natgillin/translations-raw huggingface dataset:
[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'.]
(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“.)
Viola Macolić Šarinić (Croatia)
Viola Macolić Šarinić (Hrvaška)
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.
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.
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.
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“.
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.
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.
A group has been set up to propose alternatives at the June meeting.
Ustanovljena je bila skupina za pripravo predlogov nadomestnih možnosti za junijsko sejo.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
Held in London, 21-22 March 2012
V Londonu, 21.-22. marca 2012
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.
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.
• The proposal on the revision of the veterinary medicines legislation planned for 2013.
• predlogom za revizijo zakonodaje o veterinarskih zdravilih, načrtovano za leto 2013;
Mr Houÿez also shared his experience from public hearings at the US Food and Drug Administration and made a number of practical suggestions.
Poleg tega je razkril svoje izkušnje z javnimi obravnavami v ameriški upravi za hrano in zdravila in podal več praktičnih predlogov.
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.
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.
• The action plan and road map to tackle antimicrobial resistance.
• akcijskim in časovnim načrtom za boj proti protimikrobni odpornosti;
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).
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).
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.
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.
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.
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.
Amendments to the Management Board implementing rules on the Agency's fees
Spremembe izvedbenih pravil upravnega odbora o pristojbinah agencije
• Presentation on PRAC rapporteurs: Proposed principles for appointment and roles/responsibilities of PRAC rappoerteurs.
• Predstavitev o poročevalcih odbora PRAC: predlagana načela za imenovanje in vloge oziroma odgovornosti poročevalcev odbora PRAC.
Policies on conflicts of interests a.) Second update on implementation
Politike agencije o navzkrižjih interesov a) Druga posodobitev informacij o izvajanju
Amending budget 01-2012 for changes to entry grade for a post
Sprememba proračuna 01-2012 zaradi sprememb vstopnega razreda za delovno mesto
• The legislative proposals for clinical trials and medical devices planned for 2012.
• zakonodajnimi predlogi za klinične preizkuse in medicinske pripomočke, načrtovano za leto 2012;
This was agreed upon by the Board.
Upravni odbor se je s tem strinjal.
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.
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.
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.
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.
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.
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.
The Board suggested organising a mock-up hearing at some stage, and using the experience gained from this when finalising the procedure.
Upravni odbor je predlagal, naj se v neki fazi organizira poskusno obravnavo, pridobljene izkušnje pa naj se uporabijo pri dokončanju postopka.
• Presentation on EU legislative and policy developments in the public-health area.
• Predstavitev o razvoju zakonodaje in politike EU na področju javnega zdravja.
A delegation from the authority will visit the Agency to compare regulatory requirements in June.
Zaradi primerjave regulativnih zahtev bo delegacija organa junija obiskala agencijo.
• 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.
• dogovorom vodij agencij za zdravila, da se objavijo informacije o odobritvi kliničnih preizkušanj v EU v okviru ocene učinka revizije direktive o kliničnih preizkusih;
Draft agenda for 22 March 2012 meeting
Osnutek dnevnega reda za sejo dne 22. marca 2012
• 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.
• 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;
A broader constellation of stakeholders has to participate, including the clinical community, healthcare providers, patients, payers and industry.
Sodelovati mora še več različnih zainteresiranih strani, vključno s klinično skupnostjo, izvajalci zdravstvenih storitev, bolniki, plačniki in panoga.
A discussion on PRAC rapporteur appointment (follow-up to the February HMA meeting)
Razprava o imenovanju poročevalca odbora PRAC (nadaljevanje razprave s februarske seje skupine vodij agencij za zdravila)
[EMA/MB/47692/2012] The agenda was adopted.
(EMA/MB/47692/2012) Dnevni red je bil sprejet.
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.
Člani so razpravljali še o potrebi po jasnem ločevanju pristojnosti odborov CHMP in PRAC pri oceni razmerja med koristmi in tveganji ter obvladovanju tveganj.
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.
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.
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.
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.
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.
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.
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.
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.
• 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.
• 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;
The Board also noted that declarations of interests and professional profiles of all managers have been published on the external website.
Upravni odbor je bil tudi seznanjen, da so bili na zunanji spletni strani objavljeni izjave o interesih in strokovni profili vseh vodstvenih delavcev.
• [EMA/MB/115063/2012] Summary of transfers of appropriations in the budget 2012.
• (EMA/MB/115063/2012) Povzetek prenosov dodeljenih sredstev v proračun za leto 2012;
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.
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.
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.
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.
• Written procedure for adoption of the 74th Management Board meeting minutes closed on 9 February 2011.
• Pisni postopek za sprejetje zapisnika 74. seje upravnega odbora, končane 9. februarja 2011.
During the session, the Management Board heard expectations that patients - the main stakeholders in this process - have about public hearings.
Upravni odbor je bil med sejo obveščen o pričakovanjih, ki jih imajo bolniki kot glavne zainteresirane strani v tem postopku glede javnih obravnav.
Report on performance of national competent authorities against newly established key performance indicators (KPIs)
Poročilo o uspešnosti pristojnih nacionalnih organov na podlagi novo določenih ključnih kazalnikov uspešnosti
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.
Upravni odbor je v tem okviru podrobneje razpravljal o pogojih za začasno izključitev strokovnjaka iz njegovih dejavnosti do izida pregleda.
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.
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.
• inclusion of a reference to a system of ex-post checks, as well as the development of a breach of trust procedure.
• vključitev sklica na sistem naknadnih pregledov in razvoj postopka pri zlorabi zaupanja.
[EMA/MB/131620/2012] The Board discussed whether the current practice of holding one-day meetings is the most efficient arrangement.
(EMA/MB/131620/2012) Upravni odbor je razpravljal, ali je sedanja praksa enodnevnih sej najučinkovitejša ureditev.
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.
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.
Session 2:
2. zasedanje:
• the definition of an institution in the context of receiving grants or other funding;
• opredelitev institucije v zvezi s prejemom donacij ali drugih oblik financiranja;
• Report of performance with respect to a limited subset of quantitative KPIs 2011.
• Poročilo o uspešnosti na podlagi omejenega podniza količinskih ključnih kazalnikov uspešnosti za leto 2011.
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.
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.
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.
Razprava se je osredotočila na vprašanje, ali mora biti poročevalec odbora PRAC iz iste ali druge države članice kot poročevalec v prvi fazi ocenjevanja.
The Agency should also manage expectations about what the hearings will aim to achieve and what will not be tackled.
Agencija bi morala tudi obvladovati pričakovanja glede doseženih ciljev obravnav in glede nerešenih vprašanj.
The Board also supported the position of ensuring utmost transparency on post-authorisation matters, since these will have significant public interest.
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.
[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.
(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.
The number of applications received for initial-marketing authorisation for veterinary medicines declined slightly.
Število prejetih vlog za prvo dovoljenje za promet z zdravilom za uporabo v veterinarski medicini se je malce zmanjšalo.
• Pharmacovigilance Risk Assessment Committee (PRAC) rapporteur appointment.
• imenovanje poročevalca Odbora za ocenjevanje tveganja na področju farmakovigilance (Pharmacovigilance Risk Assessment Committee, PRAC),
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.
To je zlasti pomembno zato, ker lahko odbor CHMP in skupina CMD(h) zavzameta po javni objavi mnenja odbora PRAC drugačno stališče.
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.
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.
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.
Namerava izvajati tudi naknadne preglede ukrepov za ublažitev tveganja in predhodne kontrole za zagotovitev vključitve interesov v ustrezne dele obrazcev izjav o interesih.
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.
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.
Session 3:
3. zasedanje: