FrancophonIA/ELRC3.0 huggingface dataset:
English: After infection with virulent field myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Maltese: Wara infezzjoni minn myxomatosis virulenti xi annimali vaċċinati jistgħu jiżviluppaw ftit nefħiet, speċjalment f'partijiet tal-ġisem bla xagħar, li malajr jiffurmaw qoxra.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Maltese: MANIFATTURA ( TAS-SUSTANZA BIJOLOĠIKA ATTIVA U SID LAWTORIZZAZZJONI TAL-MANIFATTURA RESPONSABBLI
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: As a consequence, rabbits are immunised against myxoma virus and both classical and type 2 RHD viruses.
Maltese: Bħala konsegwenza, il-fniek huma immunizzati kontra l-virus myxoma kemm għal virus tip kassiku u għat-tip 2 RHD.
English: Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent.
Maltese: Ħallat fjala ta' doża waħda li fiha l- lijofilizat ma 0.5 ml tas-solvent provdut.
English: PACKAGE LEAFLET:
Maltese: Lijofilizat:
English: In pet rabbits, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur in very rare cases.
Maltese: Fil-fniek pets, f'każijiet rari ħafna, reazzjonijiet lokali bħall nekrożi, skorċa, qoxra jew telf ta' xagħar jistgħu jseħħu.
English: Reconstitute a multi-dose vial containing lyophilisate with 10 ml of the supplied solvent.
Maltese: Fjala ta' ħafna dożi Ħallat fjala ta` ħafna dożi li fiha l-lijofilizat ma 10ml tas-solvent provdut.
English: Marketing authorisation holder and manufacturer responsible for batch release: Intervet International B.V.
Maltese: U L-INDIRIZZ TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ Intervet International B.V.
English: 18 February 2010 EMA/83783/2010 EMEA/H/C/883
Maltese: EMA/476138/2010 EMEA/H/C/000883
English: The company that applied for the authorisation is Janssen-Cilag International N.V.
Maltese: Ilkumpanija li applikat għall-awtorizzazzjoni hija Janssen-Cilag International N.V.
English: Refusal of the marketing authorisation for ZefteraF F (ceftobiprole) EMA/83783/2010
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għal ZefteraF F (ceftobiprole) EMA/476138/2010
English: What is Zeftera?
Maltese: X'inhu Zeftera?
English: The active substance in Zeftera, ceftobiprole, is an antibiotic that belongs to the group ‘cephalosporins'.
Maltese: Is-sustanza attiva f'Zeftera, ceftobiprole, hija antibijotiku li jappartjeni għall-grupp ‘cephalosporins'.
English: or infusion (drip into a vein).
Maltese: Zeftera huwa trab magħmul f'soluzzjoni għal infuzjoni (dripp fil-vina).
English: What was Zeftera expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Zeftera?
English: In November 2008, the CHMP gave a positive opinion on Zeftera, recomm marketing authorisatio study sites by the Food and Drug Administration (FDA) in the United States of A concerns over the way the main clinical studies were conducted.
Maltese: Madankollu, iktar tard il-Kumitat irċieva informazzjoni dwar spezzjoni ta' siti ta' studju mill-Food and Drug Administration (FDA) fl-Istati Uniti tal-Amerika li wasslet lill-Kumitat sabiex iwaqqaf il-proċess ta' awtorizzazzjoni tal-mediċina.
English: The first study compared Zeftera with vancomycin (another an ceftazidime (another cephalosporin antibiotic) in 828 patients.
Maltese: L-ewwel studju qabbel Zeftera ma' vancomycin (antibijotiku ieħor attiv kontra l-MRSA) f'784 pazjent, u t-tieni qabblu mal-kombinazzjoni ta' vancomycin u ceftazidime (antibijotiku ta' cephalosporin ieħor) fi 828 pazjent.
English: On 18 February 2010, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product for the treatment of adults with complicated skin and soft-tissue infections.
Maltese: Fit-18 ta' Frar 2010, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, u rrakkomanda r-rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għall-prodott mediċinali Zeftera, maħsub sabiex jikkura infezzjonijiet ikkumplikati fil-ġilda u fit-tessut artab fl-adulti.
English: is active against several types of bacteria, including methicillin-resistant Staphylococcus d in humans.
Maltese: Ceftobiprole huwa attiv kontra bosta tipi ta' batterji, inkluż methicillin-resistant Staphylococcus aureus reżistenti għall-metiċillina (MRSA - methicillin-resistant Staphylococcus aureus).
English: Zeftera is a powder that is made up into a solution f substance ceftobiprole.
Maltese: Fih s-sustanza attiva ceftobiprole.
English: Page 2/2
Maltese: 24 ta' Ġunju 2010
English: How is Zeftera expected to work?
Maltese: Kif inhu mistenni li jaħdem Zeftera?
English: 1 Previously known as Zevtera.
Maltese: Qabel kienet magħrufa bħala Zevtera.
English: The effects of Zeftera were first tested in experimental models before being studie The company presented results of two main studies involving adults with complicated ski tissue infections.
Maltese: Il-kumpanija ippreżentat riżultati minn żewġ studji ewlenin li involvew adulti b'infezzjonijiet ikkumplikati tal-ġilda u tat-tessuti rotob.
English: Refusal of the marketing authorisation for Zeftera
Maltese: Rifjut tal-awtorizzazzjoni għat-tqegħid fis-suq għal Zeftera
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has t might affect the response to treatment.
Maltese: ‘Ikkumplikati' tfisser li l-infezzjoni hija diffiċli biex tiġi kkurata, minħabba li tkun infirxet għat-tessuti li jinsabu fil-fond taħt il-ġilda, jista' jkun hemm bżonn ta' kirurġija, jew ilpazjent għandu kundizzjonijiet oħra li jistgħu jaffettwaw ir-rispons għat-trattament.
English: The company informed the CHMP that that there are no consequences for patients in clinical trials with Zeftera and that there are no compassionate use programmes in progress with Zeftera.
Maltese: Jekk inti fi prova klinika u trid iktar informazzjoni dwar il-kura tiegħek, ikkuntattja lit-tabib li qiegħed jagħtihielek.
English: These subsequent inspections showed that the studies had not been conducted in ‘good clinical practice' (GCP) in some beneficial to patients, the CHMP was concerned about how reliable the results were.
Maltese: Spezzjonijiet sussegwenti wrew li f'xi siti l-istudji ma twettqux f'konformità ma' ‘prattika klinika tajba' (GCP). Għalkemm ir-riżultati tal-istudju ssuġġerew li l-mediċina kienet ta' benefiċċju għall-pazjenti, isCHMP kien imħasseb fuq kemm ir-riżultati kienu affidabbli.
English: The full EPAR for Levetiracetam ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as oblong tablets (250 mg, 500 mg, 750 mg and 1000 mg) and as an oral solution (100 mg/ml).
Maltese: Tiġi bħala pilloli f'għamla tawwalija (oblonga) (250 mg, 500 mg, 750 mg u 1,000 mg) u bħala soluzzjoni orali (100 mg/ml).
English: This summary was last updated in 06-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi 06-2011.
English: years of age with juvenile myoclonic epilepsy;
Maltese: f'pazjenti minn 12-il sena ta' età bl-epilessija mijoklonika ġovanili;
English: Levetiracetam ratiopharm is a ‘generic medicine'.
Maltese: Levetiracetam ratiopharm huwa ‘mediċina ġenerika'.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam ratiopharm on 26 August 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Levetiracetam ratiopharm fi 26 Awwissu 2011.
English: The active substance in Levetiracetam ratiopharm, levetiracetam, is an anti-epileptic medicine.
Maltese: Is-sustanza attiva fi Levetiracetam ratiopharm, levetiracetam, hija mediċina kontra l-epilessija.
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Maltese: • aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic (aċċessjonijiet maġġuri, li jinkludu telfien mis-sensi) f'pazjenti minn 12-il sena ta' età bl-epilessija ġeneralizzata idjopatika (it-tip ta' epilessija li hija maħsuba li għandha kawża ġenetika).
English: The exact way in which levetiracetam works is still unclear but it seems to interfere with a protein called synaptic vesicle protein 2A, which is found in the spaces between nerves and is involved in the release of chemical messengers from nerve cells.
Maltese: Il-mod eżatt ta' kif levetiracetam jaħdem mhuwiex ċar iżda jidher li jinterferixxi ma' proteina msejħa proteina tal-bużżieqa tas-sinapsi 2A, li tinstab fl-ispazji bejn in-nervituri u li hija nvoluta fir-rilaxx ta' messaġġiera kimiċi miċ-ċelloli tannervituri.
English: Other information about Levetiracetam ratiopharm
Maltese: Informazzjoni oħra dwar Levetiracetam ratiopharm
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Maltese: • aċċessjonijiet mijokloniċi (spażmi qosra, simili għal xokkijiet ta' muskolu jew grupp ta' muskoli)
English: In patients aged between six months and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Maltese: F'pazjenti ta' età bejn is-sitt xhur u s-17-il sena li jiżnu inqas minn 50 kg, id-doża tal-bidu hija ta' 10 mg kull kilogramm tal-piż tal-ġisem darbtejn kuljum, li tista' tiżdied għal 30 mg/kg darbtejn kuljum.
English: What is Levetiracetam ratiopharm?
Maltese: X'inhu Levetiracetam ratiopharm?
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam ratiopharm.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Levetiracetam ratiopharm.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam ratiopharm has been shown to have comparable quality and to be bioequivalent to Keppra.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Levetiracetam ratiopharm intwera li għandu kwalità komparattiva u li huwa bijoekwivalenti għal Keppra.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Maltese: Din hija tip ta' epilessija fejn hemm attività żejda f'naħa waħda tal-moħħ li tikkawża sintomi bħal movimenti f'daqqa u mhux koordinati f'parti waħda tal-ġisem, smiegħ mhux ċar, sens ta' xamm jew viżjonijiet, tnemnin, jew sens ta' biża' f'daqqa.
English: Because Levetiracetam ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Keppra.
Maltese: Minħabba li Levetiracetam ratiopharm huwa mediċina ġenerika, l-istudji fuq pazjenti ġew limitati għal testijiet biex jiddeterminaw li huwa bijoekwivalenti għall-mediċina ta' referenza, Keppra.
English: When Levetiracetam ratiopharm is added to another anti-epileptic treatment, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day.
Maltese: Meta Levetiracetam ratiopharm jingħata ma' kura oħra kontra l-epilessija, id-doża tal-bidu f'pazjenti li għandhom 'il fuq minn 12-il sena li jiżnu aktar minn 50 kg hija ta' 500 mg darbtejn kuljum.
English: Levetiracetam ratiopharm is a medicine that contains the active substance levetiracetam.
Maltese: Levetiracetam ratiopharm hija mediċina li fiha s-sustanza attiva levetiracetam.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Maltese: Għalhekk, l-opinjoni tas-CHMP kienet li, l-istess bħal Keppra, il-benefiċċju jegħleb ir-riskju identifikat.
English: When Levetiracetam ratiopharm is used on its own, the starting dose is 250 mg twice a day, increasing two weeks later to 500 mg twice a day.
Maltese: Meta Levetiracetam ratiopharm jintuża waħdu, id-doża tal-bidu hija ta' 250 mg darbtejn kuljum, li ġimagħtejn wara tiżdied għal 500 darbtejn kuljum.
English: Levetiracetam ratiopharm can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Maltese: Levetiracetam ratiopharm jista' jintuża waħdu fuq pazjenti minn 16-il sena li jkunu għadhom kif ġew dijanjostikati bl-epilessija, għall-kura ta' aċċessjonijiet tat-tip parzjali (aċċessjonijiet) bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: In babies aged between one and six months, the starting dose is 7 mg/kg twice a day, using the oral solution.
Maltese: Fi trabi ta' bejn xahar u sitt xhur, id-doża tal-bidu hija ta' 7 mg/kg darbtejn kuljum, bl-użu tas-soluzzjoni orali.
English: The daily dose can be increased up to 1500 mg twice a day.
Maltese: Id-doża ta' kuljum tista' tiżdied sa 1,500 mg darbtejn kuljum.
English: • partial-onset seizures with or without generalisation in patients from one month of age;
Maltese: • aċċessjonijiet tat-tip parzjali bi jew mingħajr ġeneralizzazzjoni f'pazjenti minn xahar ta' età;
English: The Committee recommended that Levetiracetam ratiopharm be given marketing authorisation.
Maltese: Il-Kumitat irrakkomanda li Levetiracetam ratiopharm jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Levetiracetam ratiopharm been studied?
Maltese: Kif ġie studjat Levetiracetam ratiopharm?
English: Levetiracetam ratiopharm can also be used as an add-on to other anti-epileptic medicines to treat:
Maltese: Levetiracetam ratiopharm jista' jintuża wkoll ma' mediċini oħra kontra l-epilessija fil-kura ta':
English: How is Levetiracetam ratiopharm used?
Maltese: Kif jaħdem Levetiracetam ratiopharm?
English: This means that Levetiracetam ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Maltese: Dan ifisser li Levetiracetam ratiopharm huwa simili għal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Keppra.
English: Why has Levetiracetam ratiopharm been approved?
Maltese: Għaliex ġie approvat Levetiracetam ratiopharm?
English: What are the benefits and risks of Levetiracetam ratiopharm?
Maltese: X'inhuma l-benefiċċji u r-riskji assoċjati ma' Levetiracetam ratiopharm?
English: Preparation of reference paper
Maltese: Introduzzjoni mid-Direttur Eżekuttiv
English: fostering transparency, communication and provision of information;
Maltese: promozzjoni tat-trasparenza, tal-komunikazzjoni u tal-għoti ta' informazzjoni;
English: An important part of the ERMS is the implementation of the European Network of Centres for Pharmacovigilance and Pharmacoepidemiology (ENCePP).
Maltese: Parti importanti tal-ERMS tikkostitwixxi limplimentazzjoni tan-Netwerk Ewropew taċ-Ċentri ta' Farmakoviġilanza u Farmakoepidemjoloġija (ENCePP).
English: 1 Benchmarking of European medicines agencies (BEMA).
Maltese: 1 Valutazzjoni komparattiva tal-aġenziji Ewropej għall-mediċini ((BEMA).
English: The EMEA has prepared for the creation of a new scientific committee - the Committee for Advanced Therapies - that will become fully operational in 2009.
Maltese: L-EMEA ħejjiet il-ħolqien ta' kumitat xjentifiku ġdid - il-Kumitat għat-Terapiji Avvanzati - li ser isir totalment operattiv fl-2009.
English: On the Internet at: www.emea.europa.eu By e-mail request to: info@emea.europa.eu By fax to: (44-20) 7418 8670 By writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus, Canary Wharf London E14 4HB, UK
Maltese: L-EMEA tinsab taħt pressjoni li kulma jmur qiegħda tiżdied biex tiggarantixxi li l-preżenza tagħha fl-internet tista' tissodisfa l-eżiġenzi tal-partijiet interessati billi tippubblika informazzjoni permezz tal-internet li tista' tinstab u tintuża faċilment.
English: Preparatory work has been undertaken in 2008, and the Agency should be in a position to start commissioning pharmacoepidemiological studies in 2009.
Maltese: Ix-xogħol preparatorju sar fl-2008 u l-Aġenzija għandha tkun f'pożizzjoni li tibda tikkummissjona studji farmakoepidemjoloġiċi fl-2009.
English: In order to encompass and consolidate all transparency-related activities, the Agency, after consultation with partners and stakeholders, will develop a transparency policy.
Maltese: Bilgħan li tinkludi u tikkonsolida l-attivitajiet kollha marbuta mat-trasparenza, l-Aġenzija, wara konsultazzjoni mal-imsieħba u mal-partijiet interessati, se tiżviluppa politika tat-trasparenza.
English: Coordination-group meeting dates can be found on the EMEA website at: http://www.emea.europa.eu/meetings/committee.htm2.14 Regulatory and organisational-support activities
Maltese: Fl-istess waqt, l-EMEA ilha talloka parti sinifikanti tar-riżorsi għall-iżvilupp u l-manutenzjoni tal-IT għall-iżvilupp u s-sostenn tas-sistemi telematiċi tal-UE.
English: These activities cover cooperation at European level, collaboration with the Organisation for Economic Co-operation and Development (OECD), cooperation with the European Directorate for the Quality of Medicines and HealthCare (EDQM), and at international level, EMEA participation in the International Conference on Harmonisation (ICH), work with the World Health Organization (WHO), the International Cooperation on Harmonisation for Veterinary products (VICH), the Codex Alimentarius, the World Organisation for Animal Health (OIE), work with the US Food and Drug Administration (FDA), the US Department of Agriculture (USDA) and the Japanese and Canadian authorities in the implementation of the confidentiality arrangements, and with other non-ICH regulatory authorities.
Maltese: It-tielet, lAġenzija se tikkontribwixxi b'mod attiv għall-ħidma tal-Kummissjoni UE, tal-aġenziji Komunitarji u tal-awtoritajiet nazzjonali kompetenti fir-rigward tal-valutazzjoni u, fejn ikun il-każ, tal-ġestjoni tar-riskji potenzjali għall-bniedem li jirriżultaw mill-użu ta' aġenti antimikrobiċi bħala prodotti mediċinali veterinarji.
English: The main task of the Committee for Advanced Therapies (CAT), established by the Regulation, is to provide a draft opinion to the CHMP on the evaluation of each marketingauthorisation application submitted for an advanced-therapy medicinal product, to provide specific expertise, to advise the EMEA, CHMP and European Commission scientifically on any data related to advanced-therapy medicinal products, and to evaluate applications for certification of quality and nonclinical data.
Maltese: Billi stabbiliet il-proċesuri meħtieġa għall-evalwazzjoni tal-applikazzjonijiet u għall-għoti ta' konsulenza speċifika relatata mal-prodotti mediċinali b'terapija avvanzata, l-Aġenzija se tħaddem dawn il-proċeduri u se tiżviluppa attivitajiet ta' ġestjoni tar-riskji u ta' farmakoviġilanza f'dan il-qasam ta' responsabbiltà l-ġdid.
English: The Agency's activities in the area of herbal medicines include the provision by the Committee on Herbal Medicinal Products (HMPC) of scientific opinions on questions relating to herbal medicines, the establishment of Community herbal monographs for traditional and well-established herbal medicinal products, the establishment of a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products, the provision of opinions on herbal substances at the request of the CHMP, and the evaluation for referral and arbitration procedures of traditional herbal medicinal products.
Maltese: L-Aġenzija topera f'kuntest regolatorju globali kkaratterizzat, fost tendenzi oħra, minn numru dejjem jikber ta' provi kliniċi mwettqa f'pajjiżi fejn il-perċezzjoni tal-applikazzjoni ta' prattika klinika tajba għad ma għandhiex tradizzjonijiet daqshekk stabbiliti daqs dawk flUnjoni Ewropea, fl-Istati Uniti u f'pajjiżi żviluppati oħrajn.
English: Career to date: From 1980 to 1996, Dr Westermark worked as a practitioner and a senior consultant in the Department of Internal Medicine of the University Hospital of Uppsala, and held a position as head of the Endocrinology and Diabetes section (1995 to 1996).
Maltese: Barra minn hekk, wara konsultazzjoni u xogħol preparatorju interni, l-EMEA se tadatta l-istruttura organizzattiva tagħha biex tippermetti lill-Aġenzija twettaq il-missjoni tagħha f'mod iktar effikaċi u effiċjenti.
English: Community herbal monograph on Thymi aetheroleum
Maltese: tisħiħ tan-netwerk Ewropew tal-mediċini;
English: Konstantin Keller, Chair of the HMPC, n. German
Maltese: Dawn kienu impernjati fuq li ġej:
English: Guideline on validation of immunoassay for the detection of Hepatitis B virus surface antigen (HBsAg) in plasma pools
Maltese: implimentazzjoni u tħaddim tal-leġiżlazzjoni l-ġdida dwar prodotti mediċinali b'terapija avvanzata għal użu mill-bniedem, kif ukoll leġiżlazzjoni ġdida oħra;
English: Commission (DG XI) and then in industry at Pfizer (formerly SmithKline Beecham Animal Health) as a regulatory affairs manager.
Maltese: L-EMEA tibqa' impenjata fit-titjib tad-disponibbiltà tal-mediċini veterinarji u biex din il-mira tintlaħaq, se tiffoka l-isforzi tagħha fi tliet setturi ewlenin.
English: Career to date: Dr Salmikangas is a biochemist.
Maltese: kontribut fit-titjib tad-disponibbiltà ta' mediċini għal użu mill-bniedem u veterinarju;
English: EMEA/CPMP/BPWG/1561/99 EMEA/CPMP/BPWG/1625/99 EMEA/CPMP/BPWG/198/95 rev. 1
Maltese: Bħala konsegwenza, l-Aġenzija se terġa' tniedi s-sit elettroniku tagħha lejn l-aħħar tal-2009 u se tibda taħdem biex tiggarantixxi li s-siti elettroniċi kollha indirizzati lill-pubbliku mmexxija mill-Aġenzija jkunu faċli biex jintużaw u jiġu aċċessati mill-partijiet interessati esterni.
English: Assist the chair of the CMD(v) in identifying issues that affect the efficient working of the European medicines network at the level of the CMD(v), and promote the resolution of these issues through active liaison with the Heads of Medicines Agencies, CVMP, CMD(h) and interested parties.
Maltese: Kif jista' jiġi osservat f'dan il-programm ta' ħidma, l-attivitajiet fil-qasam tal-leġiżlazzjoni implimentata reċentement dwar il-mediċini pedjatriċi jibqgħu kumplessi u dinamiċi.
English: Continue with the provision of advice on eligibility for pre-authorisation procedures of innovative types of medicinal products and with the provision of fora for discussion with stakeholders on innovative therapeutic approaches and new development methods, in line with the recommendation of the EMEA/CHMP think-tank report.
Maltese: Fil-qasam tal-innovazzjoni, l-EMEA se tiddedika l-isforzi u rriżorsi tagħha għall-attivitajiet tal-Inizjattiva dwar Mediċini Innovattivi u tal-Pjattaforma Teknoloġika Ewropea għas-Saħħa Globali tal-Annimali.
English: Education: Bachelor of Arts in languages and linguistics at the University of East Anglia and postgraduate degree in librarianship and information science at University of Wales.
Maltese: B'riżultat ta' dan, l-Aġenzija saret organizzazzjoni kumplessa li tiddependi ħafna minn teknoloġiji tal-informazzjoni u tal-komunikazzjoni effikaċi u effiċjenti.
English: Career to date: From 1991 to 1993, Dr Holm worked at the department of toxicology at H. Lundbeck A/S in Copenhagen.
Maltese: Barra minn hekk, fis-sena 2008 tqajmu kwistjonijiet dwar il-kwalità ta' prodotti li s-sustanzi attivi tagħhom kienu prodotti barra mill-UE.
English: Kerstin Westermark, Chair of the COMP, n. Swedish Education: Qualified medical doctor from the University of Uppsala.
Maltese: Din il-ħidma qiegħda ssir kemm fil-fora interni kif ukoll fi ħdan il-qafas tal-Inizjattiva dwar Mediċini Innovattivi.