FrancophonIA/ELRC3.0 huggingface dataset:
English: The two-day meeting of the Management Board of the European Medicines Agency (EMA) started on 16 March 2011 with presentations and an exchange of views on the following topics:
Danish: Det to dage lange møde i Det Europæiske Lægemiddelagenturs (EMA) bestyrelse indledtes den 16. marts 2011 med oplæg og udveksling af synspunkter om følgende emner:
English: A gradual shift from chemical to biological products, and from general to more specialised types of medicines, has also been observed, as has an increase in the number of applications from small and medium-sized enterprises.
Danish: Der er også observeret et gradvist skift fra kemiske til biologiske lægemidler og fra generelle til mere specialiserede lægemiddeltyper, og samtidig har der været en stigning i antallet af ansøgninger fra små og mellemstore virksomheder.
English: The Board supported the proposed transitional measures for the pharmaceutical industry to comply with the 2 July 2011 deadline for the electronic submission of information on medicinal products for human use.
Danish: Bestyrelsen bifaldt de foreslåede overgangsbestemmelser, så lægemiddelindustrien kan overholde fristen for elektronisk indsendelse af oplysninger om lægemidler til mennesker den 2. juli 2011.
English: The Board indicated that it expects the next Executive Director to inform it of their intentions before the end of their mandate.
Danish: Bestyrelsen gav udtryk for, at den forventer, at den næste administrerende direktør informerer om sine hensigter, før dennes mandat ophører.
English: The Board stressed that the increase in pharmacovigilance and other activities at the Agency's level will mean a higher workload for the national authorities.
Danish: Bestyrelsen understregede, at stigningen i lægemiddelovervågning og andre aktiviteter på agenturets niveau vil betyde mere arbejde for de nationale myndigheder.
English: The Board agreed on the following strategic steer, allowing for the preparation of the implementation to proceed without delay, while asking the Agency to monitor the situation on an ongoing basis as the implementation of the legislation progresses.
Danish: Bestyrelsen var enig om følgende strategiske kurs, hvor der er mulighed for at forberede gennemførelsen uden forsinkelse og samtidig bede agenturet om at overvåge situationen løbende, efterhånden som gennemførelsen af lovgivningen skrider frem.
English: • The process for the implementation of the strategy paper (the HMA meetings will be reorganised to facilitate the implementation of the strategy paper).
Danish: • Processen med at gennemføre strategipapiret (HMA-møderne reorganiseres for at lette gennemførelse af strategipapiret).
English: At the last meeting, the EMA Chair handed over the chairmanship for the group to the Chair of EFSA.
Danish: Ved det sidste møde overdrog EMA's formand formandskabet for gruppen til EFSA's formand.
English: • Plans for limited and targeted amendement to the Penalties Regulation (focusing on the scope of the Regulation; a public consultation will be launched in spring 2011).
Danish: • Planer for begrænset og målrettet ændring af forordningen om økonomiske sanktioner (med fokus på forordningens omfang; der indledes en offentlig høring i foråret 2011).
English: Revision of 'Charter of tasks and responsibilities of the Agency's accounting officer'
Danish: Revision af "charter for agenturets regnskabsførers opgaver og ansvarsområder"
English: Held in London on 16-17 March 2011
Danish: møde i London den 16.-17. marts 2011
English: This increase is mainly due to the increase in requested EU contribution to finance the implementation of the pharmacovigilance legislation in 2012, as well as an increase in fee income due to the expected increases in workload.
Danish: Denne stigning skyldes hovedsageligt stigningen i det ønskede EUbidrag til at finansiere gennemførelsen af lovgivningen om lægemiddelovervågning i 2012 samt en stigning i gebyrindtægter på grund af de forventede stigninger i arbejdsmængden.
English: The main set of new activities for the Agency derives from the implementation of the pharmacovigilance legislation, which comes into effect in July 2012.
Danish: De vigtigste nye aktiviteter for agenturet er afledt af gennemførelsen af lovgivningen om lægemiddelovervågning, som træder i kraft i juli 2012.
English: The KPIs enable the performance of the newly established cooperation agreements with national competent authorities to be monitored.
Danish: KPI'erne gør det muligt at overvåge resultaterne af nye samarbejdsaftaler med kompetente nationale myndigheder.
English: • Non-automatic carryover of appropriations from 2010 to 2011, finalised on 13 January 2011.
Danish: • Ikke-automatisk overførsel af bevillinger fra 2010 til 2011, afsluttet 13. februar 2011.
English: The conditions set by the Board also require that Mr Lönngren should neither have contact with Agency staff or committee members in the context of his professional activities, nor represent or accompany third parties at meetings with the Agency.
Danish: De betingelser, bestyrelsen har opstillet, kræver også, at Thomas Lönngren hverken må have kontakt med agenturets personale eller udvalgsmedlemmer i forbindelse med sine erhvervsmæssige aktiviteter og ikke må repræsentere eller ledsage tredjeparter ved møder i agenturet.
English: It was also agreed that chairs may ask for the possibility to sit as observers in the meetings of the boards of other agencies.
Danish: Det blev også vedtaget, at bestyrelsesformændene kan bede om mulighed for at sidde med som observatører ved bestyrelsesmøderne i andre agenturer.
English: In case the review will be completed later than the implementation work is due, the Agency requested the European Commission to provide for additional financial resources in the interim period.
Danish: Hvis revisionen afsluttes, efter at gennemførelsesarbejdet skal være afsluttet, bad agenturet Europa-Kommissionen om at sørge for yderligere økonomiske ressourcer i den mellemliggende periode.
English: Following the appointment of Marcus Müllner as Heads of Medicines Agencies (HMA) representative to the Management Board Telematics Committee (MBTC), the Chair invited members to express their interest to represent the Management Board at the MBTC.
Danish: Efter at have udpeget Marcus Müllner som repræsentant for de lokale lægemiddelstyrelser (HMA) i bestyrelsens telematikudvalg (MBTC) bad formanden medlemmerne om at udtrykke deres interesse for at repræsentere bestyrelsen i MBTC.
English: 22 March 2011
Danish: 22. marts 2011
English: • Presentation: Project 2014; Update to the Management Board.
Danish: • Præsentation: Projekt 2010, opdatering til bestyrelsen.
English: • The next cycle of the Benchmarking of the European Medicines Agencies (BEMA) exercise (the BEMA cycle will follow the five-year period of the HMA strategy and the EMA road map).
Danish: • Den næste benchmarkingcyklus for de europæiske lægemiddelagenturer (BEMA) (BEMA-cyklussen følger HMA-strategiens fem-års-periode og EMA's køreplan).
English: The Management Board also suggested considering how the training needs of regulators can be reflected in the projects undertaken under the Innovative Medicines Initiative (IMI).
Danish: Bestyrelsen foreslog også at overveje, hvordan myndighedernes uddannelsesbehov kan afspejles i de projekter, der iværksættes i henhold til initiativet vedrørende innovative lægemidler (IMI).
English: • The Mediator case (a stress test was conducted in the context of the new pharmacovigilance legislation).
Danish: • Mæglersagen (der blev gennemført en stresstest i forbindelse med den nye lovgivning om lægemiddelovervågning).
English: Any budgetary requirements concerning the implementation of the pharmacovigilance legislation were only provisionally adopted, and need to be made fully plausible in the following months.
Danish: Alle budgetønsker vedrørende gennemførelse af lovgivningen om lægemiddelovervågning blev kun foreløbigt vedtaget, og de skal begrundes fuldt ud i de kommende måneder.
English: • The progress on the five calls within the process on corporate responsibility in the field of pharmaceuticals: coordinated access to orphan medicinal products, capacity building on contractual agreements for innovative medicines, market access for biosimilars, facilitating supply in small markets and promoting a good governance for non-prescription medicines.
Danish: • Status vedrørende de fem punkter i processen om socialt ansvar på lægemiddelområdet: koordineret adgang til lægemidler til sjældne sygdomme, kapacitetsopbygning vedrørende kontaktaftaler om innovative lægemidler, markedsadgang til bioækvivalente lægemidler, fremme af forsyningen på små markeder og fremme af god forvaltning for håndkøbsmedicin.
English: The Board supported that the EudraVigilance audit should take place by Q4 2014 at the latest.
Danish: Bestyrelsen bifaldt, at EudraVigilance-revisionen skulle finde sted senest i fjerde kvartal i 2014.
English: Work programme and preliminary draft budget 2012
Danish: Arbejdsprogram og foreløbigt budgetforslag for 2012
English: The discussion was held behind closed doors and focused on two areas of potential conflict of interests: firstly, whether any activity risked the misuse of confidential or privileged information gained during his leadership of the Agency; and secondly, whether any activity risked improper influence on decisions taken by the Agency.
Danish: Drøftelsen fandt sted bag lukkede døre og fokuserede på to områder med potentielle interessekonflikter: For det første, om en aktivitet risikerede misbrug af fortrolig viden eller insiderviden, som han har fået under sin ledelse af agenturet, og for det andet, om en aktivitet risikerede utilbørlig påvirkning af beslutninger taget af agenturet.
English: Budget 2011
Danish: Budget for 2011
English: • The revision of the clinical trials legislation (target for the proposal is the second quarter of 2012).
Danish: • Revisionen af lovgivningen om kliniske forsøg (målet for forslaget er andet kvartal 2012).
English: The Board also supported the proposals for maintaining the EudraVigilance system until the new functionalities are implemented (in relation to data-quality management, support of EVDAS and the revised implementation of the EudraVigilance Access Policy).
Danish: Bestyrelsen bifaldt også forslagene til at opretholde EudraVigilance-systemet, indtil de nye funktionaliteter er indført (i forhold til datakvalitetsstyring, støtte af EVDAS og revideret gennemførelse af politik for adgang til EudraVigilance).
English: The Board was informed that the Director-General for DG SANCO has written to remind the Agency that audit reports need to be provided to the Board.
Danish: Bestyrelsen er blevet informeret om, at generaldirektøren for GD SANCO har skrevet for at minde agenturet om, at revisionsrapporterne skal indsendes til bestyrelsen.
English: With regard to financing the implementation of the new pharmacovigilance legislation, the Agency requires significant financial and human resources to accomplish the work.
Danish: Med hensyn til finansiering af gennemførelsen af den nye lovgivning om lægemiddelovervågning har agenturet behov for betydelige økonomiske og menneskelige ressourcer for at kunne udføre arbejdet.
English: The Board asked for information on the management of procurement and recruitment procedures, and on its work in the area of the management of conflicts of interests, to be included in the final work programme.
Danish: Bestyrelsen bad om, at der medtages oplysninger om styring af indkøbs- og rekrutteringsprocedurerne og om dens arbejde inden for styring af interessekonflikter i det endelige arbejdsprogram.
English: Report on the performance of the Agency's scientific procedures: key performance indicators (KPIs) for medicinal products for human and veterinary use
Danish: Rapport om resultaterne af agenturets videnskabelige procedurer: vigtige resultatindikatorer (KPI'er) for lægemidler til mennesker og dyr
English: The Board also noted the high level of activity in the area of variations.
Danish: Bestyrelsen tog også det høje aktivitetsniveau inden for ændringer til efterretning.
English: The Acting Executive Director updated the Board on the issue of products containing benfluorex, saying that the Agency had provided a platform for discussion but had not had a mandate to deal with national products.
Danish: Den fungerende administrerende direktør opdaterede bestyrelsen om lægemidler, der indeholder benfluorex, og sagde, at agenturet har leveret en platform til diskussion, men ikke har mandat til at tage sig af nationale lægemidler.
English: With regard to the transparency of application dossiers, the Board repeated the need to reach an agreement at the EU level among the stakeholders as to what information is considered commercially confidential or constitutes personal data.
Danish: Hvad angår gennemsigtigheden af ansøgningsdossiererne, gentog bestyrelsen, at der er behov for at nå frem til en aftale mellem interessenterne på EU-niveau med hensyn til, hvilke oplysninger der betragtes som forretningshemmeligheder eller er personlige data.
English: Following such a uniform position at the EU level, a proposal can be made at the level of te International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), with a view to changing the format of the dossier to enable automatic publication of application information without releasing information that is commercially confidential or contains personal data.
Danish: Efter en sådan fælles holdning på EU-niveau kan der stilles forslag til den internationale konference om harmonisering af tekniske krav til registrering af humanmedicinske lægemidler (ICH) med henblik på at ændre dossierets format for at muliggøre automatisk offentliggørelse af oplysningerne i ansøgningen uden at offentliggøre oplysninger, der betragtes som forretningshemmeligheder eller indeholder personlige data.
English: The Board noted the paper providing more detail about the ICT projects and budget for 2012.
Danish: Bestyrelsen tog det dokument, som gav flere oplysninger om ICT-projekterne og budgettet for 2012, til efterretning.
English: The Board discussion focused on the implementation of the new legislative provisions in relation to EudraVigilance and EU Telematics Controlled Terms.
Danish: Bestyrelsens drøftelse fokuserede på gennemførelsen af de nye lovgivningsbestemmelser i forhold til EudraVigilance og EU Telematics Controlled Terms.
English: The Board also discussed that the training programme for regulators is an important element to ensure that high-quality assessors are available.
Danish: Bestyrelsen drøftede også, at uddannelsesprogrammet for myndigheder er et vigtigt element for at sikre, at der er bedømmere af høj kvalitet til rådighed.
English: • Presentation: The EMA in 2010 - highlights.
Danish: • Præsentation: EMA i 2010 - højdepunkter
English: • The continued work to clarify the tasks of the EMA and ECDC in the area of substances of human origin (a concept paper is under development; a proposal will be made at the June Management Board meeting).
Danish: • Fortsat arbejde på at præcisere EMA's og ECDC's opgaver inden for stoffer af menneskelig oprindelse (et strategipapir er under udarbejdelse, og der fremlægges et forslag ved bestyrelsesmødet i juni).
English: Amendments to the delegate reimbursement rules
Danish: Ændringer til godtgørelsesregler for delegerede
English: Agenda for 17 March 2011 meeting
Danish: Dagsorden for mødet den 17. marts 2011
English: If five or more members express their reservations, the chair of the committee concerned will be approached and his/her views sought before finalising the procedure.
Danish: Hvis fem eller flere medlemmer udtrykker forbehold, rettes der henvendelse til formanden for det berørte udvalg1 for at få hans/eller hendes mening, før proceduren afsluttes.
English: Annual report 2010
Danish: Årsberetning for 2010
English: The Management Board adopted the preliminary work programme and the preliminary draft budget 2012.
Danish: Bestyrelsen vedtog det foreløbige arbejdsprogram og det foreløbige budgetforslag for 2012.
English: Update from the meeting of Chairs of the EU agencies
Danish: Opdatering fra mødet mellem formændene for EU-agenturerne
English: In adopting its decision, the Board imposed a set of limitations on these and any future activities for a period of two years after leaving the Agency, including prohibitions on taking managerial and executive positions in the pharmaceutical industry, and on providing product-related advice with regard to activities falling within the remit of the Agency.
Danish: Samtidig med at bestyrelsen vedtog sin beslutning, pålagde den disse og fremtidige aktiviteter et sæt begrænsninger i en periode på to år efter fratræden fra agenturet, herunder forbud mod at påtage sig ledende stillinger i lægemiddelindustrien og mod at levere lægemiddelrelateret rådgivning med hensyn til aktiviteter, som falder inden for agenturets kompetenceområde.
English: As regards pharmacovigilance implementation, the Commission is starting a review of the Fee Regulation in order for the Agency to charge fees for pharmacovigilance activities as foreseen in the pharmacovigilance legislation.
Danish: Med hensyn til gennemførelse af lægemiddelovervågning indleder Kommissionen en revision af gebyrforordningen, således at agenturet kan opkræve gebyrer for lægemiddelovervågningsaktiviteter som forudset i lovgivningen om lægemiddelovervågning.
English: Written procedures
Danish: Skriftlige procedurer
English: The Board supported the development of a subset of functionalities required for the EudraVigilance audit that would meet predefined high-level requirements.
Danish: Bestyrelsen bifaldt udviklingen af en undergruppe af funktionaliteter, som er nødvendige for EudraVigilance-revisionen, og som ville opfylde de høje foruddefinerede krav.
English: The minutes have been published on the Agency's website.
Danish: Referatet er offentliggjort på agenturets websted.
English: view of the urgency), followed immediately by a broad review of the entire Fee Regulation.
Danish: lægemiddelovervågning (da det haster), og umiddelbart derefter følger en bred revision af hele gebyrforordningen.
English: The Board asked, therefore, to be informed of further details on pharmacovigilance implementation, requirements for IT expenditure and staffing needs.
Danish: Bestyrelsen bad derfor om at blive informeret om yderligere oplysninger om gennemførelsen af lægemiddelovervågning, ønsker til it-udgifter og personalebehov.
English: The members noted the update report from the European Commission on a range of topics, including the following:
Danish: Medlemmerne tog Europa-Kommissionens ajourførte rapport om flere emner til efterretning.
English: • [EMA/MB/111120/2011] Summary of transfers of appropriations in the budget 2010.
Danish: • [EMA/MB/111120/2011] Sammendrag af bevillingsoverførsler på budgettet for 2010.
English: Minutes of the 70th meeting of the Management Board
Danish: Referat af bestyrelsens 70.
English: [EMA/MB/149825/2011] The Board adopted the amendments to the delegate reimbursement rules which allow flight tickets to be changed if a meeting ends two hours earlier or later than planned.
Danish: [EMA/MB/149825/2011] Bestyrelsen vedtog ændringerne i godtgørelsesreglerne for delegerede, som tillader, at flybilletter ændres, hvis et møde slutter to timer tidligere end planlagt.
English: • [EMA/MB/62985/2011] Information technology.
Danish: • [EMA/MB/62985/2011] Informationsteknologi.
English: Amendments to the Management Board implementing rules on the Agency's fees
Danish: Ændringer til bestyrelsens gennemførelsesbestemmelser vedrørende agenturgebyrer
English: • 69th Management Board minutes from 16 December 2010, finalised on 11 February 2011.
Danish: • Referat af 69. bestyrelsesmøde fra 16. december 2010, afsluttet 11. februar 2011.
English: • [EMA/MB/66833/2011] Performance of the Agency's scientific procedures: Survey 2010 for medicinal products for human use.
Danish: • [EMA/MB/66833/2011] Resultater af agenturets videnskabelige procedurer: Undersøgelse 2010 for lægemidler til mennesker.
English: finalised on 20 December 2010.
Danish: afsluttet 20. december 2010.
English: [EMA/MB/80540/2011] The Management Board adopted the revised charter of the accounting officer, which clarifies the accounting officer's obligations and responsibilities in line with the Financial Regulation.
Danish: [EMA/MB/80540/2011] Bestyrelsen vedtog det reviderede charter for regnskabsføreren, som præciserer regnskabsførerens pligter og ansvar i overensstemmelse med finansforordningen.
English: • [EMA/MB/78578/2011] Update report on the Agency's implementation of the EU telematics strategy.
Danish: • [EMA/MB/78578/2011] Ajourført rapport om agenturets gennemførelse af EU's telematikstrategi.
English: 4 February 2011.
Danish: februar 2011.
English: • The new legislation on falsified medicines (the text of the legislation is likely to be published in the
Danish: • Den nye lovgivning om forfalsket medicin (teksten til lovgivningen vil sandsynligvis blive offentliggjort i Den Europæiske Unions Tidende i maj 2011).
English: Audit reports
Danish: Revisionsrapporter
English: • [EMA/MB/105462/2011] Outcome of written procedures during the period from 17 October 2010 to
Danish: • [EMA/MB/105462/2011] Resultat af skriftlige procedurer i perioden fra den 17. oktober 2010 til den 24. november 2010.
English: [EMA/MB/808316/2010] The Management Board noted the minutes adopted by written procedure on 7 February 2011.
Danish: [EMA/MB/808316/2010] Bestyrelsen tog til efterretning, at referatet er godkendt ved skriftlig procedure 7. februar 2011.
English: Mediator
Danish: Mægler
English: • [EMA/807799/2010] Annual report 2010 of the Agency's Internal Audit.
Danish: • [EMA/807799/2010] Årsberetning 2010 fra agenturets interne revision.
English: finalised on 22 February 2011.
Danish: afsluttet 22. februar 2011.
English: [EMA/MB/146523/2011] The Management Board noted the report on performance of national competent authorities with respect to a subset of KPIs, which had been agreed by the Board in June 2010.
Danish: [EMA/MB/146523/2011] Bestyrelsen noterede sig rapporten om de nationale myndigheders resultater med hensyn til et subsæt af KPI'er, som blev aftalt med bestyrelsen i juni 2010.
English: • [EMA/786515/2010] Annual report 2010 of the Agency's Audit Advisory Committee.
Danish: • [EMA/786515/2010] Årsberetning 2010 fra agenturets rådgivende revisionsudvalg.
English: "We believe that Thomas Lönngren's advisory role regarding strategic development of the companies, as well as business plans and investment opportunities are strictly connected with privileged information and confidential data that he gained during his mandate as EMA Executive Director.
Danish: Europa-Parlamentets repræsentanter i bestyrelsen anmodede om, at følgende erklæring indføres i mødereferatet: "Vi mener, at Thomas Lönngrens rådgivende rolle i forhold til strategisk udvikling af virksomhederne samt forretningsplaner og investeringsmuligheder er nøje forbundet med insiderviden og fortrolige data, som han har haft adgang til under sit mandat som EMA's administrerende direktør.
English: EMA/MB/232704/2011 Management Board
Danish: EMA/MB/728580/2011 Bestyrelsen
English: • [EMA/MB/784841/2011] Preliminary draft budget.
Danish: • [EMA/MB/784841/2011] Foreløbigt budgetforslag.
English: Accommodation of the Agency
Danish: Agenturets lokaler
English: [EMA/MB/757388/2011] The Board adopted the amendments to the implementing rules on the Agency's fees.
Danish: [EMA/MB/757388/2011] Bestyrelsen vedtog ændringerne til gennemførelsesbestemmelserne vedrørende agenturgebyrer.
English: • The meeting with the European Commission to discuss principles of a future fee regulation (including the issue of non-remunerated tasks).
Danish: • Mødet med Europa-Kommissionen for at drøfte principper for en fremtidig gebyrforordning
English: [EMA/MB/105478/2011] The Board adopted the revised consultation procedure and the revised CV template.
Danish: [EMA/MB/105478/2011] Bestyrelsen vedtog den reviderede høringsprocedure og den reviderede cvskabelon.
English: • [EMA/MB/805742/2011] Preliminary work programme.
Danish: • [EMA/MB/805742/2011] Foreløbigt arbejdsprogram.