FrancophonIA/ELRC3.0 huggingface dataset:
English: From 1974 to 1985, he was an audit manager in Spain with Ernst and Young and from 1985 to 1995 he was financial controller at Johnson Wax Española.
Danish: 1974-1985 var han ledende revisor i Spanien ved Ernst and Young, og 1985-1995 var han finansinspektør ved
English: Integrated quality management IQM adviser
Danish: Integreret kvalitetsstyring (IQM) IQM-rådgiver
English: To prepare for provision of specialised support to small and medium-sized companies
Danish: At forberede tilvejebringelsen af specialiseret bistand til små og mellemstore virksomheder
English: Career to date: Ms Cooke worked in a number of positions within the Irish pharmaceutical industry before joining the Irish Medicines Board as a pharmaceutical assessor in 1988.
Danish: Karriereforløb: Emer Cooke beklædte en række stillinger inden for den irske lægemiddelindustri, inden hun blev ansat i Irish Medicines Board som farmaceutisk sagkyndig i 1988.
English: 30 % increase in the number of meetings to be organised due to the additional new committee and related working party meetings, as well as the planned increase in the number of scientific advice oral explanation meetings and meetings with companies
Danish: 30 % stigning i antallet af møder, der skal tilrettelægges som følge af det nye ekstra udvalg og dertil knyttede arbejdsgruppemøder, samt den planlagte stigning i antallet af møder, hvor der mundtligt gøres rede for forløbet af den videnskabelige rådgivning og i antallet af møder med erhvervslivet Stigning i antallet af anmodninger om rejse- og hotelbestillinger, der skal styres
English: 9 To provide for safe use of medicinal products, the Agency will reinforce its activities in the area of pharmacovigilance, in particular the EudraVigilance database and the implementation of the EMEA risk management strategy for medicines for human use.
Danish: Agenturet vil af hensyn til sikker brug af lægemidler styrke sine aktiviteter inden for lægemiddelovervågning, navnlig EudraVigilance-databasen og gennemførelsen af EMEA's risikostyringsstrategi for humanmedicinske lægemidler.
English: The trend in the number of generic applications which began in 2004 is anticipated to continue in
Danish: Tendensen for antallet af ansøgninger om generiske produkter, som begyndte i 2004, forventes at fortsætte i 2005
English: 1.3 EMEA Road Map to 2010
Danish: 1.3 EMEA's køreplan frem til 2010
English: Note for guidance on the clinical investigation of recombinant Factor VIII and IX products (CPMP/BPWG/1561/99) and the Note for guidance on the clinical investigation of human plasma derived Factor VIII and IX products
Danish: VIII and IX products (CPMP/BPWG/1561/99) and the Note for guidance on the clinical investigation of human plasma derived Factor VIII and IX products
English: Interaction with the US Food and Drug Administration will be further developed through enhanced cooperation in the context of the confidentiality arrangements, e.g. in the fields of orphan medicinal products, scientific advice requests, new applications, pharmacovigilance, development of guidelines and the exchange of trainees and experts
Danish: Samarbejdet med US Food and Drug Administration vil blive intensiveret yderligere inden for rammerne af fortrolighedsaftaler, f.eks. med hensyn til lægemidler til sjældne sygdomme, anmodninger om videnskabelig rådgivning, nye ansøgninger, lægemiddelovervågning, udvikling af retningslinjer og udveksling af praktikanter og eksperter
English: The activities in the administration area relate to a number of functions, which include managing revenue, expenditure and accounts according to existing rules and regulations, conducting recruitment procedures, and managing and administering staff and seconded personnel, as well as providing and running the necessary infrastructure services for effective functioning of the Agency.
Danish: Aktiviteterne på administrationsområdet vedrører en række funktioner, som omfatter indtægts-, udgiftsstyring og regnskaber i henhold til eksisterende regler og forskrifter, gennemførelse af ansættelsesprocedurer, personalestyring og -administration og administration af udlånt personale, samt tilvejebringelse og drift af de fornødne infrastrukturtjenester, der skal sikre, at agenturets fungerer effektivt.
English: The new scope encompasses medicines intended for self-medication, generic products of centrally authorised medicinal products, and biosimilar medicinal products.
Danish: Omfattet er nu lægemidler til selvmedicinering, generiske produkter af centralt godkendte lægemidler, samt bioækvivalente lægemidler.
English: The anniversary will be a good opportunity to reflect on what has been achieved so far, assess the needs of the present time, and consider what further contribution we can make to the protection and promotion of public and animal health in Europe.
Danish: vurderer behovene her og nu, og gør os nogle forestillinger om, hvad vi i det videre forløb kan bidrage med for at beskytte og fremme menneskers og dyrs sundhed i Europa.
English: The focus of its work will be on the continued harmonisation of inspection procedures and GMP interpretation, as well as on GMP implications of the new Community blood and GCP directives.
Danish: Fokus for dens arbejde vil være den fortsatte harmonisering af inspektionsprocedurerne og fortolkning af GMP, samt konsekvenserne for GMP af de nye fællesskabsdirektiver om blodpræparater og god klinisk praksis
English: The goal is to shorten the procedure time for safety referrals
Danish: Målet er at nedbringe tiden for henvisningsprocedurer i sikkerhedsrelaterede spørgsmål
English: The new legislation, in addition, introduces requirements to provide information on withdrawals of applications by applicants prior to opinion and on refusals of marketing authorisations, to prepare summaries of European public assessment reports in a manner that is understandable to the public, and to distribute appropriate pharmacovigilance information.
Danish: Den nye lovgivning indfører desuden krav om information om ansøgeres tilbageholdelse af ansøgninger forud for udtalelsen og om afslag på markedsføringstilladelser, krav om at forberede resuméer af europæiske offentlige evalueringsrapporter affattet i et almindeligt forståeligt sprog, og at formidle relevant information om lægemidler Målsætning:
English: The yearly audit cycle of the Committee for Medicinal Products for Human Use (CHMP) will contribute to the culture of continuous process improvement at CHMP level.
Danish: Udvalget for Humanmedicinske Lægemidler Den årlige tilbagevendende revision i CHMP medvirker til, at der udvikles tradition for løbende forbedringer af processerne på CHMP-niveau.
English: Revision of the safety referral process in order to shorten the timeframe for finalisation of safety referral procedures
Danish: Revision af henvisningsprocessen i sikkerhedsrelaterede spørgsmål med det formål at nedbringe tidsrammen for færdiggørelse af henvisningsprocedurerne i sikkerhedsrelaterede spørgsmål
English: Key initiatives in this area:
Danish: Centrale initiativer på dette område:
English: Postgraduate diploma in European Community law from King's College London.
Danish: Eksamensbevis efter kandidateksamen i europæisk fællesskabsret fra King's College, London.
English: Implementation of the classification process for borderline products
Danish: Gennemførelse af klassifikationsprocessen for grænseprodukter
English: She was appointed integrated quality management adviser in January 2004.
Danish: Hun blev i januar 2004 udnævnt til rådgiver inden for integreret kvalitetsstyring.
English: Achievement of consensus with the Agency's partners and stakeholders on the most adequate way to provide information on medicines to patients and healthcare professionals
Danish: Opnåelse af enighed med agenturets partnere og interessenter om den mest formålstjenlige måde at give patienter og ansatte i sundhedssektoren information om lægemidler
English: The legislation places emphasis on transparency, communication and provision of information on pharmacovigilance issues.
Danish: Lovgivningen lægger vægt på gennemsigtighed, formidling og tilvejebringelse af information om spørgsmål vedrørende lægemiddelovervågning.
English: Specialist in internal medicine and clinical pharmacology.
Danish: Specialist i intern medicin og klinisk farmakologi.
English: Discussion papers on other important organs to be considered when developing medicinal products in neonates complementary to the paper already published on renal maturation (e.g. hepatic, central nervous system)
Danish: Discussion papers on other important organs to be considered when developing a medicinal products in neonates complementary to the paper already published on renal maturation
English: This will be the first full year of activity for the Management Board with its new composition introduced by the revised pharmaceutical legislation.
Danish: Dette vil være det første fulde år, hvor bestyrelsen efter indførelsen af den nye lægemiddellovgivning fungerer i sin nye sammensætning.
English: Establish new procedures necessary to implement the new pharmaceutical legislation (conditional approval, accelerated assessment, compassionate use, opinions for medicinal products not marketed in the EU (in collaboration with the WHO), scientific advisory groups, extended scope of the centralised procedure, etc.)
Danish: Etablering af nye procedurer til gennemførelse af den nye lægemiddellovgivning (betinget godkendelse, fremskyndet vurdering, lægemidler med særlig udleveringstilladelse, udtalelser om lægemidler, der ikke markedsføres i EU (i samarbejde med WHO), grupper vedrørende videnskabelig rådgivning, udvidet anvendelse af den centraliserede procedure, osv.)
English: PhD in public health from the University of Bordeaux.
Danish: PhD i folkesundhed ved Bordeaux' universitet.
English: Line extensions are likely to increase, with eight applications foreseen for 2005.
Danish: Antallet af produktserieudvidelser forventes at stige, med skønnede otte ansøgninger for 2005.
English: Career to date: After 10 years of fundamental prostaglandin research she joined the pharmaceutical industry in 1981 as a clinical research associate.
Danish: Karriereforløb: Efter ti års grundforskning i prostaglandin blev hun i 1981 ansat i den farmaceutiske industri som klinisk forskningsassistent.
English: He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994.
Danish: 1982-1994 ledende medicinsk rådgiver for det svenske samarbejdsprogram på sundhedsområdet i Vietnam.
English: Her responsibilities there included coordination of ICH activities, relations with the FDA, pharmaceutical aspects of mutual recognition agreements, GMP and inspection-related matters, orphan medicinal products, preparatory work on a regulation on paediatric medicinal products and issues relating to EU enlargement.
Danish: Her omfattede hendes ansvarsområder koordinering af ICH-aktiviteter, forbindelserne med FDA, de farmaceutiske aspekter af aftaler om gensidig anerkendelse, god fremstillingspraksis (GMP) og tilsynsrelaterede anliggender, lægemidler til sjældne sygdomme, forberedende arbejde med henblik på en forordning om pædiatriske lægemidler og spørgsmål med relation til udvidelsen af EU.
English: Education: PhD (Chemistry) and PhD (Biochemistry), University of Ghent, Belgium.
Danish: Uddannelse: PhD (kemi) og PhD (biokemi), Universitetet i Ghent, Belgien.
English: Marijke Korteweg, Integrated quality management adviser, b. 29 May 1947, n. Belgian
Danish: Marijke Korteweg, rådgiver vedrørende integreret kvalitetsstyring, født 29. maj 1947, belgisk statsborger
English: The Committee on Herbal Medicinal Products The Committee on Herbal Medicinal Products (HMPC) will meet six times in 2005.
Danish: Udvalget for Plantelægemidler Udvalget for Plantelægemidlers (HMPC) afholder seks møder i 2005.
English: He was later appointed to the Pharmaceutical Inspectorate (Ministry of Social Affairs and Public Health) in Brussels as a chief inspector, acting as the secretary of the Belgian Medicines Commission.
Danish: Blev senere tilknyttet lægemiddelinspektoratet (under social- og sundhedsministeriet) i Bruxelles som chefinspektør, hvor han fungerede som sekretær for den belgiske medicinalkommission.
English: He is a former Belgian member of both the CPMP and CVMP and representative on the Pharmaceutical Committee, Standing Committee and Notice to Applicants working group.
Danish: Har tidligere været belgisk medlem af både CPMP og CVMP og repræsentant i Lægemiddeludvalget, Det Stående Udvalg og
English: Concept paper to be adopted for consultation during 2005
Danish: Konceptdokument vedtages med henblik på høring i løbet af 2005
English: Consultation ends 18 Apr. 2005 subsequent revision by PhVWP-V
Danish: Høring slutter den 18. apr. 2005 efterfølgende revision i PhVWP-V
English: Requests should be sent in writing to the EMEA or to
Danish: Anmodninger herom sendes skriftligt til EMEA
English: The Committee will implement its newly adopted procedure intended to facilitate communication and dialogue between the Committee and interested parties, to fulfil obligations set out in the new legislation by putting in place the necessary arrangements to organise such exchanges and improve transparency as appropriate.
Danish: der skal lette kommunikationen og dialogen mellem udvalget og interesserede parter, og overholde de i den nye lovgivning fastsatte forpligtelser ved at iværksætte de nødvendige tiltag til at organisere sådan udveksling og om nødvendigt forbedre gennemsigtigheden.
English: Proposal to the Management Board to approve an extension to the provision of free scientific advice to include products intended for use in minor uses and minor species that meet agreed criteria
Danish: Forslag til bestyrelsen om at godkende en udvidelse af bestemmelsen om gratis videnskabelig rådgivning til at omfatte lægemidler til mindre udbredte sygdomme og mindre arter, som opfylder aftalte kriterier
English: Provision of guidance to the CVMP on criteria to be considered when deciding whether an application for a product is eligible for the centralised procedure because it is “in the interests of patients and animal health at Community level” (Article 3(2)(b) of Regulation 726/2004)
Danish: Vejledning til udvalget om de kriterier, der skal lægges til grund ved beslutningen af, om en ansøgning om et lægemiddel kan blive omfattet af den centraliserede procedure, fordi det “af hensyn til patienterne eller dyrs sikkerhed er af interesse på fællesskabsplan” (artikel 3, stk. 2,
English: A pilot implementation of the data warehouse and business intelligence applications for EudraVigilance
Danish: Gennemførelse af et pilotprogram for datawarehousing- og business intelligence-applikationerne for EudraVigilance
English: Main CHMP standing and temporary working parties in 2005
Danish: De vigtigste stående og midlertidige arbejdsgrupper i CHMP i 2005
English: Implementation of an action plan for collaboration between the EMEA and the US Food and Drug Administration under the confidentiality arrangements, and close monitoring of all actions contained in this plan
Danish: Gennemførelse af retningslinjen for videnskabelige udtalelser inden for samarbejdet med WHO Gennemførelse af en handlingsplan for samarbejde mellem EMEA og US Food and Drug Administration under fortrolighedsaftalerne, og tæt overvågning af alle indsatsområder indeholdt i denne plan
English: Career to date: From 1981 to 1984, Dr Moulin worked in the Bovine Pathology Laboratory in Lyon.
Danish: Karriereforløb: 1981-1984 arbejdede dr. Moulin ved Laboratoriet for Bovinpatologi i Lyon.
English: Invitation by the CVMP, its working parties or scientific advisory groups to interested parties on specific technical/scientific issues
Danish: Invitation fra CVMP, dets arbejdsgrupper eller grupper vedrørende videnskabelig rådgivning, til en diskussion af specifikke tekniske/videnskabelige spørgsmål
English: Prior to his appointment as unit manager in pharmacovigilance, he held a number of positions in both pre- and post-authorisation areas, and was also the UK delegate to the CPMP Pharmacovigilance Working Party.
Danish: Før han blev udnævnt til leder af afdelingen for lægemiddelovervågning, bestred han en række poster inden for vurdering henholdsvis før og efter godkendelse og var også den britiske delegerede, som deltog i CPMP's arbejdsgruppe vedrørende lægemiddelovervågning.
English: Between 1974 and 1996 he held posts in the UK Medicines Division and the Medicines Control Agency, including those of inspector of pharmaceutical manufacture, reviewer of dossiers, and manager of the biotechnology and biological unit.
Danish: 1974-1996 bestred han forskellige poster i Det Forenede Kongeriges Medicines Division og Medicines Control Agency, bl.a. som tilsynsførende med lægemiddelfremstilling, behandler af dossierer og leder af Afdelingen for Bioteknologi og Biologiske Lægemidler.
English: Preparation of draft Community herbal monographs for herbal medicinal products with a wellestablished use
Danish: Forberedelse af Fællesskabets monografier for plantelægemidler med veletableret anvendelse
English: Conduct of recruitment procedures
Danish: Gennemførelse af ansættelsesprocedurer
English: In addition, the centralised procedure is open to any other product that constitutes a significant innovation or for which there is a Community interest.
Danish: Desuden kan alle andre produkter, som udgør en betydelig nyskabelse, eller som er af interesse for Fællesskabet, komme ind under den centraliserede procedure.
English: Career to date: Dr Pittner worked in the pharmaceutical industry from 1972 to 1985 where he discovered the pharmacological properties of the beta 1 - adrenoceptor antagonist celiprolol.
Danish: Karriereforløb: 1972-1985 arbejdede dr. Pittner i medicinalindustrien, hvor han opdagede de farmakologiske egenskaber hos beta 1 - adrenoceptor antagonisten celiprolol.
English: To implement the new legislative requirements in the area of scientific advice
Danish: Målsætninger: At gennemføre de nye lovgivningskrav vedrørende videnskabelig rådgivning
English: In 1995 she returned to Germany to the Ministry for Environment as scientific administrator.
Danish: I 1992 vendte hun tilbage til Tyskland, hvor hun i 1995 blev ansat som videnskabelig fuldmægtig i det tyske Miljøministerium.
English: He joined the French medicines agency in 1994 as director of pharmacotherapeutic evaluation, a post he holds today.
Danish: Ansat i det franske Lægemiddelagentur i 1994 som direktør for farmakoterapeutisk vurdering, en stilling, han stadig beklæder i dag.
English: This includes ensuring best practice in document and records management; verifying the quality of all published documents; providing staff with the most effective access to internal and external information needed to perform their professional duties; verifying the accuracy of translations; and organising and supporting Agency exhibitions.
Danish: kvaliteten af alle offentliggjorte dokumenter skal kontrolleres; det skal påses, at de ansatte får den mest effektive adgang til intern og ekstern information, som de har brug for til at varetage deres fagspecifikke opgaver; nøjagtigheden af oversættelser skal kontrolleres; agenturets udstillinger skal arrangeres og støttes.
English: Dr Brasseur has held a number of teaching posts and is currently professor of nutrition and nutrition-related diseases at the Free University of Brussels.
Danish: Dr. Brasseur har beklædt en række undervisningsstillinger og er nu ansat som professor i ernæring og ernæringsrelaterede sygdomme ved
English: Concept paper on impact of analytical methods on Commission Decision 2002/657/EC compared with current analytical requirements for the establishment of MRLs
Danish: (2002/657/EC) compared with current analytical requirements for the establishment of MRLs
English: 4.5 Sampling and testing
Danish: 4.5 Stikprøveudtagning og afprøvning
English: Following the audit of the CVMP conducted in October 2004, the Agency and Committee members will ensure the necessary responses to opportunities for improvement are implemented in full, to optimise the working practices of the Committee, its working parties and the secretariat.
Danish: Efter revisionen af CVMP i oktober 2004 vil agenturet og udvalgets medlemmer sikre, at de nødvendige tiltag til mulige forbedringer gennemføres fuldt ud med det sigte at optimere udvalgets,
English: Education: Master's degree in business administration from the Institut Superieur de Gestion in Paris.
Danish: Uddannelse: Mastergrad i virksomhedsledelse ved Institut Supérieur de Gestion i Paris.
English: Standard Operating Procedure on Urgent Safety Restrictions for Medicinal Products Authorised through Mutual Recognition Procedure
Danish: Standard Operating Procedure on Urgent Safety Restrictions for Medicinal Products Authorised through
English: Guidelines for consultation on the possible adaptation of data requirements for testing medicinal products for minor uses and minor species to facilitate their further authorisation will be drafted
Danish: Der vil blive udarbejdet udkast til retningslinjer for høring om den eventuelle tilpasning af datakrav, der skal være opfyldt for at teste lægemidler til mindre udbredte sygdomme og mindre arter, således at det bliver nemmere at give tilladelse til dem
English: To provide quality scientific advice and protocol assistance to applicants and adhere to the defined timelines
Danish: At yde videnskabelig rådgivning og protokolbistand af høj kvalitet til ansøgere og overholde de fastsatte frister
English: Provision of accurate and timely financial information to management Implementation of inventory accounting system
Danish: Levering af nøjagtige og rettidige økonomiske oplysninger til ledelsen
English: Applications received (non-orphan medicines) Applications received (orphan medicines)
Danish: Modtagne ansøgninger (ikke-sjældne lægemidler) Modtagne ansøgninger (sjældne lægemidler)
English: Develop tools for the provision of information to patients and healthcare professionals, and strengthen interaction with the Agency's stakeholders
Danish: Udvikling af informationsværktøjer for patienter og ansatte i sundhedssektoren, og styrkelse af samarbejdet med agenturets interessenter
English: To provide support to the implementation of the clinical trials legislation, in particular with respect to GCP inspection
Danish: At yde bistand til gennemførelsen af lovgivningen om kliniske forsøg, navnlig omkring GCPinspektion
English: Reimbursed meetings Videoconferences
Danish: Mødegodtgørelser Videokonferencer
English: Concept paper for preparation of guideline to be developed
Danish: Konceptdokument til forberedelse af retningslinje udvikles
English: Career to date: Mr Le Cam has 19 years of professional experience, and personal commitment, in non-governmental health and medical research organisations in France, Europe and the United States in the fields of cancer, HIV/AIDS and genetic diseases.
Danish: Karriereforløb: Le Cam har 19 års erfaring med forskning i kræft, AIDS og genetisk betingede sygdomme fra sit arbejde i franske, europæiske og amerikanske ikke-statslige organisationer, der beskæftiger sig med sundheds- og lægemiddelforskning.
English: Dr Wagner was appointed head of sector for IT in the same service in 1993.
Danish: Wagner blev udnævnt til leder af IT-sektionen inden for samme tjenestegren i 1993.
English: He joined the EMEA in 1995 as principal scientific administrator and from 1996 to 1998 he was head of sector for new chemical substances.
Danish: Ansat i EMEA som ledende videnskabelig fuldmægtig i 1995 og i perioden 1996-1998 leder af sektionen for nye kemiske stoffer.
English: Interaction between the CHMP and healthcare professionals and learned societies will be further developed.
Danish: Samarbejdet mellem CHMP og ansatte i sundhedssektoren samt ekspertforeninger vil blive videreudbygget
English: Considerations of the Scientific group to be prepared during 2005
Danish: Vurdering i gruppen vedrørende videnskabelig rådgivning forberedes i løbet af 2005
English: Objective:
Danish: Målsætning:
English: The CHMP will meet 11 times in 2005.
Danish: CHMP vil afholde 11 møder i 2005.