FrancophonIA/ELRC3.0 huggingface dataset:
English: There are a number of precursors to adaptive licensing - such as conditional marketing authorisation, new pharmacovigilance legislation, risk-management plans, periodic safety update reports, etc.
Danish: Der kendes en række forløbere for fleksibel godkendelse såsom betinget markedsføringstilladelse, den nye lovgivning om lægemiddelovervågning, planer for risikostyring, periodiske sikkerhedsberetninger osv.
English: The Board thanked them for their active involvement and valuable contributions in numerous capacitiesas members, topic coordinators and as a vice-chair - to the successful work of the Board.
Danish: Bestyrelsen takkede dem for deres aktive deltagelse og værdifulde bidrag til bestyrelsens vellykkede arbejde i deres egenskab af medlem, emnekoordinator og næstformand.
English: Amending budget 01-2012 for changes to entry grade for a post
Danish: Ændring af budget 01-2012 mht. ændring af en stillings begynderlønklasse
English: Overall, the number of applications is stable, with 112 applications for marketing authorisations for medicines for human use and 13 for veterinary use forecast.
Danish: Antallet af ansøgninger er generelt stabilt - 112 ansøgninger om markedsføringstilladelser til humanmedicinske lægemidler og 13 til veterinærmedicinske produkter.
English: A broader constellation of stakeholders has to participate, including the clinical community, healthcare providers, patients, payers and industry.
Danish: En bredere konstellation af interessenter bør inddrages, såsom hospitalsvæsenet, sundhedssektoren, patienter, betalere og industrien.
English: Patient representatives expressed concern that the legislation provides that only one member (and an alternate) representing patients shall be nominated to the PRAC, while for other committees there are two or more members.
Danish: Patientrepræsentanterne var bekymrede over, at der i henhold til lovgivningen kun skal udnævnes én repræsentant for patienterne til PRAC, mens der i andre udvalg er to eller flere.
English: The legislation states that the Agency shall make public agendas and minutes of the Committee for Medicinal Products for Human Use (CHMP), the PRAC and the Coordination Group (CMD(h)) as regards pharmacovigilance activities, and the Board heard an update on preparations for the implementation of these provisions.
Danish: I henhold til lovgivningen skal agenturet offentliggøre dagsordener og referater for Udvalget for Lægemidler til Mennesker (CHMP), PRAC og koordinationsgruppen (CMD(h)) for så vidt angår aktiviteter vedrørende lægemiddelovervågning, og bestyrelsen blev orienteret om forberedelserne til gennemførelsen af disse aktiviteter.
English: Adaptive licensing seeks to maximise the positive impact of new drugs on public health by balancing timely access for patients with the need to provide adequate evolving information on benefits and harms.
Danish: Fleksible godkendelser har til formål at øge nye lægemidlers positive indvirkning på folkesundheden ved at skabe ligevægt mellem rettidig tilgængelighed for patienter og nødvendigheden af at sikre hensigtsmæssige, nye oplysninger om fordele og ulemper.
English: The nominating authority confirmed the withdrawal of the nomination in a letter addressed to the MB Chair, received on 24 February 2012.
Danish: Den udnævnende myndighed bekræftede, at man trak udnævnelsen tilbage, i et brev stilet til bestyrelsesformanden, modtaget den 24. februar 2012.
English: The PRAC is an independent committee and, moreover, considering that the rapporteurships in the initial evaluation stage are not evenly spread out among the Member States, the Commission took the view that the PRAC rapporteur should be from a different Member State than the rapporteur in the pre-authorisation phase.
Danish: PRAC er et uafhængigt udvalg, og da medlemsstaterne ved valget af rapportører i den indledende evalueringsfase ikke er ligeligt repræsenteret, mente Kommissionen, at PRAC-rapportøren bør komme fra en anden medlemsstat end rapportøren i fasen forud for godkendelse.
English: Members also recalled a discussion at the HMA meeting, where the HMA felt that a harmonised system to manage conflicts of interests throughout the network cannot be enforced.
Danish: Medlemmerne drøftede endvidere en diskussion fra mødet med lægemiddelstyrelsescheferne, som mente, at et harmoniseret system til forvaltning af interessekonflikter i hele netværket ikke kunne håndhæves.
English: The Management Board requested details of which ICT projects will be taken forward in 2013 to be provided for the next meeting.
Danish: Bestyrelsen anmodede om på det kommende møde at blive underrettet om, hvilke IKTprojekter, der vil blive videreført i 2013.
English: While members stressed that every effort needs to be made to avoid divergence of opinions, it was recognised that the possibility of having divergent opinions is also a strength of the European system, which is based on checks and balances.
Danish: Enkelte medlemmer understregede, at der bør gøres alt for at undgå meningsuoverensstemmelser, idet det dog erkendtes, at eventuel uenighed også er en styrke ved EUsystemet, der er baseret på gensidig kontrol.
English: The Board was informed that, to date, the Agency has introduced a revised policy on managing conflicts of interests of experts, adopted rules on managing conflicts of interests of staff, discussed the Management Board policy and presented it for adoption at this meeting, drafted the breach of trust procedure, is introducing ex post controls, has published risk ratings for committee members, and has
Danish: Bestyrelsen blev orienteret om, at agenturet op til nu har revideret sin politik for styring af interessekonflikter for eksperter, vedtaget regler for styring af interessekonflikter for medarbejdere, drøftet bestyrelsens politik og fremlagt den til vedtagelse på dette møde, lavet et udkast til procedure for tillidsbrud, indført efterfølgende kontroller, offentliggjort risikovurderinger for udvalgsmedlemmer og offentliggjort faglige profiler for agenturets ledelse, udvalgsmedlemmer og bestyrelsesmedlemmer.
English: • Presentation on public hearings in Europe.
Danish: • Præsentation af offentlige høringer i Europa.
English: [EMA/MB/131620/2012] The Board discussed whether the current practice of holding one-day meetings is the most efficient arrangement.
Danish: [EMA/MB/131620/2012] Bestyrelsen drøftede, om den nuværende praksis med endagsmøder er den mest effektive ordning.
English: During the session, the Management Board heard expectations that patients - the main stakeholders in this process - have about public hearings.
Danish: Under dette punkt blev bestyrelsen orienteret om de forventninger, patienterne som hovedaktører i processen har til offentlige høringer.
English: • Report of performance with respect to a limited subset of quantitative KPIs 2011.
Danish: • Rapport om resultater med hensyn til et afgrænset delsæt af kvantitative nøgleresultatindikatorer for 2011.
English: The Chair informed the Board that he had examined declarations of interests of members, together with the secretariat, and concluded that there were no conflicts of interests that could interfere with the topics of the meeting.
Danish: Formanden meddelte bestyrelsen, at han sammen med sekretariatet havde gennemgået medlemmernes erklæringer om interessekonflikt og konkluderede, at der ikke bestod interessekonflikter vedrørende de emner, der skulle drøftes på mødet.
English: There was a 10% increase in the number of applications for initial-marketing authorisation for medicines for human use, with 100 applications received in 2011.
Danish: Der var en stigning på 10 % i antal ansøgninger om en første markedsføringstilladelse til humanmedicinske lægemidler, i alt 100 ansøgninger i 2011.
English: • [EMA/MB/115063/2012] Summary of transfers of appropriations in the budget 2012.
Danish: • [EMA/MB/115063/2012] Sammendrag af bevillingsoverførsler på budgettet for 2012.
English: Committee on Herbal Medicinal Products (HMPC) in June to discuss topics relating to herbal medicines.
Danish: Bestyrelsen påtænker at mødes med formanden for Udvalget for Plantelægemidler (HMPC) i juni for at drøfte spørgsmål om plantelægemidler.
English: [EMA/MB/47692/2012] The agenda was adopted.
Danish: [EMEA/MB/47692/2012] Dagsordenen blev vedtaget.
English: Topic coordinators
Danish: Emnekoordinatorer
English: The adoption of the pharmacovigilance proposal is expected soon.
Danish: Forslaget om lægemiddelovervågning forventes vedtaget snarest
English: • introduction of restrictions in case of a pharmaceutical company giving a grant or other funding;
Danish: • indførelse af restriktioner, når en lægemiddelvirksomhed giver tilskud eller anden finansiering
English: This would increase the overall headcount by 14 FTEs.
Danish: Herved bliver det samlede antal medarbejdere 14 FTÆ.
English: Pat O'Mahony participated on Thursday, 22 March 2012
Danish: Pat O'Mahony deltog i mødet torsdag den 22. marts 2012.
English: The number of applications received for initial-marketing authorisation for veterinary medicines declined slightly.
Danish: Antallet af ansøgninger om en første markedsføringstilladelse til veterinærmedicinske produkter faldt en anelse.
English: The Agency also plans to carry out ex-post checks on risk-mitigating actions and ex-ante controls to ensure that interests are included in correct parts of DoI forms.
Danish: Agenturet har også planer om at gennemføre efterfølgende kontrol af risikoafhjælpende foranstaltninger og forudgående kontrol for at sikre, at interesser bliver indført de rigtige steder i interesseerklæringen.
English: The Board also discussed that, when re-nominating members after the expiry of the three-year mandate, Member States may wish to reflect whether to limit the number of continuous terms to ensure the turnover of experts.
Danish: Bestyrelsen drøftede desuden muligheden for, at medlemsstaterne, for at sikre tilførsel af nye eksperter, eventuelt i forbindelse med genudnævnelse af medlemmer efter udløbet af de tre år kunne ønske at begrænse det antal gange, en ekspert vil kunne genudnævnes.
English: The Agency's financing of the pilot phase will amount to over EUR 350,000 in 2012.
Danish: Agenturet har afsat 350 000 EUR til pilotprojektfasen i 2012.
English: The agencies then signed a memorandum of understanding setting out their commitment to fostering cooperation.
Danish: Agenturerne underskrev derefter et aftalememorandum om samarbejde.
English: These systems should then ensure that all knowledge about the reasons for a decision is shared among concerned committees in a timely manner.
Danish: Dette skal sikre, at baggrunden for en beslutning formidles rettidigt til de berørte udvalg.
English: The challenges in this approach are that there may be increased pressure from external parties on the CHMP/CMD(h) and that Member States may act prior to CHMP/CMD(h) outcomes.
Danish: Problemerne med denne tilgang er, at tredjeparter eventuelt kan lægge mere pres på CHMP/CMD(h), og at medlemsstaterne måske vil handle, inden de har fået kendskab til resultaterne fra møderne i CHMP/CMD(h).
English: A discussion on the concept of public hearing and transparency
Danish: Punkt 1: Drøftelse af begreberne offentlig høring og gennemsigtighed
English: • Presentation on overview of PRAC expertise so far.
Danish: • Præsentation af oversigt over eksisterende ekspertise i PRAC.
English: The underlying principle is to allow enough time for the CHMP/CMD(h) to review and debate the outcomes of the PRAC meetings.
Danish: Det bagvedliggende princip er, at CHMP/CMD(h) bør have tilstrækkelig tid til at gennemgå og drøfte resultaterne fra PRAC's møder.
English: • The proposal on the revision of the veterinary medicines legislation planned for 2013.
Danish: • forslag om revision af lovgivning om veterinærmedicinske produkter (planlagt i 2013)
English: • The legislative proposals for clinical trials and medical devices planned for 2012.
Danish: • lovforslag vedrørende kliniske undersøgelser og medicinsk udstyr (planlagt i 2012)
English: Adaptive licensing can be defined as a prospectively planned, adaptive approach to regulation of drugs through iterative phases of evidence-gathering, followed by regulatory evaluation and license adaptation.
Danish: Fleksible godkendelser (»adaptive licensing«) kan opfattes som en fremadrettet, fleksibel tilgang til regulering af lægemidler gennem gentagne faser med indsamling af dokumentation efterfulgt af en forskriftsmæssig evaluering og tilpasning af godkendelsen.
English: • [EMA/888135/2011] MBTC-2012-02-002 Management Board Telematics Committee meeting held on 9 November 2011
Danish: • [EMA/888135/2011] MBTC-2012-02-002 Referat af mødet i telematikudvalgets bestyrelse den 9. november 2011
English: • Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur appointment.
Danish: • Udnævnelse af rapportør til Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC)
English: [EMA/MB/139702/2012] The Management Board adopted the procedure for consultation on final composition of the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: [EMA/MB/139702/2012] Bestyrelsen vedtog proceduren for høring om endelig sammensætning af Udvalget for Risikovurdering inden for Lægemiddelovervågning (PRAC).
English: Work programme and preliminary draft budget 2013
Danish: Arbejdsprogram og foreløbigt budgetforslag for 2013
English: Salvatore D'acunto participated on Thursday, 22 March 2012
Danish: Salvatore D'acunto deltog i mødet torsdag den 22. marts 2012.
English: The decision comes into effect on 1 April 2012.
Danish: Beslutningen træder i kraft den 1. april
English: • Adaptive licensing.
Danish: • Fleksible godkendelser (»adaptive licensing«).
English: Session 2:
Danish: Punkt 2:
English: Publication of agendas and minutes
Danish: Offentliggørelse af dagsordener og referater
English: The meeting noted a detailed update about progress on the implementation of provisions foreseen in the new pharmacovigilance legislation.
Danish: Mødedeltagerne modtog en grundig orientering om gennemførelsen af bestemmelserne i den nye lovgivning om lægemiddelovervågning.
English: Held in London, 21-22 March 2012
Danish: Afholdt i London den 21.-22. marts 2012
English: This is particularly relevant due to the fact that the CHMP and CMD(h) may take a different view after the PRAC opinion has been put in the public domain.
Danish: Dette er særlig relevant, fordi CHMP og CMD(h) eventuelt kan ændre opfattelse efter offentliggørelsen af PRAC's udtalelse.
English: The analysis also proposed the establishment of a breach of trust procedure and a system of ex-post checks of information provided in declarations of interests (DoIs).
Danish: Det blev desuden foreslået at indføre en procedure for tillidsbrud og et system med efterfølgende kontrol af oplysninger i interesseerklæringer.
English: [EMA/MB/13210/2012] The Management Board adopted the amended rules, adjusting the fees payable to the Agency by 3.1%, for inflation.
Danish: [EMA/MB/13210/2012] Bestyrelsen vedtog de ændrede regler og hævede agenturets gebyrer med 3,1 %, dvs. med inflationen.
English: Bilateral with the FDA
Danish: Møde med FDA
English: • [EMA/MB/2671/2012] Outcome of written procedures during the period 25 November 2010 to 29 February 2012.
Danish: • [EMA/MB/2671/2012] Resultat af skriftlige procedurer i perioden fra den 25. november 2010 til den 29. februar 2012.
English: The members of the group are: Marcus Müllner, Luca Pani, Kristin Raudsepp, Andrzej Rys, Gro Wesenberg and Kent Woods.
Danish: Gruppens medlemmer: Marcus Müllner, Luca Pani, Kristin Raudsepp, Andrzej Rys, Gro Wesenberg og Kent Woods.
English: Session 3:
Danish: Punkt 3:
English: • Publication of agendas and minutes.
Danish: • Offentliggørelse af dagsordener og referater
English: It was suggested that for already authorised products and ongoing procedures, the system of the rapporteur in the pre-authorisation stage being appointed as the PRAC rapporteur could be applied.
Danish: For allerede godkendte produkter og igangværende procedurer blev det foreslået systematisk at lade rapportøren i fasen forud for godkendelse udnævnes til PRAC-rapportør.
English: The formal process of reviewing nominations and identifying areas requiring reinforcement will take place at the June meeting.
Danish: På mødet i juni gennemføres den formelle proces med at drøfte udnævnelserne og fastlægge de områder, der skal styrkes.
English: Language regime of the Management Board meetings
Danish: Sprog på bestyrelsesmøder
English: Representative of veterinarians' organisations Observers
Danish: Repræsentant for dyrlægeorganisationer Observatører
English: [EMA/112052/2012] The Management Board noted the report on a sample of key performance indicators included in contractual arrangements with national competent authorities.
Danish: [EMA/112052/2012] Bestyrelsen tog rapporten om en stikprøve af resultatindikatorer i kontrakterne med de kompetente nationale myndigheder til efterretning.
English: • EMA/MB/157253/2012 Performance of the Agency's scientific procedures: Survey 2011 for medicinal products for human use.
Danish: • [EMA/MB/157253/2012] Resultater af agenturets videnskabelige procedurer: Undersøgelse 2011 af humanmedicinske produkter.
English: Ways to ensure efficient and timely communication between the Agency and the European Commission, and the need for adequate financing of legislative initiatives, were among the topics discussed during the visit.
Danish: Under besøget drøftedes bl.a. sikring af effektiv, rettidig kommunikation mellem agenturet og EuropaKommissionen og behovet for tilstrækkelig finansiering af lovgivningsmæssige initiativer.
English: • The endorsement of the reflection paper on ethical and GCP aspects of clinical trials in third countries.
Danish: • godkendelse af arbejdsdokumentet om etiske aspekter og aspekter vedrørende god klinisk praksis for så vidt angår kliniske undersøgelser i tredjelande
English: • [EMA/185199/2012] EU telematics projects report; [EMA/189200/2012] EU telematics operations report; [EMA/177625/2012] Minutes from the Management Board Telematics Committee meeting held on 14 February 2012.
Danish: • [EMA/185199/2012] Rapport om EU's telematikprojekter, [EMA/189200/2012] Rapport om EU's telematikaktiviteter, [EMA/177625/2012] Referat af møde i telematikudvalgets bestyrelse den 14. februar 2012.
English: • Presentation on public hearings.
Danish: • Præsentation af offentlige høringer.
English: The discussion of the Board focused on the possible divergence of opinions between the PRAC and the CHMP/CMD(h).
Danish: Bestyrelsens drøftelser koncentreredes om de eventuelle forskelle mellem holdninger i PRAC og CHMP/CMD(h).
English: [EMA/MB/977044/2011] The Management Board adopted the Agency's annual report 2011.
Danish: [EMA/MB/977044/2011] Bestyrelsen vedtog agenturets årsberetning for 2011.
English: This was agreed upon by the Board.
Danish: Bestyrelsen vedtog dette forslag.
English: The decision takes affect on 22 March 2012.
Danish: Beslutningen træder i kraft den 22. marts 2012.
English: • The appointment by the Commission of six experts and patients' and healthcare professionals' representatives for the Pharmacovigilance Risk Assessment Committee (to be finalised in Q2
Danish: • Kommissionens udnævnelse af seks eksperter og repræsentanter for patienter og sundhedsmedarbejdere til Udvalget for Risikovurdering inden for Lægemiddelovervågning (endelig vedtagelse i andet kvartal af 2012)
English: On the other hand, it was stressed that product knowledge is one aspect of PRAC rapporteurship, while specific expertise in risk management and independence from the pre-authorisation phase are other important considerations.
Danish: Det blev på den anden side understreget, at det er en PRAC-rapportørs opgave at have produktkendskab, samt at det er vigtigt at have specifik ekspertviden om risikostyring og være uafhængig af fasen forud for godkendelse.
English: [EMA/MB/955795/2012] The Management Board noted the document outlining the high-level budgetary requirements for 'Project 2014' (the move of the Agency to its new premises).
Danish: [EMA/MB/955795/2012] Bestyrelsen tog dokumentet om de høje budgetkrav til »Projekt 2014« (agenturets flytning til nye lokaler) til efterretning.
English: Its members are Klaus Cichutek, Kristin Raudsepp and Grzegorz Cessak.
Danish: Medlemmer: Klaus Cichutek, Kristin Raudsepp og Grzegorz Cessak.
English: • Consultation no. 03/2012 on the appointment of Martti Nevalainen as CVMP member, proposed by Finland ended on 2 February 2012 with Members' observations, raised in respect of the candidate's level of conflict of interests and supported by the CVMP Chair, sent to the nominating authority on 13 February 2012.
Danish: • Høring nr. 03/2012 om udnævnelse af Martti Nevalainen til medlem i CVMP, indstillet af Finland, afsluttet den 2. februar 2012, med bemærkninger fra medlemmerne vedrørende kandidatens interessekonfliktniveau og støttet af formanden for CVMP, sendt til den udnævnende myndighed den 13. februar 2012.
English: [EMA/MB/146762/2012] The Management Board noted the nominations to the PRAC provided by Member States to date.
Danish: [EMA/MB/146762/2012] Bestyrelsen tog de udnævnelser til PRAC fra medlemsstaterne, som den indtil videre har modtaget, til efterretning.
English: It was proposed that agendas and minutes of the PRAC meetings be published, initially, with those of the CHMP and CMD(h) being published in a second phase, once sufficient experience has been gathered.
Danish: Det blev foreslået, at man i første omgang skulle offentliggøre dagsordener og referater fra PRAC og i anden omgang det samme for CHMP og CMD(h), når der var indhøstet nok erfaringer.
English: • Presentation on implementation of the pharmacovigilance legislation.
Danish: • Præsentation af gennemførelsen af lovgivningen om lægemiddelovervågning.
English: [EMA/MB/33634/2012] The Management Board noted the final minutes, adopted by written procedure on 9 February 2012.
Danish: [EMA/MB/33634/2012] Bestyrelsen tog det endelige referat ad notam, som blev vedtaget efter den skriftlige procedure den 8. februar 2012.
English: [MB/EMA/155755/2012] The Management Board adopted the change to the entry grade from AST 3 to AD 6 for the post of Section Head for Financial Support services.
Danish: [MB/EMA/155755/2012] Bestyrelsen vedtog ændringen af begynderlønklassen fra AST 3 til AD 6 for stillingen som chef for finansielle støtteydelser.
English: b.) Revised conflicts of interests policy for experts
Danish: b) Revideret politik for håndtering af interessekonflikter for eksperter
English: Organisation of Management Board meetings
Danish: Tilrettelæggelse af bestyrelsens møder
English: e.) Second update on implementation of the conflicts of interests policy for staff
Danish: e) Anden orientering om gennemførelsen af politik for håndtering af interessekonflikter for personale
English: [EMA/MB/124276/2012] The Management Board appointed Michael Lenihan, Head of the Finance and Budget Sector, as the Agency's accounting officer, replacing Gerard O'Malley.
Danish: [EMA/MB/124276/2012] Bestyrelsen udnævnte Michael Lenihan, chef for finans- og budgetsektoren, til agenturets regnskabsfører.
English: d.) Revised Management Board conflicts of interests policy
Danish: d) Bestyrelsens reviderede politik for håndtering af interessekonflikter
English: Another proposal offered, which would allow knowledge about a product that had been gathered at the pre-authorisation stage to be retained, was to appoint the PRAC rapporteur from among the experts who had acted as peer-reviewers in the pre-authorisation phase.
Danish: Et andet forslag til, hvorledes viden om et produkt, der indsamles i fasen forud for godkendelse, kan registreres, gik ud på at vælge PRAC-rapportøren blandt de eksperter, der har vurderet produktet i fasen forud for godkendelse.