FrancophonIA/ELRC3.0 huggingface dataset:
English: With regard to assessment activities, the Agency is largely at cruising speed.
Slovenian: Kar zadeva dejavnosti ocenjevanja, je agencija v glavnem na ravni ustaljenega delovanja.
English: d.) Project 2014
Slovenian: d) Projekt za leto 2014
English: Chair: Sir Kent Woods
Slovenian: Predsednik: sir Kent Woods
English: Pharmacovigilance Risk Assessment Committee a.) Consultation procedure on final composition
Slovenian: Odbor za ocenjevanje tveganja na področju farmakovigilance a) Posvetovalni postopek o končni sestavi
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.
Slovenian: Po mnenju udeležencev seje v zvezi z družbeno odgovornostjo podjetij je ustrezno, da se farmacevtsko industrijo zaprosi, naj objavi imena strokovnjakov, s katerimi sodeluje.
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.
Slovenian: Zaradi številnih proračunskih negotovosti za leto 2013 še ni bilo odločeno, kateri projekti informacijske in komunikacijske tehnologije (IKT) bodo predvideni za razvoj v letu 2013, izvedbene dejavnosti v zvezi z zakonodajo o farmakovigilanci pa se bodo spremenile.
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.
Slovenian: Upravni odbor je pozdravil predstavitev višjega zdravnika agencije Hans-Georga Eichlerja ter zagotovil podporne povratne informacije o konceptu in postavljenih vprašanjih.
English: • The EU proposal to reform ICH as regards its governance, global outreach and greater transparency.
Slovenian: • predlogom EU za reformo ICH (Mednarodne konference o usklajevanju), kar zadeva njeno upravljanje, svetovno sodelovanje in večjo preglednost;
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.
Slovenian: Oceno je zahteval Evropski parlament in je osredotočena na učinek prenosa odgovornosti z nacionalne na evropsko raven po ustanovitvi agencij EU na proračun EU in nacionalne proračune.
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.
Slovenian: Poročevalka je med obiskom agencijo obvestila, da je osnutek poročila o razrešnici že končan in morebitnih pripomb, ki bi jih agencija dala med srečanjem, v njem ne bo mogoče upoštevati.
English: On a general note, the Agency agreed to continuously monitor whether the amended rules restrict access to the necessary expertise.
Slovenian: Agencija se je na splošno strinjala s stalnim spremljanjem, ali spremenjena pravila omejujejo dostop do potrebnega strokovnega znanja.
English: • The international initiative on generics (the debate about whether to make this a standalone initiative or to include it within the ICH).
Slovenian: • mednarodno pobudo za generična zdravila (razpravo o tem, ali naj bo to samostojna pobuda ali naj se vključi v ICH);
English: • clarification on the membership of an ethics committee;
Slovenian: • pojasnilo v zvezi s članstvom v odboru za etična vprašanja;
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.
Slovenian: Člani so ob sprejetju teh sprememb izrazili zaskrbljenost, da zaostrovanje politik o navzkrižju interesov ogroža dostop agencije do celotnega znanstvenega strokovnega znanja, potrebnega za najkakovostnejšo oceno zdravil.
English: The report does not aim to provide the reasons for delays in submitting assessment reports by rapporteurs and co-rapporteurs.
Slovenian: Cilj poročila ni navesti vzroke, zakaj so poročevalci in soporočevalci zamujali pri predložitvi poročil o ocenjevanju.
English: The Board stressed the importance of transparency in this context.
Slovenian: Upravni odbor je poudaril, da je pri tem pomembna preglednost.
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.
Slovenian: Upravni odbor se jim je zahvalil za njihovo dejavno vlogo in koristne prispevke v različnih vlogah (kot člani, tematski koordinatorji in podpredsednik) k uspešnemu delu upravnega odbora.
English: The adoption of the pharmacovigilance proposal is expected soon.
Slovenian: Predlog o farmakovigilanci bo sprejet predvidoma kmalu;
English: The meeting also discussed that indicators measuring the quality of reports have to be developed over time, while recognising the difficulty in establishing and monitoring such indicators.
Slovenian: Udeleženci seje so razpravljali tudi o tem, da bo sčasoma treba razviti kazalnike za merjenje kakovosti poročil, ob tem so se strinjali, da sta vzpostavitev in spremljanje takih kazalnikov težki nalogi.
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.
Slovenian: Člani so poudarili pomembnost kakovosti in jasnosti postavljenih vprašanj, da udeleženci lahko zagotovijo svoje mnenje in odgovore ter nadaljujejo razpravo.
English: The implementation plan has been completed, including the assignment of risk levels, the implementation of mitigation procedures and the provision of training.
Slovenian: Izvedbeni načrt je končan, vključno z določitvijo ravni tveganja, izvajanjem postopkov za ublažitev in zagotavljanjem usposabljanja.
English: However, members also saw challenges that need to be overcome for this marketing-authorisation route to succeed.
Slovenian: Vendar so člani videli tudi izzive, ki jih je treba odpraviti za zagotovitev uspešnosti tega načina, ki temelji na izdaji dovoljenja za promet.
English: • clarification on the involvement in academic trials and in publicly funded research/development initiatives;
Slovenian: • pojasnilo v zvezi z vključitvijo v znanstvene preizkuse in javno financirane raziskovalne oziroma razvojne pobude;
English: c.) Breach of trust policy
Slovenian: c) Politika pri zlorabi zaupanja
English: Mary Geraldine Baker participated as an observer on Wednesday, 21 March 2012
Slovenian: Mary Geraldine Baker se je seje udeležila kot opazovalka v sredo, 21. marca 2012.
English: Circulated to the Board by e-mail on 17 January 2012; recorded in the minutes of the next meeting, as relevant.
Slovenian: Poslan upravnemu odboru po e-pošti 17. januarja2012; ustrezno zapisano v zapisniku naslednje seje.
English: • Presentation on conflicts of interests policy for scientific-committee members and experts.
Slovenian: • Predstavitev o politiki o navzkrižjih interesov za člane znanstvenih odborov in strokovnjake.
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.
Slovenian: Agencija bo objavila tudi življenjepise vseh strokovnjakov v podatkovni zbirki evropskih strokovnjakov, ob tem pa je bil sprejet projekt, ki bo omogočil prejemanje elektronskih življenjepisov in njihovo samodejno objavljanje.
English: Before publishing it, the amendments clarifying the receipt of grants by an institution and membership in ethics committees will be introduced.
Slovenian: Pred njeno objavo bodo uvedene spremembe, ki pojasnjujejo primere, ko institucija prejme donacije, in članstvo v odborih za etična vprašanja.
English: • clarification on the follow-up to be taken in case a member intends to be engaged in occupational activities with a pharmaceutical company;
Slovenian: • pojasnilo v zvezi z nadaljnjim spremljanjem, če član namerava opravljati poklicne dejavnosti v farmacevtski družbi;
English: The decision comes into effect on 1 April 2012.
Slovenian: Sklep začne veljati 1. aprila 2012.
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'.]
Slovenian: (Pripis po seji: Sekretariat agencije bo po nadaljnji proučitvi sprejete spremembe in ob upoštevanju dodatnih povratnih informacij članov odbora CHMP v dokumentu z vprašanji in odgovori (ki bo objavljen na spletni strani agencije in izročen vsem članom oziroma strokovnjakom po izpolnitvi izjav o interesih) navedel, da je treba „oddelek“ razumeti kot „neposredno organizacijsko enoto, v kateri član oziroma strokovnjak deluje“.)
English: Viola Macolić Šarinić (Croatia)
Slovenian: Viola Macolić Šarinić (Hrvaška)
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.
Slovenian: Nizozemski predstavnik je dal posebno pripombo v zvezi z omejitvami, ki se bodo uporabljale v primerih, ko farmacevtsko podjetje zagotovi donacijo ali drugo obliko financiranja instituciji člana oziroma strokovnjaka za raziskovalno delo, posameznik pa nima osebnih koristi.
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.
Slovenian: Upravni odbor je bil obveščen, da je predsednik 1. februarja 2012 po prejemu sklepa Komisije z dne 23. januarja 2012 o potrditvi dogovora o pravilih agencije v skladu s členom 110 kadrovskih predpisov podpisal „sklep o pravilih, ki se nanašajo na člen 11a in člen 13 kadrovskih predpisov v zvezi z obravnavanjem navedenih interesov zaposlenih v Evropski agenciji za zdravila“.
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.
Slovenian: Upravni odbor je glede preglednosti navzkrižja interesov poudaril, da je razkritje povezav udeležencev s panožnimi ali drugimi zainteresiranimi stranmi, katerih stališča zastopajo, zelo pomembno za zagotovitev jasnosti in verodostojnosti postopka.
English: A group has been set up to propose alternatives at the June meeting.
Slovenian: Ustanovljena je bila skupina za pripravo predlogov nadomestnih možnosti za junijsko sejo.
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.
Slovenian: Vendar pa večje število zahtevkov za veterinarsko znanstveno mnenje kaže, da je še vedno veliko zanimanje za dajanje na trg inovativnih zdravil za uporabo v veterinarski medicini po centraliziranem postopku.
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.
Slovenian: Za uresničitev svojih strateških ciljev na tem področju je ustanovila oddelek za komunikacije, ki si bo prizadeval za nadaljnjo krepitev doslednosti in usklajenosti komunikacijskih dejavnosti v sodelovanju z regulativno mrežo za zdravila in institucijami EU.
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).
Slovenian: Zelo (za več kot 20 %) sta se povečala tudi obseg dejavnosti po izdaji dovoljenja za promet in število postopkov napotitve (77 v primerjavi s 55 leta 2010).
English: The Board also set up a group for the analysis and assessment of the Executive Director's annual activity report 2011, with the following members: Xavier De Cuyper, Martina Cvelbar and Gro Wesenberg.
Slovenian: Upravni odbor je ustanovil tudi skupino za analizo in oceno letnega poročila izvršnega direktorja o dejavnostih, ki jo sestavljajo naslednji člani: Xavier De Cuyper, Martina Cvelbar in Gro Wesenberg.
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.
Slovenian: Te vključujejo: izvajanje zakonodaje o farmakovigilanci brez premostitvenega proračuna ali pristojbin za farmakovigilanco ter brez možnosti poplačila pristojnih nacionalnih organov, nobenih dodatnih finančnih virov za izvajanje zakonodaje o ponarejenih zdravilih, potrebo po financiranju selitve v nove prostore ter verjetno zahtevo za financiranje delodajalčevega dela pokojninskega prispevka.
English: Held in London, 21-22 March 2012
Slovenian: V Londonu, 21.-22. marca 2012
English: Identifying different arrangements that would address this concern and that would also enable the Board to discuss documents, amend them and resubmit them for adoption at the same meeting would add to the effective conduct of business.
Slovenian: Določitev drugačne ureditve, ki bi rešila to težavo in upravnemu odboru omogočila razpravo o dokumentih, njihovo spremembo in vnovično predložitev v sprejetje na isti seji, bi povečala učinkovitost poslovanja.
English: • The proposal on the revision of the veterinary medicines legislation planned for 2013.
Slovenian: • predlogom za revizijo zakonodaje o veterinarskih zdravilih, načrtovano za leto 2013;
English: Mr Houÿez also shared his experience from public hearings at the US Food and Drug Administration and made a number of practical suggestions.
Slovenian: Poleg tega je razkril svoje izkušnje z javnimi obravnavami v ameriški upravi za hrano in zdravila in podal več praktičnih predlogov.
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.
Slovenian: Med drugimi pomisleki je poudaril, da morajo imeti take obravnave jasno in opredeljeno strukturo ter jasen in razumljiv seznam vprašanj, morajo biti pregledne glede sponzoriranja udeležencev in morajo zagotavljati, da prispevki udeležencev obogatijo razpravo.
English: • The action plan and road map to tackle antimicrobial resistance.
Slovenian: • akcijskim in časovnim načrtom za boj proti protimikrobni odpornosti;
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).
Slovenian: V prihodnosti bi bilo zato treba proučiti, v kateri fazi postopka odločanja bi bila javna obravnava najkoristnejša (npr. pri obravnavi razmerja med koristmi in tveganji ali mejnih primerov).
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.
Slovenian: Skupina EU se je sestala s skupino visokih uradnikov iz vodstva FDA in med drugim razpravljala o: poti FDA k svetovni varnosti in kakovosti proizvodov, regulativni znanosti, biološko podobnih zdravilih, svetovnem pristopu h kliničnim raziskavam in vprašanjih, povezanih z inšpekcijskimi pregledi.
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.
Slovenian: Upravni odbor je razpravljal tudi o tem, ali bi morda države članice želele pri vnovičnem imenovanju članov po poteku triletnega mandata razmisliti, ali naj se število stalnih mandatov omeji, da se zagotovi menjavanje strokovnjakov.
English: Amendments to the Management Board implementing rules on the Agency's fees
Slovenian: Spremembe izvedbenih pravil upravnega odbora o pristojbinah agencije
English: • Presentation on PRAC rapporteurs: Proposed principles for appointment and roles/responsibilities of PRAC rappoerteurs.
Slovenian: • Predstavitev o poročevalcih odbora PRAC: predlagana načela za imenovanje in vloge oziroma odgovornosti poročevalcev odbora PRAC.
English: Policies on conflicts of interests a.) Second update on implementation
Slovenian: Politike agencije o navzkrižjih interesov a) Druga posodobitev informacij o izvajanju
English: Amending budget 01-2012 for changes to entry grade for a post
Slovenian: Sprememba proračuna 01-2012 zaradi sprememb vstopnega razreda za delovno mesto
English: • The legislative proposals for clinical trials and medical devices planned for 2012.
Slovenian: • zakonodajnimi predlogi za klinične preizkuse in medicinske pripomočke, načrtovano za leto 2012;
English: This was agreed upon by the Board.
Slovenian: Upravni odbor se je s tem strinjal.
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.
Slovenian: Po drugi strani pa je bilo poudarjeno, da je znanje o proizvodu en vidik poročanja odbora PRAC, posebno strokovno znanje o obvladovanju tveganj in neodvisnost od faze pred izdajo dovoljenja za promet pa spadata med druge pomembne pomisleke.
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.
Slovenian: Vodstvenim delavcem agencije je postavila vprašanja v zvezi z več zadevami, vključno z upravljanjem javnih naročil in pogodb, postopki za obvladovanje navzkrižij interesov, postopki ocenjevanja ter pregledom sistema plačil državam članicam.
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.
Slovenian: Mogočih je več drugih oblik sej, vključno s sejami, ki bi potekale dvakrat pol dneva (ko bi se lahko o bolj zapletenih zadevah razpravljalo prvi dan in bi jih bilo mogoče nadaljevati drugi dan), zgodnejšim začetkom sej, drugačno ureditvijo dnevnih redov sej (da se zagotovi sklepčnost za točke dnevnega reda, ki jih je treba sprejeti), uporabo telekonferenc ali kombinacijo navedenih ukrepov.
English: The Board suggested organising a mock-up hearing at some stage, and using the experience gained from this when finalising the procedure.
Slovenian: Upravni odbor je predlagal, naj se v neki fazi organizira poskusno obravnavo, pridobljene izkušnje pa naj se uporabijo pri dokončanju postopka.
English: • Presentation on EU legislative and policy developments in the public-health area.
Slovenian: • Predstavitev o razvoju zakonodaje in politike EU na področju javnega zdravja.
English: A delegation from the authority will visit the Agency to compare regulatory requirements in June.
Slovenian: Zaradi primerjave regulativnih zahtev bo delegacija organa junija obiskala agencijo.
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.
Slovenian: • dogovorom vodij agencij za zdravila, da se objavijo informacije o odobritvi kliničnih preizkušanj v EU v okviru ocene učinka revizije direktive o kliničnih preizkusih;
English: Draft agenda for 22 March 2012 meeting
Slovenian: Osnutek dnevnega reda za sejo dne 22. marca 2012
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.
Slovenian: • delom skupine CMD(v) za prednostno razvrstitev zdravil za uporabo v veterinarski medicini, za katera je treba uskladiti povzetke značilnosti, in da predlaga pristop k uskladitvi teh povzetkov;
English: A broader constellation of stakeholders has to participate, including the clinical community, healthcare providers, patients, payers and industry.
Slovenian: Sodelovati mora še več različnih zainteresiranih strani, vključno s klinično skupnostjo, izvajalci zdravstvenih storitev, bolniki, plačniki in panoga.
English: A discussion on PRAC rapporteur appointment (follow-up to the February HMA meeting)
Slovenian: Razprava o imenovanju poročevalca odbora PRAC (nadaljevanje razprave s februarske seje skupine vodij agencij za zdravila)
English: [EMA/MB/47692/2012] The agenda was adopted.
Slovenian: (EMA/MB/47692/2012) Dnevni red je bil sprejet.
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.
Slovenian: Člani so razpravljali še o potrebi po jasnem ločevanju pristojnosti odborov CHMP in PRAC pri oceni razmerja med koristmi in tveganji ter obvladovanju tveganj.
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.
Slovenian: Potrdili so, da v odboru ni mogoče pokriti vseh kliničnih področij, vendar pa so ob tem menili, da bi bilo zaželeno pridobiti več kliničnih strokovnjakov za zagotovitev, da priporočila odbora PRAC ustrezno upoštevajo koristi zdravil.
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.
Slovenian: Agencija je v okviru strategije za zagotovitev učinkovite povezave s pristojnimi nacionalnimi organi in po razpravi z vodji agencij za zdravila imenovala tudi uradnika za zvezo z vodji agencij za zdravila.
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.
Slovenian: S prilagodljivim izdajanjem dovoljenj se skuša čim bolj povečati pozitivni učinek novih zdravil na javno zdravje, in sicer z uravnavanjem pravočasnega dostopa za bolnike s potrebo po zagotavljanju ustreznih novih informacij o koristih in škodljivostih.