FrancophonIA/ELRC3.0 huggingface dataset:
English: These rules are applicable to temporary agents and contract agents, and are fully in place.
Danish: Disse bestemmelser finder anvendelse på midlertidigt ansatte og kontraktansatte og er nu trådt i kraft.
English: The Agency also requested 21 additional posts, which will be financed from the fee revenue, and plans to reduce the number of contract agents by 7 full-time equivalents (FTEs).
Danish: Agenturet har ligeledes anmodet om 21 nye stillinger, som skal finansieres af indtægter fra gebyrer, og planlægger at reducere antallet af kontraktansatte med 7 fuldtidsækvivalenter (FTÆ).
English: • Presentation on EU legislative and policy developments in the public-health area.
Danish: • Præsentation af EU's lovgivningsmæssige og politiske udvikling på folkesundhedsområdet.
English: After entry into force of the new legislation, the system of the peer-reviewer becoming a PRAC rapporteur could be applied for procedures starting after 2 July 2012.
Danish: Efter den nye lovgivnings ikrafttræden vil princippet om, at peer-revieweren gøres til PRAC-rapportør, kunne anvendes for procedurer, der iværksættes efter den 2. juli 2012.
English: The Agency will consider the request and will respond to the proposal.
Danish: Agenturet vil overveje anmodningen og besvare forespørgslen.
English: The final wording will be verified with the Legal Service of the Agency.
Danish: Den endelige ordlyd vil blive efterset af agenturets juridiske tjeneste.
English: Due to travel arrangements, some members are obliged to leave before the meeting finishes.
Danish: På grund af rejseaktiviteter er nogle medlemmer nødt til at forlade mødet inden dets afslutning.
English: This is a new tool for the Agency, and the Management Board discussed this concept in order to provide guidance for a future procedure.
Danish: Dette er et nyt værktøj for agenturet, og bestyrelsen drøftede dette begreb for at kunne vejlede om en fremtidig procedure.
English: This may pose difficulties, as situations may occur when the Board is not in a position to take decisions at the end of the meeting, due to it not having a quorum.
Danish: Dette kan give problemer i situationer, hvor bestyrelsen ikke vil kunne træffe afgørelser ved mødets slutning på grund af manglende kvorum.
English: The revised rules will enter into force on 1 April 2012, pending the publication of the Commission Regulation adjusting the aforementioned fees.
Danish: De reviderede regler træder i kraft den 1. april 2012 efter offentliggørelsen af Kommissionens forordning om tilpasning af nævnte gebyrer.
English: The Commission representatives reiterated the importance of providing clear explanations in the case of divergent opinions, as this will also facilitate the task of the Commission in the decision-making phase.
Danish: Kommissionens repræsentanter gentog vigtigheden af at komme med klare forklaringer i tilfælde af meningsforskelle, da dette også vil lette Kommissionens arbejde i beslutningsfasen.
English: A delegation from the authority will visit the Agency to compare regulatory requirements in June.
Danish: En delegation fra denne myndighed vil aflægge agenturet besøg i juni for at sammenholde lovgivningsmæssige krav.
English: The draft report highlights a number of issues which the Agency believes are addressed through the developments mentioned earlier.
Danish: I dette udkast til rapport fremhæves en række områder, som efter agenturets mening allerede var blevet håndteret gennem de førnævnte udviklinger.
English: To be a communication tool, hearings should convey a clear and well-defined message.
Danish: Hvis høringer skal fungere som et kommunikationsværktøj, bør de formidle et klart, veldefineret budskab.
English: Before publishing it, the amendments clarifying the receipt of grants by an institution and membership in ethics committees will be introduced.
Danish: Inden den offentliggøres, vil ændringerne, som redegør for en institutions modtagelse af tilskud og medlemskab af etiske komitéer, blive indført.
English: The Agency and a delegation from the European Food Safety Authority (EFSA) met on 27 January to exchange views on areas of common interest in both scientific and governance fields.
Danish: Agenturet og en delegation fra Den Europæiske Fødevaresikkerhedsautoritet (EFSA) mødtes den 27. januar for at drøfte områder af fælles interesse inden for både videnskab og ledelse.
English: However, the issue that needs to be addressed in this scenario is making every effort to ensure that committee discussions on safety-related signals do not cause misunderstanding by the public.
Danish: Det centrale i dette spørgsmål er dog at gøre alt for at sikre, at udvalgets drøftelser af sikkerhedsrelaterede signaler ikke misleder offentligheden.
English: With regard to the lack of budget to fully implement the pharmacovigilance legislation, the Board stressed the importance of managing expectations of stakeholders as to what can and cannot be achieved.
Danish: For så vidt angår de manglende budgetmidler til fuld gennemførelse af lovgivning om lægemiddelovervågning understregede bestyrelsen, hvor vigtigt det er at forvalte interessenternes forventninger til, hvad der kan og ikke kan gennemføres.
English: The report reveals that, despite a challenging environment, the Agency was able to deliver a growing volume of core business in 2011.
Danish: Af beretningen fremgår det, at agenturet trods et udfordrende miljø har leveret en stigende mængde kerneydelser i 2011.
English: The Commissioner addressed the staff of the Agency and responded to questions.
Danish: Kommissæren talte med agenturets medarbejdere og besvarede spørgsmål.
English: The pilot project was begun as the result of a request from the European Commission to develop a harmonised approach for the collection and reporting of data from the Member States on the use of antimicrobial agents in animals.
Danish: Pilotprojektet blev igangsat på Kommissionens foranledning og sigtede mod at udvikle en harmoniseret tilgang til indsamling og rapportering af data fra medlemsstaterne om brug af antimikrobielle agenser til dyr.
English: The Board discussed significant constraints affecting the 2013 budget.
Danish: Bestyrelsen drøftede de store begrænsninger i 2013-budgettet.
English: • The DIA EuroMeeting, where two sessions will be dedicated to the European medicines regulatory network.
Danish: • DIA EuroMeeting, hvor der vil blive afholdt to møder til fordel for det europæiske lægemiddelnetværk (»European Medicines Regulatory Network«).
English: Annual report 2011
Danish: Årsberetning 2011
English: • The action plan and road map to tackle antimicrobial resistance.
Danish: • handlingsplan og køreplan for håndtering af resistens over for antimikrobielle stoffer
English: This step will be completed at the June Management Board meeting, once nominations from all Member States and the European Commission have been received.
Danish: Denne fase vil være afsluttet inden bestyrelsesmødet i juni, når udnævnelserne fra alle medlemsstaterne og Kommissionen er modtaget.
English: The Board also expressed continuing concern that the EU legislation was adopted without adequate consideration being given to the costs required to implement the legislation.
Danish: Bestyrelsen udtrykte fortsat bekymring over, at EU-lovgivningen vedtages uden tilstrækkeligt hensyn til omkostningerne ved dens gennemførelse.
English: With regard to pre-authorisation procedures, the general feeling was that minutes should only be published after procedures are finalised and the European Commission has taken its decision.
Danish: Med hensyn til procedurer efter godkendelse var det generelle indtryk, at referater først bør offentliggøres, når procedurerne er afsluttede, og Europa-Kommissionen har truffet en afgørelse.
English: The adopted procedure also puts in place a framework for checking the integrity of the scientific review.
Danish: Den vedtagne procedure danner også ramme for kontrol af den videnskabelige undersøgelses integritet.
English: The Executive Director stressed the Agency's commitment to contributing to combating antimicrobial resistance.
Danish: Den administrerende direktør understregede agenturets bidrag til bekæmpelsen af resistens over for antimikrobielle stoffer.
English: • clarification on the membership of an ethics committee;
Danish: • præcisering af medlemskab af en etisk komité
English: This would allow the alignment of interests and would pave the way for applying this concept in future regulatory decisions.
Danish: Dette vil kunne afbalancere forskellige interesser og bane vej for dette begrebs anvendelse i fremtidige lovgivningsmæssige afgørelser.
English: A second challenge for the Agency is to explain to the public the reason for the divergence and the impact this has.
Danish: En anden udfordring for agenturet var at fortælle offentligheden om årsagen til meningsforskellen og dens indvirkning.
English: The Management Board will develop a similar procedure applicable to its members.
Danish: Bestyrelsen vil udarbejde en tilsvarende procedure for medlemmerne.
English: The Board also noted that declarations of interests and professional profiles of all managers have been published on the external website.
Danish: Bestyrelsen tog endvidere til efterretning, at alle chefers interesseerklæringer og faglige profiler er blevet offentliggjort på det eksterne websted.
English: A number of national competent authorities will be visited as part of the study.
Danish: Som led i undersøgelsen vil der blive aflagt besøg hos en række nationale kompetente myndigheder.
English: The participants stressed that the pharmacovigilance system should be supported by fees, which are foreseen in the legislation but will not come into force until after a few years.
Danish: Deltagerne understregede, at lægemiddelovervågningssystemet bør understøttes af lovfæstede gebyrer, som dog ikke skulle træde i kraft før et par år senere.
English: Mr Houÿez also shared his experience from public hearings at the US Food and Drug Administration and made a number of practical suggestions.
Danish: Hr. Houÿez fortalte også om sine erfaringer med offentlige høringer i USA's fødevare- og lægemiddeltilsynsmyndighed (»Food and Drug Administration« - FDA) og stillede et par praktiske forslag.
English: The new pharmacovigilance legislation, which enters into force in July 2012, introduces a provision that allows public hearings to be held, in the context of the assessment of medicinal products for human use.
Danish: Med den nye lovgivning om lægemiddelovervågning, der træder i kraft i juli 2012, indføres en bestemmelse, som tillader offentlige høringer i forbindelse med vurderingen af humanmedicinske lægemidler.
English: Significant progress was made in other areas, including the launch of the EU clinical-trials register and the new online database of European experts.
Danish: Der var sket store fremskridt på andre områder, bl.a. lanceringen af EU's register over kliniske undersøgelser og den nye onlinedatabase for europæiske eksperter.
English: The report does not aim to provide the reasons for delays in submitting assessment reports by rapporteurs and co-rapporteurs.
Danish: Formålet med rapporten er ikke at beskrive årsagerne for forsinkelser med rapportørernes og medrapportørernes vurderingsrapporter.
English: The Management Board underlined that public hearings should be seen as a new way of engaging and communicating with the public, and not only as an additional tool for transparency.
Danish: Bestyrelsen understregede, at offentlige høringer bør opfattes som en ny måde at kommunikere med og inddrage offentligheden på og ikke kun som endnu et værktøj til sikring af gennemsigtighed.
English: During this interim discussion, members noted that more expertise may be needed in the areas of pregnancy and lactation.
Danish: I forbindelse med denne diskussion bemærkede medlemmerne, at der kunne blive behov for mere ekspertviden om graviditet og amning.
English: • inclusion of a reference to a system of ex-post checks, as well as the development of a breach of trust procedure.
Danish: • inddragelse af en henvisning til et system med efterfølgende kontrol samt udvikling af en procedure for tillidsbrud.
English: • Presentation on annual report 2011.
Danish: • Præsentation af årsberetningen for 2011.
English: The Board also noted the steep increase in the number of pages released under the access-todocuments legislation: from 8,000 in 2010 to over a million in 2011.
Danish: Bestyrelsen tog også den bratte stigning i antallet af sider, der blev frigivet under lovgivningen om aktindsigt, nemlig fra 8 000 i 2010 til over en million i 2011, til efterretning.
English: There was also a strong increase (over 20%) in post-authorisation activities, and a major rise in the number of referral procedures (77 compared to 55 in 2010).
Danish: Der var også en kraftig stigning (over 20 %) i antallet af aktiviteter efter godkendelse og en stor stigning i antallet af henvisningssager (77 sammenholdt med 55 i 2010).
English: In this session, the Board reflected on the concept of 'staggered' approval (also known as adaptive or progressive licensing).
Danish: Under dette punkt drøftede bestyrelsen begrebet »gradvis« godkendelse (også kendt som fleksibel eller gradvis godkendelse).
English: Circulated to the Board by e-mail on 17 January 2012; recorded in the minutes of the next meeting, as relevant.
Danish: Sendt til bestyrelsen med e-mail den 17. januar 2012, anført i referatet af det næste møde, hvis relevant.
English: Regarding the collection and use of evidence, participants were of the opinion that the use of data from electronic registries would become easier in future, which would significantly facilitate the application of the concept.
Danish: For så vidt angår indsamling og anvendelse af dokumentation fandt deltagerne, at det fremover bliver lettere at bruge data fra elektroniske registre, hvilket i høj grad vil fremme anvendelsen af begrebet.
English: The meeting discussed that the concept as such is not completely new in the regulatory world.
Danish: Mødedeltagerne konstaterede, at begrebet som sådant ikke er ganske nyt inden for lovgivningen.
English: The Commission representative stressed the importance of the Agency concentrating on its core tasks, especially because 2013 will be financially a critical year, and discussions are still ongoing in the Commission concerning the EU contribution.
Danish: Kommissionens repræsentant understregede betydningen af, at agenturet koncentrerer sig om sine kerneaktiviteter, især fordi 2013 rent finansielt bliver et kritisk år, og Kommissionen endnu ikke har vedtaget EU-bidraget.
English: • clarification on the follow-up to be taken in case a member intends to be engaged in occupational activities with a pharmaceutical company;
Danish: • præcisering af opfølgningsforanstaltninger, der skal træffes, hvis et medlem har til hensigt at indgå i faglige aktiviteter med en lægemiddelvirksomhed
English: Members stressed the importance of the quality and clarity of the questions asked, so that participants can offer their opinions and answers, and take the discussion forward.
Danish: Medlemmerne understregede vigtigheden af kvaliteten og klarheden af de stillede spørgsmål, så deltagerne kan fremlægge deres meninger og svar, og diskussionen komme videre.
English: Adaptive licensing: a useful approach for drug licensing in the EU?
Danish: Fleksible godkendelser: en brugbar tilgang til godkendelse af lægemidler i EU?
English: The Agency will also publish CVs of all experts in the European experts database, and a project to enable the receipt of electronic CVs and their automated publication was agreed.
Danish: Agenturet vil ligeledes offentliggøre cv'er for alle eksperter i den europæiske ekspertdatabase, og der blev vedtaget et projekt, som skal gøre det muligt at modtage elektroniske cv'er og automatisk offentliggøre dem.
English: With regard to assessment activities, the Agency is largely at cruising speed.
Danish: For så vidt angår vurderingsaktiviteter er agenturet stort set ajour.
English: The analysis concluded that further amendments to the policy are warranted (as described in the next section).
Danish: Analysens konklusion var, at der er behov for yderligere ændringer af politikken (jf. næste afsnit).
English: Although the appointment of a rapporteur from a different Member State could be seen as adding to the trust of the system, other members were convinced that this would unnecessarily increase the complexity and associated costs of the system.
Danish: Skønt udnævnelsen af en rapportør fra en anden medlemsstat vil kunne opfattes som en styrkelse af systemets troværdighed, mente andre medlemmer, at dette kunne føre til en unødig kompleksitet og flere omkostninger for systemet.
English: The rapporteur was of the opinion that the Agency has to do more in the area of conflicts of interests.
Danish: Ordføreren fandt, at agenturet bør arbejde mere med håndtering af interessekonflikter.
English: Amendments to the Management Board implementing rules on the Agency's fees
Danish: Ændringer i bestyrelsens gennemførelsesregler om agenturets gebyrer
English: The evaluation was requested by the European Parliament, and focuses on the impact on the EU and national budgets of a transfer of responsibilities form the national to the European level following the creation of EU agencies.
Danish: Evalueringen foretages efter anmodning af Europa-Parlamentet og fokuserer på, hvordan EU's og medlemsstaternes budgetter påvirkes af overførslen af ansvar fra nationalt til europæisk plan efter oprettelsen af EU-agenturer.
English: The final budget will be adopted once the level of the EU contribution has been decided by the European Parliament and the Council.
Danish: Det endelige budget vil blive vedtaget, når Europa-Parlamentet og Rådet har vedtaget det endelige bidrag fra EU.
English: The Board noted the budgetary uncertainties and their impact on the work programme, as described below.
Danish: Bestyrelsen tog de budgetmæssige usikkerhedsmomenter og deres indvirkning på arbejdsprogrammet, jf. nedenfor, til efterretning.
English: The committees should then have sufficient time to debate the cause for divergence and to identify any possibility to converge their views before the final decision is taken.
Danish: Udvalgene bør så gives tid nok til at drøfte årsagen til uoverensstemmelsen og identificere mulighederne for at nå til enighed, inden der træffes endelige afgørelser.
English: The Board was informed that, following the receipt of the Commission Decision of 23 January 2012 confirming agreement on the Agency's rules under Article 110 of the Staff Regulations, the Chair signed the 'Decision on rules relating to Articles 11a and 13 of the Staff Regulations concerning the handling of declared interests of employees of the European Medicines Agency', on 1 February 2012.
Danish: Bestyrelsen meddelte, at formanden efter at have modtaget Kommissionens beslutning af den 23. januar 2012, der bekræfter aftalen om agenturets bestemmelser under artikel 110 i personalevedtægten, den 1. februar 2012 underskrev »beslutning om bestemmelserne vedrørende artikel 11a og 13 i personalevedtægten om håndtering af interesser erklæret af ansatte ved Det Europæiske Lægemiddelagentur«.
English: In his presentation, François Houÿez, of the European Organisation for Rare Diseases, stressed that patients are looking for greater involvement, better understanding of already reached regulatory decisions and participation in decision making.
Danish: I sit indlæg understregede François Houÿez fra Eurordis (»European Organisation for Rare Disorders«), at patienterne ønsker at blive inddraget mere, få en dybere forståelse af allerede eksisterende lovgivningsmæssige afgørelser og deltage i beslutningsprocessen.
English: The Board continued discussions held at the meeting of the Heads of Medicines Agencies in February 2012.
Danish: Bestyrelsen fortsatte drøftelserne fra mødet med lægemiddelstyrelsescheferne i februar 2012.
English: • Written procedure for adoption of non-automatic carry-over of appropriations from 2011-2012 closed on 30 January 2012.
Danish: • Skriftlig procedure for vedtagelse af ikke-automatisk overførsel af bevillinger fra 2011-2012, afsluttet den 30. januar 2012.
English: With regard to the transparency of conflicts of interests, the Board underlined that the disclosure of participants' relations with industry or with others whose views they represent is very important, to ensure that the process is clear and trustworthy.
Danish: Med hensyn til gennemsigtighed i interessekonflikter understregede bestyrelsen, at offentliggørelse af deltagernes forbindelser med industrien eller med andre, hvis holdninger de repræsenter, er meget vigtigt for at sikre en klar, troværdig proces.
English: This action would strengthen the credibility of the system, would facilitate the work of regulators and increase the transparency of the pharmaceutical industry.
Danish: Dette initiativ vil styrke systemets troværdighed, lette lovgivernes arbejde og øge gennemsigtigheden i lægemiddelindustrien.
English: • Presentation on PRAC rapporteurs: Proposed principles for appointment and roles/responsibilities of PRAC rappoerteurs.
Danish: • Præsentation af PRAC-rapportører: forslag til principper for udnævnelse af og roller/ansvar for PRAC-rapportører.
English: The legislation states that public hearings may be held in cases of safety concerns.
Danish: Det fremgår af lovgivningen, at der kan afholdes offentlige høringer om sikkerhedsspørgsmål.
English: Evaluation of the Agency
Danish: Evaluering af agenturet
English: • The HMA's agreement to publish information on the authorisation of clinical trials in the EU as part of the impact assessment of the revision of the Clinical Trials directive.
Danish: • HMA's beslutning om at offentliggøre oplysninger om godkendelse af kliniske undersøgelser i EU som led i konsekvensvurderingen med tilknytning til revisionen af direktivet om kliniske forsøg
English: Declaration of conflicts of interests related to current agenda
Danish: Erklæring om interessekonflikt i forbindelse med dagsordenen
English: An update on the implementation of the pharmacovigilance legislation in the run-up to 2 July 2012
Danish: Orientering om gennemførelsen af lovgivning om lægemiddelovervågning i opløbet til den 2. juli 2012
English: Such divergence can be seen as an opportunity to add new views to the scientific debate and to make the final outcome of such debate more robust and of better value.
Danish: Meningsforskelle kan opfattes en chance for at tilføre den videnskabelige debat nye synspunkter og gøre resultatet mere solidt og værdifuldt.
English: However, the rise seen in the number of requests for veterinary scientific advice shows that interest remains high in bringing innovative veterinary medicines to the market through the centralised procedure.
Danish: Stigningen i antal anmodninger om videnskabelig rådgivning på det veterinærmedicinske område viste, at der fortsat er stor interesse for at markedsføre nyskabende veterinærmedicinske lægemidler gennem den centraliserede procedure.
English: Report on performance of national competent authorities against newly established key performance indicators (KPIs)
Danish: Rapport om de kompetente nationale myndigheders resultat sammenholdt med de nyligt vedtagne nøgleresultatindikatorer
English: The Board adopted the decision to hold its meetings in English only.
Danish: Bestyrelsen vedtog at afholde sine møder med engelsk som eneste sprog.
English: The audience for the hearings should represent the right balance among the Agency's stakeholders in this area - patients, healthcare professionals, academia and industry.
Danish: Deltagerne i høringerne bør repræsentere den rette balance mellem agenturets interessenter på området - patienter, sundhedspersonale, den akademiske verden og industrien.
English: As part of the strategy to ensure effective liaison with the national competent authorities, and following discussions with the Heads of Medicines Agencies, the Agency has also appointed an HMA liaison officer.
Danish: Som led i strategien for at sikre en effektiv forbindelse til de nationale myndigheder har agenturet også efter drøftelser med lægemiddelstyrelsescheferne udnævnt en HMA-forbindelsesofficer.
English: The document was adopted.
Danish: Dokumentet blev vedtaget.