FrancophonIA/ELRC3.0 huggingface dataset:
English: He worked also as research assistant in international law at the University of Pavia from 1992 to 1999, as associate professor of international law at the University of Insubria (Varese) from 1999 to 2003, and as chair professor of international law at the same University since 2004.
Danish: Ansat som forskningsassistent i international ret ved universitet i Pavia fra 1992 til 1999, som ekstern lektor i international ret ved universitet i Insubria (Varese) fra 1999 til 2003 og siden 2004 ansat som professor i international ret ved samme universitet.
English: The number of initial applications for a marketing authorisation is expected to stabilise in 2005.
Danish: Antallet af indledende ansøgninger om markedsføringstilladelse forventes at blive stabiliseret i 2005.
English: Preparation for inclusion of new mandatory therapeutic areas within the scope of the centralised procedure
Danish: Forberedelse til medtagelse af obligatoriske nye behandlingsområder inden for rammerne af den centraliserede procedure
English: ICH E14 the clinical evaluation of QT/QTs interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs
Danish: ICH E14 the clinical evaluation of QT/QTs interval prolongation and proarrhythmic potential for non antiarrhythmic drugs
English: 1.5 Transparency and communication in the European network
Danish: 1.5 Gennemsigtighed og informationsformidling i det europæiske netværk
English: To encourage greater exchange of information and dialogue on post-authorisation and safety of medicines, and to contribute to the effective utilisation of available EU resources in advancing effective pharmacovigilance for all veterinary medicines
Danish: At tilskynde til større udveksling af information og dialog om tilladelser efter markedsføring og om lægemiddelsikkerhed, og at bidrage til en effektiv udnyttelse af ressourcerne inden for EU til fremme af en effektiv lægemiddelovervågning for alle veterinærlægemidler
English: More orphan medicinal products reach the stage of marketing authorisation.
Danish: Flere lægemidler til sjældne sygdomme når den fase, hvor der opnås markedsføringstilladelse.
English: Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2
Danish: Eventuel revision, når ICH's initiativer om Q8 og Q9 er blevet stabiliseret, på trin 2
English: The Agency is in the process of revising its practices to make such information more understandable and accessible for both patients and healthcare professionals.
Danish: Agenturet er i færd med at gennemgå sin praksis med det formål at gøre disse oplysninger mere forståelige og tilgængelige for både patienter og ansatte i sundhedssektoren.
English: Publication of summaries of opinion at the time of adoption by the CVMP Regular updating of EPARs in the post-authorisation phase for procedural and scientific aspects
Danish: Offentliggørelse af resuméer af udtalelser på tidspunktet for CVMP's vedtagelse Løbende opdatering af EPAR i fasen efter tilladelsen med hensyn til proceduremæssige og videnskabelige aspekter
English: The number of requests for clarification on the list of MRLs is significant and is expected to remain at approximately 200
Danish: Tendenser: Antallet af henvendelser om præcisering af listen over maksimale grænseværdier er betragteligt og forventes fortsat at ligge på omkring 200
English: CPMP Guideline on parametric release Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2 (in collaboration with GMP inspectors)
Danish: CPMP Guideline on parametric release Eventuel revision, når ICH's initiativer om Q8 og Q9 er blevet stabiliseret, på trin 2 (i samarbejde med GMPinspektørerne)
English: These readability requirements will also be applicable to package inserts.
Danish: Disse krav til læsbarheden vil også finde anvendelse på indlægssedler.
English: The principal objectives are the development and timely and accurate management of the EMEA's human and financial resources, including personnel administration, recruitment procedures and professional training, as well as the provision of information to staff and other concerned persons on these matters
Danish: De vigtigste mål er at udvikle og på en rettidig og præcis måde forvalte EMEA's menneskelige og finansielle ressourcer, herunder personaleadministration, ansættelsesprocedurer og videreuddannelse samt informationer til personale og andre berørte personer om disse anliggender
English: New legislation requires that Member States agree within the coordination group on a list of medicinal products for which harmonised summaries of product characteristics shall be prepared to promote harmonisation of veterinary medicines authorised in the EU.
Danish: I henhold til den nye lovgivning skal medlemsstaterne blive enige med koordineringsgruppen om en liste over lægemidler, for hvilke der skal udarbejdes produktresuméer for at fremme en harmonisering af veterinærlægemidler i EU.
English: Implementation of the EU risk management strategy
Danish: Gennemførelse af EU's risikostyringsstrategi
English: Once completed, the EuroPharm database will help healthcare professionals, patients and the general public to access up-to-date and reliable information about medicinal products available on the EU market.
Danish: EuroPharm-databasen vil, når den er færdigudarbejdet, bistå ansatte i sundhedssektoren, patienter samt offentligheden med at få adgang til opdaterede og pålidelige oplysninger om de lægemidler, der er tilgængelige på markedet i EU.
English: He was appointed head of sector on 1 May 2002.
Danish: Han blev udnævnt til sektionsleder den 1. maj 2002.
English: To increase the quality, as well as the regulatory and scientific consistency, of the outcome of the scientific review.
Danish: At forbedre kvaliteten, samt den forskriftsmæssige og videnskabelige overensstemmelse, af resultatet af den videnskabelige behandling.
English: Specialist in internal medicine.
Danish: Speciale i intern medicin.
English: In 1992, he became professor of clinical pharmacology and therapeutics and director of the masters/diploma course on European registration of medicinal products (UAB).
Danish: I 1992 blev han professor i klinisk farmakologi og terapeutik og direktør for master/diplom- uddannelsen i europæisk registrering af lægemidler (UAB).
English: Contribution (see SWP)
Danish: Bidrag (se SWP)
English: She was editor for the ICH GCP guideline from February 1992 until its adoption in May 1996.
Danish: ICH GCP-retningslinjen fra 1992 til dens vedtagelse i maj 1996.
English: Management and monitoring of EudraVigilance Veterinary for its effective implementation of methodology for data analysis supported by automated signal detection
Danish: Styring og overvågning af EudraVigilance Veterinary med henblik på en effektiv gennemførelse af metoder til dataanalyse, der er understøttet af automatisk signaldetektering
English: Guideline to be developed after consultation of concept paper
Danish: Retningslinje udvikles efter høring af konceptdokument
English: EWP contribution
Danish: EWP bidrag
English: Pharmacovigilance remains a high priority of the Agency for 2005 to ensure that effective risk management is continually applied to post-authorisation monitoring of veterinary medicines throughout the EU.
Danish: Lægemiddelovervågning er også i 2005 et prioriteret indsatsområde for agenturet, der skal sikre en effektiv løbende risikostyring af overvågning efter tilladelsen af veterinærlægemidler i hele EU.
English: The working parties of the EMEA scientific committees responsible for medicinal products for human use are involved in the development and revision of guidelines, in the provision of recommendations and advice on medicinal products for which applications are made, and in marketing authorisation or post-authorisation activities, according to the specific area of responsibility of each group.
Danish: Arbejdsgrupperne under EMEA's videnskabelige udvalg, der er ansvarlige for humanmedicinske lægemidler, er inddraget i udvikling og revision af retningslinjer, udarbejdelse af anbefalinger og rådgivning om lægemidler, som der indgives ansøgning om, markedsføringstilladelser eller aktiviteter efter tilladelse, afhængigt af hver enkelt arbejdsgruppes specifikke ansvarsområde.
English: The objective for 2005 in the area of document management and publishing is to support the Agency's full compliance with all regulatory and quality requirements in the areas of records and document management and to ensure the application of best practice.
Danish: Målsætningen for 2005 på området for dokumentstyring og offentliggørelse er at understøtte agenturets fulde overholdelse af alle forskrifts- og kvalitetskrav til arkiv- og sags- og dokumentstyring samt at sikre anvendelsen af god praksis.
English: Preparatory work to provide access to dedicated information contained in the EudraVigilance database to healthcare professionals, marketing authorisation holders and the public.
Danish: Forberedelse af adgang til dedikeret information i EudraVigilance-databasen for ansatte i sundhedssektoren, indehavere af markedsføringstilladelser og offentligheden.
English: Regulatory and procedural advice is provided to the pharmaceutical industry during the lifecycle of medicinal products, from pre-submission meetings with applicants through to annual meetings with marketing authorisation holders.
Danish: Der ydes rådgivning vedrørende lovregler og procedurer til lægemiddelindustrien over lægemidlernes samlede levetid, fra møder med ansøgere før ansøgningsindgivelsen til årlige møder med indehavere af markedsføringstilladelser.
English: Development of meeting broadcasting and wider implementation of video- and teleconferencing to facilitate communication and reduce the number of reimbursed meetings
Danish: Udvikling af transmitterede møder og fortsat gennemførelse af video- og telekonferencer, der skal lette kommunikationen og nedbringe antallet af de møder, der skal ydes godtgørelse for
English: Career to date: Mr Wathion first worked as a pharmacist in a retail pharmacy.
Danish: Karriereforløb: Wathion arbejdede først som farmaceut på et apotek.
English: He was also involved in numerous multinational project management and business analysis assignments, including managing the implementation of a worldwide information management system for clinical trials on behalf of a Swiss-based pharmaceutical company.
Danish: Har endvidere deltaget i forskellige multinationale opgaver inden for projektledelse og virksomhedsanalyse og har bl.a. ledet etableringen af et globalt informationsstyringssystem for klinisk efterprøvning for et schweiziskbaseret medicinalfirma.
English: A changed working environment following the review of the Agency's founding regulation
Danish: En ændring afi arbejdsvilkår i kølvandet på revisionen af agenturets grundvedtægter
English: Facilitation of liaison with other scientific working groups and with interested parties
Danish: Understøtte samarbejdet med andre videnskabelige arbejdsgrupper og med interesserede parter
English: To improve the provision of information in the post-authorisation phase in accordance with the new legislation on variations
Danish: At forbedre tilvejebringelsen af information i fasen efter tilladelsen i overensstemmelse med den nye lovgivning om ændringer af markedsføringstilladelsen
English: Establishment of a dedicated sector for medical information
Danish: Oprettelse af en dedikeret sektion for lægemiddelinformation
English: To increase the level of transparency of Agency and European network activities
Danish: At skabe større gennemsigtighed vedrørende agenturets og det europæiske netværks aktiviteter
English: Endorse the EMEA transparency and communication strategies and related policies
Danish: Godkende EMEA's strategier for gennemsigtighed og formidling af information og politikker i tilknytning hertil
English: Implementation of Directive 2001/20/EC and of the Commission Directive on GCP at EU level will require continued support to the development of harmonised procedures within the ad hoc group of GCP inspection services
Danish: Gennemførelse af direktiv 2001/20/EF og af Kommissionens direktiv om GCP på EU-niveau vil kræve fortsat støtte til udviklingen af harmoniserede procedurer inden for GCP
English: Communications and networking Unit
Danish: Kommunikations- og netværksafdelingen
English: In 1997, he was appointed head of the pharmaceuticals assessment unit of the French veterinary agency (AFSSA-ANMV).
Danish: I 1997 blev han udnævnt til leder af Afdelingen for Vurdering af Lægemidler i det franske Veterinærmedicinske Agentur (AFSSA-ANMV).
English: The Agency plans to review its organisational structure to be able to carry out its expanded responsibilities in the areas of medical information and provision of support and incentives to small and medium-sized enterprises.
Danish: Agenturet planlægger at gennemgå sin organisatoriske struktur med det formål at kunne leve op til sit udvidede ansvar på området for lægemiddelinformation og bistand til og initiativer over for små og mellemstore virksomheder.
English: This includes the organisation of meetings, travel and hotel arrangements for delegates and hosts, reception of visitors, the reimbursement of delegates' expenses, and the payment of suppliers' invoices, as well as the preparation and follow-up of meeting room facilities.
Danish: Hertil hører møde-, rejse- og hotelarrangementer for delegerede og værter, modtagelse af besøgende, afholdelse af delegeredes udgifter, og betaling af leverandørregninger, samt forberedelse og opfølgning af mødelokalefaciliteter.
English: During implementation of the new EU pharmaceutical legislation, significant emphasis will be made on the preparation of regulatory and procedural guidance, which will complement the ongoing review of the available guidance documents
Danish: Centrale initiativer: Der vil under gennemførelsen af den nye EU-lægemiddellovgivning blive lagt særlig vægt på udarbejdelse af vejledning vedrørende lovregler og procedurer, som vil supplere den løbende gennemgang af de eksisterende vejledningsdokumenter
English: The Agency has been given significant new responsibilities for the provision of information to patients and healthcare professionals.
Danish: Agenturet har fået overdraget væsentlige nye ansvarsområder for tilvejebringelse af oplysninger til patienter og ansatte i sundhedssektoren.
English: The scope is broadened by the possibility of increased eligibility for the centralised procedure to include any veterinary medicine having importance for animal health throughout the Community.
Danish: Anvendelsesområdet er udvidet, idet der er åbnet op for større adgang til den centraliserede procedure, så den omfatter alle veterinærlægemidler, der har betydning for dyrs sundhed i hele Fællesskabet.
English: Conduct joint planning to manage the resource implications arising from the new pharmaceutical legislation, the advent of new technologies and the increase in the number of scientific resource providers
Danish: Gennemførelse af fælles planlægning til styring af de ressourcemæssige virkninger af den nye lægemiddellovgivning, fremkomsten af nye teknologier og det stigende antal videnskabelige tjenesteydere
English: He undertook long-term assignments as a management consultant until January 1997, when he joined the EMEA.
Danish: Som managementkonsulent påtog han sig langsigtede opgaver frem til januar 1997, hvor han blev ansat i EMEA.
English: To process parallel distribution notifications in accordance with the EMEA procedure and adhering to regulatory timelines
Danish: At behandle anmeldelser om paralleldistribution i overensstemmelse med EMEA's procedure og under overholdelse af forskriftsmæssige frister
English: New legislation in the fields of paediatric medicines and tissue engineering is also under development, and the Agency contributes to and monitors its development in anticipation of its future adoption.
Danish: Ny lovgivning for pædiatriske lægemidler og vævsteknik er ligeledes i støbeskeen, og agenturet bidrager til og overvåger udviklingen heraf i forventning om, at lovgivningen vedtages på et senere tidspunkt.
English: The Agency will capitalise on its previously successful initiatives to maintain contacts and exchanges with interested parties, and aims to fulfil its obligations in accordance with new legislation to facilitate greater communication and dialogue on matters of common interest.
Danish: Agenturet vil trække på de positive erfaringer fra sine tidligere initiativer til at fastholde kontakter og udveksling med interesserede parter, og det har til hensigt at leve op til sine forpligtelser i overensstemmelse med den nye lovgivning for at sikre bedre formidling af og dialog om spørgsmål af fælles interesse.
English: Numbers of certificate requests are expected to continue to increase as the pool of centrally authorised products is growing.
Danish: Antallet af anmodninger om certifikater forventes at stige i takt med, at antallet af centralt godkendte lægemidler stiger.
English: Establish procedures and a dedicated structure to provide support for small and medium-sized enterprises
Danish: Etablering af procedurer og en målrettet struktur, der skal yde bistand til små og mellemstore virksomheder
English: To implement the EU review of pharmaceutical legislation, in particular as regards the reinforced coordinating role for the EMEA in the area of pharmacovigilance and provision of information on safety aspects
Danish: At gennemføre EU‘s revision af lægemiddellovgivningen, navnlig med hensyn til EMEA's styrkede koordinerende rolle omkring lægemiddelovervågning og information om sikkerhedsaspekter
English: Contribution to the activities initiated by the Directorate-General for Research relating to emerging therapies and medicinal products for rare diseases and for developing countries
Danish: Bidrag til de aktiviteter, der er iværksat af Generaldirektoratet for Forskning vedrørende nye behandlingsformer og lægemidler til sjældne sygdomme og til udviklingslande
English: Career to date: After several years in general veterinary practice in the United Kingdom and Canada, Dr Jones joined the pharmaceutical industry in the animal health sector.
Danish: Karriereforløb: Efter flere års dyrlægepraksis i Det Forenede Kongerige og Canada blev dr. Jones ansat inden for medicinalindustrien på dyresundhedsområdet.
English: Provision of dedicated and up-to-date information on procedures for emerging therapies and technologies
Danish: Tilvejebringelse af målrettet og ajourført information om procedurer for nye behandlingsformer og teknologier
English: Revision of current procedures, including incorporation of reduced timelines for communication of opinions to the Commission from 30 to 15 days
Danish: Revision af eksisterende procedurer, der bl.a. skal omfatte en nedsættelse af fristerne for afgivelse af udtalelser til Kommissionen fra 30 til 15 dage
English: The Agency's activities in the field of herbal medicinal products will help to harmonise procedures and provisions concerning herbal medicines laid down in the Member States and to integrate further herbal medicinal products in the European regulatory framework.
Danish: Agenturets aktiviteter på plantelægemiddelområdet vil bidrage til at harmonisere de af medlemsstaterne fastlagte procedurer og lovregler vedrørende plantelægemidler, og yderligere at integrere plantelægemidler i de europæiske retsregler.
English: Implementation of the EU telematics strategy for the pharmaceutical sector
Danish: Gennemførelse af EU's telematikstrategi for lægemiddelsektoren
English: In 1991 he joined the International Regulatory Affairs Division of Glaxo Group Research Limited where he was responsible for the development and submission of a series of international registration applications in a number of therapeutic areas.
Danish: Division i Glaxo Group Research Limited, hvor han var ansvarlig for udvikling og indgivelse af en række internationale registreringsansøgninger inden for forskellige terapeutiske områder.
English: The activities entail close cooperation with the European Parliament and the Council (Budgetary Authority), as well as with the Commission and the Court of Auditors, on matters relating to administration, the budget, personnel, and rules and regulations on finances, audit and accounting.
Danish: (budgetmyndigheden), samt med Kommissionen og Revisionsretten, om spørgsmål i forbindelse med administration, budget, personale, samt regler og forskrifter om finansielle spørgsmål, revision og regnskaber.
English: Dr Lyngvig has 12 years' private-sector experience in the transport and consultancy industries and was appointed chief executive officer of the Danish Medicines Agency in 2000.
Danish: Dr. Lyngvig har 12 års erfaring i den private sektor inden for transport- og konsulentbranchen og blev udnævnt til direktør for Lægemiddelstyrelsen i 2000.
English: The area of infrastructure services at the EMEA covers a wide range of services, including security, telecommunications, reception, switchboard, archiving, mail, reprographics, technical assistance to meeting rooms, confidential waste, health & safety, fire and emergency plans, business continuity planning, inventory, office equipment and supplies, maintenance, refurbishment and fitting out, and management of the catering facilities.
Danish: Området for infrastrukturtjenester i EMEA dækker over en lang række tjenester, bl.a. sikkerhed, telekommunikation, reception, omstilling, arkivering, post, reprografi, teknisk assistance til mødelokaler, bortskaffelse af fortroligt affald, arbejdsmiljø, brand og nødplaner, driftsstabilitetsplanlægning, lagerstyring, kontorudstyr og -tilbehør, vedligeholdelse, renovering og indretning, samt administration af kantinefaciliteter.
English: Preparation of EPAR summaries that are written so they are understandable to the public, and coordination with applicants to ensure package leaflets are similarly written in a manner comprehensible to the lay person
Danish: Forberedelse af EPAR resuméer affattet i et almindeligt forståeligt sprog, og samordning med ansøgere, så det sikres, at indlægssedler tilsvarende skrives, så de er forståelige for lægmand
English: To further implement the EudraVigilance project, including the SUSAR component, in particular as regards the implementation at Member State and pharmaceutical industry level, to achieve a more operational system.
Danish: At stå for den videre gennemførelse af EudraVigilance-projektet, herunder SUSAR-komponenten, og sikre et mere operationelt system, navnlig for så vidt angår gennemførelsen på medlemsstatsniveau og i lægemiddelindustrien.
English: Career to date: Tim Buxton completed articles with Touche Ross & Co. in London in 1987.
Danish: Karriereforløb: Tim Buxton færdiggjorde sin uddannelse hos Touche Ross & Co i London i 1987.
English: The consequences of the new pharmaceutical legislation:
Danish: Konsekvenserne af den nye lægemiddellovgivning:
English: Some aspects of the new pharmaceutical legislation came into force in 2004, while fundamental changes to the European regulatory system will have their first effects in 2005.
Danish: Visse dele af den nye lægemiddellovgivning trådte i kraft i 2004, men virkningerne af de første gennemgribende ændringer i det europæiske kontrolsystem vil først begynde at slå igennem i 2005.
English: The main objective for 2005 is to manage the increased workload and issue certificates according to required timelines.
Danish: Den vigtigste målsætning for 2005 er at styre den stigende arbejdsbyrde og udstede certifikater inden for de krævede frister.
English: Concurrent administration of IVMPs in view of determining day X to be 14 days and consequent revision of the SPC guideline for immunologicals
Danish: Concurrent administration of IVMPs in view of determining day X to be 14
English: The trend for referral of issues resulting from pharmacovigilance reporting at Member State level to the CVMP will continue to grow, requiring the Committee's opinion for further actions to be taken as appropriate
Danish: Tendensen med at henvise spørgsmål, der opstår som følge af medlemsstaternes overvågningsindberetninger til CVMP, vil fortsat stige, hvilket vil stille krav til, at udvalget afgiver udtalelser om eventuelle yderligere foranstaltninger, der skal træffes