FrancophonIA/ELRC3.0 huggingface dataset:
English: Implementation of a first production version of the PIM system for 21 November 2005
Slovenian: Začetek izvajanja prve proizvodne različice sistema upravljanja informacij o izdelkih 21. novembra 2005.
English: 2.11 International activities
Slovenian: 2.11 Mednarodne dejavnosti
English: The Veterinary Unit will liaise closely with the Center for Veterinary Medicines (CVM) in the US Food and Drug Administration and with the United States Department of Agriculture to implement practical arrangements for advancing the Confidentiality Arrangements for exchange of information and documents agreed between the US and EU in late 2004.
Slovenian: Veterinarska enota se bo tesno povezala s Centrom za veterinarska zdravila pri Upravi za hrano in zdravila ZDA ter z ameriškim ministrstvom za kmetijstvo pri izvajanju praktičnih rešitev za napredovanje pri dogovorih o zaupnosti za izmenjavo informacij in dokumentov, ki sta jih sklenili
English: Overall workload to increase compared to 2004
Slovenian: Povečanje celotne delovne obremenitve v primerjavi z letom 2004.
English: She joined the EMEA Management Board in the same year, was elected vice-chairman in 2003 and re-elected vice-chairman following the EU enlargement in 2004.
Slovenian: V istem letu se je pridružila upravnemu odboru EMEA in bila leta 2003 izvoljena za podpredsednico, leta 2004 po širitvi pa ponovno izvoljena za podpredsednico.
English: The increase is due in part to inspections in the context of plasma master file and vaccine antigen master file certification, but also to the effect of an increase in applications at the end of 2004
Slovenian: Razlog za povečanje so deloma inšpekcijski pregledi v okviru certificiranja glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov, deloma pa povečanje števila vlog konec leta 2004.
English: The performance indicator for this activity is the mean time between the start of the procedure and adoption of the advice letter.
Slovenian: Kazalnik uspešnosti za to dejavnost je povprečni čas, ki poteče od začetka postopka do prejema obvestila o svetovanju.
English: Increase in the number of travel and hotel booking requests to manage
Slovenian: Povečanje števila zahtev za organiziranje potovanj in hotelske rezervacije.
English: Identification of areas for further improvement and implementation of necessary corrective actions
Slovenian: Določiti področja, na katerih je treba nadaljevati izboljšave in začeti izvajati potrebne popravne ukrepe.
English: Numbers of certificate requests are expected to continue to increase as the pool of centrally authorised products is growing.
Slovenian: Število zahtevkov za izdajo potrdil se bo predvidoma še naprej povečevalo, hkrati s povečevanjem števila centralno odobrenih izdelkov.
English: To provide support for the integration of new Member States in the GMP, GCP and GLP work of the Agency and to contribute to international cooperation and harmonisation activities
Slovenian: Zagotavljati podporo pri vključevanju novih držav članic v delo Agencije na področju dobre proizvodne, klinične in laboraorijske prakse ter prispevati k mednarodnemu sodelovanju in dejavnostim usklajevanja.
English: The new legislation sets out the legal basis and enhanced responsibilities for the Agency in the area of scientific advice.
Slovenian: Nova zakonodaja določa pravno podlago znanstvenemu svetovanju in večje pristojnosti Agencije na tem področju.
English: The main objective for 2005 is to manage the increased workload and issue certificates according to required timelines.
Slovenian: Glavni cilj za leto 2005 je obvladovati povečano delovno obremenitev in izdajati potrdila v predpisanih rokih.
English: To perform high-quality activities in the field of pharmacovigilance and adhere to required timelines
Slovenian: Izvajati visoko kakovostne dejavnosti na področju farmakovigilance in upoštevati zahtevane roke.
English: Requirement to produce financial accounts based on generally accepted accounting principles by
Slovenian: Zahteva, da se z letom 2005 začnejo pripravljati finančna poročila na podlagi splošno sprejetih računovodskih načel.
English: Authorised for 2004 Requested for 2005
Slovenian: Odobreno za 2004 Zahteve za 2005
English: Completion of the construction of an EU telematics data centre with high availability, high scalability and good performance
Slovenian: Dokončna izgradnja telematskega podatkovnega centra EU z visoko stopnjo razpoložljivosti,
English: Interaction and participation through scientific meetings and training with the WHO
Slovenian: Vzajemno delovanje in udeležba v Svetovni zdravstveni organizaciji prek znanstvenih srečanj in usposabljanja.
English: Support the implementation activities relating to GCP inspections under the Clinical Trials Directive 2001/20/EC for human medicines and the directive on GCP, in particular the implementation of the second phase of the EudraCT database
Slovenian: Podpora izvedbenim dejavnostim, povezanim z inšpekcijskimi pregledi dobre klinične prakse, v skladu z Direktivo 2001/20/ES o kliničnem preizkušanju zdravil za ljudi ter direktivo o dobri klinični praksi, in zlasti izvajanju druge faze zbirke podatkov EudraCT.
English: Education: Diploma in conference interpretation and translation from Scuola Superiore per Interpreti, Milan.
Slovenian: Izobrazba: Diplomiral iz konferenčnega tolmačenja in prevajanja na Scuoli Superiore per Interpreti v Milanu.
English: Career to date: From 1972 to 1974, Dr Purves worked in the pharmaceutical industry.
Slovenian: Dosedanja poklicna pot: Od 1972 do 1974 je dr. Purves delal v farmacevtski industriji.
English: The CHMP will meet 11 times in 2005.
Slovenian: CHMP bo leta 2005 zasedal enajstkrat.
English: Reinforcement of the scientific advice procedure to better address post-authorisation safetyrelated aspects
Slovenian: Krepitev znanstveno svetovalnega postopka za boljše obravnavanje varnostnih vidikov po izdaji dovoljenja.
English: Discussion papers on other important organs to be considered when developing medicinal products in neonates complementary to the paper already published on renal maturation (e.g. hepatic, central nervous system)
Slovenian: Discussion papers on other important organs to be considered when developing a medicinal products in neonates complementary to the paper already published on renal maturation
English: Establishment of a database to facilitate scientific memory analysis for all centralised applications submitted in the past 10 years, and for future applications, to allow for greater integrity, scientific quality and consistency of CVMP assessment reports
Slovenian: Vzpostavitev zbirke podatkov zaradi lažjega analiziranja znanstvenega pomnilnika za vse vloge, predložene po centraliziranem postopku v zadnjih desetih letih, in za prihodnje vloge, da se omogoči večja celovitost, znanstvena kakovost in skladnost poročil CVMP o oceni zdravila.
English: Contribute to EU public health strategies, including those relating to influenza pandemics, tissueengineered products and paediatric medicines
Slovenian: Prispevanje k strategijam EU za javno zdravje, vključno s strategijami za epidemije gripe, izdelke inženiringa tkiv in zdravila za otroke.
English: Following graduation with an MBA degree in 1991, she joined EFPIA, the European pharmaceutical industry association, as manager of scientific and regulatory affairs.
Slovenian: MBA leta 1991 se je pridružila EFPIA, združenju evropske farmacevtske industrije kot vodja znanstvenih in regulativnih zadev.
English: In 1995 she joined the French Medicines Agency as head of unit for pharmaco-toxico-clinical assessment.
Slovenian: Leta 1995 se je pridružila francoski Agenciji za zdravila kot vodja Enote za farmako-toksiko-klinično ocenjevanje.
English: The legislation places emphasis on transparency, communication and provision of information on pharmacovigilance issues.
Slovenian: V zakonodaji so poudarjeni preglednost, sporočanje in obveščanje o vprašanjih farmakovigilance.
English: The working parties of the EMEA scientific committees responsible for medicinal products for human use are involved in the development and revision of guidelines, in the provision of recommendations and advice on medicinal products for which applications are made, and in marketing authorisation or post-authorisation activities, according to the specific area of responsibility of each group.
Slovenian: Delovne skupine znanstvenih odborov EMEA, pristojne za zdravila za uporabo v humani medicini, so vključene v pripravo in revizijo smernic, zagotavljanje priporočil in nasvetov glede zdravil, za katera so oddane vloge, dejavnosti med pridobivanjem dovoljenja za promet in dejavnosti po izdaji tega dovoljenja, v skladu s posebnim področjem pristojnosti posameznih skupin.
English: Career to date: From 1978 to 1983, research fellow at the State University of Rome on projects in the area of clinical immunology, oncology and cellular immunology.
Slovenian: Dosedanja poklicna pot: Od leta 1978 do 1983 znanstvena sodelavka na Državni univerzi v Rimu pri projektih s področja klinične imunologije, onkologije in celične imunologije.
English: Publication of summaries of opinion for those post-authorisation activities which have an important impact on the use of the medicinal product; regular updating of European public assessment reports and publication of press releases regarding major post-authorisation activities
Slovenian: Objava povzetkov mnenj o tistih dejavnostih po izdaji dovoljenja, ki pomembno vplivajo na uporabo zdravila, sprotno dopolnjevanje evropskih javnih poročil o oceni ter objava sporočil za javnost o pomembnih dejavnostih po izdaji dovoljenja.
English: Achievement of consensus with the Agency's partners and stakeholders on the most adequate way to provide information on medicines to patients and healthcare professionals
Slovenian: Dosega soglasja s partnerji Agencije in zainteresiranimi stranmi glede najustreznejšega načina zagotavljanja informacij o zdravilih bolnikom in zdravstvenim strokovnjakom.
English: Establishment of scientific advisory groups in the new mandatory therapeutic areas
Slovenian: Ustanovitev znanstveno svetovalnih skupin na novih obveznih terapevtskih področjih.
English: To provide targeted, useful and accessible information to patients and healthcare professionals about the medicine-related aspects of the work of the Agency
Slovenian: Zagotavljati bolnikom in zdravstvenim strokovnjakom ciljno naravnane, uporabne in dostopne informacije o vidikih dela Agencije, povezanih z zdravili.
English: Other TOTAL REVENUE
Slovenian: Drugo PRIHODKI SKUPAJ
English: The EMEA coordinates the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the European Community, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
Slovenian: EMEA usklajuje preverjanje skladnosti z načeli dobre proizvodne prakse, dobre klinične prakse in dobre laboratorijske prakse ter z določenimi vidiki nadzorovanja zdravil, za katera je bilo izdano dovoljenje za promet in se uporabljajo v Evropski skupnosti, z inšpekcijskimi pregledi, ki jih zahtevata CHMP ali CVMP v zvezi z oceno vlog za izdajo dovoljenja za promet in/ali oceno zadev, ki so bile tema odboroma predložene v skladu z zakonodajo Skupnosti.
English: The major priority for 2005 will be to prepare for the implementation of the pharmaceutical legislative review, in particular the new requirements for GMP for starting materials and the setting-up of a database on manufacturing authorisations and GMP certificates
Slovenian: Najpomembnejša prednostna naloga za leto 2005 bo priprava na izvajanje farmacevtskega zakonodajnega pregleda, zlasti novih zahtev za dobro proizvodno prakso za vhodne snovi ter vzpostavitev zbirke podatkov o dovoljenjih za izdelavo in potrdilih odobri proizvodni praksi.
English: Postgraduate studies in pharmacology at the Universities of Melbourne and Auckland.
Slovenian: Podiplomski študij iz farmakologije na Univerzi v Melbournu in Aucklandu.
English: Unit for Veterinary medicines and inspections
Slovenian: Enota za veterinarska zdravila in inšpekcijske preglede
English: Postgraduate studies in management, leadership and administration.
Slovenian: Podiplomski študij iz managementa, vodenja in upravljanja.
English: Establishment of a procedure for publication of information on withdrawal of applications and refusal of Community marketing authorisations
Slovenian: Vzpostavitev postopka za objavljanje informacij o umiku vlog in zavrnitvi izdaje dovoljenja Skupnosti za promet z zdravilom.
English: Priorities for veterinary medicines in 2005:
Slovenian: Prednostne naloge za veterinarska zdravila v letu 2005:
English: Main CHMP standing and temporary working parties in 2005
Slovenian: Glavne stalne in začasne delovne skupine CHMP v letu 2005
English: Standard Operating Procedure on Urgent Safety Restrictions for Medicinal Products Authorised through Mutual Recognition Procedure
Slovenian: Standard Operating Procedure on Urgent Safety Restrictions for Medicinal Products Authorised through
English: Concept paper on impact of analytical methods on Commission Decision 2002/657/EC compared with current analytical requirements for the establishment of MRLs
Slovenian: (2002/657/EC) compared with current analytical requirements for the establishment of MRLs
English: Applications received (non-orphan medicines) Applications received (orphan medicines)
Slovenian: Prejete vloge (za zdravila, ki niso zdravila sirote) Prejete vloge (za zdravila sirote)
English: Guideline to be developed after consultation of concept paper
Slovenian: Smernica se pripravi po posvetovanju o idejnem dokumentu
English: Expenditure on data processing Other capital expenditure Postage and communications Other administrative expenditure
Slovenian: Objekti/oprema Najemnina/odhodek Odhodki za obdelavo podatkov Drugi odhodki za naložbe Poštnine in obveščanje Drugi odhodki za poslovanje
English: Cooperation on the ICH/FDA initiative on quality systems/GMP is expected to build on the need for interaction between GMP inspectors and quality assessors
Slovenian: Sodelovanje pri pobudi ICH/FDA za sisteme kakovosti/dobro proizvodno prakso naj bi predvidoma temeljilo na potrebi po medsebojnem delovanju inšpektorjev za dobro proizvodno prakso in ocenjevalcev kakovosti.
English: These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports), follow-up measures, specific obligations, annual reassessments and renewal applications.
Slovenian: Sem spadajo dejavnosti, povezane z obveščanjem o farmakovigilanci (poročila o neželenih učinkih zdravil in periodično dopolnjena poročila o njihovi varnosti), nadaljnji ukrepi, posebne obveznosti, vloge za vsakoletno ponovno oceno in podaljšanje.
English: Postgraduate studies in management and health economics.
Slovenian: Podiplomski študij iz managementa in zdravstvene ekonomike.
English: The Committee will implement its newly adopted procedure intended to facilitate communication and dialogue between the Committee and interested parties, to fulfil obligations set out in the new legislation by putting in place the necessary arrangements to organise such exchanges and improve transparency as appropriate.
Slovenian: namenjen lažjemu sporazumevanju in dogovarjanju med odborom in zainteresiranimi stranmi, da bo izpolnil obveznosti iz nove zakonodaje s sprejetjem potrebnih dogovorov za organiziranje takšnih izmenjav in ustrezno izboljšanje preglednosti.
English: Discussion of comments received on revision to be released for public consultation in 2005
Slovenian: Obravnavanje pripomb, prejetih v zvezi z revizijo, ki se da v javno posvetovanje leta 2005
English: Specialist in internal medicine and clinical pharmacology.
Slovenian: Specialist interne medicine in klinične farmakologije.
English: Objectives and key initiatives:
Slovenian: Cilji in ključne pobude:
English: Continuous monitoring of the impact of scientific advice on the outcome of applications for marketing authorisations and analysis as part of the scientific memory and scientific advice databases
Slovenian: Stalno spremljanje vpliva znanstvenega svetovanja na rešitev vlog za izdajo dovoljenja za promet in analiziranje v okviru zbirk podatkov znanstvenega pomnilnika in znanstvenega svetovanja.
English: From 1993 to 1994 he acted as the vice-chairman of the EFTA Expert Group on Pharmaceuticals and from 1994 to 1995 as the chairman of the Nordic Council on Medicines.
Slovenian: Od leta 1993 do 1994 je bil podpredsednik Izvedenske skupine EFTE za farmacevtske izdelke, od leta 1994 do 1995 pa predsednik Nordijskega sveta za zdravila.
English: Her responsibilities there included coordination of ICH activities, relations with the FDA, pharmaceutical aspects of mutual recognition agreements, GMP and inspection-related matters, orphan medicinal products, preparatory work on a regulation on paediatric medicinal products and issues relating to EU enlargement.
Slovenian: Njene tamkajšnje odgovornosti so vključevale usklajevanje dejavnosti za ICH, odnose s FDA, farmacevtske vidike sporazumov o medsebojnem priznavanju, dobro proizvodno prakso in zadeve, povezane z inšekcijskimi pregledi, zdravila sirote, pripravljalno delo za pravno ureditev zdravil za otroke ter vprašanja v zvezi s širitvijo
English: To increase the quality and the regulatory and scientific consistency of the evaluation of applications for line extensions, variations to and transfers of marketing authorisations, and adhere to regulatory timelines
Slovenian: Izboljšati kakovost ter regulativno in znanstveno doslednost pri presojanju vlog za podaljšanje rokov, spremembe in prenose dovoljenj za promet z zdravilom ter upoštevati predpisane roke.
English: Career to date: Dr Saint Raymond held a position as paediatrician in a teaching paediatric hospital in Paris, followed by a number of years working for a number of pharmaceutical companies.
Slovenian: Dosedanja poklicna pot: Dr. Saint Raymondova je bila pediatrinja v pediatrični poučevalni bolnišnici v Parizu, nato pa je več let delala za številne farmacevtske družbe.
English: He was first elected chairman of the CVMP in January 2003 and was re-elected in 2004.
Slovenian: Za predsednika CVMP je bil prvič izvoljen januarja 2003, leta 2004 pa je bil izvoljen ponovno.
English: Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolism in nonsurgical patients
Slovenian: Guideline on clinical investigation of medicinal products for the prophylaxis of venous thromboembolism in non surgical patients
English: The legislation also requires the Agency to provide information on withdrawal of an application by an applicant prior to opinion, and on refusal of marketing authorisation.
Slovenian: Zakonodaja od Agencije tudi zahteva, da zagotavlja informacije o umiku vloge s strani vlagatelja pred izdajo mnenja in o zavrnitvi izdaje dovoljenja za promet z zdravilom.
English: Career to date: From 1981 to 1984, Dr Moulin worked in the Bovine Pathology Laboratory in Lyon.
Slovenian: Dosedanja poklicna pot: Dr. Moulin je od leta 1981 do 1984 delal v patološkem laboratoriju za govedo v Lyonu.
English: Technical Requirements for Blood and Blood Components (including those used for medicinal products derived from human blood and plasma)
Slovenian: Blood Components (including those used for medicinal products derived
English: Nine applications for renewal of marketing authorisation are forecast for 2005
Slovenian: Za leto 2005 se predvideva devet vlog za obnovo dovoljenja za promet z zdravilom.
English: To increase the quality, as well as the regulatory and scientific consistency, of the outcome of the scientific review.
Slovenian: Izboljšati kakovost ter regulativno in znanstveno doslednost ugotovitev strokovne presoje.
English: Continuous collaboration with the Directorate-General for Enterprise on development of legislation relating to paediatric medicines, tissue engineering and the provision of information to the public
Slovenian: Stalno sodelovanje z Generalnim direktoratom za gospodarstvo pri razvoju zakonodaje za zdravila za otroke in inženiring tkiv ter obveščanju javnosti.
English: Education: Qualified in medicine from Sheffield University in 1983.
Slovenian: Izobrazba: Diplomiral iz medicine na Univerzi v Sheffieldu leta 1983.
English: Preparation of draft Community herbal monographs for herbal medicinal products with a wellestablished use
Slovenian: Priprava osnutkov zeliščnih monografij Skupnosti za zeliščna zdravila z dobro uveljavljeno uporabo.
English: The performance indicator for this objective is the percentage of responses provided within 14 days.
Slovenian: Kazalnik uspešnosti za ta cilj je odstotek odgovorov, zagotovljenih v štirinajstih dneh.
English: The new legislation sets forth provisions for the implementation of a risk management system as well as the possibility to set up a system of permanent follow-up of the risk/benefit balance.
Slovenian: V novi zakonodaji so navedene določbe za izvajanje sistema obvladovanja tveganja in za možnost vzpostavitve sistema stalnega spremljanja razmerja med tveganji in koristmi.
English: Priorities for inspections in 2005:
Slovenian: Prednostne naloge inšpekcijskega nadzora v letu 2005:
English: A*16 A*15 A*14 A*13 A*12 A*11 A*10 A*9 A*8 A*7 A*6 A*5 Total grade A B*11 B*10 B*9 B*8 B*7 B*6 B*5 B*4 B*3 Total grade B C*7 C*6 C*5 C*4 C*3 C*2 C*1 Total grade C D*5 D*4 D*3 D*2 Total grade D Total Staff
Slovenian: A*16 A*15 A*14 A*13 A*12 A*11 A*10
English: Reimbursed meetings Videoconferences
Slovenian: Sestanki s povrnjenimi stroški Videoconference
English: To improve transparency and provision of designation-related information to patients and other interested parties
Slovenian: Izboljšati preglednost in zagotavljanje informacij o določitvi bolnikom in drugim zainteresiranim stranem.
English: 3.3 Establishment of maximum residue limits
Slovenian: 3.3 Določitev mejne vrednosti ostankov (MRL)
English: MSc in social and regulatory pharmacy.
Slovenian: Magisterij iz socialne in regulativne farmacije.
English: In 1994, she joined the UK Veterinary Medicines Directorate as senior veterinary assessor in the pharmaceuticals and feed additives team.
Slovenian: Leta 1994 se je pridružila Direktoratu Združenega kraljestva za veterinarska zdravila kot višja veterinarska ocenjevalka v skupini za farmacevtske izdelke in krmne dodatke.
English: The EMEA and the CVMP will play an important part in contributing to the drafting of a new regulation and subsequent guidelines on residue control of veterinary medicines in food animals to succeed Council Regulation 2377/90
Slovenian: EMEA in CVMP bosta imela pomembno vlogo pri pripravi osnutka nove uredbe o nadzorovanju ostankov veterinarskih zdravil v živalih za prehrano ter nadaljnjih smernic, ki bodo nasledile Uredbo
English: Education: Law degree from the University of Pavia, Italy; PhD in European Law from the European University Institute of Florence, Italy; Avvocato, chair professor of international law.
Slovenian: Izobrazba: Diploma iz prava na Univerzi v Pavii, Italija, doktorat iz evropskega prava na Evropskem univerzitetnem inštitutu v Firencah, Italija, Avvocato, redni profesor mednarodnega prava.
English: Professor Wahlroos had a central role in the pharmaceutical sector in the preparations for the accession of Finland to the EU in 1995.
Slovenian: Prof. Wahlroos je imel osrednjo vlogo na farmacevtskem področju v pripravah na pristop
English: Professor Wahlroos was appointed director-general of the National Agency for Medicines (NAM) in 1993.
Slovenian: Leta 1993 je bil prof. Wahlroos imenovan za generalnega direktorja Nacionalne agencije za zdravila.
English: He has been executive director of the EMEA since January 2001.
Slovenian: Izvršni direktor EMEA je od januarja 2001.
English: Adopt rules for the implementation of the staff regulations
Slovenian: Sprejel pravila za izvajanje kadrovskih predpisov.