FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: V delovnem programu so za leto 2013 navedene naslednje prednostne naloge: nadaljnje izvajanje zakonodaje o farmakovigilanci in o ponarejenih zdravilih, nadaljnji razvoj komunikacijskih dejavnosti z večjo preglednostjo in boljšimi pojasnili glede postopka odločanja v agenciji, zagotavljanje učinkovitega sodelovanja med znanstvenimi odbori in povečanje učinkovitosti poslovanja agencije.
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.
Slovenian: • predlogom za direktivo o preglednosti, ki med drugimi ukrepi pojasnjuje področje uporabe, skrajšuje roke za odločitve o določanju cen in povračil ter obravnava združevanje zdravil v skupine zaradi povračil;
English: The Board also noted that declarations of interests and professional profiles of all managers have been published on the external website.
Slovenian: Upravni odbor je bil tudi seznanjen, da so bili na zunanji spletni strani objavljeni izjave o interesih in strokovni profili vseh vodstvenih delavcev.
English: • [EMA/MB/115063/2012] Summary of transfers of appropriations in the budget 2012.
Slovenian: • (EMA/MB/115063/2012) Povzetek prenosov dodeljenih sredstev v proračun za leto 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.
Slovenian: Prilagodljivo izdajanje dovoljenj se lahko opredeli kot vnaprej načrtovan, prilagodljiv pristop k regulaciji zdravil s ponavljajočimi se fazami zbiranja dokazov, ki jim sledita regulativna ocena in prilagoditev dovoljenja.
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.
Slovenian: Te med drugim vključujejo morebitne težave pri pridobivanju bolnikov za s placebom nadzorovana klinična preizkušanja po izdaji dovoljenja za promet z zdravilom, zagotavljanju podpore plačnikov, ki se odločijo za povračilo stroškov za taka zdravila, in obravnavanju pomislekov panoge same.
English: • Written procedure for adoption of the 74th Management Board meeting minutes closed on 9 February 2011.
Slovenian: • Pisni postopek za sprejetje zapisnika 74. seje upravnega odbora, končane 9. februarja 2011.
English: During the session, the Management Board heard expectations that patients - the main stakeholders in this process - have about public hearings.
Slovenian: Upravni odbor je bil med sejo obveščen o pričakovanjih, ki jih imajo bolniki kot glavne zainteresirane strani v tem postopku glede javnih obravnav.
English: Report on performance of national competent authorities against newly established key performance indicators (KPIs)
Slovenian: Poročilo o uspešnosti pristojnih nacionalnih organov na podlagi novo določenih ključnih kazalnikov uspešnosti
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.
Slovenian: Upravni odbor je v tem okviru podrobneje razpravljal o pogojih za začasno izključitev strokovnjaka iz njegovih dejavnosti do izida pregleda.
English: The European Commission representative made the remark that the Commission does not generally receive many applications for such posts from European organisations representing patients and healthcare professionals.
Slovenian: Predstavnik Evropske komisije je pripomnil, da Komisija iz evropskih organizacij, ki zastopajo bolnike in zdravstvene delavce, po navadi ne prejme veliko vlog za taka delovna mesta.
English: • inclusion of a reference to a system of ex-post checks, as well as the development of a breach of trust procedure.
Slovenian: • vključitev sklica na sistem naknadnih pregledov in razvoj postopka pri zlorabi zaupanja.
English: [EMA/MB/131620/2012] The Board discussed whether the current practice of holding one-day meetings is the most efficient arrangement.
Slovenian: (EMA/MB/131620/2012) Upravni odbor je razpravljal, ali je sedanja praksa enodnevnih sej najučinkovitejša ureditev.
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.
Slovenian: Predsednik je upravni odbor obvestil, da je pregledal izjave o interesih članov in sekretariata ter ugotovil, da ni navzkrižij interesov, ki bi posegala v teme seje.
English: Session 2:
Slovenian: 2. zasedanje:
English: • the definition of an institution in the context of receiving grants or other funding;
Slovenian: • opredelitev institucije v zvezi s prejemom donacij ali drugih oblik financiranja;
English: • Report of performance with respect to a limited subset of quantitative KPIs 2011.
Slovenian: • Poročilo o uspešnosti na podlagi omejenega podniza količinskih ključnih kazalnikov uspešnosti za leto 2011.
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.
Slovenian: V tem okviru je izziv agencije zagotoviti učinkovitost notranjih mehanizmov za podporo znanstvenim odborom, npr. poročevalcev, projektnih timov, sekretariatov odborov ter sistemov za komuniciranje in sodelovanje med odbori, pri prepoznavanju prvih znakov morebitnega razhajanja v postopku ocenjevanja.
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.
Slovenian: Razprava se je osredotočila na vprašanje, ali mora biti poročevalec odbora PRAC iz iste ali druge države članice kot poročevalec v prvi fazi ocenjevanja.
English: The Agency should also manage expectations about what the hearings will aim to achieve and what will not be tackled.
Slovenian: Agencija bi morala tudi obvladovati pričakovanja glede doseženih ciljev obravnav in glede nerešenih vprašanj.
English: The Board also supported the position of ensuring utmost transparency on post-authorisation matters, since these will have significant public interest.
Slovenian: Upravni odbor je tudi podprl stališče, naj se zagotovi čim večja preglednost zadev po pridobitvi dovoljenja za promet, saj bo javnost za to zelo zainteresirana.
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.
Slovenian: (EMA/MB/124276/2012) Upravni odbor je vodjo sektorja za finance in proračun Michaela Lenihana imenoval za računovodjo agencije, ki je tako nadomestil Gerarda O'Malleyja.
English: The number of applications received for initial-marketing authorisation for veterinary medicines declined slightly.
Slovenian: Število prejetih vlog za prvo dovoljenje za promet z zdravilom za uporabo v veterinarski medicini se je malce zmanjšalo.
English: • Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur appointment.
Slovenian: • imenovanje poročevalca Odbora za ocenjevanje tveganja na področju farmakovigilance (Pharmacovigilance Risk Assessment Committee, PRAC),
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.
Slovenian: To je zlasti pomembno zato, ker lahko odbor CHMP in skupina CMD(h) zavzameta po javni objavi mnenja odbora PRAC drugačno stališče.
English: However, patient representatives expressed their wish to see such hearings extended to other areas where patients have high expectations (e.g. unmet medical needs), where there is public concern (controversial media coverage), divergence between regulatory and HTA assessments, etc. Public hearings should address not just safety issues but also expected benefits of medicinal products.
Slovenian: Vendar so predstavniki bolnikov izrazili željo, naj se take obravnave razširijo še na druga področja, glede katerih imajo bolniki velika pričakovanja (npr. neizpolnjene zdravstvene potrebe) in glede katerih ima javnost pomisleke (sporna medijska pokritost) oziroma gre za razhajanje med regulativnim ocenjevanjem in ocenjevanjem zdravstvene tehnologije itd.
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.
Slovenian: Namerava izvajati tudi naknadne preglede ukrepov za ublažitev tveganja in predhodne kontrole za zagotovitev vključitve interesov v ustrezne dele obrazcev izjav o interesih.
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.
Slovenian: Člani so opozorili še na razpravo na sestanku vodij agencij za zdravila, pri kateri so vodje agencij za zdravila menili, da ni mogoče izvajati usklajenega sistema za obvladovanje navzkrižij interesov v vsej mreži.
English: Session 3:
Slovenian: 3. zasedanje:
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.
Slovenian: Na splošno se število vlog ne spreminja, kar pomeni predvidoma 112 vlog za izdajo dovoljenja za promet z zdravili za uporabo v humani industriji in 13 za zdravila za uporabo v veterinarski industriji.
English: The meeting noted a detailed update about progress on the implementation of provisions foreseen in the new pharmacovigilance legislation.
Slovenian: Udeleženci seje so se seznanili z najnovejšimi podrobnimi podatki o napredku pri izvajanju določb iz nove zakonodaje o farmakovigilanci.
English: • Written procedure for adoption of non-automatic carry-over of appropriations from 2011-2012 closed on 30 January 2012.
Slovenian: • Pisni postopek za sprejetje nesamodejnega prenosa odobrenih proračunskih sredstev iz leta 2011 v leto 2012, končan 30. januarja 2012.
English: Due to travel arrangements, some members are obliged to leave before the meeting finishes.
Slovenian: Nekateri člani morajo sejo zaradi potovanja zapustiti pred koncem.
English: • Presentation on public hearings in Europe.
Slovenian: • Predstavitev o javnih obravnavah v Evropi.
English: The underlying principle is to allow enough time for the CHMP/CMD(h) to review and debate the outcomes of the PRAC meetings.
Slovenian: Temeljno načelo je, naj se odboru CHMP/skupini CMD(h) omogoči dovolj časa za pregled in razpravo o ugotovitvah sej odbora PRAC.
English: e.) Second update on implementation of the conflicts of interests policy for staff
Slovenian: e) Druga posodobitev informacij o izvajanju politike o navzkrižjih interesov za osebje
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.
Slovenian: Težavi pri tem pristopu sta morebitni večji pritisk zunanjih strani na odbor CHMP/skupino CMD(h) in morebitno ukrepanje držav članic pred ugotovitvami odbora CHMP/skupine CMD(h).
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.
Slovenian: Komisija je glede na to, da je PRAC neodvisen odbor, in ob upoštevanju, da poročanje v prvi fazi ocenjevanja ni enakomerno razporejeno med države članice, menila, da mora biti poročevalec odbora PRAC iz druge države članice kot poročevalec v fazi pred izdajo dovoljenja za promet.
English: Work programme and preliminary draft budget 2013
Slovenian: Delovni program in predhodni predlog proračuna za leto 2013
English: The Board agreed on a process to prepare for the procedure.
Slovenian: Upravni odbor se je dogovoril tudi glede priprave za postopek.
English: Organisation of Management Board meetings
Slovenian: Organiziranje sej upravnega odbora
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.
Slovenian: (EMA/112052/2012) Upravni odbor se je seznanil s poročilom o vzorcu ključnih kazalnikov uspešnosti, vključenih v pogodbene dogovore s pristojnimi nacionalnimi organi.
English: Rapporteurship arrangements could be reviewed after that time.
Slovenian: Tedaj pa se bodo lahko pregledale ureditve glede poročanja.
English: European Commission Andrzej Rys Pedro Ortum Silvan
Slovenian: Andrzej Rys Pedro Ortum Silvan
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.
Slovenian: Predlagano je bilo, naj se najprej objavijo dnevni redi in zapisniki sej odbora PRAC, dnevni redi in zapisniki odbora CHMP in skupine CMD(h) pa naj se objavijo v drugi fazi, po pridobitvi zadostnih izkušenj.
English: Pat O'Mahony participated on Thursday, 22 March 2012
Slovenian: Pat O'Mahony se je seje udeležil v četrtek, 22. marca 2012.
English: The Management Board requested details of which ICT projects will be taken forward in 2013 to be provided for the next meeting.
Slovenian: Upravni odbor je naročil, naj se za naslednjo sejo pripravijo podatki o tem, kateri projekti IKT se bodo nadaljevali leta 2013.
English: The report reveals that, despite a challenging environment, the Agency was able to deliver a growing volume of core business in 2011.
Slovenian: Iz poročila je razvidno,da je agencija leta 2011 kljub neugodnim okoliščinam opravila večji obseg glavnih dejavnosti.
English: • Presentation on implementation of the pharmacovigilance legislation.
Slovenian: • Predstavitev o izvajanju zakonodaje o farmakovigilanci.
English: [EMA/MB/139702/2012] The Management Board adopted the procedure for consultation on final composition of the Pharmacovigilance Risk Assessment Committee (PRAC).
Slovenian: (EMA/MB/139702/2012) Upravni odbor je sprejel postopek za posvetovanje o končni sestavi Odbora za ocenjevanje tveganja na področju farmakovigilance (PRAC).
English: Committee on Herbal Medicinal Products (HMPC) in June to discuss topics relating to herbal medicines.
Slovenian: Upravni odbor se bo junija sestal s predsednikom Odbora za zdravila rastlinskega izvora (HMPC) in se z njim pogovoril o temah, povezanih z zdravili rastlinskega izvora.
English: • introduction of restrictions in case of a pharmaceutical company giving a grant or other funding;
Slovenian: • uvedbo omejitev, če farmacevtska družba zagotovi donacijo ali drugo obliko financiranja;
English: • Presentation on overview of PRAC expertise so far.
Slovenian: • Predstavitev o pregledu dotedanjega strokovnega znanja odbora PRAC.
English: [EMA/MB/13210/2012] The Management Board adopted the amended rules, adjusting the fees payable to the Agency by 3.1%, for inflation.
Slovenian: (EMA/MB/13210/2012) Upravni odbor je sprejel spremenjena pravila in zaradi inflacije za 3,1 % zvišal pristojbine, ki se plačajo agenciji.
English: Its members are Klaus Cichutek, Kristin Raudsepp and Grzegorz Cessak.
Slovenian: Njeni člani so Klaus Cichutek, Kristin Raudsepp in Grzegorz Cessak.
English: Salvatore D'acunto participated on Thursday, 22 March 2012
Slovenian: Salvatore D'acunto se je seje udeležil v četrtek, 22. marca 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.
Slovenian: (MB/EMA/155755/2012) Upravni odbor je sprejel spremembo vstopnega razreda iz AST 3 v AD 6 za delovno mesto vodje oddelka za storitve finančne podpore.
English: The members of the group are: Marcus Müllner, Luca Pani, Kristin Raudsepp, Andrzej Rys, Gro Wesenberg and Kent Woods.
Slovenian: Člani skupine so: Marcus Müllner, Luca Pani, Kristin Raudsepp, Andrzej Rys, Gro Wesenberg in Kent Woods.
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.
Slovenian: Število vlog za izdajo prvega dovoljenja za promet z zdravili za uporabo v humani medicini se je povečalo za 10 % in je obsegalo 100 prejetih vlog leta 2011.
English: Initiatives to set up the system for the review of raw clinical-trial data will be undertaken.
Slovenian: Sprejete bodo pobude za vzpostavitev sistema za pregled neobdelanih podatkov o kliničnih preizkusih.
English: Other members and alternates wishing to participate in these groups were invited to do so.
Slovenian: K sodelovanju so bili povabljeni tudi drugi člani in namestniki, ki si to želijo.
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.
Slovenian: Zakonodaja določa, da agencija objavi dnevne rede in zapisnike Odbora za zdravila za uporabo v humani medicini (Committee for Medicinal Products for Human Use, CHMP), odbora PRAC in skupine za usklajevanje postopka medsebojnega priznavanja in decentraliziranega postopka v humani medicini (CoOrdination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h)) v zvezi z dejavnostmi na področju farmakovigilance, upravni odbor pa je bil seznanjen z najnovejšimi informacijami v zvezi s pripravami na izvajanje teh določb.
English: The budget for 2013 is €239.1 million (2012: € 222.5 million), of which the forecast fee revenue is €181.9 million.
Slovenian: 222,5 milijona EUR) in vključuje predvideni prihodek od pristojbin v višini 181,9 milijona EUR.
English: List of participants at the 75th meeting of the Management Board, held in London, 21-22 March 2012
Slovenian: Seznam udeležencev 75. seje upravnega odbora v Londonu 21. in 22. marca 2012
English: Publication of agendas and minutes
Slovenian: Objava dnevnih redov in zapisnikov
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.
Slovenian: Med temami, ki so se obravnavale med obiskom, so bili načini za zagotovitev učinkovite in pravočasne komunikacije med agencijo in Evropsko komisijo ter potreba po ustreznem financiranju zakonodajnih pobud.
English: • EMA/MB/157253/2012 Performance of the Agency's scientific procedures: Survey 2011 for medicinal products for human use.
Slovenian: • EMA/157253/2012 Izsledki znanstvenih postopkov agencije: raziskava leta 2011 za zdravila za uporabo v humani medicini;
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).
Slovenian: Na podlagi analize je bila predlagana tudi vzpostavitev postopka pri zlorabi zaupanja in sistema naknadnih preverjanj informacij iz izjav o interesih.
English: [EMA/MB/977044/2011] The Management Board adopted the Agency's annual report 2011.
Slovenian: (EMA/MB/977044/2011) Upravni odbor je sprejel letno poročilo agencije za leto 2011.
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
Slovenian: • imenovanjem šestih strokovnjakov ter predstavnikov bolnikov in zdravstvenih delavcev po izboru Komisije v Odbor za ocenjevanje tveganja na področju farmakovigilance (predvidoma končano v drugem četrtletju leta 2012);
English: [EMA/MB/146762/2012] The Management Board noted the nominations to the PRAC provided by Member States to date.
Slovenian: (EMA/MB/146762/2012) Upravni odbor se je seznanil z imenovanji v odbor PRAC, ki so jih do tedaj predložile države članice.
English: • The endorsement of the reflection paper on ethical and GCP aspects of clinical trials in third countries.
Slovenian: • potrditvijo študije o etičnem vidiku in vidiku dobre klinične prakse glede kliničnih preizkušanj v tretjih državah;
English: • Presentation on public hearings.
Slovenian: • Predstavitev o javnih obravnavah.
English: • [EMA/MB/2671/2012] Outcome of written procedures during the period 25 November 2010 to 29 February 2012.
Slovenian: • (EMA/MB/2671/2012) Rezultat pisnih postopkov v obdobju od 25. novembra 2010 do 29. februarja 2012;
English: Language regime of the Management Board meetings
Slovenian: Jezikovna ureditev sej upravnega odbora
English: • [EMA/888135/2011] MBTC-2012-02-002 Management Board Telematics Committee meeting held on 9 November 2011
Slovenian: • (EMA/888135/2011) MBTC-2012-02-002 Zapisnik seje odbora za telematiko pri upravnem odboru z dne 9. novembra 2011.
English: The decision takes affect on 22 March 2012.
Slovenian: Sklep začne veljati 22. marca 2012.
English: • EMA/135587/2012 Annual report 2011 of the Agency's Internal Audit.
Slovenian: • EMA/135587/2012 Letno poročilo za leto 2011 o notranji reviziji agencije;
English: The change reflects the increased responsibilities - staff management, authorising and reporting officers - attached to the post.
Slovenian: Sprememba upošteva večje odgovornosti, povezane z delovnim mestom: upravljanje osebja, ocenjevalcev in odredbodajalcev.
English: • EMA/135591/2012 Annual report 2011 of the Agency's Audit Advisory Committee.
Slovenian: • EMA/135591/2012 Letno poročilo za leto 2011 revizijskega svetovalnega odbora agencije;
English: d.) Revised Management Board conflicts of interests policy
Slovenian: d) Spremenjena politika upravnega odbora o navzkrižjih interesov
English: [EMA/MB/33634/2012] The Management Board noted the final minutes, adopted by written procedure on 9 February 2012.
Slovenian: (EMA/MB/33634/2012) Upravni odbor se je seznanil s končnim zapisnikom, ki je bil sprejet s pisnim postopkom 9. februarja 2012.
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.
Slovenian: • (EMA/185199/2012) Poročilo o telematskih projektih EU; (EMA/189200/2012) Poročilo o delovanju na področju telematike v EU; (EMA/177625/2012) Zapisnik seje odbora za telematiko pri upravnem odboru z dne 14. februarja 2012;
English: [EMA/MB/64234/2012] The Management Board adopted the revised policy on managing conflicts of interests of its members.
Slovenian: (EMA/MB/64234/2012) Upravni odbor je sprejel spremenjeno politiko o obvladovanju navzkrižij interesov svojih članov.
English: b.) Revised conflicts of interests policy for experts
Slovenian: b) Spremenjena politika o navzkrižjih interesov za strokovnjake
English: Minutes of the 75th meeting of the Management Board
Slovenian: Zapisnik 75. seje upravnega odbora