FrancophonIA/ELRC3.0 huggingface dataset:
English: To improve scientific and regulatory consistency of opinions, adhere to regulatory timelines, and continue strengthening the operation of the initial evaluation procedure
Danish: At gennemføre de nye lovkrav vedrørende indledende vurdering At forbedre videnskabelig og forskriftsmæssig konsekvens af udtalelser, overholde forskriftsmæssige frister, og fortsat at styrke den indledende vurderingsprocedures funktion Præstationsindikatoren for denne målsætning er procenten af produkter, der vurderes inden for
English: MSc in social and regulatory pharmacy.
Danish: Mastergrad i socialfarmaci og retsforskrifter på lægemiddelområdet (MSc).
English: Work to start in 2005
Danish: Arbejdet indledes i 2005
English: The extended scope of the centralised procedure will be implemented in the fourth quarter of 2005 resulting in a minimal increase in the number of applications
Danish: Nogle af årsagerne hertil er bl.a.: Den udvidede anvendelse af den centraliserede procedure vil blive gennemført i fjerde kvartal af
English: 14-17 March
Danish: 14.-17. marts
English: CHMP meetings in 2005
Danish: Møder i CHMP i 2005
English: A significant impact on the activities of the Agency in 2005 is the introduction of new procedures which reinforce the safety of medicines and facilitate access to new medicines.
Danish: Indførelsen af nye procedurer, som styrker lægemiddelsikkerheden og skaber lettere adgang til nye lægemidler vil komme til at præge agenturets aktiviteter stærkt i 2005.
English: Education: Qualified pharmacist from the Free University of Brussels.
Danish: Uddannelse: Uddannet farmaceut ved Bruxelles Frie Universitet.
English: Revision to be finalised in 3/4Q 2005
Danish: Revision afsluttes i 3./4.
English: Arbitration procedures (either under Article 29 of Directive 2001/83/EC or Article 6(12) of Commission Regulation (EC) No 1084/2003) are initiated because of disagreement between Member States in the framework of the mutual recognition procedure.
Danish: Voldgiftsprocedurer (enten i henhold til artikel 29 i direktiv 2001/83/EF eller artikel 7, stk. 5, i
English: He joined the EMEA in April 1995.
Danish: Ansat i EMEA i april 1995.
English: Postgraduate degree in pharmacology; associate professor in pharmacology and toxicology at the University of Vienna.
Danish: Eksamen i farmakologi efter kandidateksamen, ekstern lektor i farmakologi og toksokologi ved universitet i Wien.
English: Education: Master's degree in pharmacy and doctor of natural sciences degree in pharmacology from the University of Vienna.
Danish: Uddannelse: Mastergrad i farmaci og doktor i farmakologi fra Wiens universitet.
English: Parallel distribution notifications received/forecast (Input)
Danish: Modtagne/skønnede anmeldelser om paralleldistribution (input)
English: 8-10 March
Danish: 8.-10. marts
English: Career to date: Dr Wagner was a research and teaching assistant at Saarbrücken University from 1976 to 1981.
Danish: Karriereforløb: 1976-1981 var dr. Wagner forsknings- og undervisningsassistent på Saarbrückens universitet.
English: Key initiatives to meet the objectives:
Danish: Centrale initiativer til opfyldelse af målsætningerne:
English: Spiros Vamvakas, Acting Deputy Head of Sector for orphan drugs and scientific advice, b. 4 September 1960, n. German/Greek
Danish: Spiros Vamvakas, fungerende vicesektionsleder af sektionen for lægemidler til sjældne sygdomme og videnskabelig rådgivning, født 4. september 1960, tysk/græsk statsborger Uddannelse: Uddannet som læge ved Wuerzburg universitet i Tyskland.
English: Business continuity plan - the exercising and testing of the plan will be carried out
Danish: Driftsstabilitetsplan - planen vil blive iværksat og testet Udvidelse af pladsen til både kontorer og møder
English: Development of a new document with PEG (Paediatrics Working Party)
Danish: PEG (Arbejdsgruppen for Pædiatriske Lægemidler)
English: The legislation allows the committees to establish scientific advisory groups in connection with the evaluation of specific types of pharmaceutical products or treatments.
Danish: Lovgivningen giver udvalgene mulighed for at nedsætte arbejdsgrupper for videnskabelig rådgivning i forbindelse med evalueringen af specifikke typer lægemidler eller behandlinger; og tidsfristen for fremsendelse af CVMP's udtalelse om veterinærlægemidler er sat ned til 15 dage.
English: Special EU contribution for orphan medicinal products Contribution from EEA Contribution from EU programmes p.m.
Danish: Bidrag fra EU-programmer p.m.
English: Education: Qualified medical doctor from the Free University of Brussels.
Danish: Uddannelse: Uddannet som læge ved Det Frie Universitet i Bruxelles.
English: Initiatives outlined in the Agency's Road Map coupled with the implementation of the new pharmaceutical legislation will further contribute to the reinforcement of an effective and robust European regulatory system.
Danish: Opfølgning på initiativer til forbedring af gennemsigtighed og tilvejebringelse af klar og forståelig information til patienter, ansatte i sundhedssektoren og offentligheden Styrkelse af agenturets internationale samarbejde De initiativer, der er beskrevet i agenturets køreplan, vil sammen med gennemførelsen af den nye lægemiddellovgivning bidrage yderligere til styrkelsen af et effektivt og robust europæisk kontrolsystem.
English: Status of medicinal products for the treatment of hepatitis B
Danish: Guideline on the clinical investigation of medicinal products for the treatment of hepatitis B
English: In 1991 Mrs Mendosa was transferred to the London office of the European Commission Representation in the UK. She joined the EMEA in November 1994 and was nominated head of sector in November 2002.
Danish: I 1991 blev Sara Mendosa overflyttet til Europa-Kommissionens repræsentationskontor i London i Det Forenede Kongerige.
English: He was appointed acting deputy head of sector for scientific advice and orphan drugs in October 2004.
Danish: I oktober 2004 udnævnt til fungerende vicesektionsleder af sektionen for lægemidler til sjældne sygdomme og videnskabelig rådgivning
English: The EMEA coordinates the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the European Community, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
Danish: god klinisk praksis (GCP) og god laboratoriepraksis (GLP), samt af visse aspekter af tilsynet med lægemidler, der er godkendt til brug i Det Europæiske Fællesskab, gennem inspektioner bestilt af
English: Unit for the Pre-authorisation evaluation of medicines for human use
Danish: Afdelingen for Vurdering af humanmedicinske Lægemidler før Godkendelse
English: He joined the secretariat of the European Parliament in 1989, serving on the secretariats of the Committee on Research, Technological Development and Energy, of the Committee on Budgets and, latterly, of the Parliament's Bureau and Conference of Presidents.
Danish: Forskning, Teknologisk Udvikling og Energi samt Budgetudvalget og til sidst i Præsidiets og
English: medicinal products for human use
Danish: Communication for Medicinal Products for Human Use
English: Efficacy Working Party
Danish: arbejdsgruppe vedrørende kvalitet
English: To be released for consultation in 1/2Q
Danish: Sendes til høring i 1./2.
English: Associate professor for pharmacology and toxicology in the University of Würzburg.
Danish: Ekstern lektor i farmakologi og toksikologi ved universitet i Wuerzburg.
English: Concept paper to be prepared
Danish: Konceptdokument forberedes
English: HMPC meetings in 2005
Danish: Møder i HMPC i 2005
English: John Purves, Head of Sector for quality of medicines, b. 22 April 1945, n. British
Danish: John Purves, leder af sektionen for lægemiddelkvalitet, født 22. april 1945, britisk statsborger Uddannelse: Uddannet farmaceut ved Heriot-Watt-universitetet i Edinburgh.
English: CHMP Guideline for the preparation of assessment reports on periodic safety update reports
Danish: Assessment Reports on Periodic Safety
English: The EMEA was given the responsibility to implement the EU telematics strategy and projects agreed by the European Commission, Member States and the Agency, which, once implemented, will increase efficiency of the network, provide better information to users of medicinal products, and contribute to the safe and effective use of medicinal products.
Danish: Når denne strategi er implementeret, vil den gøre netværket mere effektivt, tilvejebringe bedre information til brugere af lægemidler, samt bidrage til en sikker og effektiv brug af lægemidler.
English: Unit for the Post-authorisation evaluation of medicines for human use
Danish: Afdelingen for Vurdering af Humanmedicinske lægemidler efter Godkendelse
English: To be finalised following end of consultation
Danish: Afsluttes efter høring
English: She joined the EMEA in May 1995.
Danish: indtil hun påbegyndte sit virke i EMEA i maj 1995.
English: Electronic reporting of adverse reactions in the veterinary sector will begin in January 2005 for the competent authorities, which will see a growth in development of electronic reporting by marketing authorisation holders as well
Danish: sikkerhedsindberetninger Den elektroniske indberetning af bivirkninger i veterinærsektoren vil begynde i januar 2005 for de kompetente myndigheders vedkommende, og samtidig vil vi også opleve en vækst i udviklingen af elektroniske indberetninger fra indehavere af markedsføringstilladelser Det fortsatte ansvar for organiseringen af og støtten til den fælles implementeringsgruppe vedrørende veterinærlægemidler, koordineringen af uddannelse, styringen af registreringsansøgningerne for adgang til EudraVigilance, samt dataindsamling, analyse,
English: To be released for consultation in 3Q
Danish: Sendes til høring i 3. kv.
English: He joined the EMEA in September 1995.
Danish: Han har arbejdet for EMEA siden september 1995.
English: Special EU contribution for IT Telematics strategy
Danish: Særligt EU-tilskud til IT
English: Invented Name Review Group
Danish: Arbejdsgruppen vedrørende revision af særnavne
English: Key initiatives to meet the objective:
Danish: Centrale initiativer til overholdelse af målsætningen:
English: Key initiative to meet the objective:
Danish: Centralt initiativ til overholdelse af målsætningen:
English: Applications received/forecast (Input)
Danish: Modtagne/skønnede ansøgninger (input)
English: He has held a number of appointments in research and regulatory affairs in multinational companies both in the UK and overseas.
Danish: Han har beklædt en række hverv inden for forskning og forskriftsmæssige anliggender i multinationale selskaber, senest som seniordirektør for International Regulatory Affairs for Animal Health Products for Merck Sharp and Dohme i New
English: To be released for consultation in 4Q
Danish: Sendes til høring i 4. kv.
English: In 1986 he joined the Austrian drug regulatory authority; since 2003 he has been deputy head of the drug authorisation department of the Austrian Ministry of Health and Women.
Danish: Siden 2003 viceafdelingsleder af afdelingen for godkendelse af lægemidler i sundheds- og kvindeministeriet.
English: The Agency will improve handling of referral procedures to provide faster opinions on questions related to safety of medicines 9 The Agency will remain committed to managing effectively and efficiently its increased tasks and responsibilities, ensuring that patients and users of medicines have access to safe and effective medicinal products within the timelines laid down in the legislation 9 The Agency will work for greater transparency of its operations and activities 9 EMEA will further extend its capacity to provide scientific advice and the quality of that advice 9 It will strive to increase availability of veterinary medicines intended for minor uses and minor species
Danish: Agenturet vil fortsætte sin engagerede indsats for at styre de stadig flere opgaver og ansvarsområder, det får pålagt, effektivt og sikre, at patienter og brugere af lægemidler har adgang til sikre og effektive lægemidler inden for de tidsfrister, der er fastlagt i lovgivningen
English: Riccardo Ettore, Deputy Head of Sector for information technology, b. 8 April 1953, n. Italian
Danish: Riccardo Ettore, viceleder af sektionen for informationsteknologi,
English: Hannes Wahlroos, Chairman of the Management Board, b. 7 July 1952, n. Finnish
Danish: Hannes Wahlroos, formand for bestyrelsen, født 7. juli 1952, finsk statsborger Uddannelse: Uddannet farmaceut fra universitet i Helsingfors.
English: To improve business continuity arrangements, i.e. to put in place the necessary infrastructure and processes to guarantee that the Agency's core business will not be interrupted for more than one working day
Danish: Opnåelsen af disse målsætninger vil blive overvåget gennem centrale præstationsindikatorer, som f.eks. systemernes tilgængelighed, responstider og rettidig levering, inden for budgettet og i henhold til specifikationerne, for nye og forbedrede informationssystemer At overveje nye og innovative metoder for anvendelse af tekniske løsninger på afholdelse af møder, herunder fremme af større brug af videokonferencer og webstreaming At forbedre ordninger for driftsstabilitet, dvs. oprette den nødvendige infrastruktur og processer, der skal sikre, at agenturets primære forretningsområde ikke afbrydes i mere end én arbejdsdag
English: 1/2Q 2005
Danish: D*2
English: To be released for consultation in 1Q
Danish: Sendes til høring i 1. kv.
English: The Committee on Orphan Medicinal Products
Danish: Udvalget for Lægemidler til Sjældne Sygdomme
English: Dr Pittner joined the Herbal Medicinal Products Working Party (HMPWP) in 1999 and was vice-chairman of the HMPWP from 2002 until 2004.
Danish: 2002 til 2004 næstformand for HMPWP.
English: Pharmacovigilance Working Party Biotechnology Working Party Joint CHMP/CVMP Quality Working Party Blood Products Working Party Efficacy Working Party (plenary) Safety Working Party (plenary)
Danish: Arbejdsgruppen vedrørende blodpræparater Arbejdsgruppen vedrørende virkninger (plenarmøde)
English: The Management Board will meet four times in 2005:
Danish: Der blev afholdt fire bestyrelsesmøder i 2005.
English: If revision is needed, revision expected to be released for consultation in 2005 and finalised in 2006
Danish: Revision forventes sendt til høring i 2005 og færdigudarbejdet i 2006
English: Coordination of the necessary workload for the initiation of such referrals that can be handled by the secretariat and CVMP in 2005
Danish: Samordning af den nødvendige arbejdsbyrde for iværksættelse af sådanne indbringelser, som kan håndteres af sekretariatet og CVMP i 2005 Behandling af proceduremæssige, forskriftsmæssige og videnskabelige spørgsmål som følge af den gensidige anerkendelsesprocedure, herunder en vejledning for god praksis for operationelle procedurer vedrørende sådanne indbringelser
English: Building on the experience obtained in 2004, the CHMP will strengthen its interaction with patients through a further development of the activities undertaken at the level of the EMEA/CHMP Working Group with Patients' Organisations.
Danish: 2004 udvide sit samarbejde med patienter ved at videreudvikle de aktiviteter, der gennemføres mellem
English: Certificate requests received/forecast (Input)
Danish: Modtagne/skønnede anmodninger om certifikat (input)
English: Career to date: Dr Saint Raymond held a position as paediatrician in a teaching paediatric hospital in Paris, followed by a number of years working for a number of pharmaceutical companies.
Danish: Karriereforløb: Dr. Saint Raymond var ansat som pædiater ved et pædiatrisk universitetshospital i
English: Total Title 3 TOTAL EXPENDITURE 84,179,000
Danish: Lønninger Vikarer og andre hjælpeansatte 1,845,000
English: Establishment of a dedicated forum which would include the EMEA and Member State competent authorities, as well as the Agency's stakeholders, to discuss and propose the optimal way forward in providing information to patients and healthcare professionals from the European medicines network
Danish: Videreudvikling af EuroPharm databasen med det formål at øge tilgængeligheden til information om lægemidler, der sælges i Den Europæiske Union Tilrettelæggelse af en dedikeret workshop vedrørende humanmedicinske lægemidler, hvor der skal diskuteres spørgsmål om information og kommunikation med ansatte i sundhedssektoren Oprettelse af et målrettet forum, som vil omfatte EMEA og medlemsstaternes kompetente myndigheder, samt agenturets interessenter, og som skal diskutere og foreslå den bedste måde,
English: Total Title 1
Danish: Afsnit1 i alt
English: To be finalised in 1Q 2005
Danish: Afsluttes i 1. kv.
English: She joined the EMEA in September 1997.
Danish: Ansat i EMEA siden september 1997.
English: CHMP Pharmacovigilance Working Party
Danish: CHMP-arbejdsgruppen vedrørende lægemiddelovervågning
English: Consultation ended 18 Oct 04, under revision by SWP-V for adoption in 1Q 2005
Danish: 04, under revision i SWP-V til vedtagelse i 1. kv.
English: 12-14 July
Danish: 12.-14. juli
English: To be re-released for consultation in 1Q 2005
Danish: Sendes til ny høring i 1. kv.
English: Draft version 1 to be released for consultation in 1/2Q 2005
Danish: Udkast til version 1 sendes til høring i 1./2.
English: Education: Bachelor of law from the University of Birmingham, qualified as a member of the Institute of Chartered Accountants in England and Wales.
Danish: Uddannelse: Eksamensbevis som "Bachelor of Laws" fra Birminghams universitet og medlem af
English: Revision to be finalised in 1/2Q 2005
Danish: Revision afsluttes i 1./2.
English: To be released for public consultation by Q2 2005
Danish: Sendes til offentlig høring i 2. kv.
English: Guideline on product information for
Danish: Guideline on Handling Public
English: Education: Master of science in economics and bachelor of science in public administration from Trinity College Dublin.
Danish: irsk statsborger Uddannelse: Mastergrad i økonomi (MSc) og bachelorgrad i offentlig forvaltning fra Trinity College i
English: To be released for public consultation by Q4 2005
Danish: Sendes til offentlig høring i 4. kv.
English: Draft revision 2 to be released for consultation in 1/2Q 2005
Danish: Udkast til revision 2 sendes til høring i 1./2.
English: Paediatrics Working Party
Danish: Arbejdsgruppen for Pædiatriske Lægemidler
English: Occupied as per
Danish: Han blev ansat i
English: To provide quality opinions during post-authorisation activities adhering to regulatory timelines and to communicate post-authorisation information to interested parties The performance indicator for this objective is the percentage of applications evaluated within the 30, 60 or 90-day timeline (depending on the procedure).
Danish: At udføre kvalitetsvurderinger af ansøgninger om maksimale grænseværdier og aktiviteter i forbindelse hermed og at overholde forskriftsmæssige frister Præstationsindikatoren for denne målsætning er procenten af ansøgninger, der evalueres inden for 120-dages fristen.
English: For enquiries concerning certificates for centrally E-mail: certificate@emea.eu.int authorised medicines for human or veterinary use Fax: (44-20) 74 18 85 95
Danish: E-mail: certificate@emea.eu.int human- eller veterinærmedicinske lægemidler, der er godkendt via den centraliserede procedure
English: CHMP Efficacy Working Party
Danish: CHMP-arbejdsgruppen vedrørende virkninger
English: Arbitration and Community referrals received/forecast (Input)
Danish: Modtagne/skønnede voldgifter og henvisninger af sager til Fællesskabet (input)
English: Applications for designation are expected to remain stable at the pre-2004 level with 85 applications in 2005
Danish: Tendenser: Antallet af ansøgninger om udpegelse forventes at ligge stabilt på samme niveau som før 2004
English: Tim Buxton, Head of Sector for project management, b. 27 February 1959, n. British
Danish: Tim Buxton, leder af sektionen for projektstyring,
English: 2003 final
Danish: 2003 endelig 2004 endelig 2005 fremskrevet
English: To be finalised in 2Q 2005
Danish: Afsluttes i 2. kv.
English: To implement new legislative mechanisms to optimise drug safety
Danish: At gennemføre mekanismer til optimering af sikkerheden på lægemiddelområdet i den nye lovgivning Centrale initiativer til overholdelse af målsætningerne:
English: To improve transparency and provision of designation-related information to patients and other interested parties
Danish: Målet er at have 100 % af ansøgningerne vurderet inden for denne frist At forbedre gennemsigtigheden og give patienter og andre interesserede parter mere information vedrørende udpegelse
English: Out of hours telephone: (44-7880) 55 06 97
Danish: Fax: (44-20) 74 18 85 90 Tlf. nr. uden for arbejdstiden: (44-7880) 55 06 97
English: He was re-elected as vice-chairman of the CHMP in 2004.
Danish: Han blev genvalgt som næstformand i 2004.
English: She joined the EMEA in April 1996.
Danish: Hun blev ansat i EMEA i april
English: Draft revision 1 to be released for consultation in 1/2Q 2005
Danish: Udkast til revision 1 sendes til høring i 1./2.
English: To be finalised in 4Q 2005
Danish: Afsluttes i 4. kv.
English: Establish scientific advisory groups, in particular for mandatory therapeutic fields of the centralised procedure
Danish: Etablering af grupper vedrørende videnskabelig rådgivning, navnlig til obligatoriske terapeutiske områder af den centraliserede procedure Forberedelse til indgivelse af ansøgninger vedrørende bioækvivalente og generiske lægemidler samt lægemidler til selvmedicinering
English: 21 - 22 July
Danish: - 22. juli
English: Inspections
Danish: Dokumentation
English: He has been a member of the EMEA management board since 1995.
Danish: Medlem af EMEA's bestyrelse siden 1995 og valgt som formand for bestyrelsen i maj 2004.
English: To be finalised in 3/4Q 2005
Danish: Afsluttes i 3./4.
English: These estimates relate to centrally authorised products
Danish: Authorised Products
English: Draft revision 1 to be released for consultation in 2/3Q 2005
Danish: Udkast til revision 1 sendes til høring i 2./3.
English: To implement the new legislative requirements in the area of scientific advice To provide quality scientific advice to applicants and adhere to regulatory timelines The performance indicator for this activity is the percentage of applications resulting in adoption of the advice letter within the 30, 60 or 90-day deadline (depending on the procedure).
Danish: Præstationsindikatoren for denne aktivitet er procenten af ansøgninger, der fører til vedtagelse af rådgivningsbrevet inden for 30-, 60- eller 90-dages fristen (afhængigt af proceduren).
English: Reporting and feedback on pharmacovigilance issues relating to centralised procedures to the Member States, interested parties and the public
Danish: Indberetning af og feedback om spørgsmål vedrørende lægemiddelovervågning i forbindelse med centraliserede procedurer til medlemsstaterne, interesserede parter og offentligheden Fortsat ansvar for den fælles implementeringsgruppe vedrørende veterinærlægemidler og dennes koordinering af uddannelse og ansøgninger om adgang til EudraVigilance, samt dataindsamling,
English: Impact of Process Analytical Technologies on quality aspects of assessment and inspection
Danish: Concept paper on impact of analytical methods on Commission Decision
English: Focus on health & safety in the workplace
Danish: Folkesundhed og Fødevaresikkerhed.
English: Pharmacovigilance Working Party
Danish: Pharmacovigilance Information
English: The performance indicator for this objective is the percentage of applications evaluated within the 120-day timeline.
Danish: Præstationsindikatoren for denne målsætning er procenten af ansøgninger, der evalueres inden for