FrancophonIA/ELRC3.0 huggingface dataset:
English: A number of other important issues that have an impact on the Agency's operations will also require attention: the emergence of innovative new medical technologies and therapies; the increasing globalisation of the pharmaceutical industry and its regulatory environment; the competitiveness of Europe's biotechnology, pharmaceutical and healthcare industries; and the increased expectations of civil society with regard to information, communication and transparency.
Danish: Der er yderligere en række vigtige forhold, som vil komme til at påvirke agenturets virksomhed, og som også kræver opmærksomhed: Fremkomsten af nye medicinske teknologier og behandlingsformer, den stigende globalisering inden for lægemiddelindustrien og dennes reguleringsrammer, konkurrenceevnen i Europas biotek-, lægemiddel- og sundhedssektor; og civilsamfundets stadig større forventninger til information, formidling og gennemsigtighed.
English: Publication of summaries of opinion for those post-authorisation activities which have an important impact on the use of the medicinal product; regular updating of European public assessment reports and publication of press releases regarding major post-authorisation activities
Danish: Offentliggørelse af resuméer af udtalelser vedrørende disse aktiviteter efter tilladelsen, som har en betydelig virkning på brugen af lægemidler, løbende ajourføring af europæiske offentlige evalueringsrapporter og offentliggørelse af pressemeddelelser vedrørende væsentlige aktiviteter efter tilladelsen
English: ICH-E2E: Pharmacovigilance Planning To be incorporated in revised Volume 9 (see above)
Danish: ICH-E2E: Pharmacovigilance Planning Medtages i revideret Bind 9 (se ovenfor)
English: VICH Target animal safetypharmaceuticals
Danish: VICH Target animal safety pharmaceuticals
English: In addition, the Agency provides advice to sponsors of designated orphan medicines.
Danish: Derudover yder agenturet rådgivning til sponsorer af udpegede lægemidler til sjældne sygdomme.
English: The Paediatrics Working Party will be consulted at an early stage of the drafting of guidelines which are relevant to paediatric population developed by any CHMP working parties
Danish: The Paediatrics Working Party will be consulted at an early stage of the drafting of guidelines, which are relevant to paediatric population,
English: Development and implementation of methodologies and tools for data analysis supporting signal detection; provision of adequate training to all users of the EudraVigilance system, including the new SUSAR component
Danish: Udvikling og gennemførelse af metoder og værktøjer til dataanalyse, der understøtter signaldetektering; relevant uddannelse af alle brugere af EudraVigilance-systemet, herunder den nye SUSAR-komponent
English: 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.
Danish: COMP har også ansvaret for at rådgive Europa-Kommissionen om udarbejdelsen af en strategi for lægemidler til sjældne sygdomme og for at yde bistand i samarbejde med internationale partnere og patientorganisationer.
English: From 1993 to 1994 he acted as the vice-chairman of the EFTA Expert Group on Pharmaceuticals and from 1994 to 1995 as the chairman of the Nordic Council on Medicines.
Danish: Fra 1993 til 1994 fungerede han som næstformand for EFTA's ekspertgruppe vedrørende lægemidler og fra 1994 til 1995 som formand for Nordisk Lægemiddelnævn.
English: 1.2 Implementation of the new pharmaceutical legislation 1.3 EMEA Road Map to 2010
Danish: 1.2 Gennemførelse af den nye lægemiddellovgivning 1.3 EMEA's køreplan frem til 2010
English: She joined the EMEA Management Board in the same year, was elected vice-chairman in 2003 and re-elected vice-chairman following the EU enlargement in 2004.
Danish: Hun trådte ind i EMEA's bestyrelse samme år, blev valgt som næstformand i 2003 og genvalgt som næstformand efter udvidelsen i 2004.
English: Requirement to produce financial accounts based on generally accepted accounting principles by
Danish: Krav om senest i 2005 at opstille finanskonti baseret på almindeligt anerkendte regnskabsprincipper
English: 3.9 Coordination group
Danish: 3.9 Koordineringsgruppe
English: Objectives and key initiatives:
Danish: Målsætninger og centrale initiativer:
English: Development of scientific advice procedures in line with the new legislation, including procedures for particular support for small and medium-sized enterprises and emerging therapies
Danish: Udvikling af procedurer for videnskabelig rådgivning i overensstemmelse med den nye lovgivning, herunder procedurer for specifik bistand til små og mellemstore virksomheder og for nye behandlingsformer
English: Contribute to EU public health strategies, including those relating to influenza pandemics, tissueengineered products and paediatric medicines
Danish: Bidrag til EU's strategier på folkesundhedsområdet, herunder strategier, der vedrører pandemisk influenza, produkter fremstillet ved vævsteknik og pædiatriske lægemidler
English: 4.2 Implementation of the Clinical Trials Directive
Danish: 4.2 Gennemførelse af direktivet om kliniske forsøg
English: Continuous collaboration with the Directorate-General for Enterprise on development of legislation relating to paediatric medicines, tissue engineering and the provision of information to the public
Danish: Fortsat samarbejde med Generaldirektoratet for Erhvervspolitik om udformning af lovgivning for pædiatriske lægemidler, vævsteknik og tilvejebringelse af information til offentligheden
English: Integration into the CVMP assessment procedure of advice and recommendations of the scientific advisory group concerning applications for new antimicrobials
Danish: Integration i CVM¨'s vurderingsprocedure af rådgivning og anbefalinger fra gruppen vedrørende videnskabelig rådgivning i forbindelse med ansøgninger om nye antimikrobielle stoffer
English: He is the head of the ‘Particular therapies' division, which is in charge of the pharmaceutical und clinical assessment of herbal, homeopathic and anthroposophic products.
Danish: Leder afdelingen for “særlige behandlinger”, som står for den farmaceutiske og kliniske vurdering af urtemedicin og homøpatiske og antroposofiske lægemidler.
English: She worked at the Danish Environment Ministry from 1979 to 1985, first as a consultant and later as an official, before moving to the City of Copenhagen Environment Protection Agency until 1988.
Danish: Hun arbejdede i det danske Miljøministerium fra 1979 til 1985, først som konsulent og senere som embedsmand, før hun flyttede til Miljøkontrollen under Københavns Kommune, hvor hun var til 1988.
English: Activities in relation to plasma and vaccine antigen master files and to medical devices containing biotechnology and blood-derived medicinal products will develop further
Danish: Aktiviteterne i forbindelse med masterfiler vedrørende plasma og vaccineantigener og medicinsk udstyr, der indeholder bioteknologi og lægemidler fremstillet af blod, vil blive videreudviklet
English: She worked for the pharmaceutical industry from 1992 to 1995 before joining the EMEA in July 1995.
Danish: Arbejdede inden for lægemiddelindustrien 1992-1995, indtil hun blev ansat i EMEA i juli 1995.
English: TEMPORARY POSTS
Danish: Midlertidige stillinger
English: Development and implementation of document management, records management and mail registration policies will be undertaken in 2005.
Danish: Der vil i 2005 blive gennemført dokumentstyrings-, arkiv- og sagsstyrings- og postregistreringspolitikker.
English: These projects have been agreed as being EudraNet, EudraVigilance, the EuroPharm database, electronic submissions, implementation of the Clinical Trials Directive and the good manufacturing practice database.
Danish: Der er enighed om, at disse projekter er EudraNet, EudraVigilance, EuroPharm-databasen, elektroniske ansøgninger, gennemførelse af direktivet om kliniske forsøg og databasen for god fremstillingspraksis.
English: Other TOTAL REVENUE
Danish: Andre Indtægter i alt
English: Similarly, the entry into force of the remaining provisions on 20 November 2005 will be the focus of our attention this year.
Danish: Ligeledes vil der også blive fokuseret på de øvrige retsregler, der træder i kraft den 20. november 2005.
English: The implementation of a new accounting system
Danish: Gennemførelse af et nyt regnskabssystem
English: After a three-year stay in Prague, Czech Republic, where she worked as a consultant on European pharmaceutical matters as well as continuing her work with EFPIA, she joined the pharmaceuticals unit of the European Commission in September 1998.
Danish: Efter et 3-årigt ophold i Prag i Den Tjekkiske Republik, hvor hun sideløbende med sit arbejde i EFPIA arbejdede som konsulent i europæiske lægemiddelanliggender, blev hun ansat i Europa-Kommissionens afdeling for farmaceutiske produkter i september 1998.
English: Consolidation of the new Staff Regulations
Danish: Konsolidering af den nye personalevedtægt
English: Provision of appropriate support to rapporteurs and co-rapporteurs
Danish: Relevant støtte til rapportører og medrapportører
English: 31 May - 1 June
Danish: 31. maj - 1. juni
English: Clarification of the status of guidance prepared by the Herbal Medicinal Products Working Party between 1997 and 2004
Danish: Præcisering af status for den vejledning, som Arbejdsgruppen for Plantelægemidler udarbejdede mellem 1997 og 2004
English: 2.11 International activities
Danish: 2.11 Internationale aktiviteter
English: Delivery of first production versions of the EuroPharm medicines information system, the EudraVigilance data warehouse and pharmacointelligence tools, and the product information management system (PIM), plus completion of phase 2a of the European Clinical Trials registration database system (EudraCT).
Danish: Levering af de første operationelle versioner af EuroPharmlægemiddelinformationssystemet, EudraVigilance-værktøjerne for datawarehousing og lægemiddeloplysninger, og produktinformationsstyringssystemet (PIM), samt færdiggørelse af delparti 2A af den europæiske registreringsdatabase over kliniske forsøg (EudraCT).
English: 2.9 Regulatory activities
Danish: 2.9 Forskriftsmæssige aktiviteter
English: To provide targeted, useful and accessible information to patients and healthcare professionals about the medicine-related aspects of the work of the Agency
Danish: At tilvejebringe målrettet, nyttig og tilgængelig information til patienter og ansatte i sundhedssektoren om de lægemiddelrelaterede dele af agenturets arbejde
English: Continuation of work with the World Health Organization and the World Organisation for Animal Health (OIE), and participation in other international forums.
Danish: Health (OIE), og deltagelse i andre internationale fora.
English: Career to date: David Drakeford worked with Telecom Eireann where he managed the implementation of a national data communication network.
Danish: Karriereforløb: Ansat i Telecom Eireann, hvor han ledede etableringen af et landsdækkende datakommunikationsnet.
English: Internal guideline to be developed
Danish: Intern retningslinje udvikles
English: He has been executive director of the EMEA since January 2001.
Danish: Har været administrerende direktør i EMEA siden januar 2001.
English: In 1987, she joined the German Environmental Agency as scientific administrator involved in risk assessment of industrial chemicals.
Danish: I 1987 blev hun ansat som videnskabelig fuldmægtig i det tyske Miljøagentur, hvor hun deltog i risikovurderinger af industrikemikalier.
English: Preparation for progressive submission of applications for emerging therapies and new technologies, and for applications for self-medication and generic products
Danish: Forberedelse til progressiv fremsendelse af ansøgninger for nye behandlingsformer og nye teknologier, og for ansøgninger vedrørende selvmedicinering og generiske produkter
English: Postgraduate studies in management, leadership and administration.
Danish: Studier efter kandidateksamen i forvaltning, ledelse og administration.
English: Conduct analysis and assessment of the Executive Director's annual activity report for 2004
Danish: Vedtage regler for gennemførelsen af personalevedtægten Gennemføre analyse og vurdering af den administrerende direktørs årsberetning for 2004
English: Approximately 3,500 European experts are used by the EMEA in its scientific evaluation work.
Danish: EMEA gør brug af ca. 3 000 eksperter til sine faglige vurderinger.
English: To implement the new legislative requirements and increase the quality of assessment of such applications and adhere to regulatory timelines
Danish: At gennemføre de nye lovkrav og forbedre kvaliteten af vurderingen af sådanne ansøgninger og overholde forskriftsmæssige frister
English: Reinforcement of the scientific advice procedure to better address post-authorisation safetyrelated aspects
Danish: Styrkelse af proceduren for videnskabelig rådgivning, således at de sikkerhedsrelaterede aspekter efter tilladelsen tilgodeses bedre
English: The European medicines network faces important opportunities as well as challenges stemming from political, institutional, legislative and, particularly, scientific developments, the result of the latter being the advent of new technologies for treatment of diseases
Danish: Tendenser: Det europæiske lægemiddelnetværk står over for både store muligheder og udfordringer, som er et resultat af udviklingen på det politiske, institutionelle, lovgivningsmæssige og især videnskabelige område, hvor der er udviklet nye teknologier til sygdomsbehandling
English: Postgraduate qualifications in internal medicine (FRCP) and pharmaceutical medicine (FFPM).
Danish: Uddannelse efter kandidateksamen i intern medicin (FRCP) og farmaceutisk medicin (FFPM).
English: The legislation provides for compliance with GMP requirements by manufacturers of active substances and for the establishment of a database containing information on GMP certificates and on manufacturing authorisations.
Danish: Lovgivningen fastsætter regler for producenter af aktive stoffer og for deres overholdelse af GMP-kravene og for oprettelse af en database, der indeholder oplysninger om GMP-certifikater og om fremstillingsgodkendelser.
English: She was appointed deputy head of sector for safety and efficacy of medicines in January 2001, and since then has been in charge of EMEA activities in the field of innovation, emerging therapies & technologies, and the coordination of scientific training.
Danish: Udnævnt til vicesektionsleder af sektionen for lægemidlers sikkerhed og virkninger i januar 2001 og har siden været ansvarlig for EMEA's aktiviteter inden for nye terapier og teknologier samt koordinering af videnskabelige uddannelsesforløb.
English: The EMEA receives safety reports from within and outside the EU concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Danish: EMEA modtager både EU-interne og EU-eksterne sikkerhedsrapporter, som vedrører lægemidler godkendt via den centraliserede procedure, og koordinerer indsatsen for lægemidlers sikkerhed og kvalitet.
English: A Community marketing authorisation is valid throughout the EU and a centrally authorised medicinal product is by definition identical in all Member States.
Danish: En EU-markedsføringstilladelse er gyldig i hele EU, og et centralt godkendt lægemiddel er pr.
English: Concurrent development work on all EU telematics projects will have to be carried out, and five of the EU telematics systems - EudraNet, EudraVigilance, EudraCT, EuroPharm and eSubmission - will have to be operated, supported and maintained
Danish: Sideløbende hermed skal der arbejdes på udvikling af alle EU's telematikprojekter, og fem af EU's telematiksystemer - EudraNet, EudraVigilance, EudraCT, EuroPharm og e-Submission - skal styres, supporteres og vedligeholdes
English: She has led the Agency's integrated quality management system and internal audit system since November 1999.
Danish: 1999 stået i spidsen for agenturets integrerede kvalitetsstyringssystem og interne auditsystem.
English: Objectives:
Danish: Målsætninger:
English: Certificat de Hautes Etudes Européennes (economics) from the College of Europe, Bruges.
Danish: Hautes Etudes Européennes (økonomi) fra Europakollegiet i Brügge.
English: This relates to the provision of scientific advice to sponsors during the research and development of medicinal products.
Danish: Dette vedrører tilvejebringelsen af videnskabelig rådgivning til sponsorer i forbindelse med forskning og udvikling af lægemidler.
English: Scientific advice is a priority area for the EMEA and is provided on any aspect of research and development relating to quality, safety or efficacy of medicinal products.
Danish: Videnskabelig rådgivning er et prioriteret område for EMEA og ydes i forbindelse med alle aspekter af forskning og udvikling i relation til lægemidlers kvalitet, sikkerhed og effektivitet.
English: Career to date: Worked for the food industry (1976-1977), biological laboratory of the Free University of Amsterdam (1977-1978).
Danish: Karriereforløb: Arbejdede for fødevareindustrien (1976-1977), arbejdede på det biologiske laboratorium på Amsterdams Frie Universitet (1977-1978).
English: 9 Particular attention will be given to the implementation of provisions reinforcing the safety of medicines, accelerating the availability of medicines to EU patients and creating the right environment to stimulate research.
Danish: Der vil være særlig fokus på gennemførelsen af de bestemmelser, der styrker sikkerheden på lægemiddelområdet, fremmer adgangen for patienter fra EU til lægemidler og skaber de rigtige rammebetingelser til fremme af forskningen.
English: The Agency ensures full compliance with all regulatory and quality requirements in the areas of document and records management.
Danish: Agenturet sikrer fuld overholdelse af alle forskrifts- og kvalitetskrav til dokument- og arkiv- og sagsstyring.
English: Management and reinforcement of the procedure, introduced in 2004, for the handling of safety concerns, both pre- and post-authorisation, for centrally processed applications
Danish: Styring og styrkelse af proceduren, der blev vedtaget i 2004 til håndtering af sikkerhedsaspekterne af de ansøgninger, der behandles centralt, både før og efter godkendelsen.
English: Develop procedures for more systematic and repeated use of scientific advice and protocol assistance during the development of products, particularly for rare diseases and new therapies
Danish: Udvikling af procedurer for mere systematisk og gentagen brug af videnskabelig rådgivning og protokolbistand i forbindelse med udviklingen af lægemidler, især til sjældne sygdomme og nye behandlingsformer
English: The Veterinary Unit will liaise closely with the Center for Veterinary Medicines (CVM) in the US Food and Drug Administration and with the United States Department of Agriculture to implement practical arrangements for advancing the Confidentiality Arrangements for exchange of information and documents agreed between the US and EU in late 2004.
Danish: Medicines (CVM) i US Food and Drug Administration og med det amerikanske landbrugsministerium om gennemførelsen af praktiske tiltag til fremme af fortrolighedsaftaler for udveksling af information og dokumenter, der blev aftalt mellem USA og EU i slutningen af 2004.
English: This harmonisation work will include the development of GMP guidelines on products used as gene and cell therapies.
Danish: Dette harmoniseringsarbejde vil omfatte udvikling af retningslinjer for GMP på præparater anvendt inden for gen- og celleterapi.
English: He moved briefly to the pharmaceutical industry from 1986 to 1987, before returning to clinical work at the Queen Fabiola Children's University Hospital in Brussels as head of the nutrition and pharmacodynamics unit, a post he continues to hold today.
Danish: Arbejdede dernæst en kort periode inden for medicinalindustrien 1986-1987, indtil han vendte tilbage til en klinisk stilling ved Dronning Fabiolas universitetshospital for børn i Bruxelles som leder af afdelingen for ernæring og farmakodynamik, en stilling, han stadig beklæder.
English: She is also in charge of issues relating to medicines used in children and has been acting head of sector for safety & efficacy since October 2004.
Danish: Hun er også ansvarlig for spørgsmål vedrørende lægemidler til børn og siden oktober 2004 sektionsleder for lægemidlers sikkerhed og virkninger.
English: Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for foodproducing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)
Danish: Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
English: Annex 4 EMEA contact points
Danish: BILAG 4 EMEA's kontaktpunkter
English: In 1986 he joined the University of Bordeaux and was involved in various research areas in public health, including epidemiology, clinical research, pharmacovigilance, tropical and infectious diseases, health economy and health education.
Danish: I 1986 ansat ved Bordeaux' universitet, hvor han deltog i forskning inden for folkesundhed, bl.a. epidemiologi, klinisk forskning, lægemiddelovervågning, tropesygdomme og smitsomme sygdomme, økonomi og uddannelse inden for sundhedssektoren.
English: Provision of secretariat support to the scientific advice working party and support to potential applicants
Danish: Sekretariatsstøtte til arbejdsgruppen for videnskabelig rådgivning og bistand til potentielle ansøgere
English: 100 % of fees for protocol assistance
Danish: 100 % af gebyrerne til protokolbistand
English: These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports), follow-up measures, specific obligations, annual reassessments and renewal applications.
Danish: Hertil hører aktiviteter vedrørende oplysninger om lægemiddelovervågning (indberetninger af bivirkninger og periodisk opdaterede sikkerhedsindberetninger), opfølgningsforanstaltninger, særlige forpligtelser, fornyede årlige vurderinger og fornyelsesansøgninger.
English: 10 March
Danish: 10. marts
English: The EMEA is preparing for its new responsibility of providing secretarial support to the new coordination group, which will include:
Danish: EMEA forbereder sig på sit nye ansvarsområde med at yde sekretariatsstøtte til den nye koordineringsgruppe.
English: The Executive Director is responsible for setting up administrative structures and procedures in consultation with scientific committees allowing the development of advice for undertakings, particularly regarding new therapies, on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products.
Danish: Den administrerende direktør er i samråd med de videnskabelige udvalg ansvarlig for fastlæggelsen af administrative strukturer og procedurer, der gør det muligt at udvikle rådgivningen til virksomheder, bl.a. med hensyn til udvikling af nye behandlingsformer baseret på udførelsen af forskellige tests og forsøg, der er nødvendige for at påvise lægemidlers kvalitet, sikkerhed og virkninger.
English: The major priority for 2005 will be to prepare for the implementation of the pharmaceutical legislative review, in particular the new requirements for GMP for starting materials and the setting-up of a database on manufacturing authorisations and GMP certificates
Danish: Den vigtigste prioritet for 2005 vil være at forberede gennemførelsen af revisionen af lægemiddellovgivningen, navnlig de nye krav om god fremstillingspraksis (GMP) for råvarer, og oprettelsen af en database for fremstillingsgodkendelser og GMP-certifikater
English: SWP contribution
Danish: SWP bidrag