natgillin/translations-raw huggingface dataset:
During the discussion, the Management Board considered both nominations in their wider context of the workings of the Committees and reflected favourably on both of the nominees' background and professional experience, with the exception of the European Parliament representative, Prof. Giuseppe Nisticò, who asked that his specific remarks be included in the minutes: “The previous Polish CHMP member's curriculum, who was considered in the CHMP as the reference member for assessment of drug treatment in respiratory diseases, is much more specific and appropriate in terms of regulatory and clinical competence, as opposed to that of the newly proposed member.
Med razpravo je obravnaval obe imenovanji v širšem okviru delovanja odborov ter pozitivno ocenil poklicne in delovne izkušnje kandidatov, le predstavnik Evropskega parlamenta, prof. Giuseppe Nisticò, je zahteval, naj se v zapisnik vključijo njegove posebne pripombe: „Življenjepis prejšnjega poljskega člana odbora CHMP, ki je v odboru CHMP veljal za referenčnega člana za ocenjevanje zdravil za zdravljenje bolezni dihal, je precej podrobnejši in ustreznejši v smislu regulativne in klinične usposobljenosti v primerjavi z življenjepisom novega predlaganega člana.
During its discussion, the Board reflected on the issue that a significant amount of work done by the national competent authorities is not compensated in the current fee system.
Upravni odbor je med razpravo o sistemu opozoril, da v sedanjem sistemu pristojbin veliko dela, ki ga opravijo nacionalni pristojni organi, ni plačanega.
• Agenda point 10_Advertisement of the vacancy notice for the recruitment of the Executive Director for the EMA.
• Točka 10 dnevnega reda - Naznanilo obvestila o prostem delovnem mestu za zaposlitev izvršnega direktorja agencije EMA.
In the context of the two appeals, the European Ombudsman concluded that the Agency has to grant access to adverse drug reaction reports and clinical trial data.
Varuh človekovih pravic je v zvezi z dvema pritožbama ugotovil, da mora agencija dodeliti dostop do poročil o neželenih učinkih zdravil in podatkov o kliničnih preskušanjih.
• [EMEA/221701/2010] Update report on the Agency's implementation of the EU telematics strategy.
• [EMEA/221701/2010] Dopolnjeno poročilo o telematski strategiji EU, ki jo izvaja agencija.
The members noted the update report from the European Commission on a range of topics, including the following:
Člani odbora so se seznanili s posodobljenim poročilom Evropske komisije v zvezi z več temami, vključno s/z:
The Executive Director announced the appointment of Jean-Claude Brival as head of the newly created Product Data Management Sector in Veterinary Medicines and Product Data Management Unit and Alexis Nolte as head of the Sector for Quality of Medicines.
Izvršni direktor je napovedal imenovanje Jeana-Clauda Brivala za vodjo novega oddelka za upravljanje podatkov o proizvodih v enoti za zdravila za uporabo v veterinarski medicini in upravljanje podatkov o proizvodih, ter Alexisa Nolteja za vodjo oddelka za kakovost zdravil.
The Board thanked the topic coordinators - Jytte Lyngvig, Pat O'Mahony and Kristin Raudsepp - for preparing a comprehensive draft analysis and assessment of the report.
Upravni odbor se je tematskim koordinatorjem - Jytte Lyngvig, Patu O'Mahonyju in Kristin Raudseppzahvalil za pripravo celovitega osnutka analize in ocene poročila.
HMA supported the constitution of a permanent group of medical devices competent authorities.
Vodje agencij za zdravila so podprli oblikovanje stalne skupine pristojnih organov za medicinske pripomočke.
Legislation on access to documents requires making documents held by the Agency public, while the requirements to safeguard commercially confidential information and personal data restrict access.
Čeprav zakonodaja o dostopu do dokumentov določa, da so dokumenti, ki jih hrani agencija, javni, pa dostop omejujejo zahteve za varstvo komercialno zaupnih informacij in osebnih podatkov.
The Board stressed that it is of utmost importance to guarantee the involvement of best scientific expertise to ensure assessments of the highest quality.
Poudaril je, da je za zagotavljanje visokokakovostnih ocen bistveno zagotoviti vključenost najboljših znanstvenih strokovnjakov.
While the number of referrals for arbitrations arising from consideration of applications by CMDv eased, the referrals taking up increasingly resources of the Committee and the Agency secretariat relate particularly to harmonisation and ‘Community interest' referrals which set precedents and practice that will be followed in subsequent, similar cases.
Medtem ko se je število napotitev za arbitražo, ki izhajajo iz obravnave vlog, ki jo izvaja Koordinacijska skupina za postopek medsebojnega priznavanja in decentralizirani postopek (veterina) (CMDv), nekoliko zmanjšalo, pa zahtevajo čedalje več virov Odbora in sekretariata agencije napotitve, ki se nanašajo zlasti na usklajevalne napotitve in napotitve v zvezi z „interesom Skupnosti“, ki določajo precedense in prakso, ki se bodo upoštevali v poznejših podobnih primerih.
The Board made a general scrutiny reservation about the report.
Upravni odbor je v zvezi s poročilom podal splošni proučitveni pridržek.
Memorandum of understanding between the EMA and the NCAs on the monitoring of the scientific level and independence of evaluations
Memorandum o soglasju, sklenjen med agencijo EMA in nacionalnimi pristojnimi organi o spremljanju znanstvene ravni in neodvisnosti vrednotenja
The Board thanked the topic coordinators -Jean Marimbert and Lisette Tiddens - for their contribution to this work.
Upravni odbor se je zahvalil tematskima koordinatorjema Jeanu Marimbertu in Lisette Tiddens za njun prispevek k temu delu.
A further update will be provided in October.
Nove posodobljene informacije bodo predložene oktobra.
Chairs of management boards of EU agencies
Predsedniki upravnih odborov agencij EU
Fourteen agencies participated and elected Pat O'Mahony as the chair of the group.
Udeležili so se ga predstavniki 14 agencij, ki so Pata O'Mahonyja izvolili za predsednika skupine.
Following the discussion at the March 2010 meeting about the allocation of responsibility within the EU on a vigilance system for substances of human origin, the Executive Director wrote a letter to the European Commission that was followed by a discussion between DG Sanco and EMA staff.
Izvršni direktor je po razpravi o podelitvi pristojnosti za sistem stalnega nadzora za snovi človeškega izvora v EU, ki je potekala na seji marca 2010, Evropski komisiji poslal dopis, temu pa je sledila razprava med GD za zdravje in potrošnike ter osebjem agencije EMA.
The report will now be presented to the HMA in July and published on the Agency's website.
Poročilo bo julija predstavljeno vodjem agencij za zdravila (HMA) in objavljeno na spletni strani agencije.
The updated document will be presented at the HMA meeting in July and submitted to the Management Board for adoption by written procedure.
Posodobljeni dokument bo predstavljen na julijskem sestanku vodij agencij za zdravila (HMA) in predložen upravnemu odboru v sprejetje s pisnim postopkom.
• Improving linkage between HMA and medical devices competent authorities.
• izboljšanjem povezav med vodjami agencij za zdravila in pristojnimi organi za medicinske pripomočke.
Einar Magnússon (Iceland) Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Einar Magnússon (Islandija) Brigitte Batliner (Lihtenštajn) Gro Ramsten Wesenberg (Norveška)
A detailed report on lessons learned will be provided for the October meeting.
Podrobno poročilo o spoznanjih bo predloženo na oktobrski seji.
[EMA/MB/210895/2010] The agenda was adopted with amendments to agenda item 14.
[EMA/MB/210895/2010] Dnevni red je bil sprejet s spremembami točke 14. 2.
The Board stressed that it is essential for the national competent authorities to recover the costs fully.
Poudaril je, da je za te bistveno, da v celoti izterjajo stroške.
Members suggested that a questionnaire be prepared to gather and share information on what practices are put in place in NCAs with regards to the handing of conflicts of interest.
Člani so predlagali oblikovanje vprašalnika za zbiranje in izmenjavo informacij o praksah nacionalnih pristojnih organov za obravnavo primerov navzkrižja interesov.
The group met with a Commission representative to discuss the findings of the evaluation of the EU agencies carried out by the European Commission in
Skupina se je sestala s predstavnikom Komisije in z njim razpravljala o ugotovitvah ocenjevanja agencij EU, ki ga je Evropska komisija izvedla leta 2009.
In the meantime, the Agency will present its proposals for the policy on access to documents, which will also address the release of clinical trials data following completion of procedures, at the July meeting of the Heads of Medicines Agencies.
Agencija bo medtem na julijskem sestanku vodij agencij za zdravila predstavila predloge za politiko o dostopu do dokumentov, v kateri bo obravnavano tudi objavljanje podatkov iz kliničnih preskušanj po dokončanju postopkov.
[EMA/MB/289198/2010] Pending the receipt of the opinion of the Court of Auditors on provisional accounts, a written procedure will be launched shortly to adopt the Management Board opinion on the Agency's annual accounts for the year ended 31 December 2009.
[EMA/MB/289198/2010] V pričakovanju mnenja Računskega sodišča o začasnih računovodskih izkazih se bo kmalu začel pisni postopek za sprejetje mnenja upravnega odbora o končnih računovodskih izkazih agencije za leto, ki se je končalo 31. decembra 2009.
A high-level update on the outcomes of the workshop will be provided to the Management Board in October.
Upravnemu odboru bodo oktobra predložene posodobljene informacije na visoki ravni o izidih delavnice.
Report from the European Commission
Poročilo Evropske komisije
Draft reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA
Osnutek študije o etičnem vidiku in vidiku dobre klinične prakse glede kliničnih preskušanj zdravil za uporabo v humani medicini, ki se izvajajo v tretjih državah in so agenciji EMA predložena kot del vloge za pridobitev dovoljenja za promet
• [EMEA/MB/298753/2010] Summary of transfers of appropriations in the budget 2010.
• [EMEA/MB/298753/2010] Povzetek prerazporeditve sredstev v proračunu za leto 2010.
The HMA aims to complete the paper by the end of this year.
Vodje agencij za zdravila ga nameravajo dokončati do konca tega leta;
• [EMA/MB/281850/2010] Outcome of written procedures during the period from 26 February 2010 to 2 June 2010.
• [EMA/MB/281850/2010] Rezultat pisnih postopkov v obdobju od 26. februarja 2010 do
[EMA/MB/302460/2010] The Management Board had adopted revised contractual arrangements which contain a number of key performance indicators.
[EMA/MB/302460/2010] Upravni odbor je sprejel spremenjene pogodbene ureditve, ki vključujejo več ključnih kazalnikov uspešnosti.
[EMA/MB/298741/2010] The Management Board discussed two ongoing consultation procedures: one for the CVMP and one for the CHMP.
[EMA/MB/298741/2010] Upravni odbor je razpravljal o dveh trenutnih postopkih posvetovanja in sicer enem za odbor CVMP in enem za odbor CHMP.
[EMA/MB/297535/2010; EMA/MB/168222/2010] The Management Board adopted the analysis and assessment of the annual activity report 2009.
[EMA/MB/297535/2010; EMA/MB/168222/2010] Upravni odbor je potrdil analizo in oceno letnega poročila o dejavnostih za leto 2009.
[EMA/MB/311466/2010] The Management Board discussed the memorandum of understanding (MoU) which clarifies the responsibilities between the EMA and national competent authorities for monitoring of the scientific level and independence of evaluations.
[EMA/MB/311466/2010] Upravni odbor je razpravljal o memorandumu o soglasju, v katerem so pojasnjene obveznosti agencije EMA in nacionalnih pristojnih organov za spremljanje znanstvene ravni in neodvisnosti vrednotenja.
Documents for information
Dokumenti v vednost
Minutes of the 67th meeting of the Management Board
Zapisnik 67. seje upravnega odbora
[EMA/MB/338709/2010; EMA/712397/2009] The Management Board noted the draft reflection paper, which elaborates on four areas of action from the strategy paper 'Acceptance of clinical trials conducted in third countries for evaluation in Marketing Authorisation Applications'.
[EMA/MB/338709/2010; EMA/712397/2009] Upravni odbor se je seznanil z osnutkom študije, v kateri so podrobneje obravnavana štiri področja ukrepov iz strateškega dokumenta „Sprejemanje kliničnih preskušanj, izvedenih v tretjih državah, za ocenjevanje v vlogah za pridobitev dovoljenja za promet“.
Representatives of patients' organisations
Predstavniki organizacij bolnikov
Election of the Management Board Chair
Izvolitev predsednika upravnega odbora
[EMA/MB/354158/2010] The Management Board endorsed the appointment of an ad interim accounting officer until the return to office of the accounting officer.
[EMA/MB/354158/2010] Upravni odbor je potrdil imenovanje začasnega računovodje, dokler se ne bo računovodja vrnil na delo.
[EMA/MB/276960/2010; EMA/319831/2010] The Management Board noted the Agency's report to the European Commission providing the Agency's views on the experience with the Fee Regulation.
[EMA/MB/276960/2010; EMA/319831/2010] Upravni odbor se je seznanil s poročilom agencije Evropski komisiji, v katerem so navedena njena stališča glede izkušenj z uredbo o pristojbinah.
[EMA/MB/13787/2009] The Management Board noted the update report on the implementation of EudraVigilance for veterinary products.
[EMA/MB/13787/2009] Upravni odbor se je seznanil s posodobljenim poročilom o izvajanju sistema EudraVigilance za proizvode za uporabo v veterinarski medicini.
Report from the Heads of Medicines Agencies
Poročilo vodij agencij za zdravila
[EMA/MB/345587/2010] The Management Board discussed the new format of the EudraVigilance report.
[EMA/MB/345587/2010] Upravni odbor je razpravljal o novi obliki poročila o sistemu EudraVigilance.
Chair: Pat O'Mahony
Predsednik: Pat O'Mahony
The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Člani upravnega odbora so se seznanili s posodobljenim poročilom vodij agencij za zdravila o več temah, vključno s/z:
[EMA/MB/298674/2010] The Management Board adopted its meeting dates for 2011 and noted tentative meeting dates for 2012.
[EMA/MB/298674/2010] Upravni odbor je potrdil datume sej za leto 2011 in se seznanil z okvirnimi datumi sej za leto 2012.
[EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] The Management Board discussed and agreed in principle on a way forward for introducing changes to the way the Agency handles potential conflicts of interests of experts involved in the evaluation of medicines.
[EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] Upravni odbor je razpravljal o prihodnjih ukrepih za uvedbo sprememb načina, kako agencija obravnava mogoča navzkrižja interesov strokovnjakov, ki sodelujejo pri vrednotenju zdravil, in se načelno strinjal s prihodnjimi ukrepi.
[EMA/MB/282448/2010] The Management Board heard the report on arbitration and referral activities of the CVMP.
[EMA/MB/282448/2010] Upravni odbor se je seznanil s poročilom o dejavnostih arbitraže in napotitev odbora CVMP.
[EMA/MB/372194/2010, EMA/MB/400828/2010] The Management Board noted the decision of the European Commission to re-open the vacancy announcement following advice of the European Commission legal service with regard to a wider publication of the vacancy.
[EMA/MB/372194/2010, EMA/MB/400828/2010] Upravni odbor se je seznanil s sklepom Evropske komisije, da v skladu z nasvetom pravne službe Evropske komisije, da je treba poskrbeti za širšo objavo prostega delovnega mesta, znova objavi obvestilo o prostem delovnem mestu.
• The progress on the HMA strategy paper.
• napredkom pri strateškem dokumentu vodij agencij za zdravila.
The Board constituted a group of topic coordinators to work together with the Agency's staff: Chair, Vice-chair, Kent Woods, Giuseppe Nisticò, Guido Rasi.
V njej bodo predsednik, podpredsednica, Kent Woods, Giuseppe Nisticò in Guido Rasi.
Otherwise, the national competent authorities may have significant difficulties contributing to activities which are important for public health.
Treba je vzpostaviti povezavo med obsegom dela in razpoložljivimi viri za opravljanje potrebnega dela, drugače bodo nacionalni pristojni organi le težko prispevali k dejavnostim, ki so pomembne za javno zdravje.
Representative of veterinarians' organisations
Predstavniki veterinarskih organizacij
Veterinary medicinal products
Zdravila za uporabo v veterinarski medicini
Human medicinal products
Zdravila za uporabo v humani medicini
[EMA/MB/194352/2010] The Management Board noted the final minutes, adopted by written procedure on 26 April 2010.
Zapisnik 66. seje, ki je potekala 17. in 18. marca 2010 [EMA/MB/194352/2010] Upravni odbor se je seznanil s končnim zapisnikom, ki je bil s pisnim postopkom sprejet 26. aprila 2010.
Pending completion of these steps, the Board expressed a scrutiny reservation.
Upravni odbor je do dokončanja teh ukrepov podal proučitveni pridržek.
Representative of doctors' organisations
Predstavniki zdravniških organizacij
List of participants at the 67
Seznam udeležencev 67. seje upravnega odbora, ki je potekala v Londonu 10. junija 2010
Ref. EMEA/652773/2009 EMEA/H/C/1040
: EMEA/769850/2009 EMEA/H/C/1040
London, 22 October 2009 Doc.
London, 22. oktobra 2009 Sklic dok.
It was expected to be available as tablets (50 and 150 mg).
Na voljo naj bi bilo v obliki tablet (50 in 150 mg).
However that trial was being stopped.
Vendar so preskušanje ustavili.
If you are a patient in this trial and need more information about your treatment, contact the doctor who is treating you.
Če ste vključeni v to preskušanje ter potrebujete več informacij o zdravljenju, se obrnite na zdravnika, ki vam je predpisal zdravljenje.
Questions and answers on the withdrawal of the marketing authorisation application for Zunrisa casopitant
Vprašanja in odgovori v zvezi z umikom vloge za pridobitev dovoljenja za promet z zdravilom Zunrisa kasopitant
After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues.
Potem ko je CHMP ocenil odgovore družbe na seznam vprašanj, so nekatera tehtna vprašanja še vedno ostala nerešena.
The effects of Zunrisa were first tested in experimental models before being studied in humans.
Učinki zdravila Zunrisa so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Zunrisa?
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Zunrisa?
It blocks a chemical in the body called substance P from attaching to the NK1 receptors.
V telesu preprečuje, da bi se kemikalija, ki jo imenujemo snov P, vezala na receptorje NK1.
The company presented data from large studies in cancer patients receiving chemotherapy.
Predlagatelj je predstavil podatke iz velikih študij, opravljenih pri bolnikih z rakom, ki so prejemali kemoterapijo.
When substance P attaches to these receptors, it can cause nausea and vomiting.
Če se snov P veže na omenjene receptorje, lahko povzroči slabost in bruhanje.
The company informed the CHMP that at the time of the withdrawal one clinical trial with Zunrisa was ongoing.
Družba je obvestila CHMP, da v času umika poteka eno klinično preskušanje zdravila Zunrisa.
The active substance in Zunrisa, casopitant, is a ‘neurokinin 1 (NK1) receptor antagonist'.
Zdravilna učinkovina v zdravilu Zunrisa je „antagonist receptorja za nevrokinin 1 (NK1)“.
The Committee also asked the company to reconsider the target population for patients having surgery to ensure it adequately reflected the kind of patients who were involved in the studies.
Odbor je prosil predlagatelja, da spremeni ciljno populacijo bolnikov po operativnem posegu tako, da bi primerno odražala bolnike, ki so sodelovali v študijah.
What is Zunrisa?
Kaj je zdravilo Zunrisa?
The main measure of effectiveness was the number of patients who did not vomit or needed to be given rescue medication for vomiting in the first five days following the start of a cycle of chemotherapy.
Glavno merilo učinkovitosti je bilo število bolnikov, ki niso bruhali ali niso potrebovali rešilnega zdravila za bruhanje v prvih petih dneh po začetku cikla kemoterapije.
Zunrisa is a medicine that contains the active substance casopitant.
Zdravilo Zunrisa vsebuje zdravilno učinkovino kasopitant.
The patients were given a combination of Zunrisa with two other medicines (dexamethasone and ondansetron) or the combination without Zunrisa.
Bolnikom so dali bodisi kombinacijo zdravila Zunrisa in še dveh zdravil (deksametazona in ondansetrona) bodisi kombinacijo brez zdravila Zunrisa.
On 25 September 2009, Glaxo Group Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zunrisa, for the prevention of nausea and vomiting in patients undergoing surgery or receiving chemotherapy.
Družba Glaxo Group Ltd je dne 25. septembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Zunrisa, namenjenim preprečevanju slabosti in bruhanja pri bolnikih po operativnih posegih ali med kemoterapijo.
What was Zunrisa expected to be used for?
Za kaj naj bi se zdravilo Zunrisa uporabljalo?
The company also presented data from studies in patients at a high risk of having nausea and vomiting after surgery.
Predlagatelj je predstavil tudi podatke iz študij z bolniki, pri katerih je bilo tveganje slabosti in bruhanja po operativnem posegu zelo veliko.
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Zunrisa could not have been approved for use with other medicines in the prevention of nausea and vomiting in patients receiving chemotherapy or in those undergoing surgery.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih je do umika vloge zastavil CHMP, je Odbor izrazil določene zadržke in je začasno menil, da zdravila Zunrisa ni mogoče odobriti za uporabo z drugimi zdravili za preprečevanje slabosti in bruhanja pri bolnikih, ki prejemajo kemoterapijo, ali po operativnih posegih
The main measure of effectiveness for the study was the number of patients who did not vomit or needed to be given any rescue medication in the first 24 hours after surgery.
Glavno merilo učinkovitosti je bilo število bolnikov, ki niso bruhali ali niso potrebovali rešilnega zdravila za bruhanje v prvih štiriindvajsetih urah po operativnem posegu.
After looking at the results of the main studies, the CHMP noted that, while the studies showed that Zunrisa was effective in some cancer patients receiving chemotherapy, its use in patients receiving chemotherapy treatments that are moderate triggers of nausea and vomiting was not fully supported by the results.
Po pregledu rezultatov glavne študije je CHMP ugotovil, da študije sicer kažejo učinkovitost zdravila Zunrisa pri določenih bolnikih z rakom, ki prejemajo kemoterapijo, vendar rezultati ne podpirajo popolnoma uporabe tega zdravila pri bolnikih, ki prejemajo kemoterapevtike, ki so zmerni spodbujevalci slabosti in bruhanja.
Zunrisa was expected to be used in combination with other medicines to prevent nausea and vomiting in patients receiving chemotherapy treatments (medicines to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Zdravilo Zunrisa naj bi se uporabljalo v kombinaciji z drugimi zdravili za preprečevanje slabosti in bruhanja pri bolnikih po zdravljenju s kemoterapevtiki (zdravili za zdravljenje raka), ki so zmerni do močni spodbujevalci slabosti in bruhanja.
The patients received Zunrisa with ondansetron or ondansetron alone.
Bolniki so prejeli zdravilo Zunrisa in ondansetron ali pa samo ondansetron.