FrancophonIA/ELRC3.0 huggingface dataset:
English: To respond to the growing number of meetings and visiting delegates, and to rationalise resource use, the Agency will progress the development of integrated videoconferencing and other virtual meetings solutions, in line with specific meeting requirements.
Slovenian: V odziv na vedno večje število sestankov in gostujočih delegatov in zaradi racionalne uporabe sredstev si bo Agencija prizadevala za nadaljnji razvoj uporabe videokonferenc in drugih virtualnih rešitev za sestanke, v skladu s specifičnimi zahtevami sestankov.
English: The objective of the exercise is to optimise key Agency processes, improve the costeffectiveness of its operations, improve performance and boost customer and stakeholder satisfaction.
Slovenian: Cilj tega izboljševanja je racionalizacija ključnih procesov v Agenciji, izboljšanje stroškovne učinkovitosti njenega delovanja, izboljšanje uspešnosti ter povečanje zadovoljstva strank in interesnih skupin.
English: 5 Good manufacturing practice (GMP).
Slovenian: 5 Dobra proizvodna praksa (Good manufacturing practice, GMP).
English: The Agency will organise training activities on GCP and Quality/GMP and will further develop the cooperation between inspection and assessment functions, particularly through the work of the Process Analytical Technology team and joint sessions with GMP inspectors/Quality assessors and GCP inspectors /Clinical assessors.
Slovenian: Agencija bo organizirala usposabljanje za GCP in kakovost/GMP ter še naprej razvijala sodelovanje med inšpekcijskimi in ocenjevalnimi dejavnostmi, predvsem skozi delo skupine za procesnoanalitično tehnologijo (PAT) in skupna srečanja inšpektorjev/ocenjevalcev kakovosti za GMP in inšpektorjev/ocenjevalcev kakovosti za GCP.
English: The Agency will also continue its efforts to develop and strengthen interaction with and the participation of the Agency's stakeholders - healthcare professionals, patients and consumers - in the work of the Agency.
Slovenian: Agencija si bo še naprej prizadevala razviti in okrepiti medsebojno povezanost s svojimi interesnimi skupinami - zdravstvenimi strokovnjaki, bolniki in potrošniki - ter njihovo sodelovanje pri delu Agencije.
English: The number of new veterinary medicines for food-producing animals is expected to remain relatively stable, and the number of new MRL applications is predicted to remain constant, with 3 applications being forecast.
Slovenian: Pričakuje se, da bo število novih veterinarskih zdravil za živali, namenjene proizvodnji hrane, ostalo razmeroma stabilno in da se število novih vlog za MVO ne bo spremenilo - predvidene so 3 vloge.
English: Work will be done to progress a risk-based approach to the selection of products and parameters for testing in view of generic applications and advances in technology (Process Analytical Technology), and the Agency will review a ‘one-laboratory testing scheme' concept and assess its possible introduction for biological products.
Slovenian: Potekala bodo prizadevanja za nadaljnji razvoj na tveganju temelječega pristopa za izbiro proizvodov in parametrov za preizkušanje glede na generične vloge in tehnološki napredek (procesno-analitična tehnologija), Agencija pa bo preučila koncept „sheme preizkušanja v enem laboratoriju“ in ocenila morebitno uvedbo te sheme za biološke proizvode.
English: Up to three releases are planned, implementing increases in functionality in the product dictionary, the first part of signal tracking and access by specific audiences.
Slovenian: Načrtovane so do tri sprostitve v uporabo, ki uresničujejo povečanja funkcionalnosti na področju slovarja proizvoda, prvega dela signalnega sledenja in dostopa posebnih uporabnikov.
English: Quarterly releases are anticipated, implementing increases in functionality in the areas of search, use by specific audiences, data entry, interaction with other systems and use of controlled vocabularies.
Slovenian: Pričakovati je četrtletne sprostitve v uporabo, ki uresničujejo povečanja funkcionalnosti na področjih iskanja, uporabe s strani posebnih uporabnikov, vnosa podatkov, interakcije z drugimi sistemi in uporabe nadzorovanega besedišča.
English: The EMEA receives safety reportsand product defect reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Slovenian: EMEA prejema varnostna poročila in poročila o pomanjkljivosti proizvodov za zdravila, za katera je bilo izdano dovoljenje po centraliziranem postopku v Evropski uniji in zunaj nje, ter usklajuje ukrepe, ki se nanašajo na varnost in kakovost zdravil.
English: Safety of medicines is a priority area for the EMEA and the Agency will continue to strengthen its efforts to ensure the safe use of centrally authorised medicinal products.
Slovenian: Varnost zdravil je prednostno področje EMEA in Agencija bo še naprej krepila svoja prizadevanja za zagotovitev varne uporabe zdravil, za katera je bilo izdano dovoljenje po centraliziranem postopku.
English: 1.2 Transparency, communication and provision of information
Slovenian: 1.2 Preglednost, obveščanje in zagotavljanje informacij
English: − Continue supporting the European Commission through the stages leading to the new regulation on advanced therapies; participate in the work of the Innovative Medicines Initiative for human medicines, the European Technology Platform for Global Animal Health for veterinary medicines, and in other international initiatives to improve drug development.
Slovenian: − nadaljnja podpora Evropski komisiji v fazah sprejemanja nove uredbe o naprednih terapijah; sodelovanje v dejavnostih Pobude za inovativna zdravila (Innovative Medicines Initiative) za zdravila za uporabo v humani medicini, evropske tehnološke platforme za globalno zdravje živali (European Technology Platform for Global Animal Health) za zdravila za uporabo v veterinarski medicini in v drugih mednarodnih pobudah za izboljšanje razvoja zdravil.
English: The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier.
Slovenian: Certifikacijski postopek EMEA za PMF/VAMF je ocena dokumentacije za vlogo za PMF/VAMF.
English: The Agency expects that the overall number of applications for veterinary medicinal products will remain at around 14 applications in 2007.
Slovenian: Agencija pričakuje, da bo v letu 2007 celotno število vlog za veterinarska zdravila ostalo pri približno 14 vlogah.
English: Similar biological products
Slovenian: Zdravila s podobnimi biološkimi lastnostmi
English: The EMEA Paediatric Committee will conduct assessment of, agreement on, and verification of compliance with, paediatric investigation plans and waivers.
Slovenian: Odbor za pediatrijo EMEA bo vodil ocenjevanje, sprejemanje dogovora in potrjevanje skladnosti s načrti pediatričnih raziskav in sistemom opustitev.
English: The Agency's efforts to support these objectives in 2007 will focus on: providing scientific advice; providing special support for small and medium-sized enterprises; conducting research into the consistency of the Agency's decision-making; and contributing to pan-European initiatives for facilitating innovative research.
Slovenian: Da bi Agencija podprla te cilje, si bo v letu 2007 prizadevala predvsem zagotavljati znanstveno svetovanje ter posebno podporo za mala in srednje velika podjetja, izvajati raziskave glede skladnosti odločanja Agencije in prispevati k vseevropskim pobudam za podpiranje inovativnih raziskav.
English: The procedures include: pre-authorisation procedure for risk-management plans, conditional marketing authorisation, accelerated assessment, procedures for generic and similar biological products, procedures for compassionate use and for products intended for non-EU markets.
Slovenian: Ti postopki zajemajo postopek pred izdajo dovoljenja za načrte za obvladovanje tveganj, postopek za pogojno dovoljenje za promet, postopek za pospešeno oceno, postopke za generična in biološko podobna zdravila ter postopke za sočutno uporabo zdravil in za zdravila, ki niso namenjena trgom EU.
English: The Agency will focus on ensuring the quality of opinions arising from arbitration and referral procedures, and will work to adhere to regulatory timelines.
Slovenian: Agencija se bo osredotočila na zagotavljanje kakovosti mnenj, ki izhajajo iz postopkov arbitraže in napotitve, ter si prizadevala za izpolnjevanje zakonskih rokov.
English: These projects will be complemented by work to enhance the electronic document management system (Managing Meeting Documents, eCollaboration and setting up workflows), which will rationalise processes linked to managing meeting-related documentation.
Slovenian: Te projekte bodo spremljala prizadevanja za povečanje sistema elektronskega vodenja dokumentacije (vodenje dokumentacije za sestanke, e-sodelovanje in določanje pretokov dela), ki bodo racionalizirala procese, povezane z vodenjem dokumentacije za sestanke.
English: The Agency will review the effectiveness of the procedures and will reinforce the link between scientific advice and marketing authorisation application phases.
Slovenian: Agencija bo preverila učinkovitost postopkov in okrepila povezavo med fazo znanstvenega svetovanja in fazo izdaje dovoljenja za promet z zdravilom.
English: The Agency expects an 18% increase in the number of certificate requests due to the increasing number of approved marketing authorisations.
Slovenian: Agencija pričakuje, da se bo zaradi povečanega števila odobrenih dovoljenj za promet število zahtevkov za potrdila povečalo za 18 %.
English: 1.1 European medicines network
Slovenian: 1.1 Evropska mreža zdravil
English: 2.5 Post-authorisation activities
Slovenian: 2.5 Dejavnosti po izdaji dovoljenja
English: This will be coupled with further developments in document management, records management (including retention policies) and mail registration activities.
Slovenian: Temu bo sledil nadaljnji razvoj na področju vodenja dokumentacije, vodenja evidenc (vključno s politikami hranjenja) in registriranja pošte.
English: An agreed paediatric investigation plan may lead to information on the paediatric use of medicines being included in a centralised or national marketing authorisation for new medicinal products, and in a paediatric-use marketing authorisation for offpatent products.
Slovenian: Dogovorjeni načrt pediatričnih raziskav lahko pripelje do informacij o pediatrični uporabi zdravil, ki so vključene v dovoljenje za promet za nova zdravila, izdano po centraliziranem ali nacionalnem postopku, ter v dovoljenje za promet za pediatrično uporabo proizvodov brez patenta.
English: − Further develop EudraVigilance, one of the main pillars of the ERMS, by implementing and starting the operation of quantitative signal-detection methods, by providing the Agency's stakeholders access to EudraVigilance information, and by setting up and implementing a network of academic centres for the intensive monitoring of targeted medicines;
Slovenian: − nadaljnji razvoj EudraVigilance, ki je eden glavnih stebrov evropske strategije obvladovanja tveganja, vključno z uvajanjem in začetkom delovanja kvantitativnih metod odkrivanja opozoril, zagotavljanjem dostopa do informacij EudraVigilance interesnim skupinam Agencije ter ustanavljanjem in izvajanjem mreže akademskih središč za intenzivno spremljanje ciljno usmerjenih zdravil;
English: This intensification must be supported by improved cost-effectiveness of the Agency's operations and further improvement of its quality assurance systems.
Slovenian: Zaradi večje intenzivnosti je treba izboljšati stroškovno učinkovitost delovanja Agencije in še naprej izboljševati sistem zagotavljanja kakovosti.
English: − Fulfil the Agency's obligations with regard to coordinating the supervision of veterinary medicines once authorised, through effective implementation of pharmacovigilance as well as through the dissemination of information on adverse drug reactions.
Slovenian: − izpolnjevanje obveznosti Agencije v smislu usklajevanja nadzora nad veterinarskimi zdravili po izdaji dovoljenja z učinkovitim izvajanjem farmakovigilance in s širjenjem informacij o neželenih učinkih zdravil.
English: Good laboratory practice (GLP).
Slovenian: Dobra laboratorijska praksa (Good laboratory practice, GLP).
English: EMEA/MB/442095/2006
Slovenian: EMEA/119323/2007
English: The Agency will conduct its core activities in the areas of authorisation and supervision of medicines for human and veterinary use to the highest quality standards.
Slovenian: Agencija bo izvajala svoje glavne naloge na področjih izdajanja dovoljenj za zdravila za uporabo v humani medicini in za zdravila za uporabo v veterinarski medicini ter njihovega nadzorovanja v skladu s standardi najvišje kakovosti.
English: Applications for designation (input) Opinions on designation (output)
Slovenian: Zahtevki za določitev (vhodni podatek) Mnenja o določitvi (izhodni podatek)
English: Another trend is the advent of new technologies and emerging therapies, for which the Agency and the network will begin preparations.
Slovenian: Poleg tega se pojavljajo tudi nove tehnologije in terapije, zato se bosta Agencija in mreža začeli pripravljati nanje.
English: Streamlining of meeting management will be achieved by enhancing the Agency's Meeting Management System to include a tracking system for hotel and travel details and, via the EMEA website, online booking facilities for delegates.
Slovenian: Racionalizacija upravljanja sestankov bo dosežena s širitvijo sistema Agencije za upravljanje sestankov, ki bo vsebovala sistem sledenja hotelskim in potovalnim podatkom ter možnosti spletnih rezervacij za odposlance prek spletne strani EMEA.
English: The Agency's Committee on Herbal Medicinal Products (HMPC) provides scientific opinions on questions relating to herbal medicines, establishes Community herbal monographs for traditional and well-established herbal medicinal products, and prepares a draft list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
Slovenian: Odbor za zdravila rastlinskega izvora (HMPC) pripravlja strokovna mnenja o vprašanjih v zvezi z zdravili rastlinskega izvora, oblikuje monografije rastlin Skupnosti za tradicionalna in dobro uveljavljena zdravila rastlinskega izvora ter pripravlja osnutek seznama snovi rastlinskega izvora, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zdravilih rastlinskega izvora.
English: These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Slovenian: Ta potrjujejo izdajo dovoljenja za promet in dober proizvodni status zdravil v EU, uporabljajo pa se kot spremni dokumenti k vlogam za izdajo dovoljenja za promet v državah, ki niso članice EU, in za izvoz v te države.
English: Finally, the Agency plans to grant access to adverse drug reaction data to the stakeholders.
Slovenian: Tretjič, Agencija načrtuje, da bo zainteresiranim strankam zagotovila dostop do podatkov o neželenih učinkih zdravil.
English: Scientific-advice and follow-up requests Protocol-assistance and follow-up requests
Slovenian: Zahtevki za znanstveno svetovanje in spremljanje Zahtevki za pomoč pri protokolu in spremljanje
English: Transparency, communication and provision of information
Slovenian: Preglednost, obveščanje in zagotavljanje informacij:
English: The sampling and testing programme for centrally authorised products will continue in 2007, and will enable the quality of medicinal products on the market in the EEA to be monitored, using the expertise of the EEA official medicines-control laboratories network.
Slovenian: Program vzorčenja in preizkušanja za zdravila, odobrena po centraliziranem postopku, se bo v letu 2007 nadaljeval in sicer z uporabo strokovnega znanja mreže uradnih laboratorijev EGP za nadzor zdravil, ki omogočajo nadzor kakovosti zdravil na trgu EGP.
English: Actual and estimated numbers of EU and non-EU ADR reports transmitted to the EMEA
Slovenian: Dejansko in ocenjeno število poročil o neželenih učinkih zdravil iz EU in zunaj EU, poslanih EMEA
English: EudraGMP (In final testing)
Slovenian: EudraGMP (v fazi končnega preizkušanja)
English: Implementation of legislation on medicines for children
Slovenian: Izvajanje zakonodaje o zdravilih za otroke:
English: Periodic safety-update reports (PSURs).
Slovenian: Redno posodobljena poročila o varnosti (PSUR).
English: It also provides opinions on herbal substances at the request of the CHMP and conducts referral and arbitration procedures involving traditional herbal medicinal products.
Slovenian: Pripravlja tudi mnenja o snoveh rastlinskega izvora na zahtevo Odbora za zdravila za uporabo v humani medicini (CHMP) ter vodi postopke napotitve in arbitraže, ki vključujejo tradicionalna zdravila rastlinskega izvora.
English: This takes into account the increasing number of authorised products requiring re-inspection, increasing numbers of variations, the impact of generic applications, and new requirements for GMP for active substances.
Slovenian: To pričakovanje temelji na večjem številu proizvodov z dovoljenjem za promet, za katere je potreben ponoven pregled, na večjem številu sprememb, vplivu generičnih vlog in novih zahtevah za dobro proizvodno prakso (GMP) pri zdravilnih učinkovinah.
English: on the Internet at www.emea.europa.eu by email request to info@emea.europa.eu by fax to (44-20) 7418 8670 by writing to:
Slovenian: na internetu na www.emea.europa.eu na podlagi zahtevka, ki ga pošljete na e-naslov info@emea.europa.eu po faksu na št. (44-20) 7418 8670 pisno na:
English: Reimbursed meetings Videoconferences
Slovenian: Sestanki s povrnjenimi stroški Videokonference
English: Operational expenditure 300 Meetings
Slovenian: 300 Sestanki
English: In addition to evaluation of the applications, the Agency plans to continue strengthening the quality-assurance system as well as the scientific and regulatory consistency of scientific assessments in 2007.
Slovenian: Agencija načrtuje, da bo v letu 2007 poleg ocene vlog še naprej krepila sistem zagotavljanja kakovosti ter tudi znanstveno in regulativno usklajenost znanstvenih ocen.
English: New medicinal products (orphan)
Slovenian: Nova zdravila (sirote)
English: Press office
Slovenian: Tiskovni urad
English: 2 Committee for Medicinal Products for Human Use (CHMP).
Slovenian: 2 Odbor za zdravila za uporabo v humani medicini (CHMP).
English: The Agency will focus on the effective management of referral and arbitration procedures, and will work to further strengthen the quality and the regulatory and scientific consistency of CHMP opinions and assessment reports.
Slovenian: Agencija se bo osredotočila na učinkovito upravljanje postopkov napotitve in arbitraže, poleg tega pa si bo prizadevala še naprej krepiti kakovost ter regulativno in znanstveno skladnost mnenj in poročil o oceni Odbora za zdravila za uporabo v humani medicini (CHMP).
English: Number of reimbursed delegates
Slovenian: Število odposlancev s povrnjenimi stroški
English: Inspection activities
Slovenian: Inšpekcijske dejavnosti
English: Applications for initial evaluation (Human medicines)
Slovenian: Vloge za začetno oceno (Zdravila za uporabo v humani medicini)
English: 2.1 Orphan medicinal products for human use
Slovenian: 2.1 Zdravila sirote za uporabo v humani medicini
English: Integrated quality management and audit
Slovenian: Integrirano upravljanje kakovosti in
English: The Agency is facing a steady intensification of activities relating to the evaluation and supervision of medicinal products.
Slovenian: Dejavnosti Agencije, povezane z ocenjevanjem in nadzorovanjem zdravil, so vse bolj intenzivne.
English: Type-II (clinical) variations
Slovenian: (Klinične) spremembe tipa II
English: The EMEA issues plasma master file (PMF) and vaccine antigen master file (VAMF) certificates of a medicinal product in conformity with the arrangements laid down by Community legislation.
Slovenian: EMEA za zdravila izdaja potrdila o glavnem dosjeju plazme (PMF) in glavnem dosjeju virusnih antigenov (VAMF) v skladu z ureditvami v zakonodaji Skupnosti.
English: Function Group & Grade
Slovenian: Funkcionalna skupina in stopnja
English: Committee for Medicinal Products for Veterinary Use (CVMP).
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP).
English: Arbitration, Community referrals and opinions on scientific matters (Human medicines)
Slovenian: Arbitraža, napotitve Skupnosti in mnenja o strokovnih zadevah (zdravila za uporabo v humani medicini)
English: EudraCT-Paediatrics Database (At inception)
Slovenian: Pediatrična zbirka podatkov EudraCT (v zametkih)
English: 5.4 EMEA document management and publishing
Slovenian: 5.4 Upravljanje in objave dokumentov EMEA
English: Scientific-advice requests (Veterinary medicines)
Slovenian: Zahtevki za znanstveno svetovanje (Zdravila za uporabo v veterinarski medicini)
English: Scientific-advice and protocol-assistance requests (Human medicines)
Slovenian: Zahtevki za znanstveno svetovanje in pomoč pri protokolu (Zdravila za uporabo v humani medicini)
English: Compassionate-use products
Slovenian: Zdravila za sočutno uporabo
English: In addition, the implementation of a business-continuity IT solution will be advanced to support a range of disaster-recovery scenarios.
Slovenian: Poleg tega bo nadgrajeno izvajanje informacijsko-tehnoloških rešitev za neprekinjenost poslovanja, da bi podprla različne možnosti, kako vzpostaviti prvotno stanje, če se zgodi nesreča.
English: Conference, as well as work with the World Health Organization (for example, on medicinal products for use in developing countries), the Codex Alimentarius, the World Organisation for Animal Health, the US Food and Drug Administration (FDA) and the US Department of Agriculture.
Slovenian: Dejavnosti Agencije na mednarodnem področju zajemajo usklajevanje sodelovanja strokovnjakov EU na mednarodnih konferencah/mednarodnem sodelovanju o usklajevanju (ICH in VICH) in 7. konferenci ICH ter tudi sodelovanje s Svetovno zdravstveno organizacijo (na primer glede zdravil za uporabo v državah v razvoju), Codexom Alimentariusom, Svetovno organizacijo za zdravje živali, Uradom za živila in zdravila (FDA) iz ZDA in Ministrstvom za kmetijstvo iz ZDA.
English: 2.9 Herbal medicinal products
Slovenian: 2.9 Zdravila rastlinskega izvora
English: Maximum residue limit applications
Slovenian: Vloge za mejne vrednosti ostankov
English: Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.europa.eu
Slovenian: Martin HARVEY ALLCHURCH Direktni telefon: (44-20) 74 18 84 27 E-naslov: press@emea.europa.eu
English: Line extensions
Slovenian: Razširitev indikacij
English: − In light of the increasing tasks at the EU level and the arrival of novel therapies and technologies, work to ensure availability for the network of the highest-quality expertise at EU level for the evaluation of medicines and for monitoring and assessing their safety.
Slovenian: − prizadevanje, da se zagotovi razpoložljivost mreže strokovnega znanja najvišje kakovosti na ravni EU za vrednotenje zdravil ter spremljanje in ocenjevanje njihove varnosti glede na vse številnejše naloge na ravni EU ter prihod novih terapij in tehnologij.
English: Variation and extension applications (Veterinary medicines)
Slovenian: Vloge za spremembe in razširitve (Zdravila za uporabo v veterinarski medicini)
English: E-mail: peter.richardson@emea.europa.eu
Slovenian: E-naslov: peter.richardson@emea.europa.eu
English: One or two new releases of both the review and light authoring systems are anticipated.
Slovenian: Pričakujeta se ena ali dve novi sprostitvi v uporabo pri sistemih za izdajanje dovoljenj in pregledovanje uporabniškega programa za upravljanje informacij o izdelkih.
English: The Agency will publish Q&A documents at the time of adoption of the CHMP opinion, thus ensuring transparency on arbitration and referral procedures.
Slovenian: Agencija bo v času sprejetja mnenja Odbora za zdravila za uporabo v humani medicini objavila dokumente z vprašanji in odgovori ter tako zagotovila preglednost postopkov arbitraže in napotitve.
English: Type-II (quality) variations
Slovenian: (Kakovostne) spremembe tipa II