FrancophonIA/ELRC3.0 huggingface dataset:
English: Establish a scientific memory database for centrally authorised medicinal products to underpin the quality and consistency of scientific assessment within the CVMP, thereby reinforcing the risk/benefit analysis prior to authorisation of new veterinary medicines
Danish: Der vil den 1. januar 2005 blive iværksat elektronisk indberetning af bivirkninger for alle veterinærlægemidler under EudraVigilance Veterinary At etablere en database for videnskabelig hukommelse for centralt godkendte lægemidler med det formål at understøtte kvaliteten og konsekvensen af videnskabelig vurdering inden for CVMP, hvorved risk/benefit-analysen forud for tilladelsen til nye veterinærmedicinske lægemidler styrkes
English: To consolidate operational aspects of the respective MRAs (all agreements, with the exception of that with the US, are fully operational at least within the old Member States) To complete inclusion of the new Member State authorities in the MRAs (EC-Canada) To expand the scope of the EC-Japan agreement
Danish: At konsolidere operationelle aspekter af de respektive gensidige anerkendelsesaftaler (MRA) (alle aftaler, med undtagelse af aftalen med USA, er fuldt operationelle i hvert fald i de gamle medlemsstater)
English: Education: Pharmacist, doctorate in natural sciences (pharmacognosy) from the University of Saarbrücken.
Danish: Uddannelse: Farmaceut, doktorgrad i naturvidenskab (farmakognosi ) fra universitetet i Saarbrücken.
English: There will be continued technical support to the Commission in its membership of Codex Alimentarius, and the Agency and CVMP will continue their representation at other international forums, including the WHO, OIE and FAO.
Danish: Codex Alimentarius, og agenturet og CVMP vil fortsat være repræsenteret i andre internationale fora,
English: He served on the management board of the French National Agency for Health Evaluation and Hospital Accreditation (ANAES) from 2000 to 2004, and on its executive committee from 2002 to 2004.
Danish: Fra 2000 til 2004 medlem af bestyrelsen for ANAES (Agence française pour l'accréditation et l'évaluation en santé) og medlem af eksekutivudvalget for ANAES fra 2002 til 2004.
English: Andreas Pott, Head of Unit, b. 14 April 1949, n. German
Danish: Andreas Pott, afdelingsleder, født 14. april 1949, tysk statsborger
English: 23-26 May
Danish: 23.-26. maj
English: He moved to the Translation Centre for Bodies of the European Union in 1999 as head of the department for interinstitutional cooperation.
Danish: Unions Organer som leder af Afdelingen for Interinstitutionelt Samarbejde.
English: Concept paper to be prepared during
Danish: Konceptdokument forberedes i løbet af
English: Concept paper and recommendations to be developed and completed in 2005
Danish: Konceptdokument og anbefalinger udvikles og færdigudarbejdes i 2005
English: The initial evaluation phase covers a number of EMEA activities ranging from pre-submission discussions with future applicants, through the evaluation by the CVMP, to the granting by the European Commission of the product marketing authorisation.
Danish: Den indledende vurderingsfase dækker over en række aktiviteter i EMEA, der rækker fra diskussioner før ansøgningsindgivelsen med kommende ansøgere, over vurdering af CVMP, til Europa
English: Enlargement of the Community to 25 Member States may mean that there is a greater challenge in reaching consensus in the mutual recognition procedure, with the potential for an increase in referrals to the CVMP for arbitration (Article 33) on the grounds of potential risk to human or animal health, or to the environment
Danish: Fællesskabets udvidelse til 25 medlemsstater vil kunne betyde, at det vil blive en større udfordring at opnå enighed inden for den gensidige anerkendelsesprocedure, og det vil på sin side kunne indebære en stigning i antallet af indbringelser af sager til afgørelse ved voldgift i CVMP
English: The programme for sampling and testing centrally authorised products will continue in 2005, with 37 human and veterinary products to be tested.
Danish: Programmet for stikprøveudtagning og afprøvning af centralt godkendte produkter vil fortsætte i 2005,
English: EMEA establishment plan 2003-2005
Danish: EMEA stillingsfortegnelse for 2003-2005
English: Expenditure on data processing Other capital expenditure Postage and communications Other administrative expenditure
Danish: Bygninger/udstyr Husleje/afgifter Udgifter til databehandling Andre kapitaludgifter
English: Discussion of comments received on revision to be released for public consultation in 2005
Danish: Diskussion af modtagne kommentarer til revision sendes til offentlig høring i
English: He joined the EMEA on 1 May 2002.
Danish: EMEA den 1. maj 2002.
English: 27-28 January
Danish: 27.-28. januar
English: Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Danish: Marijke KORTEWEG Tlf.: (direkte nummer) (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
English: Cooperation with other public-health-oriented scientific and regulatory institutions and agencies at European Union level will develop further as a result of the increased responsibilities given to the Agency by the new European pharmaceutical legislation
Danish: niveau, der beskæftiger sig med folkesundhed, vil blive videreudviklet som et resultat af de stadig flere ansvarsområder, som agenturet får overdraget gennem den nye lægemiddellovgivning
English: 22-23 March
Danish: 22.-23. marts
English: Monitor the assessment procedures for PMFs and VAMFs, and review the procedures on the basis of experience gained
Danish: At vurdere PMF- og VAMF-dossiererne inden for de frister, der er fastlagt i lovgivningen At overvåge vurderingsprocedurerne for PMF og VAMF og at gennemgå procedurerne på grundlag af de indhøstede erfaringer
English: In 1984 Dr Korteweg created the regulatory compliance/quality assurance audit department for the European pharmaceutical R&D division of BristolMyers Squibb, later becoming director of worldwide regulatory compliance (auditing).
Danish: I 1984 oprettede Dr. Korteweg afdelingen for regeloverholdelse/kvalitetssikringsaudit i European Pharmaceutical R&D Division i Bristol-Myers
English: Support the implementation activities relating to GCP inspections under the Clinical Trials Directive 2001/20/EC for human medicines and the directive on GCP, in particular the implementation of the second phase of the EudraCT database
Danish: 2001/20/EF om lægemidler til human brug og direktivet om anvendelse af god klinisk praksis, og navnlig gennemførelsen af anden fase af EudraCT-databasen
English: 17-19 May
Danish: 17.-19. maj
English: CPMP Note for Guidance on the rapid alert system and non-urgent information system in pharmacovigilance
Danish: Alert System and Non-Urgent Information System in Pharmacovigilance
English: He joined the EMEA in June 1995, and was appointed head of the veterinary unit in December of the same year, and took on responsibility for the inspections sector in January 2002.
Danish: Ansat i EMEA i juni 1995 og udnævnt til leder af afdelingen for vurdering af veterinærlægemidler i december samme år, hvor han desuden overtog ansvaret for tilsynssektionen i januar 2002.
English: Arbitration and Community referrals made to EMEA (Input)
Danish: Voldgifter og henvisninger af sager til Fællesskabet, til EMEA (input)
English: 10-12 May
Danish: 10.-12. maj
English: Melanie Leivers, Deputy Head of Sector for veterinary marketing authorisation procedures, b. 1 December 1958, n. British
Danish: Melanie Leivers, viceleder af sektionen for veterinærmedicinske markedsføringstilladelser, født 1. december 1958, britisk statsborger
English: Other documents on working practices and work-sharing as well as new document management and communication/information exchange/tracking tools, in particular
Danish: Other documents on working practices and work-sharing as well as new document management and communication/information exchange/tracking tools, in particular with view to implementing the EU Risk Management Strategy and the revised PhVWP Mandate of September 2003
English: He was nominated press officer in September 2001 and appointed head of executive support in January
Danish: Blev udnævnt til pressesekretær i september 2001 og til leder af sektionen for ledelsmæssig støtte i januar 2004.
English: 3.7 Regulatory activities
Danish: 3.7 Kontrolaktiviteter
English: Career to date: From 1984 Professor Vamvakas held positions in the department of pharmacology and toxicology at the University of Würzburg and in the department of pharmacology at the Medical Centre of the University of Rochester NY, USA.
Danish: Karriereforløb: Siden 1984 har prof Vamvakas beklædt stilinger i afdelingen for farmakologi og toksikologi ved universitetet i Wuerzburg og afdelingen for farmakologi i “Medical Centre” ved universitetet Rochester NY i USA.
English: Core SPC for human plasma derived and recombinant coagulation Factor IX products
Danish: Core SPC for human plasma derived and recombinant coagulation Factor IX
English: Further to the restructuring of the Human Medicines Evaluation Unit in 2001, he was appointed head of unit for the post-authorisation evaluation of medicines for human use.
Danish: I forlængelse af omstruktureringen af afdelingen for vurdering af humanmedicinske lægemidler i 2001 blev han udnævnt til leder af afdelingen for vurdering af humanmedicinske lægemidler efter godkendelse.
English: Dr Tsintis joined the EMEA as head of sector, pharmacovigilance and post-authorisation safety and efficacy of medicines in March
Danish: Dr. Tsintis blev ansat i EMEA i marts 2002 som leder af sektionen for lægemiddelovervågning og tilsyn med lægemidlers sikkerhed og virkning efter godkendelse.
English: 5 EU TELEMATICS STRATEGY AND INFORMATION TECHNOLOGY
Danish: 5 EU'S TELEMATIKSTRATEGI OG INFORMATIONSTEKNOLOGI 6 STØTTEAKTIVITETER
English: Establishment of processes for preparation of summaries of EPARs written in a manner that is understandable to the public
Danish: Etablering af processer til forberedelse af resuméer af EPAR affattet i et almindeligt forståeligt sprog
English: 3 VETERINARY MEDICINES 3.1 Scientific advice
Danish: 2.12 Koordineringsgruppe 3 VETERINÆRLÆGEMIDLER 3.1 Videnskabelig rådgivning 3.2 Indledende vurdering
English: EMEA/CHMP Working Party with Patients' Organisations
Danish: EMEA/CHMP-arbejdsgruppen og patientorganisationer.
English: Deadline for comments March
Danish: Frist for kommentarer i marts 2005
English: EU Comments in preparation of revised VICH Guidelines
Danish: EU-kommentarer til forberedelse af revideret VICH retningslinjer
English: 4-6 October
Danish: 4.-6. oktober
English: 10-13 October
Danish: 10.-13. oktober
English: For enquiries concerning VAMF certificates
Danish: Forespørgsler om VAMF-certifikater
English: 3.4 Post-authorisation activities
Danish: 3.4 Aktiviteter efter tilladelse
English: Postgraduate qualifications in paediatrics and methodology.
Danish: Uddannelse efter kandidateksamen inden for pædiatri og metodologi.
English: The performance indicator for this objective is the percentage of applications evaluated within the 90-day timeline.
Danish: Præstationsindikatoren for denne målsætning er procenten af ansøgninger, der vurderes inden for 90-dages fristen.
English: The CVMP will meet 11 times during the year.
Danish: Ledelse og organisering af CVMP CHMP vil afholde 11 møder i løbet af året.
English: Sabine Brosch, Deputy Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 17 August 1963, n. Austrian
Danish: Sabine Brosch, viceleder af sektionen for lægemiddelovervågning og tilsyn med lægemidlers sikkerhed og virkninger efter godkendelse, født 17. august 1963, østrigsk statsborger
English: The ad hoc group of GCP inspection services will meet four times in 2005.
Danish: GCP-inspektionstjenesterne vil mødes fire gange i 2005.
English: He joined the EMEA in September 1997 where he was appointed head of sector for new chemical substances in June 1998 and head of sector for orphan drugs and scientific advice in January 2001.
Danish: Han blev ansat i EMEA i september 1997 og udnævnt til leder af sektionen for nye kemiske stoffer i juni 1998 og til leder af sektionen for videnskabelig rådgivning og lægemidler til sjældne sygdomme i januar 2001.
English: Guideline to be developed
Danish: Retningslinje udvikles
English: EU Comments in preparation of revised VICH Guideline
Danish: EU-kommentarer til forberedelse af revideret VICH retningslinje
English: New applications for veterinary medicines received/forecast (Input)
Danish: Modtagne/skønnede nye ansøgninger om veterinærmedicinske lægemidler (input)
English: The level of international activity is expected to continue to increase, taking into account the Agency's reinforced role in an enlarged European Union, resulting in an increasing interest in the Agency's work from non-EU regulatory authorities
Danish: Tendenser: Agenturets styrkede rolle i en udvidet Europæisk Union skaber en stigende interesse i agenturets arbejde fra tredjelandes kontrolmyndigheder, hvilket indebærer, at det internationale samarbejde forventes at blive intensiveret yderligere
English: Protocol assistance and follow-up finalised Scientific advice and follow-up finalised
Danish: Protokolbistand og opfølgning, afsluttet Videnskabelig rådgivning og opfølgning, afsluttet
English: Good Pharmacovigilance Practice (GVP)
Danish: Good Pharmacovigilance Practice
English: 11-13 January
Danish: 11.-13. januar
English: Postgraduate degrees in tropical medicine, clinical research and epidemiology.
Danish: Har efter kandidateksamen taget flere eksaminer i tropemedicin, klinisk forskning og epidemiologi.
English: Ms Fayl joined the EMEA in April 1995.
Danish: Beatrice Fayl blev ansat i EMEA i april 1995.
English: To be finalised following end of public consultation
Danish: Afsluttes efter offentlig høring
English: Draft to be transmitted to CHMP by Q2
Danish: Udkast fremsendes til CHMP i 2. kv.
English: 18-20 October
Danish: 18.-20. oktober
English: Martin Harvey Allchurch, Head of Executive Support, b. 20 October 1966, n. British
Danish: Martin Harvey Allchurch, leder af sektionen for ledelsmæssig støtte og pressesekretær, født 20. oktober 1966, britisk statsborger
English: He was re-elected vice-chairman of the CVMP in 2004.
Danish: Han blev genvalgt som næstformand for CVMP i 2004.
English: Guideline to be finalised in 2005
Danish: Retningslinje afsluttes i 2005
English: Review of audiovisual and interpretation equipment in the meeting rooms
Danish: Effektivisering af proceduren for indkøb og forvaltningen af kontrakter Kontrol af audiovisuelt udstyr og tolkeudstyr i mødelokalerne
English: Note for Guidance on the conduct of pharmacovigilance for medicinal products authorised through mutual recognition
Danish: Pharmacovigilance for Medicinal Products Authorised through Mutual Recognition
English: Temporary working parties on new emerging therapies and new technologies, i.e. pharmacogenetics, gene therapy and cell therapy, will continue to meet in 2005 as the Agency is likely to receive applications in relation to emerging therapies.
Danish: genterapi og celleterapi, vil fortsat afholde møder i 2005, idet agenturet formodes at modtage ansøgninger vedrørende nye behandlingsformer.
English: Applications for initial evaluation (Input)
Danish: Ansøgninger om indledende evaluering (input)
English: Orphan medicinal products are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in the European Community, or where for economic reasons such medicines would not be developed without incentives.
Danish: Lægemidler til sjældne sygdomme er bestemt til diagnose, forebyggelse eller behandling af livstruende eller kronisk invaliderende sygdomstilstande, der påvirker højest fem ud af 10 000
English: Establishment of a database to facilitate scientific memory analysis for all centralised applications submitted in the past 10 years, and for future applications, to allow for greater integrity, scientific quality and consistency of CVMP assessment reports
Danish: Oprettelse af en database for videnskabelig hukommelse, der skal lette analysen for alle centraliserede ansøgninger, der er indgivet i de seneste 10 år, og for fremtidige ansøgninger,
English: 3.5 Pharmacovigilance and maintenance activities
Danish: 3.5 Lægemiddelovervågning og ajourføringsaktiviteter
English: He joined the Swedish Medicinal Products Agency in 1990, serving as director of operations and later as deputy director-general.
Danish: Thomas Lönngren blev ansat i den svenske Lægemiddelstyrelse i 1990, først som direktør for operationelle anliggender og dernæst som vicegeneraldirektør.
English: Career to date: From 1976 to 1978, lecturer at the University of Uppsala.
Danish: Karriereforløb: 1976-1978 lektor ved Uppsalas universitet.
English: Annex 1 EMEA establishment plan 2003-2005 Annex 2 Revenue and expenditure overview 2003-2005 Annex 3 Guidelines and working documents in 2005 Annex 4 EMEA contact points Annex 5 Profiles of EMEA personalities
Danish: Bilag 1 Emea's stillingsfortegnelse for 2003-2005 Bilag 2 Oversigt over udgifter og indtægter For 2003-2005 Bilag 3 Retningslinjer og arbejdsdokumenter i 2005
English: In 1994, she joined the UK Veterinary Medicines Directorate as senior veterinary assessor in the pharmaceuticals and feed additives team.
Danish: Veterinary Medicines Directorate som ledende veterinærrådgiver i gruppen for lægemidler og tilsætningsstoffer til foderstoffer.
English: To be prepared during 2005
Danish: Forberedes i 2005
English: EU Comments in preparation of VICH Guideline after consultation
Danish: VICH retningslinje efter høring
English: Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisations.
Danish: Aktiviteterne efter godkendelsen vedrører ændringer, produktserieudvidelser og overførsler af markedsføringstilladelser.
English: Career to date: From 1988 to 1992, Dr Brosch worked as an assistant professor at the department of pharmacology and toxicology at the University of Vienna, where she specialised in electrophysiology.
Danish: Karriereforløb: 1988-1992 var dr. Brosch ansat som docent ved Afdelingen for Farmakologi og Toksikologi ved Wiens universitet med speciale i elektrofysiologi.
English: Such increase will be influenced by the revised classification of variations and the status of implementation of new Community legislation on certification of plasma master files and vaccine antigen master files
Danish: Aktiviteterne efter tilladelsen til indledende certificering af masterfiler vedrørende plasma og vaccineantigener vil blive udviklet yderligere En sådan stigning vil blive påvirket af den reviderede klassificering af ændringer og status for gennemførelsen af den nye fællesskabslovgivning om certificering af masterfiler vedrørende plasma og vaccineantigener
English: Contribution to development of haemovigilance procedures and mechanisms for interaction between haemovigilance and pharmacovigilance systems if requested
Danish: Bidrag til udvikling af procedurer for overvågning af blodpræparater og mekanismer for samordning af systemerne for overvågning af blodpræparater og lægemidler, hvis der anmodes derom
English: Discussions on work programmes of CVMP working parties and scientific advisory groups
Danish: Præsentationer forestået af ledende repræsentanter for interesserede parter Drøftelser vedrørende arbejdsprogrammer for CVM's arbejdsgrupper og grupper vedrørende videnskabelig rådgivning
English: Miss Leivers joined the EMEA in February 1996 and was appointed deputy head of sector in June 2001.
Danish: Melanie Leivers blev ansat i EMEA i februar 1996 og udnævnt til vicesektionsleder i juni 2001.
English: She joined the EMEA as head of sector for inspections in July 2002.
Danish: Hun blev ansat i EMEA som leder af sektionen for tilsyn i juli 2002.
English: Education: Bachelor of Arts in languages and linguistics at the University of East Anglia and postgraduate degree in librarianship and information science at the University of Wales.
Danish: oktober 1959, dansk statsborger Uddannelse: Bachelor i sprog og lingvistik ved East Anglia Universitet og studier efter kandidateksamen i biblioteks- og informationsvidenskab ved Wales Universitet.
English: Opinions adopted (Output)
Danish: Afgivne udtalelser (output)
English: Career to date: From 1982 to 1986, Dr Bénéfice was a researcher at the University of Montpellier, France.
Danish: Karriereforløb: 1982-1986 var Sylvie Bénéfice ansat som forsker ved Montpelliers universitet i Frankrig.
English: Work to be continued in 2005
Danish: Arbejdet fortsætter i 2005
English: Education: Graduated in pharmacology from King's College London.
Danish: Uddannelse: Uddannet i farmakologi på King's College ved Londons universitet.
English: Performance indicators for this objective are: o percentage of summaries of opinion published at the time of publication of the press release following the CVMP meeting.
Danish: Præstationsindikatorer for denne målsætning er: o antal procent af resuméer af udtalelser, der er offentliggjort på tidspunktet for offentliggørelsen af pressemeddelelsen efter CVMP mødet.
English: Type I variation opinions Type II variation opinions Line extension opinions
Danish: Type II ændringsudtalelser Type I ændringsudtalelser
English: Performance indicators for this objective are: o percentage of summaries of opinion published at the time of publication of the press release following the CHMP meeting.
Danish: Præstationsindikatorer for denne målsætning er: o antal procent af resuméer af udtalelser, der er offentliggjort på tidspunktet for offentliggørelsen af pressemeddelelsen efter CHMP mødet.
English: Update the EMEA guidance to parallel distributors taking into account the experience gathered
Danish: At ajourføre EMEA's vejledning til paralleldistributører under hensyntagen til de indhøstede erfaringer At afdække områder, der kan forbedres yderligere og at gennemføre nødvendige korrigerende indgreb
English: Periodic safety update reports received/forecast (Input)
Danish: Modtagne/skønnede periodisk opdaterede sikkerhedsindberetninger (input)
English: Daniel Brasseur, Chairman of the CHMP, b. 7 June 1951, n. Belgian
Danish: EMEA's videnskabelige udvalg Daniel Brasseur, formand for CPMP, født 7. juni 1951, belgisk statsborger
English: He joined the EMEA in May 1999 and one of his major activities in recent years was the establishment of orphan drug designation and protocol assistance in the EMEA.
Danish: I maj 1999 blev han ansat i EMEA, hvor han i de senere år hovedsagelig har beskæftiget sig med udpegelse af lægemidler til sjældne sygdomme og protokolbistand.
English: Education: Qualified pharmacist with a master's degree in pharmaceutical chemistry and a master's degree in business administration (MBA) from Trinity College Dublin.
Danish: Uddannelse: Uddannet farmaceut med mastergrad i farmaceutisk kemi og marstergrad i virksomhedsledelse (MBA) fra Trinity College i Dublin.
English: He currently holds the positions of director and professor at the Federal Institute for Drugs and Medical Devices.
Danish: Beklæder på nuværende tidspunkt en stilling ved “Bundesinstitut für Arzneimittel und Medizinprodukte” som direktør og professor.
English: Unit for Veterinary medicines and inspections
Danish: Afdelingen for veterinærlægemidler og tilsyn
English: Panos Tsintis, Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 18 September 1956, n. British
Danish: Panos Tsintis, leder af sektionen for lægemiddelovervågning og tilsyn med lægemidlers sikkerhed og virkning efter godkendelse, født 18. september 1956, britisk statsborger
English: Guidance on the development of vaccines against emerging and reemerging diseases such as SARS, pathogens potentially used in bioterrorism, monovalent polio vaccines
Danish: Guidance on the development of vaccines against emerging and re emerging diseases such as SARS,