FrancophonIA/ELRC3.0 huggingface dataset:
English: The Board provided final comments about the Agency's role in the area of clinical trials and in responding to European health threats.
Danish: Bestyrelsen kom med endelige bemærkninger om agenturets rolle med hensyn til kliniske undersøgelser og med hensyn til at reagere på sundhedstrusler i Europa.
English: The Agency is reviewing working parties in order to further streamline their activities and participation.
Danish: Agenturet ser nærmere på samarbejdspartnere for bedre at strømline deres aktiviteter og deltagelse.
English: The Agency hosted visits of many interested parties, including the French Senate, The French National Assembly and the IGAS inspectorate, and responded to enquires of committees conducting investigations into the circumstances surrounding the product, as well as to enquiries from the media.
Danish: Agenturet modtog besøg fra mange interesserede parter, herunder fra det franske senat, den franske nationalforsamling, og IGAS-inspektoratet, og besvarede spørgsmål på henvendelser fra udvalg, der gennemfører undersøgelser af forholdene omkring produktet, samt på henvendelser fra medierne.
English: First update on the implementation of conflicts of interests policy for experts and staff
Danish: Første ajourføring af gennemførelsen af en politik om interessekonflikter for eksperter og medarbejdere
English: This is the last meeting of the Board for Andreas Pott in his capacity as the Acting Executive Director of the Agency.
Danish: Dette er det sidste møde i bestyrelsen for Andreas Pott i dennes egenskab af fungerende administrerende direktør.
English: The parties involved recognise that the area of conflicts of interests is complex, and requires managing a variety of scenarios as well as public perception of ‘factual' and ‘perceived' conflicts of interests.
Danish: De involverede parter anerkender, at området for interessekonflikter er komplekst og kræver, at der forholdes til mange forskellige scenarier, samt at der i offentligheden er en bevidsthed om, hvad der udgør "faktiske" og "opfattede" interessekonflikter.
English: The revised criteria, among other changes, broaden the involvement of the organisations and revise the transparency criterion regarding the provision of information about funding sources.
Danish: Med de reviderede kriterier udvides bl.a. organisationernes inddragelse, og gennemsigtighedskriteriet vedrørende offentliggørelse af oplysninger om finansieringskilder gennemgås igen.
English: Highlights from the Acting Executive Director
Danish: Højdepunkter fra den fungerende administrerende direktør
English: • Falsified medicines directive (the date of implementation is January 2013; the three areas of activity for implementing measures are the implementation of the safety feature, control of import of active pharmaceutical ingredients and preparing a logo for online pharmacies).
Danish: • Direktivet om forfalskede lægemidler (tidspunktet for gennemførelsen er januar 2013; de tre aktivitetsområder for gennemførelsesforanstaltninger er gennemførelsen af sikkerhedsfunktionen, kontrol af importen af aktive ingredienser i lægemidler og udarbejdelse af et logo for netapoteker).
English: • Establishment and functioning of health technology assessment bodies and arrangements to grant financial support to HTA activities.
Danish: • Oprettelse og drift af organer for vurdering af sundhedsteknologi (HTA) og ordninger for ydelse af finansiel støtte til HTA-aktiviteter.
English: • The Commission is preparing an impact assessment for the revision of the legislation on clinical trials (the aim is to prepare a proposal in the third quarter of 2012).
Danish: • Kommissionen er ved at udarbejde en konsekvensanalyse af revisionen af lovgivningen om kliniske forsøg (formålet er at udarbejde et forslag i tredje kvartal 2012).
English: • HMA paper published in the context of the review of the veterinary legislation.
Danish: • HMA-dokument offentliggjort i forbindelse med gennemgangen af veterinærlovgivningen.
English: The objectives of the meeting were to address strategic issues requiring HMA orientation, with particular focus on challenging aspects impacting on the NCAs; and to raise awareness on specific areas.
Danish: Formålene med mødet var at tage fat om strategiske spørgsmål, der kræver en HMA-vinkling, med særligt fokus på udfordrende aspekter, der berører de nationale kompetente myndigheder; og at skabe større opmærksomhed om specifikke områder.
English: The Agency is implementing the so-called OpEx programme that aims, amongt other objectives, to further increase efficiency of processes through their redesign.
Danish: Agenturet gennemfører det såkaldte OpEx-program, der som et af sine mål gennem omstrukturering sigter mod at øge effektiviteten af processer.
English: [EMA/MB/650168/2011] The agenda was adopted.
Danish: [EMA/MB/650168/2011] Dagsordenen blev vedtaget.
English: The group will aim to propose a draft for discussion at the December 2011 meeting.
Danish: Gruppen sigter mod at kunne fremlægge et diskussionsudkast på mødet i december 2011.
English: In cases where discussions are controversial, meeting minutes shall provide further details of the discussion and shall record dissenting opinions.
Danish: I de tilfælde, hvor diskussionerne er kontroversielle, skal mødereferatet indeholde yderligere oplysninger om diskussionen og skal referere afvigende opfattelser.
English: The Board was reminded that the group on procurement is reviewing the Agency's procedures and will make recommendations to reinforce procurement practices at the Agency.
Danish: Bestyrelsen blev mindet om, at gruppen for indkøb er ved at gennemgå agenturets procedurer og vil fremsætte henstillinger til styrkelse af indkøbspraksis i agenturet.
English: • Written procedure for adoption of the draft minutes of the 72
Danish: • Skriftlig procedure for vedtagelse af udkastet til referat af bestyrelsens 72.
English: • The review of the legislation on veterinary medicinal products (the proposal will be made as a package with the legislation on medicated feed; the timeline for the proposal is to be set).
Danish: • Gennemgangen af lovgivningen om lægemidler til dyr (forslaget vil blive fremsat som en pakke sammen med lovgivningen om foderlægemidler; der skal fastsættes en tidsfrist for forslaget).
English: • Wednesday, 21 March & Thursday, 22 March;
Danish: • onsdag, den 21. marts, og torsdag, den 22. marts
English: Processes that are subject to this approach are Type I variations, validation, management of requests to access documents and information.
Danish: Processer, der er omfattet af denne tilgang, er Type Ivariationer, godkendelse, håndtering af anmodninger om aktindsigt i dokumenter samt information.
English: The European Commission provided an update on a number of items, including the following.
Danish: Europa-Kommissionen gjorde status over en række punkter, bl.a.:
English: 7bis EU telematics projects report
Danish: 7a Rapport om EU's telematikprojekt
English: With regard to the request to open the group to a larger number of representatives from Member States, the European Commission confirmed that the steering group should remain small, representing the three settings EMA, ECDC and NCAs for tissues and cells, considering also that this group is doing the preparatory work.
Danish: Med hensyn til en henvendelse om at åbne gruppen op for et større antal repræsentanter fra medlemsstater bekræftede Europa-Kommissionen, at antallet af medlemmer af styregruppen burde begrænses, og at udvalget bør repræsentere de tre områder EMA, ECDC og nationale kompetente myndigheder med ansvar for væv og celler, også set i lyset af, at denne gruppe udfører det forberedende arbejde.
English: Review of meeting practices
Danish: Gennemgang af mødepraksis
English: The Management Board noted the oral report by the Chair on the progress made following the last meeting.
Danish: Bestyrelsen tog formandens mundtlige statusrapport efter det sidste møde til efterretning.
English: The Board was informed that the European Court of Auditors is conducting an audit on systems and policies for managing conflicts of interest in several EU agencies.
Danish: Bestyrelsen blev informeret om, at Revisionsretten er i gang med at gennemføre en revision af systemer og politikker for håndtering af interessekonflikter i flere EU-agenturer.
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Apologies from Norway
Danish: Rannveig Gunnarsdóttir (Island) Brigitte Batliner (Liechtenstein) Afbud fra Norge
English: Two representatives of the Board, Walter Schwerdtfeger and Lisette Tiddens, were appointed to the steering group set up by the European Commission to provide support to the implementation of arrangements in the area of traceability of tissues and cells.
Danish: To repræsentanter for bestyrelsen, Walter Schwerdtfeger og Lisette Tiddens, blev udpeget til den at Europa-Kommissionen nedsatte styregruppe, der skal yde støtte til gennemførelsen af ordninger for sporbarhed af væv og celler.
English: Implementation of the pharmacovigilance legislation
Danish: Gennemførelse af lovgivningen om lægemiddelovervågning
English: Membership of the Management Board Telematics Committee
Danish: Medlemskab af bestyrelsens telematikudvalg
English: Management Board decision-making process
Danish: Bestyrelsens beslutningsproces
English: The group aims to provide its recommendations for the December Management Board meeting.
Danish: Gruppen bestræber sig på at have sine henstillinger klar til bestyrelsens møde i december.
English: The Board thanked the topic coordinators (Christina Åkerman, Aginus Kalis, Jytte Lyngvig, Marcus Müllner, Giuseppe Nisticó and Lisette Tiddens) for their role in preparing this document.
Danish: Bestyrelsen takkede emnekoordinatorerne (Christina Åkerman, Aginus Kalis, Jytte Lyngvig, Marcus Müllner, Giuseppe Nisticó og Lisette Tiddens) for deres indsats i udarbejdelsen af dette dokument.
English: The Chair informed the Board that he had reviewed declarations of interests of Board members and alternates and will send a number of letters to clarify certain issues.
Danish: Formanden informerede bestyrelsen om, at han havde modtaget erklæringer om interesseforhold fra bestyrelsesmedlemmer og suppleanter, og at han vil fremsende en række breve for at få præciseret visse problemstillinger.
English: The Management Board topic coordinators Xavier De Cuyper (Belgium), Walter Schwerdtfeger (Germany) and Lisette Tiddens (Vice-chair) are revising the conflicts of interests policy applicable to the Board.
Danish: Bestyrelsens emnekoordinatorer Xavier De Cuyper (Belgien), Walter Schwerdtfeger (Tyskland) og Lisette Tiddens (næstformand) er i færd med at revidere politikken for interessekonflikter, der finder anvendelse på bestyrelsen.
English: Members of the group are: Björn Lemmer, Jytte Lyngvig, Guido De Clercq and Vincenzo Salvatore.
Danish: Medlemmer af gruppen er: Björn Lemmer, Jytte Lyngvig, Guido De Clercq og Vincenzo Salvatore.
English: • HMA work in the area of support to innovation (health technology assessment, discussions on medical devices and the impact of the recast of the related legislation).
Danish: • HMA-arbejde omkring støtte til innovation (vurdering af sundhedsteknologi, diskussioner om medicinsk udstyr og virkningerne af revisionen af den tilsvarende lovgivning).
English: Historically, a complex governance structure, loss of knowledge during the implementation phase, loss of continuity between projects and inadequate representation of business users were among the negative factors that partly affected delivery of projects.
Danish: Medlemmerne diskuterede det forhold, at styringen af EU's telematikprogram skal strammes yderligere op. Historisk var en kompleks styringsstruktur, manglende viden under gennemførelsesfasen, manglende kontinuitet blandt projekter og utilstrækkelig repræsentation af kommercielle brugere, nogle af de faktorer, der i et vist omfang påvirkede leveringen af projekter negativt.
English: The Management Board noted the presentation on the implementation of the policies on conflicts of interests for experts and for staff.
Danish: Bestyrelsen tog præsentationen af gennemførelsen af politikkerne om interessekonflikter for eksperter og for medarbejdere til efterretning.
English: More specifically, in five Member States responsibility for SoHO is given to NCAs responsible for medicinal products, in a further ten some of the responsibility in the field is given to NCAs responsible for medicinal products, while in twelve Member States responsibility for SoHO is given to NCAs that are not responsible for medicinal products.
Danish: der er ansvarlige for lægemidler, i yderligere ti medlemsstater lægges en del af ansvaret på nationale kompetente myndigheder, mens ansvaret for SoHO i 12 medlemsstater overdrages til nationale kompetente myndigheder, der ikke er ansvarlige for lægemidler.
English: • Thursday, 13 December.
Danish: • torsdag, den 13. december.
English: • Amendments of the fee regulation to include fees foreseen in the pharmacovigilance legislation (a European Commission proposal is expected later in 2012.
Danish: • Ændringer i gebyrforordningen, så den kommer til at omfatte gebyrer, der er fastlagt i lovgivningen om lægemiddelovervågning (der forventes et forslag fra Europa-Kommissionen senere i 2012).
English: The Management Board noted the presentation summarising the discussions on the implementation of the pharmacovigilance legislation which were held during the meeting of the Heads of Medicines Agencies on 5 October 2011.
Danish: Bestyrelsen tog redegørelsen om diskussionerne om gennemførelsen af lægemiddelovervågningslovgivningen, der fandt sted på mødet af chefer for de nationale lægemiddelstyrelser (HMA) den 5. oktober 2011.
English: [EMA/MB/729369/2011] The Management Board reinstated Gerard O'Malley as the Agency's accounting officer, effective 6 October 2011, following his return from long-term absence.
Danish: [EMA/MB/729369/2011] Bestyrelsen genindsatte Gerard O'Malley som agenturets regnskabsfører med virkning fra den 6. oktober 2011, efter hans tilbagevenden efter lang tids fravær.
English: [EMA/MB/751210/2011] The Management Board appointed Sir Kent Woods as a member of the Management Board Telematics Committee following the departure of Pat O'Mahony from the committee earlier this year.
Danish: [EMA/MB/751210/2011] Bestyrelsen udpegede Sir Kent Woods som medlem af bestyrelsens telematikudvalg efter Pat O'Mahonys udtræden af udvalget tidligere på året.
English: • [EMA/MB/730141/2011] Summary of transfers of appropriations in the budget 2011.
Danish: • [EMA/MB/730141/2011] Sammendrag af bevillingsoverførsler på budgettet for 2011.
English: [EMA/MB/746083/2011] The Management Board discussed whether to review the decision-making process in cases where there is evidence of a lack of consensus.
Danish: [EMA/MB/746083/2011] Bestyrelsen diskuterede, om beslutningsprocessen skulle revurderes i de tilfælde, hvor der skønnes at være manglende konsensus.
English: 3bis Appointment of Guido Rasi as Executive Director
Danish: 3a Udnævnelse af Guido Rasi til administrerende direktør
English: • [EMA/MB/714970/2011] Outcome of written procedures during the period from 17 May 2011 to 14
Danish: • [EMA/MB/714970/2011] Resultat af skriftlige procedurer i perioden 17. maj 2011 til 14. september
English: Following the appointment, Guido Rasi joined the meeting of the Management Board.
Danish: Efter sin udnævnelse deltog Guido Rasi på bestyrelsens møde.
English: The Board appointed Guido Rasi as Executive Director of the Agency.
Danish: Bestyrelsen udnævnte Guido Rasi til administrerende direktør for agenturet.
English: Personnel matter
Danish: 10. Personaleanliggender
English: [EMA/MB/550544/2011] The Management Board endorsed the implementation plan for the 'Road map to 2015'.
Danish: [EMA/MB/550544/2011] Bestyrelsen godkendte gennemførelsesplanen for "Køreplanen frem til 2015".
English: [EMA/MB/742275/2011; EMA/MB/751326/2011; EMA/MB/742295/2011; EMA/MB/752482/2011] The Management Board adopted the following implementing rules:
Danish: [EMA/MB/742275/2011; EMA/MB/751326/2011; EMA/MB/742295/2011; EMA/MB/752482/2011] Bestyrelsen vedtog følgende gennemførelsesbestemmelser:
English: [EMA/MB/376489/2011] The Management Board adopted the following meeting dates in 2012:
Danish: [EME/MB/376489/2011] Bestyrelsen vedtog følgende mødedatoer i 2012:
English: • [EMA/MB/793451/2011] EU telematics Operations Report.
Danish: • [EMA/MB/793451/2011] Rapport om EU's telematikaktiviteter.
English: [EMA/MB/744342/2011; EMA/MB/24913/2005/rev.1] The Management Board adopted the revised criteria that have to be fulfilled by patients' and consumers' organisations involved in EMA activities.
Danish: [EMA/MB/744342/2011; EMA/MB/24913/2005/rev.1] Bestyrelsen vedtog de reviderede kriterier, der skal være opfyldt af patient- og forbrugerorganisationer, der er involveret i EMA-aktiviteter.
English: The Management Board noted the update on a number of items, including the following.
Danish: Bestyrelsen gjorde status over en række punkter, bl.a.:
English: • No 09/2011 - the appointment of Michel Tougouz Nevessignsky as CHMP alternate, proposed by Belgium, finalised on 9 September 2011.
Danish: • Nr. 09/2011 - udnævnelse af Michel Tougouz Nevessignsky til CHMP-suppleant, indstillet af Belgien, afsluttet den 9. september 2011.
English: • No 08/2011 - the appointment of Janne Komi as CHMP member, proposed by Finland, finalised on 14 July 2011.
Danish: • Nr. 08/2011 - udnævnelse af Janne Komi til CHMP-suppleant, indstillet af Finland, afsluttet den 14. juli 2011.
English: • No 07/2011 - the appointment of Helder Mota-Filipe as CHMP alternate, proposed by Portugal, finalised on 5 July 2011.
Danish: • Nr. 07/2011 - udnævnelse af Helder Mota-Filipe til CHMP-suppleant, indstillet af Portugal, afsluttet den 5. juli 2011.
English: rd meeting of the Management Board, held in London on 6 October 2011
Danish: møde i bestyrelsen, afholdt i London den 6. oktober 2011
English: [EMA/MB/465305/2011] The Management Board noted the final minutes, adopted by written procedure on 11 August 2011.
Danish: [EMA/MB/465305/2011] Bestyrelsen tog det endelige referat, vedtaget ved skriftlig procedure den 11. august 2011, til efterretning.
English: Management Board meeting dates
Danish: Mødedatoer for bestyrelsen
English: [EMA/MB/744981/2011; EMA/632696/2011] The Management Board noted the report on the interactions with patients' and consumers' organisations within the framework agreed in 2005.
Danish: [EMA/MB/744981/2011; EMA/632696/2011] Bestyrelsen tog rapporten om interaktionerne med patient- og forbrugerorganisationer inden for de fastlagte rammer i 2005 ad notam.
English: • Thursday, 7 June;
Danish: • torsdag den 7. juni
English: [EMA/MB/744682/2011] The Management Board noted the regular update report on the status of implementation of the European database for the collection of adverse events related to veterinary medicines.
Danish: [EMA/MB/744682/2011] Bestyrelsen noterede sig den løbende statusrapport om gennemførelsen af den europæiske database for indsamling af bivirkninger og forbindelse med lægemidler til dyr.
English: [EMA/MB/743894/2011; EMA680110/2011] The Management Board noted the report on the implementation of the MUMS policy.
Danish: [EMA/MB/743894/2011; EMA680110/2011] Bestyrelsen tog beretningen om gennemførelsen af MUMSpolitikken til efterretning.
English: • HMA initiatives in the area of clinical trials in the context of the review of clinical trials legislation
Danish: • HMA-initiativer vedrørende kliniske forsøg inden for rammerne af gennemgangen af lovgivningen om kliniske forsøg (frivillig harmoniseringsprocedure).
English: [EMA/MB/793453/2011] The Management Board noted the report on the implementation of telematics projects.
Danish: [EMA/MB/793453/2011] Bestyrelsen tog rapporten om gennemførelse af telematikprojekterne til efterretning.
English: • Thursday, 4 October;
Danish: • torsdag den 4. oktober
English: EMA/MB/828587/2011 Adopted Management Board
Danish: EMA/511017/2012 Vedtaget Bestyrelsen
English: [EMA/MB/653974/2011] The Management Board noted the mid-year report 2011.
Danish: [EMA/MB/653974/2011] Bestyrelsen tog halvårsberetningen for 2011 til efterretning.
English: Representative of doctors' organisations
Danish: Repræsentant for lægeorganisationer
English: EudraVigilance status report for veterinary medicinal products
Danish: Statusrapport om lægemiddelovervågning af lægemidler til dyr
English: • [EMA/MB/711444/2011; EMA/MB/711456/2011; EMA/MB/711459/2011] Minutes from the
Danish: • [EMA/MB/711444/2011; EMA/MB/711456/2011; EMA/MB/711459/2011] Referat af møderne i bestyrelsens telematikudvalg (MBTC) fra marts, maj og juni.
English: Minutes from the 72nd meeting, held on 8-9 June 2011
Danish: møde den 8.-9. juni 2011
English: Representative of veterinarians' organisations
Danish: Repræsentant for vetrinærorganisationer
English: Not known Not known Not known Not known Not known
Danish: Ikke kendt Ikke kendt Ikke kendt Ikke kendt
English: Never take two doses on the same day.
Danish: Tag aldrig to doser på samme dag.
English: Date of first authorisation: 01 October 2009 Date of latest renewal: 18 July 2014
Danish: Dato for første markedsføringstilladelse: 1. oktober 2009 Dato for seneste fornyelse: 18. juli 2014
English: Significance not tested.
Danish: ¶ Signifikans ikke undersøgt.
English: • if you are taking insulin.
Danish: • hvis du tager insulin.
English: These changes were not considered to be clinically meaningful.
Danish: Disse ændringer blev ikke anset for at være klinisk betydningsfulde.
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Danish: Det vides ikke, om denne medicin er sikker og effektiv hos børn og teenagere under 18 år.
English: n=Randomised patients (primary efficacy-intention-to-treat analysis) with data available.
Danish: n=Randomiserede patienter (primær efficacy-intention-to-treat analyse) med tilgængelige data.
English: -0.6 (evening)
Danish: -0,6 (aften)
English: In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Danish: Du skal især fortælle det til lægen, hvis du bruger medicin, som indeholder et af de følgende aktive stoffer:
English: The tablet can be taken at any time of the day, however, try to take your tablet at the same time each day.
Danish: Tabletten kan indtages når som helst på dagen, men forsøg at tage tabletten på samme tidspunkt hver dag.
English: The intent-to-treat analysis showed consistent results.
Danish: Intent-to-treat-analysen viste tilsvarende resultater.
English: Only in the initial combination therapy.
Danish: Kun ved initial kombinationsbehandling.
English: This is an antibiotic used to treat infections such as tuberculosis.
Danish: Dette er et antibiotikum til behandling af infektioner som tuberkulose.
English: You can take the tablet with or without food.
Danish: Du kan tage tabletten med eller uden mad.
English: This is to help keep your blood sugar under control.
Danish: Det hjælper dig med at holde dit blodsukker under kontrol.
English: This may be used to treat inflammation in different body parts and organs.
Danish: Dette kan anvendes til at behandle inflammation i forskellige kropsdele og organer.
English: • as monotherapy when metformin is inappropriate due to intolerance or contraindications
Danish: • som monoterapi når metformin er uhensigtsmæssig på grund af intolerans eller kontraindikationer
English: Event rate per 100 patient-yrs
Danish: Hyppigheden af episoder pr. 100 patientår
English: There was no statistically significant difference compared to placebo.
Danish: Der var ingen statistisk signifikant forskel sammenlignet med placebo.
English: Tablets must not be split or cut.
Danish: Tabletterne må ikke deles eller knuses.
English: • Do not take a double dose to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis som erstatning for den glemte tablet.
English: Keep taking Onglyza until your doctor tells you to stop.
Danish: Bliv ved med at tage Onglyza, indtil lægen siger, du skal stoppe.
English: ADD-ON/COMBINATION STUDIES
Danish: TILLÆGS/KOMBINATIONS STUDIER