FrancophonIA/ELRC3.0 huggingface dataset:
English: The procedures are not remunerated, which also impacts on national competent authorities' ability to volunteer for the work.
Danish: Der blev ikke ydet godtgørelse for disse procedurer, hvilket også påvirkede nationale kompetente myndigheders mulighed for at melde sig frivilligt til dette arbejde.
English: On the other side, care should be taken to avoid micromanagement of agencies and avoid creating a single model for all agencies that would take away flexibility when implementing tasks under their responsibility.
Danish: Omvendt burde det tilstræbes at undgå detailstyring af agenturerne og skabe en enkelt model gældende for alle agenturer, hvorved man ville fjerne fleksibiliteten i forbindelse med gennemførelsen af opgaver under deres ressort.
English: The Executive Director thanked the members of the Committee for Medicinal Products for Human Use and vaccine working party for their work in the field.
Danish: Den administrerende direktør takkede medlemmerne af Udvalget for Humanmedicinske Lægemidler og arbejdsgruppen vedrørende vacciner for deres arbejde på området.
English: Members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Danish: Medlemmerne blev anmodet om at afgive erklæring om specifikke interesser, der kunne betragtes som skadelige for deres uafhængighed i henseende til dagsordenspunkterne.
English: The Board discussed that it is important to understand that EU agencies differ in their roles, the sectors they operate in and the stakeholders they are accountable for.
Danish: Bestyrelsen diskuterede, at det var vigtigt at forstå, at EU's agenturer var forskellige med hensyn til deres roller, de sektorer, de arbejdede i, og de interessenter, som de stod til ansvar overfor.
English: In addition, the members enquired whether it would be useful to determine the level of conflicts of interest of new nominees during the nomination procedure, raising potential issues with the nominating authority.
Danish: Desuden forespurgte medlemmerne, om det ville være til nogen hjælp at fastlægge niveauet for interessekonflikter hos nye kandidater under udvælgelsesproceduren og tage potentielle problemer op med den udnævnende myndighed.
English: The Management Board was informed that the court of first instance dismissed a company's application in relation to suspension of the Agency's decision and the adoption of interim measures.
Danish: Bestyrelsen blev informeret om, at Førsteinstansretten havde afvist en virksomheds ansøgning vedrørende suspendering af agenturets beslutning og vedtagelsen af foreløbige forholdsregler.
English: The Board expressed concern about the European Commission's intention to cancel the arrangements which allowed treating positive balance of the Agency's outturn account as ‘earmarked revenue' for the Agency for subsequent years.
Danish: Bestyrelsen udtrykte bekymring over Europa-Kommissionens intention om at annullere de ordninger, der gør det muligt at behandle en positiv saldo på agenturets resultatopgørelse som “formålsbestemte indtægter” for agenturet for efterfølgende år.
English: The Executive Director announced the appointment of Edit Weidlich as head of the Agency's internal audit and Fergus Sweeney as head of the Agency's inspections sector.
Danish: Den administrerende direktør gav meddelelse om udnævnelsen af Edit Weidlich som leder af agenturets interne revision, og Fergus Sweeney som leder af agenturets inspektionssektion.
English: Update on EMEA work in relation to novel influenza
Danish: Opdatering om EMEA's arbejde i relation til ny influenza
English: The members noted the update report from the European Commission on a range of topics, including: work on novel influenza and the Council's conclusions regarding strategy for vaccine development; pharmaceutical package and good progress with pharmacovigilance and anticounterfeiting proposals, as well as Member States' concerns over the proposal for drug information provisions.
Danish: Medlemmerne tog den opdaterede rapport fra Europa-Kommissionen om en række emner til efterretning, herunder arbejdet med ny vaccine og Rådets konklusioner vedrørende strategien for udvikling af en vaccine, lægemiddelpakken og gode fremskridt med hensyn til forslagene vedrørende lægemiddelovervågning og bekæmpelse af forfalskninger samt medlemsstaternes bekymringer over forslaget til bestemmelser om lægemiddelinformation.
English: This process should be seen as a possibility to recognise EU agencies in the governance landscape of the EU.
Danish: Denne proces skulle ses som en mulighed for at tænke EU's agenturer ind i EU's ledelseslandskab.
English: London, 11 June 2009
Danish: London, den 11. juni 2009
English: The Agency works with vaccine manufacturers to identify the required data to allow for the modification of the marketing authorisation which would replace the current mock-up virus with one of the A/H1N1-derived pandemic-like strains as recommended by the WHO.
Danish: Agenturet arbejdede sammen med vaccineproducenter om at identificere de oplysninger, der er nødvendige for at tillade en ændring af markedsføringstilladelsen, som skulle erstatte den nuværende testvirus med en af de A/H1N1-afledte pandemiske stammer som anbefalet af WHO.
English: The group intends to work in three stages: draft the statements in consultation with the agencies under some 35 topics; consider the experience under those topics; make proposals for the future.
Danish: Gruppen påtænkte at arbejde i tre etaper: udforme udtalelserne i samarbejde med agenturerne inddelt i ca. 35 emner, vurdere erfaringerne på basis af disse emner og stille forslag fremadrettet.
English: *As part of the cooperation between the Management Board and the Heads of Medicines Agencies, Mr Johannes Löwer, the chair of the HMA management group, participated in the Board meeting as an observer.
Danish: *Som led i samarbejdet mellem bestyrelsen og cheferne for de nationale lægemiddelstyrelser deltog Johannes Löwer, formand for lægemiddelchefernes styringsgruppe, på bestyrelsesmødet som observatør.
English: The Management Board is involved in 4 stages of the process: the provision of the opinion on the vacancy notice, nomination of an observer to a pre-selection committee at the European Commission, nomination of a director from a shortlist proposed by the European Commission, and appointment of the director after the nominee's presentation at a committee of the European Parliament (in the case of the EMEA - the concerned committee is the Committee on Environment, Public Health and Food Safety).
Danish: Bestyrelsen var inddraget i 4 faser af processen: udarbejdelsen af en udtalelse om stillingsopslaget, udpegelse af en observatør til et bedømmelsesudvalg i Europa-Kommissionen, udpegelse af en direktør fra en shortlist foreslået af Europa-Kommissionen og udnævnelse af direktøren efter kandidatens præsentation for et udvalg i Europa-Parlamentet (for EMEA er det relevante udvalg Udvalget om Miljø, Folkesundhed og Fødevaresikkerhed).
English: The proposals aim to create visual identity for the Agency, to further promote its recognition and reputation.
Danish: Med forslagene tilsigtedes det at skabe en visuel identitet for agenturet, der skulle fremme anerkendelsen af agenturet og dets omdømme.
English: Amendments to the Fee implementing rules
Danish: Ændringer af gebyrgennemførelsesbestemmelserne
English: − Report on experience covering the period 2006-2008
Danish: Rapport om erfaringerne for perioden 2006-2008
English: The proposals, including scheduling of referrals in line with the ability of the Committee to manage them, will be submitted to the Management Board and the Heads of Medicines Agencies.
Danish: Forslagene, herunder fastlæggelse af henvisningssager i overensstemmelse med udvalgets kapacitet til at håndtere dem, ville blive fremsendt til bestyrelsen og lægemiddelstyrelsernes chefer.
English: The members invited the Agency to elaborate more on the mandate and role of the coordinating group of the proposed network, the composition of this group and expected competencies of members.
Danish: Medlemmerne opfordrede agenturet til at redegøre nærmere for det foreslåede netværks koordinerende gruppe og dens mandat og rolle, sammensætningen af denne gruppe og medlemmernes forventede kompetencer.
English: The Management Board considered that it is feasible to increase the level of allowable conflicts of interests, but this needs to be matched with increased transparency to assure the public that opinions and decisions will continue to be reached with utmost independence.
Danish: Bestyrelsen var af den opfattelse, at det kunne lade sig gøre at hæve niveauet for tilladelige interessekonflikter, men dette skulle holdes op mod princippet om større gennemsigtighed, der skulle forvisse offentligheden om, at udtalelser og beslutninger fortsat ville blive truffet med den størst mulige uafhængighed.
English: The proposed rules transpose the rules that are applied in the European Commission for secondment of their staff to organisations outside the EU.
Danish: De foreslåede regler gennemførte de regler, der anvendes i Europa-Kommissionen for udstationering af dens personale til organisationer uden for EU.
English: The Management Board stressed that it is essential to come to an agreement at the EU and intentional levels on the requirements for pandemic vaccines.
Danish: Bestyrelsen understregede, at det er vigtigt at nå til enighed på EU- og internationalt plan om kravene til pandemiske vacciner.
English: The Management Board discussed that the grade should reflect the size and complexity of an agency.
Danish: Bestyrelsen diskuterede, at løntrinnet skulle afspejle et agenturs størrelse og kompleksitet.
English: The Management Board heard an update on the Agency's work in the field of novel swine influenza (so called A/H1N1).
Danish: Bestyrelsen fik en opdatering om agenturets arbejde i forbindelse med ny svineinfluenza (den såkaldte A/H1N1).
English: The Management Board noted the update report on progress of the preparations for exchange of staff between the EMEA and the US FDA.
Danish: Bestyrelsen tog den ajourførte rapport om status for forberedelserne til udveksling af personale mellem EMEA og det amerikanske FDA til efterretning.
English: The rules follow those of the European Commission with derogation regarding the calculation of the duration of the mission for departure and arrival times from London stations and airports.
Danish: Reglerne fulgte EuropaKommissionens regler med afvigelser for så vidt angår beregningen af tjenesterejsens varighed ved afgangs- og ankomsttider fra stationer og lufthavne i London.
English: The assignment of the EMEA counterpart is in progress.
Danish: Ansættelsen af EMEA's modpart var undervejs.
English: The decision is at the discretion of the European Commission.
Danish: Det var op til Europa-Kommissionen at træffe beslutning.
English: The notice will be sent to all Board members for comments.
Danish: Annoncen ville blive sendt til alle bestyrelsens medlemmer til kommentering.
English: In preparation for the bird flu pandemic, the Agency has developed a novel approach using a mock-up virus for assessment of pandemic vaccines.
Danish: Agenturet havde som forberedelse til fugleinfluenzapandemien udviklet en ny strategi med brug af en testvirus til vurdering af pandemiske vacciner.
English: The members suggested sending the public vacancy notice through the Heads of Medicines Agencies to the national authorities for publishing on national websites.
Danish: Medlemmerne foreslog at sende stillingsopslaget via lægemiddelstyrelsescheferne til de nationale myndigheder til offentliggørelse på nationale websteder.
English: Developing the European Medical Information network
Danish: Udvikling af det europæiske netværk for lægemiddelinformation
English: The Chair invited the members to submit their expression of interests to participate as observers in the preselection committee.
Danish: Formanden opfordrede medlemmerne til at fremsende deres interessetilkendegivelser med hensyn til at deltage som observatører i bedømmelsesudvalget.
English: Draft agenda for 11 June 2009 meeting [EMEA/MB/45799/2009] The agenda was adopted.
Danish: Forslag til dagsorden for mødet den 11. juni 2009 [EMEA/MB/45799/2009] Dagsordenen blev vedtaget.
English: The proposal will then be submitted to the Heads of Medicines Agencies for discussion.
Danish: Forslaget ville dernæst blive forelagt for lægemiddelstyrelsernes chefer til drøftelse.
English: Recommendations from the Management Board group on the consultation of nominations to the committees
Danish: Henstillinger fra bestyrelsens gruppe vedrørende høring om udnævnelser til udvalgene
English: EMEA policy and procedure on the handling of conflicts of interests of EMEA scientific committees' members and experts
Danish: EMEA's politik og procedure for håndtering af interessekonflikter hos de videnskabelige udvalgs medlemmer og eksperter i EMEA
English: Draft EMEA transparency policy
Danish: Udkast til gennemsigtighedspolitik for EMEA
English: The Executive Director undertook to update the Management Board on the progress of the inter-institutional discussions.
Danish: Den administrerende direktør påtog sig at opdatere bestyrelsen om, hvordan diskussionerne mellem institutionerne skred frem.
English: Necessary mitigating actions need to be implemented and their conflicts of interests should be made public.
Danish: Der skulle gennemføres forebyggelsestiltag, og eksperternes interessekonflikter skulle lægges frem offentligt.
English: Also, further reflection is needed as to the type of support, information and overall added benefit such a network will provide.
Danish: Desuden skulle der gøres flere overvejelser om den type støtte, information og generel merværdi, et sådant netværk ville bidrage med. Forslaget ville blive behandlet mere indgående på mødet til oktober.
English: The European Commission guidelines state that directors of EU agencies are appointed at the AD14 grade.
Danish: I henhold til Europa-Kommissionens retningslinjer blev direktører for EU's agenturer udnævnt på løntrin AD14.
English: Rules on attachment of staff
Danish: Regler for udstationering af personale
English: Report from the Heads of Medicines Agencies The members noted the written report.
Danish: Rapport fra cheferne for de nationale lægemiddelstyrelser Medlemmerne tog den skriftlige rapport til efterretning
English: European Medicines Network, as having different practices would have a negative impact on the network, and robust policies need to be implemented alongside the transparency policy.
Danish: Det er derfor vigtigt at finde måder, hvorpå der kunne sikres en konsekvent tilgang i hele det europæiske lægemiddelnetværk, idet forskellige praksisser kunne have negative konsekvenser for netværket, ligesom der skulle gennemføres omfattende politikker sideløbende med gennemsigtighedspolitikken.
English: The Board will approach the European Commission with a request to review the recruitment grade for the EMEA's director.
Danish: Bestyrelsen ville kontakte Europa-Kommissionen med en anmodning om at revidere indplaceringen for EMEA's direktør.
English: [EMEA/11007/2009; EMEA/18113/2009] Annual audit-related reports: Audit advisory committee; EMEA internal auditor; Internal Audit Service of the Commission.
Danish: [EMEA/11007/2009; EMEA/18113/2009] Årlige revisionsrelaterede beretninger: Det rådgivende revisionsudvalg; EMEA's interne revisor; Kommissionens interne revisionstjeneste.
English: The Management Board discussed the guidelines for appointment of executive directors of EU agencies.
Danish: Bestyrelsen diskuterede retningslinjerne for udnævnelse af administrerende direktører for EU's agenturer.
English: A consequence analysis, including resource needs, will follow this proposal.
Danish: Dette forslag ville blive fulgt op af en konsekvensanalyse, herunder en analyse af ressourcebehov.
English: The group will continue its work presenting the proposals at a Heads of Medicines Agencies meeting.
Danish: Gruppen ville fortsætte sit arbejde og ville fremlægge forslagene på et møde for cheferne for de nationale lægemiddelstyrelser.
English: [EMEA/MB/284297/2009/Rev.1] The Management Board discussed the first proposal on simplification of contractual arrangements in December 2006.
Danish: [EMEA/MB/284297/2009/Rev.1] Bestyrelsen diskuterede det første forslag om en forenkling af kontrakter i december 2006.
English: Changes to the Mission rules [EMEA/MB/694348/2008] The Management Board adopted the rules on missions.
Danish: Ændringer af reglerne om tjenesterejser [EMEA/MB/694348/2008] Bestyrelsen vedtog reglerne om tjenesterejser.
English: New appointments
Danish: Nyudnævnelser
English: [EMEA/MB/279887/2009] Following the consultation process, the Management Board considered and endorsed the proposals for the new corporate identity of the EMEA, including the new logo and acronym of the Agency.
Danish: [EMEA/MB/279887/2009] I kølvandet af høringsprocessen overvejede og godkendte bestyrelsen forslagene til en ny virksomhedsidentitet for EMEA, herunder det nye logo og agenturets akronym.
English: A proposal taking into account the Board's views will be submitted in December 2009.
Danish: Der ville blive fremsat et forslag i december 2009, der ville afspejle bestyrelsens synspunkter.
English: Chair: Pat O'Mahony
Danish: Formand: Pat O'Mahony Medlemmer
English: [EMEA/MB/170391/2009/Rev.2] The Management Board adopted the revisions to Articles 3(2) and 4 of the Fee implementing rules.
Danish: [EMEA/MB/170391/2009/Rev.2] Bestyrelsen vedtog revisionerne af artikel 3, stk. 2, og artikel 4, i gebyrgennemførelsesbestemmelserne.
English: The Board was briefed about the ongoing inter-institutional debate on the creation and role of EU agencies.
Danish: Bestyrelsen blev briefet om den igangværende debat mellem institutionerne om oprettelsen af EUagenturer og deres rolle.
English: − Review of EMEA policy on Handling of Conflicts of Interests of EMEA Scientific
Danish: Gennemgang af EMEA's politik for håndtering af interessekonflikter hos EMEA's videnskabelige udvalg
English: [EMEA/MB/90876/2009] Summary of transfers of appropriations in the budget 2009.
Danish: [EMEA/MB/90876/2009] Sammendrag af bevillingsoverførsler på budgettet for 2009.
English: − Preparation for written procedure on amending budget 1/2009
Danish: Anmodning om udtalelse om agenturets årsregnskab pr. 31. december 2008 Forberedelse til skriftlig procedure om ændringsbudget 1/2009
English: [EMEA/MB/301036/2009] The members heard EMEA concerns that due to high number of referrals, the ability of the Committee for Medicinal Products for Veterinary Use (CVMP) to handle these procedures is reaching capacity.
Danish: [EMEA/MB/301036/2009] Medlemmerne blev gjort bekendt med EMEA's bekymring over, at Udvalget for Veterinærlægemidler (CVMP) var ved at nå sin kapacitetsgrænse får så vidt angik håndteringen af disse procedurer på grund af et stort antal indbringelser.
English: [EMEA/MB/300234/2009] The topic coordinators presented three proposals to improve the consultation procedure: the revision of the CV template to obtain more information on scientific qualifications of nominees; a pre-selection panel listing its advantages and disadvantages; and amendments to the request for nomination letter.
Danish: [EMEA/MB/300234/2009] Emnekoordinatorerne fremlagde tre forslag til forbedring af høringsproceduren: en revision af CV-skabelonen for at indhente flere oplysninger om kandidaternes videnskabelige kvalifikationer, et bedømmelsesudvalg med angivelse af fordele og ulemper ved et sådant udvalg og ændringer i anmodningen om udvælgelsesbrev.
English: The Board thanked the topic coordinators (Mindaugas Būta, Jytte Lyngvig Marcus Müllner, Pat O'Mahony and Kristin Raudsepp) for detailed review of the report and the proposed analysis and assessment.
Danish: Bestyrelsen takkede emnekoordinatorerne (Mindaugas Būta, Jytte Lyngvig, Marcus Müllner, Pat O'Mahony og Kristin Raudsepp) for deres detaljerede gennemgang af beretningen og den foreslåede analyse og vurdering.
English: Specifically, the scientific committee reviewed scientific information and recommended extending the shelf life of Tamiflu from 5 to 7 years; it also provided an opinion on the use of antiviral medicine Tamiflu in children under one year and in pregnant and breastfeeding women.
Danish: Mere specifikt gennemgik det videnskabelige udvalg de videnskabelige oplysninger og anbefalede en forlængelse af Tamiflus holdbarhed fra 5 til 7 år.
English: [EMEA/MB/306935/2009] The Management Board discussed the proposal to establish a European medical information network.
Danish: [EMEA/MB/306935/2009] Bestyrelsen diskuterede forslaget om oprettelse af et europæisk netværk for lægemiddelinformation.
English: EMEA corporate-identity project
Danish: EMEA's projekt om agenturets identitet
English: Participants at the sixty-third meeting of the Management Board London, 11 June 2009
Danish: møde i bestyrelsen London, den 11. juni 2009
English: − European Commission communication
Danish: Europa-Kommissionens meddelelse
English: Minutes from the 62nd meeting, held on 4-5 March 2009 [EMEA/MB/45799/2009] The Management Board noted the adoption of the minutes by written procedure.
Danish: møde den 4.-5. marts 2009 [EMEA/MB/45799/2009] Bestyrelsen tog godkendelsen af referatet ved skriftlig procedure til efterretning.
English: [EMEA/MB/246063/2009; EMEA/MB/251948/2009] The members noted the information on upcoming written procedures.
Danish: [EMEA/MB/246063/2009; EMEA/MB/251948/2009] Medlemmerne tog oplysningerne om kommende skriftlige procedurer til efterretning.
English: European Commission communication on EU agencies
Danish: Europa-Kommissionens meddelelse om EU's agenturer
English: The Board considered that the recruitment grade for a future director of the Agency should be increased.
Danish: Bestyrelsen var af den opfattelse, at en kommende direktør for agenturet skulle indplaceres på et højere løntrin.
English: [EMEA/MB/174828/2009] Revision timing for Implementing Rules to EMEA Financial Regulation.
Danish: [EMEA/MB/174828/2009] Fastlæggelse af tidsfrist for gennemførelsesbestemmelser for EMEA's finansforordning.
English: [EMEA/MB/295158/2009] The Board discussed the EMEA rules on attachment of staff.
Danish: [EMEA/MB/295158/2009] Bestyrelsen diskuterede EMEA's regler for udstationering af personale.
English: [EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] The Board heard a presentation on the experience with the policy on the handling of conflicts of interests at the EMEA committees and working parties.
Danish: [EMEA/MB/138548/2009; EMEA/MB/305863/2009; EMEA/MB/356427/2009] Bestyrelsen fik præsenteret erfaringerne med politikken for håndtering af interessekonflikter hos EMEA's udvalg og arbejdsgrupper.
English: EMEA/MB/366757/2009/EN/Rev.1*
Danish: EMEA/718002/2009/DA/Rev.1
English: Governance of EU agencies
Danish: Ledelse af EU-agenturer
English: The topic coordinators (Jean Marimbert and Marcus Müllner) were thanked for their contributions.
Danish: Emnekoordinatorerne (Jean Marimbert og Marcus Müllner) modtog tak for deres bidrag.
English: [EMEA/MB/186559/2009; EMEA/MB/319028/2009] The Management Board adopted the analysis and assessment of the Executive Director's annual activity report 2008.
Danish: [EMEA/MB/186559/2009; EMEA/MB/319028/2009] Bestyrelsen godkendte analysen og vurderingen af den administrerende direktørs årsberetning for 2008.
English: European Commission guidelines on appointment of directors of the EU agencies
Danish: Europa-Kommissionens retningslinjer for udnævnelse af direktører i EU's agenturer
English: [EMEA/MB/321843/2009] Outcome of written procedures on: Consultation on changes in the membership of the CHMP and CVMP committees; Fee implementing rules; Annual Report 2008; Fee implementing rules relating to MUMs; Fee implementing rules relating to Pandemic situations.
Danish: [EMEA/MB/321843/2009] Resultat af skriftlige procedurer om: Høring om ændringer i medlemskabet af CHMP- og CVMP-udvalgene; gebyrgennemførelsesbestemmelser; årsberetning for gebyrgennemførelsesbestemmelser vedrørende