FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency should also manage expectations about what the hearings will aim to achieve and what will not be tackled.
Danish: Agenturet skal også forvalte forventninger til høringernes formål, og hvad man ikke ønsker behandlet på høringer.
English: The Dutch member asked the European Commission and the Parliament representatives to bring these concerns to the attention of the EU Parliament, and to make the Parliament aware that full implementation of the pharmacovigilance legislation in July will not be possible.
Danish: Det nederlandske medlem bad Europa-Kommissionens og Parlamentets repræsentanter formidle dette til EuropaParlamentet og gøre sidstnævnte bekendt med, at det inden juli ikke vil være muligt at gennemføre lovgivningen om lægemiddelovervågning fuldt ud.
English: This raised concern about the possible outcome of the discharge procedure even though considerable improvements had been made.
Danish: dechargeproceduren, også selv om der var gjort store forbedringer.
English: The concept is being debated among regulators worldwide, and is referred to in the Agency's strategy document on the subject, which states that a key issue for regulators will be whether a more staggered approval concept should be envisaged for situations not covered by conditional marketing authorisations.
Danish: Begrebet blev drøftet af lovgivere i hele verden og nævnes i agenturets strategidokument, hvor det anføres, at det for lovgiverne er et centralt spørgsmål, hvorvidt der bør indføres en mere gradvis godkendelsesprocedure for de situationer, som ikke er omfattet af betingede markedsføringstilladelser.
English: A specific comment was made by the Netherlands' representative in relation to the restrictions that will apply in situations where the member's/ expert's institution receives a grant or other funding from a pharmaceutical company for research work and the individual receives no personal gain.
Danish: Den nederlandske repræsentant kommenterede især de restriktioner, der vil gælde i de situationer, hvor medlemmets/ekspertens institution modtager tilskud eller anden finansiering fra en lægemiddelvirksomhed til forskningsarbejde, uden at den enkelte person opnår personlig vinding.
English: • introduction of restrictions in case current direct interests of one or more household members have been declared;
Danish: • indførelse af restriktioner, hvis der indgives erklæring om direkte interesser for et eller flere medlemmer af en husholdning
English: According to the procedure, the Board will issue its recommendations on whether any of the areas of PRAC expertise need strengthening.
Danish: Ifølge proceduren skal bestyrelsen udstede sine anbefalinger til, om der er behov for at styrke PRAC's ekspertområder.
English: The minutes were adopted.
Danish: Referatet blev vedtaget.
English: In the context of the social corporate responsibility, the meeting considered it appropriate that the pharmaceutical industry should be asked to publish names of experts with whom it cooperates.
Danish: I forbindelse med virksomhedernes sociale ansvar fandt mødedeltagerne det hensigtsmæssigt, at lægemiddelindustrien bør anmodes om at offentliggøre navne på de eksperter, som virksomhederne samarbejder med.
English: • Presentation on proposal for a directive of the European Parliament and the Council relating to the transparency measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems.
Danish: • Præsentation af forslag til Europa-Parlamentets og Rådets direktiv om gennemsigtighed i prisbestemmelserne for lægemidler til mennesker og disse lægemidlers inddragelse under de nationale sygesikringsordninger.
English: Mary Geraldine Baker participated as an observer on Wednesday, 21 March 2012
Danish: Mary Geraldine Baker deltog som observatør i mødet onsdag den 21. marts 2012.
English: In addition, members were asked to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Danish: Medlemmerne blev desuden anmodet om at afgive erklæring om specifikke interesser, der kunne påvirke deres uafhængighed for så vidt angår punkterne på dagsordenen.
English: The EU contribution remains at the 2012 level of €38.8 million.
Danish: EU's bidrag er det samme som i 2012, nemlig 38,8 mio. EUR.
English: The Board agreed on a process to prepare for the procedure.
Danish: Bestyrelsen vedtog en proces for forberedelsen af proceduren.
English: It was suggested that such hearings could be streamed to national competent authorities and that the public could participate in hearings from their premises.
Danish: Det blev foreslået, at høringerne streames til de nationale kompetente myndigheder, og at offentligheden gives mulighed for at deltage i høringer fra deres egen lokalitet.
English: During the visit, the rapporteur informed the Agency that the draft discharge report had already been finalised and any comments made by the Agency during the meeting could not be reflected in the report.
Danish: Under besøget meddelte ordføreren agenturet, at der allerede var lagt sidste hånd på et udkast til betænkning om decharge, og at eventuelle bemærkninger fra agenturet fremsat under mødet ikke vil blive afspejlet i betænkningen.
English: The Chair of the HMA management group provided an update on a number of items, including the following:
Danish: Formanden for lægemiddelstyrelseschefernes ledergruppe (HMA) orienterede om en række punkter, bl.a.:
English: Annually, the Management Board dedicates the first day of its March meeting to discussions on strategic topics.
Danish: Bestyrelsen afsatte den første dag af mødet i marts til den årlige drøftelse af strategiske spørgsmål.
English: Members reiterated their concern at the consistently low number of entries to the list of herbal substances, due to the unavailability of genotoxicity data.
Danish: Medlemmerne gentog deres bekymring over det konstant lave antal registreringer på listen over plantestoffer, der skyldes manglende adgang til data om gentoksicitet.
English: Future reflection should therefore consider at which stage of the decision process a public hearing would be most valuable (e.g. when addressing benefit-risk or borderline issues).
Danish: Fremover burde man derfor overveje, i hvilken fase af beslutningsprocessen en offentlig høring vil være af størst værdi (f.eks. i vurderingen af fordele-risici eller grænsetilfælde).
English: The meeting was informed that the Agency had received a European Court of Auditors draft audit report on conflicts of interests conducted in 2011.
Danish: Mødedeltagerne blev orienteret om, at agenturet havde modtaget Revisionsrettens udkast til rapport om interessekonflikter fra 2011.
English: The Board welcomed the presentation by Hans-Georg Eichler, the Agency's Senior Medical Officer, and provided supportive feedback about the concept and issues raised.
Danish: Bestyrelsen takkede for indlægget fra Hans-Georg Eichler, agenturets cheflæge, og kom med feedback til begrebet og de rejste spørgsmål.
English: European Commission Andrzej Rys Pedro Ortum Silvan
Danish: Europa-Kommissionen Andrzej Rys Pedro Ortum Silvan
English: To achieve its strategic objectives in this area, the Agency established the Communications Sector, which will aim to further strengthen consistency and coordination of communication activities, in cooperation with the medicines regulatory network and the EU institutions.
Danish: For at virkeliggøre de strategiske målsætninger på dette område har agenturet etableret kommunikationssektoren til styrkelse af sammenhængen mellem og koordinationen af kommunikationsaktiviteter i samarbejde med lægemiddelstyrelsesnetværket og EU's institutioner.
English: A discussion on PRAC rapporteur appointment (follow-up to the February HMA meeting)
Danish: Drøftelsen af udnævnelse af en PRAC-rapportør (opfølgning på lægemiddelstyrelseschefernes møde i februar)
English: Initiatives to set up the system for the review of raw clinical-trial data will be undertaken.
Danish: Der vil blive iværksat initiativer til etablering af systemet for revision af rådata fra kliniske undersøgelser.
English: The debate focused around the issue of whether a PRAC rapporteur should be from the same Member State as the rapporteur in the initial evaluation stage, or from a different one.
Danish: Debatten vedrørte især, hvorvidt en PRAC-rapportør bør komme fra samme medlemsstat som rapportøren i den indledende evalueringsfase eller fra en anden.
English: The Board also extended its invitation to the observers from civil society to participate at the next meeting, in June, if the nomination process for new representatives is not completed in time for the meeting.
Danish: Bestyrelsen inviterede observatørerne fra civilsamfundet til at deltage i det næste møde i juni, hvis udnævnelsesprocessen for nye repræsentanter ikke er afsluttet inden dette møde.
English: The EU team met with a high-level team from the FDA's leadership, and discussed, among other topics: the FDA's pathway to global product safety and quality; regulatory science; biosimilars; a global approach to clinical studies; and inspection-related matters.
Danish: EU's delegation mødtes med en højtstående delegation fra FDA's ledelse og drøftede bl.a. følgende emner: FDA's vej til global produktsikkerhed og kvalitet, regulatorisk forskning, biosimilære produkter, en global tilgang til kliniske undersøgelser og tilsynsrelaterede spørgsmål.
English: These include: implementation of the pharmacovigilance legislation without the bridging budget or pharmacovigilance fees, and without the possibility of remunerating national competent authorities; no additional financial resources for the implementation of the falsified medicines legislation; the need to finance the move to new premises; and a likely requirement to finance the employer's part of the pension contribution.
Danish: Disse omfatter bl.a. gennemførelse af lovgivning om lægemiddelovervågning, uden budgetforøgelse eller gebyrer fra overvågning af lægemidler og uden mulighed for at betale nationale kompetente myndigheder, ingen yderligere finansielle ressourcer til gennemførelsen af lovgivning om kopimedicin, nødvendigheden af at finansiere flytningen til nye lokaler og et sandsynligt krav til finansiering af arbejdsgivers del af pensionsbidraget.
English: Viola Macolić Šarinić (Croatia)
Danish: Viola Macolić Šarinić (Kroatien)
English: However, members also saw challenges that need to be overcome for this marketing-authorisation route to succeed.
Danish: Der skal dog også håndteres en række udfordringer, hvis løsningen med denne markedsføringstilladelse skal blive en succes.
English: Policies on conflicts of interests a.) Second update on implementation
Danish: 10. Politikker for håndtering af interessekonflikter a) Anden orientering om gennemførelse
English: The rapporteur questioned the Agency's management team on a number of issues, including procurement and contract management, procedures for managing conflicts of interests, assessment procedures, and review of the system of payments to Member States.
Danish: Ordføreren stillede spørgsmål til agenturets ledelse på en række områder, herunder indkøbs- og kontraktforvaltning, procedurer til håndtering af interessekonflikter, vurderingsprocedurer og en revision af systemet med betalinger til medlemsstaterne.
English: When adopting these changes, members voiced their concern that increased tightening of conflicts of interests policies threatens to deny the Agency access to the full range of scientific expertise that is necessary for the highest-quality assessment of medicines.
Danish: Under vedtagelsen af disse ændringer udtrykte nogle medlemmer bekymring over, at den øgede stramning af politikker for håndtering af interessekonflikter truede med at hindre agenturet i at få adgang til al den videnskabelige ekspertviden, der var nødvendig for at sikre den bedst mulige vurdering af lægemidler.
English: Patient representatives requested a possibility for both a member and an alternate to attend all PRAC meetings.
Danish: Patientrepræsentanterne anmodede om muligheden for, at både et medlem og en suppleant kan deltage i møderne i PRAC.
English: The challenge for the Agency in this context is to ensure that the internal mechanisms to support the scientific committees - e.g. the rapporteurs, product teams, committee secretariats and systems for communication and cooperation among the committees - are effective at capturing early signals of possible divergence in the assessment process.
Danish: I denne forbindelse er det agenturets opgave at sikre, at de interne mekanismer til støtte for de videnskabelige komitéer, f.eks. rapportører, produkthold, udvalgssekretariater og systemer til kommunikation og samarbejde mellem udvalgene, effektivt opfanger tidlige signaler på potentielle meningsforskelle i vurderingsprocessen.
English: A number of alternative meeting formats are possible, including holding meetings over two half-days (where more complex items could be discussed on the first day, allowing for any follow-up on the second), starting meetings earlier, arranging meeting agendas differently (to ensure the quorum for items requiring adoption), using teleconferencing, or a combination of these measures.
Danish: En anden mulighed kunne være at afholde møder over to halve dage (hvor de mere komplekse punkter kunne drøftes den første dag med opfølgning den anden dag), starte mødet tidligere, ændre på dagsordenen (for at sikre kvorum til de emner, der skulle vedtages), benytte telekonferencer eller en kombination af disse foranstaltninger.
English: The policy takes into account comments made at the previous meeting and those received by correspondence.
Danish: I politikken tages der hensyn til bemærkningerne fra det foregående møde, herunder de fremsendte synspunkter.
English: The document will be published on the Agency's website.
Danish: Dokumentet offentliggøres på agenturets websted.
English: • the definition of an institution in the context of receiving grants or other funding;
Danish: • definition af en institution i forbindelse med modtagelse af tilskud eller anden finansiering
English: Members also discussed that a clear distinction of responsibilities between the CHMP and the PRAC is needed with regard to benefit-risk assessment and risk management.
Danish: Medlemmerne drøftede ligeledes nødvendigheden af en klar sondring mellem CHMP's og PRAC's ansvarsområder for så vidt angår vurdering af fordele/risici og risikostyring.
English: He underlined that, among other considerations, such hearings should have a clear and defined structure, a clear and understandable list of questions, be transparent about sponsorship of participants, and ensure that contributions by participants add to the discussion.
Danish: Han understregede bl.a., at sådanne høringer bør have en klar, veldefineret struktur, en klar, forståelig liste med spørgsmål, være gennemsigtig for så vidt angår sponsering af deltagere og sikre, at deltagernes bidrag tilfører drøftelsen indhold.
English: The representative, supported by other Board members, expressed concerns about the impact of such restrictions on the availability of members/experts from academia.
Danish: Repræsentanten fik opbakning fra andre bestyrelsesmedlemmer og udtrykte bekymring over følgerne af sådanne restriktioner, dvs. om der fortsat vil være adgang til medlemmer/eksperter fra den akademiske verden.
English: • Presentation on conflicts of interests policy for scientific-committee members and experts.
Danish: • Præsentation af politik for håndtering af interessekonflikter blandt medlemmer af videnskabelige udvalg og eksperter.
English: The Agency will draft a reflection paper based on the guidance provided today, and will seek written comments from the Board.
Danish: Agenturet vil lave et udkast til arbejdsdokument om den vejledning, der ydes i dag, og indhente skriftlige bemærkninger fra bestyrelsen.
English: Draft agenda for 22 March 2012 meeting
Danish: Forslag til dagsorden for mødet den 22. marts 2012
English: The implementation plan has been completed, including the assignment of risk levels, the implementation of mitigation procedures and the provision of training.
Danish: Gennemførelsesplanen er blevet udført, herunder tildelingen af risikoniveauer, gennemførelsen af risikoreducerende procedurer og leveringen af undervisning.
English: • The EU proposal to reform ICH as regards its governance, global outreach and greater transparency.
Danish: • EU's forslag til reform af den internationale harmoniseringskonference (IHC) for så vidt angår ledelse, global udbredelse og større gennemsigtighed
English: This information would be important for regulators and for society at large in further ensuring that interests of experts contributing to the regulatory assessment of medicines are known.
Danish: Denne oplysning vil være vigtig for lovgivere og samfundet som helhed for at sikre kendskabet til de interesser, som eksperter, der deltager i den lovgivningsmæssige vurdering af lægemidler, har.
English: A further discussion on ICT projects is planned for the June meeting.
Danish: IKT-projekter vil desuden blive diskuteret på mødet i juni.
English: The change reflects the increased responsibilities - staff management, authorising and reporting officers - attached to the post.
Danish: Ændringen skyldes det øgede ansvarpersonaleledelse samt godkendelse og rapportering - der var knyttet til stillingen.
English: • The CMD(v)'s work to prioritise the veterinary medicinal products for which summaries of product characteristics (SmPCs) should be harmonised and to propose an approach to SmPC harmonisation.
Danish: • CMD(v)'s arbejde med at prioritere de veterinærmedicinske produkter, hvor produktresuméerne bør harmoniseres, herunder forslag til en tilgang for denne harmonisering
English: Although recognising that it is not possible to cover all clinical areas within the committee, members considered that more clinical experts would be welcome, to ensure that PRAC recommendations take due account of the benefits of medicinal products.
Danish: Skønt medlemmerne erkendte, at det ikke er muligt at dække alle kliniske områder, fandt de, at det er vigtigt at få flere kliniske eksperter for at sikre, at der i PRAC's anbefalinger tages behørigt hensyn til fordelene ved lægemidler.
English: These include, among others, the possible difficulty of enrolling patients for placebocontrolled clinical trials after the product has been authorised, assuring the support of payers who decide on reimbursement for such products, and addressing concerns of the industry.
Danish: Det omhandler bl.a. eventuelle problemer med at få patienter til at deltage i placebo-kontrollerede kliniske undersøgelser efter produktets godkendelse, at sikre støtte fra de betalere, som træffer afgørelser om godtgørelse for sådanne produkter, og at håndtere industriens eventuelle problemer.
English: Another key opinion of the Board was that hearings should add value to the assessment process by offering views of the patient community or the general public.
Danish: Bestyrelsen mente desuden, at høringer bør tilføre vurderingsprocessen værdi i form af adgang til patientsamfundets eller offentlighedens synspunkter.
English: Due to the number of budgetary uncertainties for 2013, the decision about which information and communications technology (ICT) projects will be planned for development in 2013 is pending, and the implementation activities for the pharmacovigilance legislation are subject to change.
Danish: På grund af de mange usikkerhedsmomenter i budgettet for 2013 var der ikke truffet beslutning om, hvilke informations- og kommunikationsteknologiprojekter, der skulle udvikles i 2013, og gennemførelsesaktiviteterne forbundet med lovgivning om lægemiddelovervågning vil sandsynligvis blive ændret.
English: [Post-meeting note: the Agency secretariat, when further reflecting on the amendment made, and taking into account additional feedback from CHMP members, will specify in a Q&A document (which will be published on the Agency's website, as well as being provided to all members/experts when completing their DoI) that a 'department' needs to be understood as 'the immediate organisational entity in which the member/expert operates'.]
Danish: [Note efter mødet: Agenturets sekretariat vil, efter yderligere overvejelser om denne ændring og under hensyntagen til anden feedback fra medlemmer af CHMP i et dokument med spørgsmål og svar (som vil blive offentliggjort på agenturets websted og sendt til alle medlemmer/eksperter, når de har udfyldt interesseerklæringen), specificere, at en »afdeling« bør forstås som »den umiddelbare organisatoriske enhed, som medlemmet/eksperten arbejder i«.] På et mere overordnet plan vedtog agenturet fortsat at overvåge, om de ændrede regler begrænser adgangen til den nødvendige ekspertviden.
English: • The international initiative on generics (the debate about whether to make this a standalone initiative or to include it within the ICH).
Danish: • det internationale initiativ om generiske lægemidler (debat om, hvorvidt dette skal være et enkeltstående initiativ eller omfattet af ICH)
English: The Board also supported the position of ensuring utmost transparency on post-authorisation matters, since these will have significant public interest.
Danish: Bestyrelsen var også enig i betydningen af at sikre størst mulig gennemsigtighed om spørgsmål vedrørende forhold efter godkendelse, da disse er af stor interesse for offentligheden.
English: The Board suggested organising a mock-up hearing at some stage, and using the experience gained from this when finalising the procedure.
Danish: Bestyrelsen foreslog at afholde en prøvehøring på et tidspunkt og udnytte erfaringerne herfra for at kunne færdiggøre proceduren.
English: The work programme sets the following priorities for 2013: continued implementation of the legislation on pharmacovigilance and on falsified medicines; further development of the communication activities, with increased transparency and better explanation of how the Agency arrives at decisions; ensuring efficient interactions between the scientific committees; and increasing the efficiency of the Agency's operations.
Danish: I arbejdsprogrammet fastlægges følgende prioriteter for 2013: fortsat gennemførelse af lovgivning om lægemiddelovervågning og kopimedicin, videreudvikling af kommunikationsaktiviteterne i form af øget gennemsigtighed og bedre redegørelse for, hvordan agenturet når frem til sine afgørelser, sikring af effektivt samspil mellem de videnskabelige udvalg samt øget effektivitet i agenturets aktiviteter.
English: In this context, the Board discussed in more detail the conditions for the suspension of an expert from his or her activities pending the outcome of the review.
Danish: Bestyrelsen drøftede indgående betingelserne for at suspendere en ekspert fra sine aktiviteter under afventningen af undersøgelsens resultat.
English: • The proposal for the transparency directive, which, among many measures, clarifies the scope, reduces the time limits for pricing and reimbursement decisions, and addresses the grouping of medicines for reimbursement purposes.
Danish: • forslaget til direktiv om gennemsigtighed, der bl.a. afklarer anvendelsesområdet, sænker tidsfristerne for beslutninger om prisfastsættelse og godtgørelse og omhandler gruppering af lægemidler af godtgørelseshensyn
English: Some members argued that unless benefits of having a different rapporteur can be demonstrated and quantified, they would be unwilling to provide the additional resources needed.
Danish: Enkelte medlemmer anførte, at medmindre det kan påvises og sættes tal på fordelene ved at have en rapportør fra en anden medlemsstat, ville de afvige at bevilge de fornødne ekstra ressourcer.
English: Rannveig Gunnarsdóttir (Iceland) Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norway)
Danish: Rannveig Gunnarsdóttir (Island) Brigitte Batliner (Liechtenstein) Gro Wesenberg (Norge)