FrancophonIA/ELRC3.0 huggingface dataset:
English: Continuous implementation of EMEA transparency policy measures adopted by the EMEA Management Board in October 2003 relating to European public assessment reports, information on referral procedures, inspection-related activities, meeting summaries, summaries of opinions, and question and answer documents
Slovenian: Stalno izvajanje ukrepov za preglednost politike EMEA, ki jih je sprejel njen upravni odbor oktobra 2003 in se nanašajo na evropska javna poročila o oceni, obveščanje o postopkih za predložitev, dejavnosti, povezane z izvajanjem inšpekcijskih pregledov, povzetke sestankov, povzetke mnenj ter na dokumente z vprašanji in odgovori.
English: Definition and establishment of the dictionaries to be implemented centrally, together with an agreed process for managing dictionary maintenance
Slovenian: Opredelitev in vzpostavitev slovarjev, ki se bodo izvajali centralno, skupaj z dogovorjenim postopkom za vodenje vzdrževanja slovarjev.
English: Implementation of a pilot programme for parallel scientific advice with the US Food and Drug Administration and monitoring of its effectiveness
Slovenian: Izvajanje pilotskega programa vzporednega znanstvenega svetovanja Uprave za hrano in zdravila ZDA ter spremljanje njegove učinkovitosti.
English: To implement confidentiality arrangements with the FDA on inspection-related activities
Slovenian: Izvajati dogovore o zaupnosti s FDA pri dejavnostih, povezanih z inšpekcijskimi pregledi.
English: Career to date: Mr Salvatore acted as a private practice lawyer from 1991 to 2004, dealing with arbitration and litigation cases mainly in the fields of public procurement, competition, international trade and contracts.
Slovenian: Dosedanja poklicna pot: G. Salvatore je bil od 1991 do 2004 odvetnik z zasebno prakso in se je v glavnem ukvarjal z arbitražnimi in pravdnimi zadevami s področja javnega naročanja, konkurence, mednarodne trgovine in pogodb.
English: A number of other important issues that have an impact on the Agency's operations will also require attention: the emergence of innovative new medical technologies and therapies; the increasing globalisation of the pharmaceutical industry and its regulatory environment; the competitiveness of Europe's biotechnology, pharmaceutical and healthcare industries; and the increased expectations of civil society with regard to information, communication and transparency.
Slovenian: Pozornost bo treba nameniti tudi številnim drugim pomembnim vprašanjem, ki vplivajo na delovanje Agencije: pojav novih inovativnih medicinskih tehnologij in terapij, vse večja globalizacija farmacevtske industrije in njenega regulativnega okolja, konkurenčnost evropske biotehnologije, farmacevtska in zdravstvena industrija ter povečana pričakovanja civilne družbe glede obveščanja, sporočanja in preglednosti.
English: Implementation of Directive 2001/20/EC and of the new legislation will add to demands on community inspection resources
Slovenian: Izvajanje Direktive 2001/20/ES in nove zakonodaje bo povečalo povpraševanje po virih skupnosti za izvajaje inšpekcijskih pregledov.
English: Major corporate IT programmes for 2005 include an electronic document management system and a meeting management system.
Slovenian: Med pomembnejše podjetniške programe IT za leto 2005 spadata elektronski sistem vodenja dokumentacije in sistem vodenja sestankov.
English: Operation, maintenance, support and further development of two important sub-systems: product information management system (PIM) and user identity management, together with legally enforceable digital signatures.
Slovenian: Izvajanje, vzdrževanje, podpiranje in nadaljnji razvoj dveh pomembnih podsistemov: sistem upravljanja informacij o izdelkih in upravljanje identitet uporabnikov, skupaj s pravnomočnimi digitalnimi podpisi.
English: Article 30 referrals are mainly initiated in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States.
Slovenian: Predložitve iz člena 30 se uvedejo predvsem, da se v Skupnosti uskladijo pogoji za izdajo dovoljenj za izdelke, ki so jim države članice že izdale dovoljenja.
English: A moderate increase in parallel distribution compared to 2004 is forecast.
Slovenian: Predvideva se skromno povečanje vzporedne distribucije v primerjavi z letom 2004.
English: The number of requests for clarification on the list of MRLs is significant and is expected to remain at approximately 200
Slovenian: Trendi: Število zahtev za pojasnitev seznama MRL je precejšnje, po predvidevanjih naj bi ostalo pri številki približno 200.
English: In 1986 she joined the French National Scientific Research Centre (CNRS) as Chargé de recherche 1ère classe and became officer for European affairs in 1991.
Slovenian: Leta 1986 se je pridružila francoskemu Nacionalnemu znanstveno raziskovalnemu centru (CNRS) kot Chargé de recherche 1. razreda in leta 1991 postala uradnica za evropske zadeve.
English: From 1992 to 1998 he served as director-general of AIDES Fédération Nationale.
Slovenian: Od leta 1992 do 1998 je bil generalni direktor AIDES Fédération
English: The EMEA will continue to fulfil its obligations under the new EU legislation with regard to coordination of pharmacovigilance responsibilities, with particular emphasis on effective communication to healthcare professionals and other interested parties.
Slovenian: EMEA bo nadaljevala izpolnjevanje svojih obveznosti iz nove zakonodaje EU v zvezi z usklajevanjem odgovornosti za farmakovigilanco, s posebnim poudarkom na učinkovitem obveščanju zdravstvenih strokovnjakov in drugih zainteresiranih strani.
English: The agreed action plan for revision of the programme requires an update of all documentation and SOPs at both the EMEA and EDQM.
Slovenian: Dogovorjeni akcijski načrt za revizijo programa zahteva posodobitev celotne dokumentacije in standardnih operativnih postopkov v EMEA in EDQM.
English: The number of marketing authorisation applications for orphan medicinal products is expected to remain unchanged at 10 applications
Slovenian: število vlog za izdajo dovoljenja za promet z zdravili sirotami bo predvidoma ostalo nespremenjeno pri desetih vlogah.
English: The Agency continues its role in coordinating the input and participation of the EU at VICH, and will be represented at the VICH 3 conference scheduled to take place in Washington DC in May 2005.
Slovenian: Agencija bo še naprej imela svojo vlogo pri usklajevanju prispevkov in sodelovanja EU pri VICH ter bo poslala svoje predstavnike na konferenco VICH 3, ki naj bi predvidoma potekala maja 2005 v
English: Conduct analysis and assessment of the Executive Director's annual activity report for 2004
Slovenian: Analiziral in ocenil letno poročilo izvršnega direktorja o delu v letu 2004.
English: To encourage greater exchange of information and dialogue on post-authorisation and safety of medicines, and to contribute to the effective utilisation of available EU resources in advancing effective pharmacovigilance for all veterinary medicines
Slovenian: Spodbujati večjo izmenjavo informacij ter dialog o dejavnostih po izdaji dovoljenja in o varnosti zdravil ter prispevati k učinkoviti uporabi razpoložljivih virov EU pri razvijanju učinkovite farmakovigilance za vsa veterinarska zdravila.
English: He was the UK representative of the Biotechnology Working Party, involved in the generation of many guidelines relating to biotechnology and biological products.
Slovenian: Bil je predstavnik združenega kraljestva v Delovni skupini za biotehnologijo in sodeloval pri oblikovanju številnih smernic za biotehnološke in biološke izdelke.
English: The new legislation introduced a simplified registration procedure for traditional herbal medicinal products in the EU Member States and established a Committee on Herbal Medicinal Products (HMPC).
Slovenian: Nova zakonodaja je uvedla poenostavljeni postopek registracije tradicionalnih zeliščnih zdravil v državah članicah EU in ustanovila Odbor za zeliščna zdravila.
English: In addition, the Agency provides advice to sponsors of designated orphan medicines.
Slovenian: Agencija svetuje tudi sponzorjem zdravil, določenih za zdravila sirote.
English: The forecast for electronic reporting for non-centrally authorised products in relation to EU and non-EU cases is 15,000
Slovenian: Napoved za elektronsko poročanje o izdelkih, ki so bili odobreni necentralno, za primere iz EU in zunaj nje znaša 15.000.
English: Publication of summaries of opinion and EPARs, together with the product information, in all official EU languages after the European Commission decision granting marketing authorisation
Slovenian: Objavljanje povzetkov mnenj in EPAR-ov, skupaj z informacijami o izdelkih, v vseh uradnih jezikih EU po sprejetju odločitve Evropske komisije o izdaji dovoljenja za promet z zdravilom.
English: The target for 2005 is to have a majority of Member State competent authorities and a significant number of pharmaceutical companies reporting through the system
Slovenian: Cilj za leto 2005 je, da bi po tem sistemu poročala večina pristojnih organov držav članic in precejšnje število farmacevtskih podjetij.
English: The Agency ensures full compliance with all regulatory and quality requirements in the areas of document and records management.
Slovenian: Agencija zagotavlja popolno upoštevanje vseh regulativnih in kakovostnih zahtev na področju vodenja dokumentacije in poročil.
English: The COMP ad hoc biotechnology group will support the designation process for emerging therapies, and the COMP group with interested parties will continue its activities on a regular basis
Slovenian: Ad hoc biotehnološka skupina COMP bo podpirala postopek določitve za nove terapije, skupina COMP za zainteresirane strani pa bo nadaljevala redno izvajanje svojih dejavnosti.
English: Similarly, the entry into force of the remaining provisions on 20 November 2005 will be the focus of our attention this year.
Slovenian: Podobno bo letos naša pozornost usmerjena k 20. novembru 2005, začetku veljavnosti preostalih določb.
English: The Agency's mandate for openness and provision of information is expanded.
Slovenian: Naloge in pooblastila Agencije glede odprtosti in zagotavljanja informacij so večja.
English: After serving as a pharmacist (Captain) in a pharmaceutical control laboratory of the German Army, he joined the former German Federal Health Office in 1983.
Slovenian: Potem ko je delal kot farmacevt (vodja) v farmacevtskem nadzornem laboratoriju nemške vojske, se je leta 1983 pridružil bivšemu nemškemu Zveznemu uradu za zdravje.
English: The EMEA is preparing for its new responsibility of providing secretarial support to the new coordination group, which will include:
Slovenian: EMEA se pripravlja na svojo novo pristojnost za opravljanje tajniških del za novo skupino za usklajevanje, ki bo vključevala:
English: The new legislation introduces changes to the administrative structure of the Agency, extends the scope of the Agency's activities, reinforces its activities in the area of providing scientific advice to companies, and enables the Agency to provide administrative and scientific support to small and medium-sized enterprises.
Slovenian: Nova zakonodaja uvaja spremembe v upravni organiziranosti Agencije, razširja obseg njenih dejavnosti, krepi njeno dejavnost na področju znanstvenega svetovanja podjetjem ter ji omogoča zagotavljanje administrativne in znanstvene podpore majhnim in srednje velikim podjetjem.
English: After a year in merchant banking, he was finance director of a private company from 1988 to 1995.
Slovenian: Po enem letu v komercialnem bančništvu je bil od 1988 do 1995 finančni direktor zasebnega podjetja.
English: Reach agreement on a final list and a timetable for the list of medicinal products for SPC harmonisation with the Commission, following recommendations from the coordination group
Slovenian: Doseči soglasje glede dokončnega seznama in časovnega razporeda za seznam zdravil za uskladitev SPC s Komisijo po priporočilih skupine za usklajevanje.
English: Further strengthening of the Agency's coordinating role in the field of pharmacovigilance, as a result of the implementation of new Community legislation
Slovenian: Nadaljnja krepitev usklajevalne vloge Agencije na področju farmakovigilance kot rezultat izvajanja nove zakonodaje Skupnosti.
English: Revision of current procedures, including incorporation of reduced timelines for communication of opinions to the Commission from 30 to 15 days
Slovenian: Revizija sedanjih postopkov, med katere spada tudi vključitev skrajšanih rokov za sporočanje mnenj Komisiji s 30 na 15 dni.
English: More biosimilar products are anticipated in 2005 compared to 2004
Slovenian: leta 2005 se v primerjavi z letom 2004 pričakuje več biološko podobnih izdelkov;
English: In 2005, the Integrated Quality Management/Audit group will also have a training and coordination role in the EU benchmarking system, involving the national competent authorities of the European medicines network.
Slovenian: V letu 2005 bo imela vlogo usposabljanja in usklajevanja v sistemu EU za primerjalne analize tudi Integrirana skupina za upravljanje kakovosti/revizije, v kateri bodo sodelovali pristojni nacionalni organi Evropske mreže zdravil.
English: Clarification of the requirements related to the content of a dossier for a registration application.
Slovenian: Pojasnitev zahtev, ki se nanašajo na vsebino dokumentacije v vlogi za registracijo.
English: Pharmacovigilance remains a high priority of the Agency for 2005 to ensure that effective risk management is continually applied to post-authorisation monitoring of veterinary medicines throughout the EU.
Slovenian: Farmakovigilanca ostaja pomembna prednostna naloga Agencije v letu 2005, ki zagotavlja, da se pri spremljanju po izdaji dovoljenja za promet z veterinarskimi zdravili v vsej EU stalno uporablja učinkovito obvladovanje tveganja.
English: Establishment of the necessary measures to provide assistance to companies producing veterinary products which have limited markets or are intended for diseases with a regional distribution (Article 79 of Regulation 726/2004)
Slovenian: Uvedba potrebnih ukrepov, da se zagotovi pomoč podjetjem proizvajalcem veterinarskih izdelkov, ki imajo omejene trge ali so namenjeni regionalno porazdeljenim boleznim (člen 79
English: In addition, the EMEA will organise training of national assessors on topics agreed with the Agency's scientific committees and EU national competent authorities
Slovenian: EMEA bo organizirala tudi usposabljanje nacionalnih ocenjevalcev o temah, ki jih skupno določijo znanstveni odbori Agencije in pristojni nacionalni organi EU.
English: Annex 3 Guidelines and working documents in 2005
Slovenian: Priloga 3 Smernice in delovni dokumenti za leto 2005
English: It is expected that further extrapolation of existing MRLs to additional species will continue as agreed within the CVMP's policy on minor uses and minor species as a direct response to specific applications from marketing authorisation holders
Slovenian: Po pričakovanjih naj bi se nadaljnja ekstrapolacija sedanjih MRL na dodatne vrste nadaljevala, kot je bilo dogovorjeno v okviru politike CVMP za manjše uporabe in manj pomembne vrste, kot neposredni odgovor na posebne vloge imetnikov dovoljenj za promet z zdravilom.
English: CHMP Concept paper and guideline on quality requirements for manufacturing in and distribution from climatic zones 3 and 4
Slovenian: CHMP Concept paper and guideline on quality requirements for manufacturing in and distribution from climatic zones
English: In November 2000, he became director-general of the Advanced Centre of Services and Training for Health and Life Sciences, Dr Rober Foundation (UAB).
Slovenian: Novembra 2000 je postal generalni direktor Sodobnega centra za storitve in usposabljanje za zdravje in znanosti o življenju, Fundacije dr. Roberja (UAB).
English: Address procedural, regulatory and scientific issues arising from the mutual recognition procedure, including best practice guide for standard operating procedures for all such referrals
Slovenian: Obravnava postopkovnih, regulativnih in znanstvenih vprašanj, ki izhajajo iz postopka medsebojnega priznavanja, vključno z navodili najboljše prakse za običajne operativne postopke za vse takšne predložitve.
English: The growing number of meetings managed by the Agency and increasing number of delegate days will require the development of meeting technologies such as IP telephony, videoconferencing and web streaming.
Slovenian: Naraščajoče število sestankov, ki jih vodi Agencija, in vse večje število delegatskih dni bo zahtevalo razvoj tehnologij za sestanke, kot je telefonija IP, prenašanje preko videokonference in neprekinjen pretok po spletu (web streaming).
English: Ms Nuttall then served with the Food and Agriculture Organisation of the United Nations from 1990 to 1995.
Slovenian: Nuttallova od 1990 do 1995 delala v Organizaciji ZN za prehrano in kmetijstvo.
English: To monitor and facilitate the implementation of the new legislation affecting the Agency, increase the transparency of its activities, and provide timely reports and opinions to EU institutions
Slovenian: Spremljati in omogočiti izvajanje nove zakonodaje, ki zadeva Agencijo, povečati preglednost njenih dejavnosti ter institucijam EU pravočasno zagotavljati poročila in mnenja.
English: The scope of medicines for which the centralised procedure is mandatory extends to include new therapeutic categories.
Slovenian: Obseg zdravil, za katera je centralizirani postopek obvezen, se razširi z vključitvijo novih terapevtskih kategorij.
English: To improve the scientific advice procedure and stimulate its use throughout the lifecycle of medicinal products, including the post-authorisation phase.
Slovenian: Izboljšati postopek znanstvenega svetovanja in spodbujati njegovo uporabo v celotnem življenjskem ciklu zdravil, vključno s fazo po izdaji dovoljenja za promet.
English: Despite this rather negative environment, there appears to be a small but steady flow of new products in the pipeline, with 11 full centralised applications forecast for 2005
Slovenian: Kljub temu dokaj neugodnemu okolju se zdi, da je se pripravlja manjši, a stalen dotok novih izdelkov, saj je za leto 2005 predvidenih enajst vlog, ki naj bi se v celoti obravnavale po centraliziranem postopku.
English: Periodic safety update reports, follow-up measures and specific obligations (Input)
Slovenian: Periodično dopolnjena poročila o varnosti, nadaljnji ukrepi in posebne obveznosti (Vhodni podatek)
English: Coordination of the necessary workload for the initiation of such referrals that can be handled by the secretariat and CVMP in 2005
Slovenian: Uskladitev potrebne delovne obremenitve za uvedbo takšnih predložitev, ki jo zmoreta sekretariat in CVMP v letu 2005.
English: The principal objectives are the development and timely and accurate management of the EMEA's human and financial resources, including personnel administration, recruitment procedures and professional training, as well as the provision of information to staff and other concerned persons on these matters
Slovenian: Glavna cilja sta razvoj ter pravočasno in natančno upravljanje človeških in finančnih virov EMEA, vključno z upravljanjem osebja, zaposlitvenimi postopki in strokovnim usposabljanjem, ter zagotavljanje informacij osebju in drugim zadevnim osebam o teh zadevah.
English: The Agency's activities in the field of herbal medicinal products will help to harmonise procedures and provisions concerning herbal medicines laid down in the Member States and to integrate further herbal medicinal products in the European regulatory framework.
Slovenian: Dejavnosti Agencije na področju zeliščnih zdravil bodo pripomogle k uskladitvi postopkov in predpisov o zeliščnih zdravilih, določenih v državah članicah, in vključitvi dodatnih zeliščnih zdravil v evropski regulativni okvir.
English: The first ten VAMF applications should be received in 2005.
Slovenian: Prvih deset vlog za VAMF naj bi prispelo v letu 2005.
English: Annex 2 Revenue and expenditure overview 2003-2005
Slovenian: Priloga 2 Pregled prihodkov in odhodkov za obdobje 2003-2005
English: There will be a continuous need for adaptation, maintenance and upgrading of the EudraVigilance database and data processing network, in collaboration with IT and project management teams at the Agency
Slovenian: Stalno bo treba prilagajati, vzdrževati in nadgrajevati zbirko podatkov EudraVigilance in mrežo za obdelavo podatkov v sodelovanju s skupinami za IT in vodenje projektov v Agenciji.
English: Implementation of the 2005 budget
Slovenian: Izvajanje proračuna za leto 2005.
English: The table below gives an overview of the likely workload in accounts in 2005.
Slovenian: V priloženi tabeli je naveden pregled verjetne delovne obremenitve računovodstva v letu 2005.
English: Referrals are initiated either in order to obtain harmonisation within the Community of the conditions of authorisation for products already authorised by the Member States (Article 34 of Directive 2001/82/EC), or in case of Community interest and for safety-related issues (Articles 35 and 40 of Directive 2001/82/EC).
Slovenian: Predložitve se izvedejo, zato da se v Skupnosti zagotovi uskladitev pogojev za izdajo dovoljenja za izdelke, za katere so države članice že izdale dovoljenje (člen 34 Direktive 2001/82/ES), ali če gre za interes Skupnosti ali za varnostna vprašanja (člena 35 in
English: Continued implementation and maintenance of the electronic transmission of ICSRs and support of the day-to-day operation and maintenance of the electronic ICSR transmission process for the pre- and post-authorisation phase via EudraVigilance
Slovenian: Nadaljnje izvajanje in vzdrževanje elektronskega prenosa ICSR ter podpora vsakodnevnemu delovanju in vzdrževanju postopka elektronskih prenosov ICSR za fazo pred izdajo dovoljenja in po njej prek EudraVigilance.
English: In 1997, he was appointed head of the pharmaceuticals assessment unit of the French veterinary agency (AFSSA-ANMV).
Slovenian: Leta 1997 je bil imenovan za vodjo ocenjevalne enote za farmacevtske izdelke pri francoski veterinarski agenciji (AFSSA-ANMV).
English: The EMEA/CHMP Working Party with Patients' Organisations will meet regularly and provide a forum allowing patients to provide their input into the regulatory system
Slovenian: Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov se bo redno sestajala in zagotavljala pristojno mesto, kjer bodo bolniki lahko oddali svoj prispevek k regulativnemu sistemu.
English: Increased transparency on arbitration/referral procedures and consistent presentation of available information regarding arbitration/referral procedures irrespective of the legal basis of such procedures
Slovenian: Povečanje preglednosti arbitražnih postopkov/postopkov za predložitev ter dosledno zagotavljanje razpoložljivih informacij o arbitražnih postopkih/postopkih za predložitev, ne glede na njihovo pravno podlago.
English: Objective for 2005:
Slovenian: Cilj za leto 2005:
English: Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to veterinary medicines, with particular emphasis on risk management of antimicrobial resistance, which may result from use of antimicrobials in animals, and on ensuring the adequacy of the environmental risk assessment in accordance with new EU legislation
Slovenian: Uvedba začetne faze plana za izvajanje usmeritvenega načrta EMEA do leta 2010 za veterinarska zdravila, s posebnim poudarkom na obvladovanju tveganja protimikrobne odpornosti, ki je lahko posledica uporabe protimikrobnih sredstev pri živalih, in zagotavljanju ustreznosti ocene tveganja za okolje v skladu z novo zakonodajo EU.
English: She worked for the pharmaceutical industry from 1992 to 1995 before joining the EMEA in July 1995.
Slovenian: Od 1992 do 1995 je delala za farmacevtsko industrijo, preden se je julija 1995 pridružila EMEA.