FrancophonIA/ELRC3.0 huggingface dataset:
English: Anticoagulants, antiplatelets, and thrombolytics Interaction with other medicinal products affecting haemostasis
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu Antikoagulanti, antiplejtlits u trombolitiċi Interazzjoni ma' prodotti mediċinali oħra li jaffettwaw lemostażi
English: - medicines for high blood pressure or heart problems (e.g., diltiazem) - antidepressant medicines called selective serotonin re-uptake inhibitors or serotonin
Maltese: - mediċini għal pressjoni tad-demm għolja jew problemi tal-qalb (eż., diltiazem) - mediċini antidepressivi msejħa inibituri selettivi tal-assorbiment mill-ġdid ta' serotonina jew inibituri tal-assorbiment mill-ġdid ta' serotonina-norepinefrina
English: These may all be symptoms of a serious and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML).
Maltese: Dawn kollha jistgħu jkunu sintomi ta' kundizzjoni serja u potenzjalment fatali tal-moħħ magħrufa bħala lewkoenċefalopatija multifokali progressiva (PML, progressive multifocal leukoencephalopathy).
English: SSRIs/SNRIs: As with other anticoagulants the possibility may exist that patients are at increased risk of bleeding in case of concomitant use with SSRIs or SNRIs due to their reported effect on platelets (see section 4.4).
Maltese: SSRIs/SNRIs: Bħal b'antikoagulanti oħra tista' teżisti l-possibbiltà li l-pazjenti jkunu f'riskju akbar ta' fsada f'każ ta' użu konkomitanti ma' SSRIs jew SNRIs minħabba l-effett irrapportat tagħhom fuq ilpjastrini (ara sezzjoni 4.4).
English: Eliquis should be used with caution when coadministered with SSRIs/SNRIs or NSAIDs (including acetylsalicylic acid) because these medicinal products typically increase the bleeding risk.
Maltese: Eliquis għandu jintuża b'kawtela meta jingħata flimkien ma' SSRIs / SNRIs jew NSAIDs (inkluż acetylsalicylic acid) minħabba li dawn ilprodotti mediċinali normalment iżidu r-riskju ta' fsada.
English: Warnings and precautions
Maltese: Twissijiet u prekawzjonijiet
English: EudraVigilance status report 2009
Maltese: Rapport ta' status tal-EudraViġilanza 2009
English: 32 votes cast
Maltese: 32 vot mitfugħa
English: 10bis Appointment of Accounting Officer ad interim
Maltese: 10bis Ħatra ta' Uffiċjal tal-Kontabilità ad interim
English: Observers
Maltese: Osservaturi
English: The reflection paper has been released for public consultation until 30 September 2010.
Maltese: Id-dokument ta' riflessjoni ġie rilaxxat għal konsultazzjoni pubblika sat-30 ta' Settembru 2010.
English: 4 August 2010 EMA/MB/404038/2010
Maltese: EMA/440554/2011
English: Mary G. Baker Mike O'Donovan
Maltese: Baker Mike O'Donovan
English: Documents for information
Maltese: Dokumenti għall-informazzjoni
English: Chair: Pat O'Mahony
Maltese: President: Pat O'Mahony
English: Nominations to CVMP and CHMP under consultation
Maltese: Nominazzjonijiet għas-CVMP u s-CHMP taħt konsultazzjoni
English: Lessons learned during the volcanic eruption
Maltese: Punti prinċipali Lezzjonijiet mitgħallma matul l-eruzzjoni vulkanika
English: Representative of veterinarians' organisations
Maltese: Rappreżentant ta' organizzazzjonijiet talveterinarji
English: Minutes from the 66th meeting, held on 17-18 March 2010
Maltese: 3. Minuti mis-66 laqgħa, li saret fis-17-18 ta' Marzu 2010
English: • The progress on the HMA strategy paper.
Maltese: • Il-progress dwar id-dokument ta' strateġija tal-HMA.
English: The proposals will be implemented in a stepwise approach.
Maltese: tiġi adottata proposta leġiżlattiva ġdida.
English: Referrals to CVMP of veterinary medicinal products: a report from the Agency
Maltese: Referenzi lis-CVMP ta' prodotti mediċinali għal użu veterinarju: rapport mill-Aġenzija
English: [EMA/MB/297535/2010; EMA/MB/168222/2010] The Management Board adopted the analysis and assessment of the annual activity report 2009.
Maltese: [EMA/MB/297535/2010; EMA/MB/168222/2010] Il-Bord ta' Tmexxija adotta l-analiżi u l-valutazzjoni tar-rapport ta' attività annwali 2009.
English: The Board noted the proposed agenda of the workshop.
Maltese: Il-Bord ħa nota tal-aġenda proposta tal-workshop.
English: In accordance with Management Board Rules of procedure there are 35 voting members in the Management Board, 28 members were present at the time of the election and 4 proxies were received: from the Czech Republic to Denmark, DG Enterprise to DG Sanco, Greece to Italy and Sweden to Slovenia.
Maltese: Skont ir-Regoli ta' proċedura tal-Bord ta' Tmexxija hemm 35 membru li jivvotaw fil-Bord ta' Tmexxija, 28 membru kienu preżenti fil-ħin tal-elezzjoni u ġew riċevuti 4 prokuri: mir-Repubblika Ċeka lid-Danimarka, mid-DĠ Intrapriża lid-DĠ Sanco, mill-Greċja lill-Italja u mill-Isvezja lis-Slovenja.
English: The final adoption of an updated policy is expected in October 2010.
Maltese: L-adozzjoni finali ta' politika aġġornata mistennija ssir f'Ottubru 2010.
English: • [EMEA/221701/2010] Update report on the Agency's implementation of the EU telematics strategy.
Maltese: • [EMEA/221701/2010] Rapport ta' aġġornament dwar l-implimentazzjoni tal-istrateġija tattelematika tal-UE mill-Aġenzija.
English: The Board discussed the possibility of publishing, in future, information on Member States' compliance with the legal timeframe of 15 days for transmission of individual case safety reports (ICSRs) to the Agency.
Maltese: Il-Bord iddiskuta l-possibbiltà li fil-futur jippubblika informazzjoni dwar il-konformità tal-Istati Membri mal-qafas ta' żmien legali ta' 15-il ġurnata għat-trasmissjoni ta' rapporti dwar is-sigurtà ta' każijiet individwali (ICSRs) lill-Aġenzija.
English: The members noted the update report from the Heads of Medicines Agencies (HMA) on a number of topics, including:
Maltese: Il-membri ħadu nota tar-rapport ta' aġġornament mill-Kapijiet tal-Aġenziji tal-Mediċini (Heads of Medicines Agencies - HMA) dwar numru ta' suġġetti, inkluż:
English: The second meeting of the chairs took place on 31 May 2010.
Maltese: It-tieni laqgħa tal-presidenti saret fil-31 ta' Mejju 2010.
English: HMA supported the constitution of a permanent group of medical devices competent authorities.
Maltese: L-HMA appoġġjat il kostituzzjoni ta' grupp permanenti ta' awtoritajiet kompetenti tat-tagħmir mediku.
English: Held in London on 10 June 2010
Maltese: Li saret f'Londra fl-10 ta' Ġunju 2010
English: 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.
Maltese: Il-Bord ikkostitwixxa grupp ta' koordinaturi tassuġġetti biex jaħdmu flimkien mal-persunal tal-Aġenzija: President, Viċi President, Kent Woods, Giuseppe Nisticò u Guido Rasi.
English: [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.
Maltese: [EMA/MB/311343/2010; EMA/255244/2010; EMA/MB/353273/2010] Il-Bord ta' Tmexxija ddiskuta u qabel fil-prinċipju dwar triq 'il quddiem għall-introduzzjoni tal-bidliet għall-mod kif l-Aġenzija tittratta lkonflitti ta' interess potenzjali tal-esperti involuti fl-evalwazzjoni tal-mediċini.
English: The whole report can be found on the website of the Commission: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf
Maltese: Ir-rapport sħiħ jista' jinstab fuq is-sit elettroniku tal-Kummissjoni: http://ec.europa.eu/health/files/pharmacos/news/emea_final_report_vfrev2.pdf Il-Kummissjoni Ewropea u l-Aġenzija sejrin jorganizzaw konferenza fit-30 ta' Ġunju 2010 biex jiddiskutu r-riżultati tal-evalwazzjoni mal-partijiet interessati.
English: [EMA/MB/282448/2010] The Management Board heard the report on arbitration and referral activities of the CVMP.
Maltese: [EMA/MB/282448/2010] Il-Bord ta' Tmexxija sema' r-rapport dwar l-attivitajiet ta' arbitraġġ u riferiment tas-CVMP.
English: [EMA/MB/345587/2010] The Management Board discussed the new format of the EudraVigilance report.
Maltese: [EMA/MB/345587/2010] Il-Bord ta' Tmexxija ddiskuta l-format il-ġdid tar-rapport tal-EudraViġilanza.
English: • [EMEA/MB/298753/2010] Summary of transfers of appropriations in the budget 2010.
Maltese: • [EMEA/MB/298753/2010] Sommarju tat-trasferimenti tal-approprjazzjonijiet fil-baġit għall-2010.
English: Ombudsman and access to EMA documents
Maltese: L-Ombudsman u l-aċċess għad-dokumenti tal-EMA
English: [EMA/MB/210895/2010] The agenda was adopted with amendments to agenda item 14.
Maltese: [EMA/MB/210895/2010] L-aġenda ġiet adottata b'emendi fil-punt 14 tal-aġenda.
English: The activity of the newly proposed member in his capacity of a surgeon is only very marginally linked with the objectives of the CHMP.
Maltese: L-attività tal-membru ġdid propost fil-kapaċità tiegħu ta' kirurgu hija biss marbuta marġinalment ħafna mal objettivi tas-CHMP.
English: 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.
Maltese: Il-Bord irringrazzja lill-koordinaturi tas-suġġetti - Jytte Lyngvig, Pat O'Mahony u Kristin Raudsepp - talli ħejjew abbozz komprensiv ta' analiżi u valutazzjoni tar-rapport.
English: [EMA/MB/298674/2010] The Management Board adopted its meeting dates for 2011 and noted tentative meeting dates for 2012.
Maltese: [EMA/MB/298674/2010] Il-Bord ta' Tmexxija adotta d-dati tal-laqgħat tiegħu għall-2011 u ħa nota taddati tal-laqgħat sperimentali għall-2012.
English: [EMA/MB/194352/2010] The Management Board noted the final minutes, adopted by written procedure on 26 April 2010.
Maltese: [EMA/MB/194352/2010] Il-Bord ta' Tmexxija ħa nota tal-minuti finali, adottati permezz ta' proċedura bil-miktub fis-26 ta' April 2010.
English: A separate discussion with the ECDC will be organised.
Maltese: Barra minn hekk, sejra tiġi organizzata diskussjoni separata mal-ECDC.
English: Therefore for all the aforementioned reasons, Prof. Nisticò does not endorse the nomination of the new nominee from Poland as CHMP member".
Maltese: Nisticò ma japprovax in-nominazzjoni tan-nominat il-ġdid mill-Polonja bħala membru tas-CHMP".
English: Following the adoption, the Board's opinion and the final accounts will be sent to the relevant EU institutions.
Maltese: Wara l-adozzjoni, l-opinjoni talBord u l-kontijiet finali jintbagħtu lill-istituzzjonijiet rilevanti tal-UE.
English: The number of data fields to be removed varies in different cases.
Maltese: In-numru ta' oqsma tad-dejta li għandhom jitneħħew ivarja f'każijiet differenti.
English: The Management Board re-elected Pat O'Mahony as its Chair for a new three-year term, by unanimous vote.
Maltese: Il-Bord ta' Tmexxija reġa' eleġġa lil Pat O'Mahony bħala l-President tiegħu għal mandat ġdid ta' tliet snin, permezz ta' vot unanimu.
English: 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.
Maltese: Giuseppe Nisticò, li talab biex ir-rimarki speċifiċi tiegħu jiġu inklużi fil-minuti: “Il-kurrikulu preċedenti tal-membru Pollakk tas-CHMP, li kien meqjus fis-CHMP bħala l-membru ta' referenza għallvalutazzjoni tat-trattament tal-mediċina f'mard respiratorju, huwa ferm aktar speċifiku u addatt f'termini ta' kompetenza regolatorja u klinika, kuntrarju għal dak tal-membru ġdid propost.
English: Fourteen agencies participated and elected Pat O'Mahony as the chair of the group.
Maltese: Erbatax-il aġenzija pparteċipaw u eleġġew lil Pat O'Mahony bħala l-president tal-grupp.
English: [EMA/MB/13787/2009] The Management Board noted the update report on the implementation of EudraVigilance for veterinary products.
Maltese: [EMA/MB/13787/2009] Il-Bord ta' Tmexxija ħa nota tar-rapport ta' aġġornament dwar limplimentazzjoni tal-EudraViġilanza għal prodotti veterinarji.
English: Due to the disruption of travel following the volcanic eruption in Iceland, the Agency's Committee for Medicinal Products for Human Use worked extensively using teleconferencing tools.
Maltese: Minħabba t-tħarbit fl-ivvjaġġar wara l-eruzzjoni vulkanika fl-Islanda, il-Kumitat tal-Aġenzija għal Prodotti Mediċinali għall-Użu mill-Bniedem ħadem b'mod estensiv permezz ta' għodod ta' telekonferenzi.
English: • Progress on legislative proposals on pharmacovigilance, falsified medicines and information to patients.
Maltese: • Il-progress dwar il-proposti leġiżlattivi dwar il-farmakoviġilanza, il-mediċini ffalsifikati u l informazzjoni lill-pazjenti.
English: [EMA/MB/298741/2010] The Management Board discussed two ongoing consultation procedures: one for the CVMP and one for the CHMP.
Maltese: [EMA/MB/298741/2010] Il-Bord ta' Tmexxija ddiskuta żewġ proċeduri ta' konsultazzjoni li għaddejjin: waħda għas-CVMP u waħda għas-CHMP.
English: European Commission initiative on vigilance system for substances of human origin: cells, tissues, blood
Maltese: Inizjattiva tal-Kummissjoni Ewropea fuq sistema ta' viġilanza għal sustanzi ta' oriġini umana: ċelloli, tessuti, demm
English: [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'.
Maltese: [EMA/MB/338709/2010; EMA/712397/2009] Il-Bord ta' Tmexxija ħa nota tal-abbozz tad-dokument ta' riflessjoni, li jelabora fuq erba' oqsma ta' azzjoni mid-dokument ta' strateġija 'L-aċċettazzjoni tal-provi kliniċi mwettqa f'pajjiżi terzi għal evalwazzjoni fl-Applikazzjonijiet għall-Awtorizzazzjoni għat-Tqegħid fis-Suq'.
English: Einar Magnússon (Iceland) Brigitte Batliner (Liechtenstein) Gro Ramsten Wesenberg (Norway)
Maltese: Brigitte Batliner (il-Liechtenstein)
English: The current fee system consists of around 130 different fees.
Maltese: Is-sistema tal-ħlasijiet attwali tikkonsisti minn madwar 130 ħlas differenti.
English: • [EMA/MB/281850/2010] Outcome of written procedures during the period from 26 February 2010 to 2 June 2010.
Maltese: • [EMA/MB/281850/2010] Riżultat tal-proċeduri bil-miktub matul il-perjodu mis-26 ta' Frar 2010 sat2 ta' Ġunju 2010.
English: Giuseppe Nisticó Björn Lemmer
Maltese: Kent Woods Il-Parlament Ewropew Giuseppe Nisticó Björn Lemmer Il-Kummissjoni Ewropea
English: [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.
Maltese: [EMA/MB/311466/2010] Il-Bord ta' Tmexxija ddiskuta l-memorandum ta' fehim (MoU) li jikkjarifika rresponsabbiltajiet bejn l-EMA u l-awtoritajiet nazzjonali kompetenti għall-monitoraġġ tal-livell xjentifiku u l-indipendenza tal-evalwazzjonijiet.
English: [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.
Maltese: [EMA/MB/372194/2010, EMA/MB/400828/2010] Il-Bord ta' Tmexxija ħa nota tad-deċiżjoni talKummissjoni Ewropea li terġa' tiftaħ l-avviż ta' post battal wara parir tas-servizz legali tal-Kummissjoni Ewropea fir-rigward ta' pubblikazzjoni usa' tal-post battal.
English: A workshop will be organised on 6-7 September 2010 as part of the consultation process, to which a wide range of EU and third-country regulators and stakeholders will be invited.
Maltese: Bejn is6 u s-7 ta' Settembru 2010 sejjer jiġi organizzat workshop bħala parti mill-proċess ta' konsultazzjoni, li għalih sejrin jiġu mistiedna firxa wiesgħa ta' regolaturi u partijiet interessati mill-UE u minn pajjiżi terzi.
English: 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.
Maltese: Id-Direttur Eżekuttiv ħabbar il-ħatra ta' Jean-Claude Brival bħala kap tas-Settur li nħoloq dan l-aħħar għall-Ġestjoni tad-Dejta dwar il-Prodotti ta' Mediċina Veterinarja u t-Taqsima għall-Ġestjoni tad-Dejta dwar il-Prodotti u Alexis Nolte bħala kap tas-Settur għall-Kwalità tal-Mediċini.
English: 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
Maltese: Abbozz ta' dokument ta' riflessjoni dwar l-aspetti etiċi u ta' GCP tal-provi kliniċi ta' prodotti mediċinali għal użu mill-bniedem imwettqa f'pajjiżi terzi u sottomessi flapplikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq lill-EMA
English: The Board was informed that the CVMP established a Task Force on referrals which will review strategic options for the harmonisation of products, develop a methodology for prioritisation of issues for referral and will develop proposals in relation to future legislation concerning veterinary medicinal products on issues related to referrals.
Maltese: Task Force dwar ir-referenzi li tanalizza l-għażliet strateġiċi għall-armonizzazzjoni tal-prodotti, tiżviluppa metodoloġija għall-prijoritizzazzjoni tal-kwistjonijiet għal referenza u sejra tiżviluppa proposti fir-rigward tal-leġiżlazzjoni futura dwar prodotti mediċinali għal użu veterinarju dwar kwistjonijiet relatati mar-referenzi.
English: • Agenda point 10_Advertisement of the vacancy notice for the recruitment of the Executive Director for the EMA.
Maltese: • Punt 10 fuq l-aġenda_Reklam tal-avviż ta' post battal għar-reklutaġġ tad-Direttur Eżekuttiv għall
English: [EMA/MB/302460/2010] The Management Board had adopted revised contractual arrangements which contain a number of key performance indicators.
Maltese: [EMA/MB/302460/2010] Il-Bord ta' Tmexxija adotta l-arranġamenti kuntrattwali riveduti li fihom numru ta' indikaturi tal-prestazzjoni ewlenin.
English: [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.
Maltese: [EMA/MB/354158/2010] Il-Bord ta' Tmexxija approva l-ħatra ta' uffiċjal tal-kontabilità ad interim sakemm jerġa' jieħu l-kariga l-uffiċjal tal-kontabilità.
English: London, 10 June 2010
Maltese: 4 ta' Awwissu 2010
English: The Vice-Chair, Lisette Tiddens-Engwirda, opened the meeting by welcoming meeting participants and by asking Members to declare any specific interests that could be considered to be prejudicial to their independence with respect to the items on the agenda.
Maltese: Il-Viċi President, Lisette Tiddens-Engwirda, fetħet il-laqgħa billi laqgħat lill-parteċipanti tal-laqgħa u billi talbet lill-Membri biex jiddikjaraw kwalunkwe interess speċifiku li jista' jitqies bħala preġudizzjali għallindipendenza tagħhom fir-rigward tal-punti fuq l-aġenda.
English: 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.
Maltese: Filwaqt li n-numru ta' referenzi għal arbitraġġi li jirriżultaw mill-kunsiderazzjoni tal-applikazzjonijiet minn CMDv naqas, ir-referenzi li jieħdu aktar riżorsi tal-Kumitat u s-segretarjat talAġenzija jirrelataw b'mod partikolari mal-armonizzazzjoni u r-referenzi ta' ‘interess Komunitarju' li jistabbilixxu preċedenti u prattika li sejrin jiġu segwiti f'każijiet simili sussegwenti.
English: Common systems need to be developed for proactive release of information.
Maltese: Jeħtieġ li jiġu żviluppati sistemi komuni għar-rilaxx proattiv talinformazzjoni.
English: [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.
Maltese: [EMA/MB/276960/2010; EMA/319831/2010] Il-Bord ta' Tmexxija ħa nota tar-rapport tal-Aġenzija lillKummissjoni Ewropea billi pprovda l-fehmiet tal-Aġenzija dwar l-esperjenza bir-Regolament dwar ilĦlasijiet.
English: The dates for 2011 are as follows: 16-17 March, 9 June, 6 October and 15 December.
Maltese: Id-dati għall-2011 huma kif ġej: is-16-17 ta' Marzu, id-9 ta' Ġunju, is-6 ta' Ottubru u l-15 ta' Diċembru.
English: Contractual arrangements: monitoring of key performance indicators
Maltese: Arranġamenti kuntrattwali: il-monitoraġġ ta' indikaturi tal-prestazzjoni ewlenin
English: Highlights
Maltese: Apoloġiji
English: In response to this observation, the Polish representative to the Board emphasised that: “The decision to nominate a candidate to the CHMP is a sovereign decision of a Member State and Poland based its decision on the candidate's scientific background and professional experience.”
Maltese: B'reazzjoni għal din l-osservazzjoni, ir-rappreżentant Pollakk għall-Bord enfasizza li: “Id-deċiżjoni li jiġi nnominat kandidat għas-CHMP hija deċiżjoni sovrana ta' Stat Membru u l-Polonja bbażat id-deċiżjoni tagħha fuq l-isfond xjentifiku u l-esperjenza professjonali tal-kandidat.
English: In total there were 32 votes cast.
Maltese: B'kollox, kien hemm 32 vot mitfugħa.
English: The actions encompass EMA processes having an impact on clinical trials carried out at different stages of the lifecycle of medicinal products and the relationship with regulators in all parts of the world, with a view to achieving a robust framework for the oversight and conduct of clinical trials.
Maltese: L-azzjonijiet jinkludu l-proċessi tal-EMA li jħallu impatt fuq il-provi kliniċi mwettqa fi stadji differenti taċ-ċiklu tal-ħajja tal-prodotti mediċinali u r-relazzjoni mar-regolaturi fil-partijiet kollha tad-dinja, bilgħan li jinkiseb qafas robust għas-sorveljanza u t-twettiq tal-provi kliniċi.
English: 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.
Maltese: Wara d-diskussjoni fil-laqgħa ta' Marzu 2010 dwar l-allokazzjoni tar-responsabbiltà fi ħdan l-UE rigward sistema ta' viġilanza għal sustanzi ta' oriġini umana, id-Direttur Eżekuttiv kiteb ittra lill-Kummissjoni Ewropea li kienet segwita minn diskussjoni bejn id-DĠ Sanco u l-persunal tal-EMA. Meta tiġi biex tiddeċiedi fejn talloka r-responsabbiltajiet għall-kompitu l-ġdid, il-Kummissjoni Ewropea tista' tikkunsidra jekk għandhiex tikkombina l-kapaċitajiet u l-esperjenza tal-kollaborazzjoni taż-żewġ aġenziji (l-EMA u l-ECDC).
English: The Board stressed that it is essential for the national competent authorities to recover the costs fully.
Maltese: Il-Bord enfasizza li huwa essenzjali għall-awtoritajiet nazzjonali kompetenti li jirkupraw l-ispejjeż kompletament.
English: Currently, the Agency uses teleconferencing for meetings involving small numbers of participants.
Maltese: Attwalment, l-Aġenzija qiegħda tuża t-telekonferenzi għal laqgħat li jinvolvu numri żgħar ta' parteċipanti.
English: • A strategic discussion on the benefits of e-readiness and the different systems being used by medicines agencies to work in an electronic-only environment.
Maltese: • Diskussjoni strateġika dwar il-benefiċċji tal-prontezza elettronika u s-sistemi differenti li qegħdin jintużaw mill-aġenziji tal-mediċini biex jaħdmu f'ambjent elettroniku biss.