natgillin/translations-raw huggingface dataset:
The members noted the update report from the European Commission on a range of topics, including:
Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno z:
The management were satisfied that both the Agency and the US Food and Drug Administration cooperated in this matter and made a coordinated announcement of respective decisions.
Uprava z zadovoljstvom ugotavlja, da sta v tej zadevi sodelovala agencija in Urad za hrano in zdravila iz ZDA (Food and Drug Administration) ter usklajeno objavila ustrezni odločitvi.
Amendment to the Agency's internal control standard on sensitive functions
Sprememba standarda notranjega kontrole agencije o občutljivih funkcijah
The topic coordinators will continue to work with the Agency on this matter which is expected to be ready for the decision by the end of 2010 or beginning of 2011.
Tematski koordinatorji bodo pri tej zadevi še naprej sodelovali z agencijo in pričakuje se, da bo odločitev sprejeta konec leta 2010 ali na začetku leta 2011.
The Board noted that the conclusions in the HAI report are based only on information found on the internet.
Odbor je navedel, da sklepne ugotovitve organizacije HAI temeljijo le na informacijah, dobljenih na spletu.
The work has started whereby the Agency has communicated its experience of the fee system to the European Commission and presented the topic to its stakeholders at the conference in June 2010.
Agencija je na podlagi začetega dela glede sistema pristojbin izkušnje sporočila Evropski komisiji in temo predstavila svojim zainteresiranim stranem na konferenci junija 2010.
It was also put forward that a world-wide arrangement could be envisaged, e.g. within the context of ICH.
Navedeno je bilo tudi, da je mogoče predvideti ureditev na svetovni ravni, na primer v okviru mednarodne konference o usklajevanju (ICH).
• Draft Council conclusions on Innovation and Solidarity in the Pharmaceutical Sector prepared by the Presidency
• Osnutek sklepnih ugotovitev Sveta o inovacijah in solidarnosti v farmacevtskem sektorju, ki ga je pripravilo predsedstvo
Kent Woods, the Board's observer in the Commission part of the selection process, together with a few members will prepare questions for the interview, assuring that the selection criteria were adequately explored.
Kent Woods, ki je opazovalec v upravnem odboru za Komisijin del izbirnega postopka, bo skupaj z nekaterimi člani pripravil vprašanja za razgovor, ter zagotovil, da so izbirna merila ustrezno upoštevana.
• Revision of the clinical trials directive.
• pregledom direktive o kliničnih preskušanjih
The Management Board provided comments with regards to the reasons for the decline in the number of applications for human medicinal products, the increase in applications for paediatric investigation plans and the previous discussions of the Board on the payment system to national competent authorities.
Upravni odbor je predložil pripombe o razlogih za padec števila vlog za zdravila za uporabo v humani medicini, o povečanju vlog za načrte pediatričnih raziskav in predhodno razpravo odbora o sistemu plačevanja nacionalnim pristojnim organom.
The Board also agreed to the proposal that the Chair of the Management Board will be invited to attend one meeting of the AAC per year and the Chair of the Committee will be invited to attend one meeting of the Board per year.
Upravni odbor se je tudi strinjal s predlogom, da bo predsednik upravnega odbora povabljen na eno sejo odbora za presojo in svetovanje na leto, predsednik tega odbora pa bo povabljen na eno sejo upravnega odbora na leto.
The Board was informed that contacts were established with the European Commission on the matter.
Odbor je bil obveščen, da so bili o tej zadevi vzpostavljeni stiki z Evropsko komisijo.
The meeting considered that a special session is needed at the Management Board to gain a more thorough overview of work done in the area of health technology assessment at the level of the Council and the European Parliament.
Upravni odbor je menil, da je potrebna posebna seja za temeljitejši pregled dela, opravljenega pri ocenjevanju zdravstvene tehnologije na ravni Sveta in Evropskega parlamenta.
The group will contribute to the work aiming to encourage the development and regulatory acceptance of alternative approaches to animal testing, will reinforce the role of the Agency in the area of animal welfare and will facilitate communication with stakeholders.
Skupina bo prispevala k delu za spodbujanje razvoja in regulativne ustreznosti alternativnih pristopov k poskusom na živalih, okrepila vlogo agencije na področju dobrega počutja živali in olajšala komunikacijo med zainteresiranimi stranmi.
An international workshop in the area of GCP and ethical requirements for clinical trials
Mednarodna delavnica na področju dobre klinične prakse in etičnih zahtev za klinično preskušanje
The Board discussed that transparency of deliberations leading to the decision need to be improved and more information has to be provided to the public at different stages of the decision.
Odbor je razpravljal o tem, da je treba izboljšati preglednost posvetovanj, ki privedejo do odločitve, in javnosti v različnih fazah odločanja zagotoviti več informacij.
The hearing addressed such topics as coordination of procurement of vaccines, adequacy of the mechanisms to declare a pandemic, risk assessment, arrangements to manage of conflicts of interest and other.
Na razpravi so bile obravnavane teme, kot so usklajevanje nabave cepiv, ustreznost mehanizmov za razglasitev pandemije, ocenjevanje tveganja, ureditev za reševanje navzkrižja interesov in drugo.
The Management Board discussed ways to establish closer relation between the Committee and the Management Board.
Upravni odbor je razpravljal o načinih, kako vzpostaviti tesnejše odnose med tem odborom in upravnim odborom.
Lisette Tiddens-Engwirda and Jean Marimbert will act as topic coordinators for the revision of the rules applied to members of the Management Board and will take into account experience gained with the above policy.
Lisette Tiddens-Engwirda in Jean Marimbert bosta tematska koordinatorja za pregled pravil, ki se uporabljajo za člane upravnega odbora, ob upoštevanju izkušenj, pridobljenih pri zgornji politiki.
Revision of EMA Financial Regulation and its Implementing Rules
Pregled finančne uredbe za agencijo EMA in njenih izvedbenih pravil
In the context of the Management Board consultation procedure on nominations to the scientific committees, the Board discussed the level of scientific competence of nominees to the committees and the desired scientific and regulatory qualifications and experience of members.
Odbor je v okviru postopka posvetovanja o imenovanjih v znanstvene odbore razpravljal o stopnji znanstvene usposobljenosti kandidatov za odbore ter želenih znanstvenih in regulativnih kvalifikacijah in izkušnjah članov.
The meeting also considered future interactions between the two groups and a concept of performance indicators applicable to members of a management board.
Na sestanku so proučili tudi medsebojno delovanje obeh skupin v prihodnosti in pojem kazalnikov uspešnosti, ki se uporabljajo za člane upravnega odbora.
The effects of the policy will be monitored and further changes introduced as needed.
Spremljali se bodo njeni učinki, po potrebi pa bodo uvedene dodatne spremembe.
It was suggested that, in future, an agreement with the industry on the format of marketing authorisation applications in a way that would facilitate access without the need for redacting of commercial confidential and information containing personal data throughout the document should be explored.
Predlagano je bilo, da bi bilo treba v prihodnosti proučiti sporazum z industrijo o obliki vlog za izdajo dovoljenja za promet, ki bi omogočila dostop, ne da bi bilo treba iz dokumenta odstraniti komercialno zaupne informacije in informacije z osebnimi podatki.
Financing of the Agency
Financiranje agencije
The Board nominated the vice-chair, Lisette Tiddens-Engwirda, as the Board representative to the Committee.
Upravni odbor je imenoval podpredsednico Lisette Tiddens-Engwirda za predstavnico upravnega odbora v tem odboru.
The publication will take place after the official announcement has been made.
Objava bo sledila uradni najavi.
• The final English version of the announcement for the selection procedure for the Executive
• Končna angleška različica najave obvestila za izbirni postopek izvršnega direktorja
Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway) Apology received from Iceland
Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška) Opravičilo iz Islandije
A further discussion will take place at the December meeting.
Razprava se bo nadaljevala na decembrski seji.
However, to further increase transparency in the area, the Board endorsed the proposal to make further improvements in related procedures and suggested including links to the websites of the concerned organisations to enable easier consultation by the public.
Odbor je za večjo preglednost na tem področju potrdil predlog za nadaljnje izboljšave povezanih postopkov in predlagal, naj se za lažji vpogled javnosti vključijo povezave na spletne strani zadevnih organizacij.
The amendments concerns extensions of marketing authorisation, Type II variations, annual fees, variations to plasma master files and vaccine antigen master files.
Spremembe zadevajo razširitev dovoljenja za promet, spremembe tipa II, letne pristojbine, spremembe glavne dokumentacijo o plazmi in glavne dokumentacije o antigenu cepiva.
The Board stressed that a collective approach to transparency of the decision making process is needed in the network.
Odbor je poudaril, da je pri postopku odločanja v mreži potreben skupni pristop k preglednosti.
The Agency held an international workshop, on 6-7 September 2010 as part of the public consultation on the draft Reflection paper on GCP and ethical requirements for clinical trials conducted in third countries and submitted in marketing authorisation applications to the Centralised Procedure.
Agencija je 6. in 7. septembra 2010 organizirala mednarodno delavnico kot del javnega posvetovanja o osnutku študije o etičnem vidiku in vidiku dobre klinične prakse glede kliničnih preskušanj, ki se izvajajo v tretjih državah in so agenciji EMA predložene kot vloge za pridobitev dovoljenja za promet po centraliziranem postopku.
Amongst further activities, the Agency plans to revise the “Framework of Interaction” between the EMA and PCOs and to explore how patients and consumers can be involved in the benefit/risk assessment of medicinal products.
Agencija namerava med nadaljnjimi ukrepi pregledati „okvir medsebojnega sodelovanja“ med agencijo EMA ter organizacijami bolnikov in potrošnikov ter proučiti način vključevanja bolnikov in potrošnikov v oceno prednosti/tveganj zdravil.
The last meeting of the group discussed the ongoing inter-institutional review of the EU agencies with the participation of the chair of the EU executive directors group.
Posodobljene informacije skupine predsednikov agencij EU Na zadnjem sestanku skupine so razpravljali o sedanjem medinstitucionalnem pregledu agencij EU, pri katerem sodeluje predsednik skupine izvršnih direktorjev EU.
The Board discussed that in future information about signal management activities will need to be provided.
Odbor je razpravljal, da bo treba v prihodnosti zagotoviti informacijo o začetnih dejavnosti uprave.
Following the request from the Spanish Member of the Board, the Members noted the Draft Council conclusions on Innovation and Solidarity in the Pharmaceutical Sector prepared by the Presidency.
Člani odbora so se na zahtevo španskega člana odbora seznanili z osnutkom sklepnih ugotovitev Sveta o inovacijah in solidarnosti v farmacevtskem sektorju, ki ga je pripravilo predsedstvo.
The Management Board was given a presentation on the current options available to the Agency in respect of its future accommodation and the criteria applied to evaluate the options.
Upravnemu odboru so bile predstavljene trenutne možnosti za prihodnje prostore agencije in merila za njihovo ocenjevanje.
Executive Director briefed the Management Board about the hearing at the European Parliament.
Izvršni direktor je obvestil upravni odbor o razpravi v Evropskem parlamentu.
EMA Mid-year report 2010
Vmesno poročilo agencije EMA za leto 2010
List of participants at the 68th meeting of the Management Board, held in London, 7 October 2010
Seznam udeležencev 68. seje upravnega odbora, ki je potekala v Londonu 7. oktobra 2010
Revised policy on the handing of conflicts of interests
Revidirana politika o obravnavi primerov navzkrižja interesov
• [EMA/MB/535239/2010] Outcome of written procedures during the period from 7 June 2010 to
• [EMA/MB/535239/2010] Rezultat pisnih postopkov v obdobju od 7. junija 2010 do
Minutes of the 68th meeting of the Management Board
Zapisnik 68. seje upravnega odbora
The Agency's transparency policy due to be finalised next year will address this aspect.
Ta vidik bo obravnavan v politiki preglednosti agencije, ki naj bi bila dokončno oblikovana naslednje leto.
• Nomination form and CV for the nomination to the CVMP
• Obrazec in življenjepis za imenovanje v odbor CVMP
• [EMA/MB/528844/2010] Summary of transfers of appropriations in the budget 2010.
• [EMA/MB/528844/2010] Povzetek prenosov dodeljenih sredstev v proračunu za leto 2010.
Nomination to the CVMP
Imenovanje v odbor CVMP
The establishment of a Joint CVMP/CHMP ad-hoc Expert Group on the application of the 3Rs (Replacement, Reduction and Refinement) in the development of medicinal products
Ustanovitev skupne strokovne skupine odborov CVMP in CHMP za uporabo zamenjave, zmanjšanja in izboljšane uporabe živali pri razvoju zdravil
The Agency will publish a summary report with slides on the meeting and will finalise the paper in 2011.
Agencija bo objavila zbirno poročilo o srečanju s prosojnicami in študijo dokončala v letu 2011.
[EMA/MB/531926/2010] The Management Board discussed the issue raised in the report by the Health Action International which suggested that not all patient and consumer organisations fulfil the Agency's financial transparency criteria.
[EMA/MB/531926/2010] Upravni odbor je razpravljal o vprašanju, zastavljenem v poročilu organizacije Health Action International(HAI), da vse organizacije bolnikov in potrošnikov ne izpolnjujejo meril finančne preglednosti agencije.
EU legislation on Substances of Human Origin sets out responsibilities for the EU Member States and the Commission in this area.
Pobuda Evropske komisije o stalnem nadzoru za snovi človeškega izvora Pristojnosti držav članic EU in Komisije na področju snovi človeškega razvoja so določene v zakonodaji EU na tem področju.
[EMA/MB/398075/2010] The agenda was adopted with the following item added: Draft Council conclusions on innovation and solidarity in the pharmaceutical sector.
[EMA/MB/398075/2010] Dnevni red je bil sprejet z dodano naslednjo točko: Osnutek sklepnih ugotovitev Sveta o inovacijah in solidarnosti v farmacevtskem sektorju.
2009 EudraVigilance Human Status Report 2009
Poročilo o stanju sistema EudraVigilance za zdravila za uporabo v humani medicini za leto 2009
[EMA/MB/575364/2010] The Management Board noted the proposal for a written procedure for the adoption of the aforementioned policy which will be launched after the Agency receives the opinion of the European Data Protection Supervisor.
[EMA/MB/575364/2010] Upravni odbor se je seznanil s predlogom pisnega postopka za sprejetje zgoraj navedene politike, ki bo uvedena, ko bo agencija prejela mnenje evropskega nadzornika za varstvo podatkov.
The Management Board adopted the procedure for the selection of the Executive Director.
Upravni odbora je sprejel postopek za izbiro izvršnega direktorja.
[EMA/MB/603657/2010] The Management Board adopted the transfer of € 4.4 million of ‘provisional appropriation' (€ 5.4 million) that was set aside for possible variations in fee income.
[EMA/MB/603657/2010] Upravni odbor je sprejel prerazporeditev 4,4 milijona EUR „začasnih sredstev“ (5,4 milijona EUR), namenjenih morebitnim spremembam pri prihodkih od pristojbin.
• [EMA/496888/2010] Update report on the Agency's implementation of the EU telematics strategy
• [EMA/496888/2010] Dopolnjeno poročilo o izvajanju telematske strategije EU, ki jo izvaja agencija
Future accommodation of the Agency
Prihodnji prostori agencije
Amendments to Fees payable to the European Medicines Agency and other measures
Spremembe pristojbin, ki se plačujejo agenciji EMA, in drugi ukrepi
The current Executive Director will make the appointment.
Imenovanje bo opravil sedanji izvršni direktor.
As experience is gathered, the CVMP may need to further clarify the borderline between MUMS and other products.
Po pridobitvi izkušenj bo morebiti potrebno, da odbor za zdravila za uporabo v veterinarski medicini (CVMP) dodatno razjasni mejo med manjšo uporabo in manj pomembnimi živalskimi vrstami ter drugimi proizvodi.
• The HMA's endorsement of the draft Memorandum of Understanding on the monitoring of the scientific level and independence of the evaluation carried out by the NCAs for the Agency.
• potrditvijo vodij agencij za zdravila osnutka memoranduma o soglasju o spremljanju znanstvene ravni in neodvisnosti vrednotenja, ki so ga za agencijo pripravili nacionalni pristojni organi;
[EMA/MB/575243/2010] The Executive Director had established the Audit Advisory Committee to oversee and advice him on internal controls, financial and risk management, and audits in order to help secure good governance and effective accountability and transparency.
[EMA/MB/575243/2010] Izvršni direktor je ustanovil odbor za presojo in svetovanje za nadzor in svetovanje o notranjem nadzoru, finančnem poslovodenju in obvladovanju tveganj ter presojah kot pomoč pri zagotavljanju dobrega vodenja, učinkovite odgovornosti in preglednosti.
Resource consequences, should new responsibilities be granted, need to be examined.
Če bi bile podeljene nove pristojnosti, je treba proučiti, kakšne so posledice za vire.
The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Člani so se seznanili s posodobljenim poročilom vodij agencij za zdravila o različnih temah, vključno s:
All three concerned parties - European Commission, ECDC and EMA - have been working together to propose a solution.
Pri tem sodelujejo vse tri zadevne stranke, in sicer Evropska komisija ter agenciji ECDC in EMA.
• Presentation on the EMA Policy on the Handling of Conflicts of Interest for Scientific Committee
• Predstavitev politike agencije EMA o obravnavi primerov navzkrižja interesov članov in strokovnjakov znanstvenega odbora
[EMA/MB/578243/2010] Taking into account that a new Executive Director will not be selected in time to take office from 1 January 2011, the Board discussed the appointment of an acting Executive Director and recommended the appointment of Andreas Pott, Head of Administration.
Imenovanje vršilca dolžnosti izvršnega direktorja [EMA/MB/578243/2010] Ob upoštevanju, da novi izvršni direktor ne bo izbran pravočasno, da bi delovne naloge začel opravljati s 1. januarjem 2011, je odbor razpravljal o imenovanju vršilca dolžnosti izvršnega direktorja in priporočil Andreasa Potta, vodjo administracije.
The report concluded that the new scheme is achieving the objective of incentivising the development and authorisation of new veterinary medicinal products for MUMS.
V poročilu je ugotovljeno, da novi program dosega cilj spodbujanja razvoja in odobritve zdravil za uporabo v veterinarski medicini za manjšo uporabo in manj pomembne živalske vrste.
[EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] The Management Board adopted the revised EMA Financial Regulation and implementing rules.
[EMA/MB/528780/2010; EMA/MB/216485/2009; EMA/MB/281870/2010] Upravni odbor je sprejel pregledano finančno uredbo za agencijo EMA in izvedbena pravila.
In addition to the annual report, any other reports from the AAC will be presented to the Board.
Odbor za presojo in svetovanje bo upravnemu odboru poleg letnega poročila predložil tudi vsa druga poročila.
[EMA/MB/400828/2009] The Board noted that the vacancy notice for the selection of the Executive Director of the EMA will be published on 27 October 2010 with a closing date for applications on 24 November 2010.
[EMA/MB/400828/2009] Upravni odbor se je seznanil, da bo obvestilo o prostem delovnem mestu za izvršnega direktorja agencije EMA objavljeno 27. oktobra 2010 in da bo rok za prijavo 24. november 2010.
[EMA/MB/568706/2010] The Management Board adopted the proposed revision to the Agency's internal control standard on sensitive functions.
[EMA/MB/568706/2010] Upravni odbor je sprejel predlagani pregled standarda notranjega nadzora agencije o občutljivih funkcijah.
The Board endorsed the AAC approach to its remit in March 2005.
Upravni odbor je marca 2005 potrdil, da je pristop odbora za presojo in svetovanje v njegovi pristojnosti.
[EMA/MB/599720/2010] The Management Board endorsed the EudraVigilance status report for Human medicinal products for 2009.
[EMA/MB/599720/2010] Upravni odbor je potrdil Poročilo o stanju sistema EudraVigilance za zdravila za uporabo v humani medicini za leto 2009.
[EMA/MB/818152/2009] The Management Board adopted the amendments to the implementing rules on the Agency's fees.
[EMA/MB/818152/2009] Upravni odbor je sprejel spremembe izvedbenih pravil o pristojbinah, ki se plačujejo agenciji.
The Agency receives financial statements of each of the organisations during the evaluation of their eligibility to work with the EMA.
Med ocenjevanjem upravičenosti posamezne organizacije za delo z agencijo EMA, ta pošlje agenciji svoj izkaz stanja.
A report proposing an operational level solution will be prepared following these discussions and will be presented to the Management Boards of the ECDC and EMA in November and December 2010 respectively.
Na podlagi teh razprav sta bili upravnima odboroma agencij ECDC in EMA novembra in decembra 2010 predloženi poročili s predlogom rešitve na operativni ravni.
[EMA/MB/578660/2010] The Board noted the nomination to the CVMP.
[EMA/MB/578660/2010] Odbor se je seznanil z imenovanjem v odbor CVMP.
[EMA/MB/404038/2010] The Management Board noted the final minutes, adopted by written procedure on 4 August 2010.
Zapisnik 67. seje, ki je potekala 10. junija 2010 [EMA/MB/404038/2010] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil s pisnim postopkom sprejet 4. avgusta 2010.
Audit Advisory Committee contribution paper to the Management Board
Poročilo odbora za presojo in svetovanje upravnemu odboru
Consumers' Organisations (PCOs) during 2009 and includes information about the status of implementation of the actions and recommendations that were identified in previous reports.
Dokument opisuje sedanji napredek medsebojnega delovanja med agencijo EMA ter organizacijami bolnikov in potrošnikov v letu 2009 ter vključuje informacije o stanju izvajanja ukrepov in priporočil iz prejšnjih poročil.
[EMA/MB/577848/2010; EMA/577855/2010] The Management Board endorsed the annual report on the operation of the Minor Use Minor Species (MUMS) policy and the proposal to continue with the scheme for an additional year.
[EMA/MB/577848/2010; EMA/577855/2010] Upravni odbor je potrdil letno poročilo o delovanju politike glede manjše uporabe in manj pomembnih živalskih vrst (MUMS) ter predlog za podaljšanje programa za dodatno leto.
[EMA/MB/511582/2010] The Management Board noted the mid-year report 2010.
[EMA/MB/511582/2010] Upravni odbor se je seznanil z vmesnim poročilom za leto 2010.
Apology reveived
Opravičilo
[EMA/MB/588579/2010; EMA/MB/589332/2010] The Management Board endorsed the Agency's updated policy on the handling of conflicts of interests of Scientific Committee members and experts, and noted the document providing an overview of the allowable interests for the EMA scientific activities.
[EMA/MB/588579/2010; EMA/MB/589332/2010] Upravni odbor je potrdil dopolnjeno politiko o obravnavi primerov navzkrižja interesov članov ter strokovnjakov znanstvenega odbora in se seznanil z dokumentom o pregledu dovoljenih interesov za znanstvene dejavnosti agencije EMA.
Management Board procedure for the selection of the Executive Director
Postopek upravnega odbora za izbiro izvršnega direktorja