for inspektioner i 2005
English: The post-designation workload is expected to increase by 35 % (the number of designated orphan medicinal products was 246 at the end of 2004)
Danish: Arbejdsbyrden efter udpegelsen forventes at stige med 35 % (antallet af udpegede lægemidler til sjældne sygdomme var 246 ved udgangen af 2004) Styring og opfølgning af ca. 175 årlige beretninger i 2005 om lægemidler til sjældne sygdomme
English: 2.10 Provision of information to healthcare professionals and patients
Danish: 2.10 Information til sundhedspersoner og patienter
English: Gerard O'Malley, Head of Sector for accounting, b. 14 October 1950, n. Irish
Danish: Gerard O'Malley, leder af sektionen for bogholderi, født 14. oktober 1950, irsk statsborger
English: To develop a database on manufacturing authorisations and GMP certificates
Danish: At udvikle en database over fremstillingsgodkendelser og GMP-certifikater
English: Education: PhD in microbiology from the University of Lyon.
Danish: Uddannelse: PhD i mikrobiologi fra Lyons universitet.
English: Revised guideline on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
Danish: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products