FrancophonIA/ELRC3.0 huggingface dataset:
English: A number of Board members felt that, while the final decision on appointment of a member lies with the Member State in accordance with Art. 61 of Regulation (EC) No 726/2004, only appropriately scientifically qualified members should be accepted.
Slovenian: Številni člani odbora so menili, da čeprav končno odločitev o imenovanju članov sprejme država članica v skladu s členom 61 Uredbe (ES) št. 726/2004, bi morali biti sprejeti le člani z ustreznimi znanstvenimi kvalifikacijami.
English: The Agency demonstrated good performance against objectives set in the work programme.
Slovenian: Agencija je bila uspešna glede na cilje, zastavljene v delovnem programu.
English: • The progress on the "pharmaceutical package"; pharmacovigilance legislation which is due to become applicable in mid-2012), legislative proposals on preventing entry into legal supply chain of falsified medicines and information to patients).
Slovenian: • napredkom pri „svežnju zdravil“; zakonodajo o farmakovigilanci, ki naj bi začela veljati sredi leta 2012; zakonodajnih predlogih o preprečevanju vstopa ponarejenih zdravil v zakonito dobavno verigo in obveščanju bolnikov;
English: The endorsed document follows the public consultation launched in December 2008 and takes into account recommendations from the European Ombudsman.
Slovenian: Potrjeni dokument izvira iz javne razprave, ki je potekala decembra 2008, in upošteva priporočila evropskega varuha človekovih pravic.
English: There should be an EU level interconnectivity between these areas to ensure a comprehensive approach to vigilance and traceability of products.
Slovenian: Ta področja morajo biti medsebojno povezana na ravni EU, da se zagotovi celovit pristop k stalnemu nadzoru in sledljivosti proizvodov.
English: By introducing the new policy, the Agency aims to ensure the widest possible access to its documents whilst respecting a number of principles set out in the policy, including the protection of commercial confidential information and personal data.
Slovenian: Agencija namerava z uvedbo nove politike zagotoviti najširši možni dostop do svojih dokumentov ob upoštevanju številnih načel, določenih v politiki, vključno z varstvom komercialno zaupnih informacij in osebnih podatkov.
English: The Board also endorsed the publication of the meeting document with a few amendments.
Slovenian: Upravni odbor je tudi potrdil objavo dokumenta o seji z nekaterimi spremembami.
English: The Board discussed that due to the nature of the Agency's operations any future options should provide for a maximum degree of flexibility for expansion or reduction.
Slovenian: Odbor je razpravljal, da bi glede na naravo delovanja agencije vse prihodnje možnosti morale zagotoviti kar najvišjo stopnjo prožnosti za njeno širitev ali zmanjševanje.
English: The organisations are also subject to regular re-evaluation of their eligibility.
Slovenian: Njihova upravičenost se tudi redno ponovno ocenjuje.
English: This practice reflected well on both agencies and needs to be maintained in future.
Slovenian: Obe agenciji menita, da je takšna praksa ustrezna in jo je treba ohraniti tudi v prihodnje.
English: Sponsoring of patients' organisations by pharmaceutical industry - proposed actions
Slovenian: Sponzoriranje farmacevtske industrije organizacij bolnikov - predlagani ukrepi
English: Proposed changes will be introduced and the report will be published on the website.
Slovenian: Sledila bo uvedba predlaganih sprememb, poročilo pa bo objavljeno na spletni strani.
English: The financial and workload impact of the scheme and the Agency's and the network's ability to respond will continue to be monitored and reviewed if needed.
Slovenian: Finančni učinek in učinek delovne obremenitve programa ter sposobnost odzivanja agencije in mreže se bosta po potrebi še naprej spremljala in pregledovala.
English: The transfer follows the evaluation of its budgetary situations as at 31 August 2010 which showed favourable budget trend.
Slovenian: Prerazporeditev je sledila oceni proračunskega stanja na dan 31. avgust 2010, ki je pokazala ugoden proračunski razvoj.
English: It aims at balancing out the need to secure Europe's best scientific experts for the evaluation and supervision of medicines while ensuring that these experts have no financial or other interests in the pharmaceutical industry that could affect their impartiality.
Slovenian: Njen namen je uravnotežiti potrebo po zagotavljanju najboljših evropskih strokovnjakov za vrednotenje in nadzor zdravil ob zagotavljanju, da ti strokovnjaki nimajo finančnih ali drugih interesov v farmacevtski industriji, ki bi lahko vplivali na njihovo nepristranskost.
English: It was emphasised that the same principles are applied for all experts, those from national authorities, academia and civil society representatives, working in the EMA's committees.
Slovenian: Poudarjeno je bilo, da se enaka načela uporabljajo za vse strokovnjake, to je strokovnjake iz nacionalnih organov, akademike in predstavnike civilne družbe, ki delajo v odborih agencije EMA.
English: The released part of the provisional appropriation will be used to finance and bring forward ICT projects that might be insufficiently financed in 2011 due to reductions in the EU contribution for 2011.
Slovenian: Sproščeni del začasnih sredstev bo uporabljen za financiranje in spodbujanje projektov informacijske in komunikacijske tehnologije, za katere bo morda v letu 2011 na voljo manj sredstev, ker se bodo znižali prispevki EU za leto 2011.
English: The Agency will meet with patients/consumers' and healthcare professionals' representatives to explain how the policy will be applied.
Slovenian: Agencija se bo srečala s predstavniki bolnikov/potrošnikov in zdravstvenih strokovnjakov, da bo pojasnila, kako se bo politika izvajala.
English: The new EMA Financial Regulation follows the revision of the Framework Financial Regulation (EC, EURATOM) No 2343/2002 in 2008 and takes into account comments made by the European Commission.
Slovenian: EMA temelji na pregledu okvirne finančne uredbe (ES, EURATOM) št. 2343/2002 iz leta 2008 in upošteva pripombe, ki jih je predložila Evropska komisija.
English: • The preparation for the third cycle of Benchmarking of European Medicines Agencies and endorsement of its continuation.
Slovenian: • pripravo tretjega cikla primerjalne analize evropskih agencij za zdravila in potrditvijo njenega nadaljevanja.
English: It is anticipated that the first meeting of the group will take place towards the end of 2010 or in early 2011.
Slovenian: Pričakuje se, da bo prvi sestanek skupine proti koncu leta 2010 ali na začetku leta 2011.
English: The EMA's involvement in this process relates to the fact that a part of substances of human origin are processed to advanced therapies, which are then covered by specific legislation.
Slovenian: Vključenost agencije EMA v ta proces se nanaša na dejstvo, da se del snovi človeškega izvora predela za napredno zdravljenje, ki je nato vključeno v posebno zakonodajo.
English: The European Commission had been informed of the proposal.
Slovenian: Evropska komisija je bila obveščena o predlogu.
English: The Committee for Medicinal Products for Human Use recommended the suspension of Avandia.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je priporočil začasni umik zdravila Avandia.
English: Third report on the progress of the interaction with Patients' and Consumers' Organisations during 2009
Slovenian: Tretje poročilo o napredku medsebojnega delovanja med organizacijami bolnikov in potrošnikov v letu 2009
English: Members discussed whether the new policy may restrict participation of representatives of patients and academia in EMA activities, particularly in cases of smaller organisations.
Slovenian: Člani so razpravljali, ali nova politika lahko omeji sodelovanje predstavnikov bolnikov in akademikov v dejavnostih agencije EMA, zlasti v manjših organizacijah.
English: The members noted the update report from the European Commission on a range of topics, including:
Slovenian: Člani so se seznanili s posodobljenim poročilom Evropske komisije o različnih temah, vključno z:
English: 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.
Slovenian: 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.
English: Amendment to the Agency's internal control standard on sensitive functions
Slovenian: Sprememba standarda notranjega kontrole agencije o občutljivih funkcijah
English: 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.
Slovenian: 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.
English: The Board noted that the conclusions in the HAI report are based only on information found on the internet.
Slovenian: Odbor je navedel, da sklepne ugotovitve organizacije HAI temeljijo le na informacijah, dobljenih na spletu.
English: 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.
Slovenian: Agencija je na podlagi začetega dela glede sistema pristojbin izkušnje sporočila Evropski komisiji in temo predstavila svojim zainteresiranim stranem na konferenci junija 2010.
English: It was also put forward that a world-wide arrangement could be envisaged, e.g. within the context of ICH.
Slovenian: Navedeno je bilo tudi, da je mogoče predvideti ureditev na svetovni ravni, na primer v okviru mednarodne konference o usklajevanju (ICH).
English: • Draft Council conclusions on Innovation and Solidarity in the Pharmaceutical Sector prepared by the Presidency
Slovenian: • Osnutek sklepnih ugotovitev Sveta o inovacijah in solidarnosti v farmacevtskem sektorju, ki ga je pripravilo predsedstvo
English: 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.
Slovenian: 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.
English: • Revision of the clinical trials directive.
Slovenian: • pregledom direktive o kliničnih preskušanjih
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The Board was informed that contacts were established with the European Commission on the matter.
Slovenian: Odbor je bil obveščen, da so bili o tej zadevi vzpostavljeni stiki z Evropsko komisijo.
English: 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.
Slovenian: Upravni odbor je menil, da je potrebna posebna seja za temeljitejši pregled dela, opravljenega pri ocenjevanju zdravstvene tehnologije na ravni Sveta in Evropskega parlamenta.
English: 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.
Slovenian: 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.
English: An international workshop in the area of GCP and ethical requirements for clinical trials
Slovenian: Mednarodna delavnica na področju dobre klinične prakse in etičnih zahtev za klinično preskušanje
English: 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.
Slovenian: Odbor je razpravljal o tem, da je treba izboljšati preglednost posvetovanj, ki privedejo do odločitve, in javnosti v različnih fazah odločanja zagotoviti več informacij.
English: 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.
Slovenian: 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.
English: The Management Board discussed ways to establish closer relation between the Committee and the Management Board.
Slovenian: Upravni odbor je razpravljal o načinih, kako vzpostaviti tesnejše odnose med tem odborom in upravnim odborom.
English: 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.
Slovenian: 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.
English: Revision of EMA Financial Regulation and its Implementing Rules
Slovenian: Pregled finančne uredbe za agencijo EMA in njenih izvedbenih pravil
English: Access to documents
Slovenian: Dostop do dokumentov
English: 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.
Slovenian: 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.
English: The meeting also considered future interactions between the two groups and a concept of performance indicators applicable to members of a management board.
Slovenian: Na sestanku so proučili tudi medsebojno delovanje obeh skupin v prihodnosti in pojem kazalnikov uspešnosti, ki se uporabljajo za člane upravnega odbora.
English: The effects of the policy will be monitored and further changes introduced as needed.
Slovenian: Spremljali se bodo njeni učinki, po potrebi pa bodo uvedene dodatne spremembe.
English: 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.
Slovenian: 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.
English: Financing of the Agency
Slovenian: Financiranje agencije
English: The Board nominated the vice-chair, Lisette Tiddens-Engwirda, as the Board representative to the Committee.
Slovenian: Upravni odbor je imenoval podpredsednico Lisette Tiddens-Engwirda za predstavnico upravnega odbora v tem odboru.
English: The publication will take place after the official announcement has been made.
Slovenian: Objava bo sledila uradni najavi.
English: • The final English version of the announcement for the selection procedure for the Executive
Slovenian: • Končna angleška različica najave obvestila za izbirni postopek izvršnega direktorja
English: Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway) Apology received from Iceland
Slovenian: Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška) Opravičilo iz Islandije
English: A further discussion will take place at the December meeting.
Slovenian: Razprava se bo nadaljevala na decembrski seji.
English: 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.
Slovenian: 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.
English: The amendments concerns extensions of marketing authorisation, Type II variations, annual fees, variations to plasma master files and vaccine antigen master files.
Slovenian: Spremembe zadevajo razširitev dovoljenja za promet, spremembe tipa II, letne pristojbine, spremembe glavne dokumentacijo o plazmi in glavne dokumentacije o antigenu cepiva.
English: The Board stressed that a collective approach to transparency of the decision making process is needed in the network.
Slovenian: Odbor je poudaril, da je pri postopku odločanja v mreži potreben skupni pristop k preglednosti.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The Board discussed that in future information about signal management activities will need to be provided.
Slovenian: Odbor je razpravljal, da bo treba v prihodnosti zagotoviti informacijo o začetnih dejavnosti uprave.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Upravnemu odboru so bile predstavljene trenutne možnosti za prihodnje prostore agencije in merila za njihovo ocenjevanje.
English: Executive Director briefed the Management Board about the hearing at the European Parliament.
Slovenian: Izvršni direktor je obvestil upravni odbor o razpravi v Evropskem parlamentu.
English: EMA Mid-year report 2010
Slovenian: Vmesno poročilo agencije EMA za leto 2010
English: List of participants at the 68th meeting of the Management Board, held in London, 7 October 2010
Slovenian: Seznam udeležencev 68. seje upravnega odbora, ki je potekala v Londonu 7. oktobra 2010
English: Revised policy on the handing of conflicts of interests
Slovenian: Revidirana politika o obravnavi primerov navzkrižja interesov
English: • [EMA/MB/535239/2010] Outcome of written procedures during the period from 7 June 2010 to
Slovenian: • [EMA/MB/535239/2010] Rezultat pisnih postopkov v obdobju od 7. junija 2010 do
English: Minutes of the 68th meeting of the Management Board
Slovenian: Zapisnik 68. seje upravnega odbora
English: The Agency's transparency policy due to be finalised next year will address this aspect.
Slovenian: Ta vidik bo obravnavan v politiki preglednosti agencije, ki naj bi bila dokončno oblikovana naslednje leto.
English: • Nomination form and CV for the nomination to the CVMP
Slovenian: • Obrazec in življenjepis za imenovanje v odbor CVMP
English: • [EMA/MB/528844/2010] Summary of transfers of appropriations in the budget 2010.
Slovenian: • [EMA/MB/528844/2010] Povzetek prenosov dodeljenih sredstev v proračunu za leto 2010.
English: Nomination to the CVMP
Slovenian: Imenovanje v odbor CVMP
English: 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
Slovenian: Ustanovitev skupne strokovne skupine odborov CVMP in CHMP za uporabo zamenjave, zmanjšanja in izboljšane uporabe živali pri razvoju zdravil
English: The Agency will publish a summary report with slides on the meeting and will finalise the paper in 2011.
Slovenian: Agencija bo objavila zbirno poročilo o srečanju s prosojnicami in študijo dokončala v letu 2011.
English: [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.
Slovenian: [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.
English: EU legislation on Substances of Human Origin sets out responsibilities for the EU Member States and the Commission in this area.
Slovenian: 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.
English: [EMA/MB/398075/2010] The agenda was adopted with the following item added: Draft Council conclusions on innovation and solidarity in the pharmaceutical sector.
Slovenian: [EMA/MB/398075/2010] Dnevni red je bil sprejet z dodano naslednjo točko: Osnutek sklepnih ugotovitev Sveta o inovacijah in solidarnosti v farmacevtskem sektorju.
English: 2009 EudraVigilance Human Status Report 2009
Slovenian: Poročilo o stanju sistema EudraVigilance za zdravila za uporabo v humani medicini za leto 2009