natgillin/translations-raw huggingface dataset:
Despite initiatives taken by the CVMP1 to facilitate the authorisation of products for minor uses and minor species, the number of associated extensions and modifications has remained stable over the last years - a situation likely to continue in 2007, with 5 applications being predicted.
Kljub pobudam CVMP1, s katerimi je ta želel poenostaviti izdajanje dovoljenj za zdravila za manj pomembne uporabe in vrste, se število povezanih razširitev in sprememb mejnih vrednosti ostankov v zadnjih letih ni spremenilo - tako bo verjetno ostalo tudi v letu 2007, v katerem se pričakuje 5 vlog.
Work will continue on strengthening the quality and the regulatory and scientific consistency of CHMP2 opinions and assessment reports in the post authorisation phase, building on improvements introduced in 2006.
Nadaljevale se bodo dejavnosti v zvezi s krepitvijo kakovosti ter regulativne in znanstvene skladnosti mnenj in poročil o oceni CHMP2 v fazi po izdaji dovoljenja, pri čemer se bo gradilo na izboljšavah, ki so bile uvedene v letu 2006.
The Agency will also update interested parties on the operations of the HMPC, with particular emphasis on prioritisation of herbal substances identified for list entry/monograph development.
Agencija bo še naprej obveščala zainteresirane stranke o dejavnostih HMPC, poseben poudarek pa bo na prednostni opredelitvi snovi rastlinskega izvora, določenih za vnos v seznam/razvoj monografije.
20 Investment in immovable property, renting of building and asset costs
20 Naložbe v nepremičnine, najemi objektov in s tem povezani stroški
To respond to the increasing number of meetings, and to improve the meetings-organisation workflow and procedures, the Agency will focus on two aspects: streamlining the management of meetings and providing alternative meeting solutions.
Zaradi vedno večjega števila sestankov in izboljšanja pretoka dela in postopkov pri organizaciji sestankov se bo Agencija osredotočila na dva vidika: racionalizacijo upravljanja sestankov in zagotavljanje alternativnih rešitev za sestanke.
* With the implementation of the mandatory electronic reporting of ICSRs and the EudraVigilance Data Warehouse and Analysis System, a new method has been developed to present the number of ICSRs received/expected over time.
* Z uresničitvijo obveznega elektronskega sporočanja varnostnih poročil o posameznih primerih (ICSR) ter sistema za shranjevanje in analizo podatkov EudraVigilance je bila razvita nova metoda za predstavljanje števila varnostnih poročil o posameznih primerih, prejetih/pričakovanih v določenem času.
− Further maintain and improve measures for facilitating innovation and research, and thus increasing availability of medicines, in particular through: continuous support for the orphan medicinal products policy; the provision of scientific advice; support for micro, small and medium-sized enterprises; research into the impact and consistency of the Agency's decision making;
− ohranjanje in nadaljnje izboljševanje ukrepov za spodbujanje inovacij in raziskav ter s tem povečanje dostopnosti zdravil, zlasti v smislu stalne podpore politiki za zdravila sirote; zagotavljanja znanstvenega svetovanja; podpore za mikro, mala in srednje velika podjetja; raziskav vpliva in skladnosti odločanja Agencije;
Important areas of interaction with the European Commission on public-health issues will include: work associated with the legislation and initiatives relating to advanced therapies; support on the updating and further development of the Notice to Applicants; work within the framework of the public-private partnership aimed at providing quality information to patients; and assistance in revision of legislation governing variations to marketing authorisations.
Med pomembnimi področji sodelovanja z Evropsko komisijo o vprašanjih javnega zdravja bodo: delo, povezano z zakonodajo in pobudami, povezanimi z naprednimi terapijami; podpora pri posodabljanju in nadaljnjem razvoju Obvestila vlagateljem (Notice to Applicants); delo v okviru javno-zasebnega partnerstva za zagotavljanje kakovostnih informacij bolnikom; pomoč pri reviziji zakonodaje, ki ureja spremembe dovoljenj za promet.
The EMEA will continue ongoing activities in areas including: EU programme to reduce animal testing and develop modern approaches to safety assessment of medicines, minimisation of the occurrence of antimicrobial resistance, and environmental risk-assessment for medicinal products.
EMEA bo nadaljevala dejavnosti, ki potekajo na naslednjih področjih: program EU za zmanjšanje preizkusov na živalih in razvoj sodobnih pristopov k ocenjevanju varnosti zdravil; zmanjševanje pojava antimikrobne rezistence; ocena okoljskega tveganja zdravil.
Earlier and improved availability of medicines
Zgodnja in izboljšana dostopnost zdravil:
The EMEA will continue its initiatives aimed at improving the availability of veterinary medicines for minor uses and minor species.
EMEA bo nadaljevala svoje pobude, katerih cilj je izboljšati dostopnost veterinarskih zdravil za manj pomembne uporabnike in vrste.
The Agency will focus its initiatives in the following areas: implementation of transparency and communication provisions relating to medicines for paediatric use and paediatric clinical trials; improving the provision of information on scientific non-product related issues; completion of the implementation of the legislation on access to documents; provision of access to information on adverse drug reactions contained in the EMEA EudraVigilance database; and provision of product-related information in the new Community languages, Bulgarian and Romanian, and, following expiry of the derogation, in Maltese.
Svoje pobude bo usmerila na naslednja področja: izvajanje določb o preglednosti in obveščanju v zvezi z zdravili za pediatrično uporabo in pediatričnimi kliničnimi preizkušanji; izboljšanje zagotavljanja informacij o znanstvenih vprašanjih, ki se ne nanašajo na zdravilo; dokončanje izvajanja zakonodaje o dostopnosti dokumentov; zagotavljanje dostopa do informacij o neželenih učinkih zdravil, vsebovanih v zbirki podatkov EMEA EudraVigilance; zagotavljanje z zdravili povezanih podatkov v novih jezikih Skupnosti, bolgarščini in romunščini ter, po poteku prehodnega obdobja odloga, tudi v malteškem jeziku.
303 Studies and consultants 304 Publications
303 Študije in svetovalci
1.4 Emerging therapies and new technologies
1.4 Nove terapije in tehnologije
This is an important new mandate for the EMEA, giving the Agency a significant role in stimulating the availability of safe and effective medicines for children.
To je pomembna nova naloga za Agencijo, saj je ta dobila pomembno vlogo v spodbujanju dostopnosti varnih in učinkovitih zdravil za otroke.
The Agency estimates around 400 requests or applications relating to paediatric activities (such as paediatric investigation plans, waivers and scientific advice) will be received in the first year of activity.
Agencija pričakuje, da bo v prvem letu delovanja prejela okrog 400 zahtevkov ali vlog v zvezi s pediatričnimi dejavnostmi (kot so načrti pediatričnih raziskav, opustitve in znanstveno svetovanje).
It is expected that over 70 centrally authorised veterinary products will be available by 2007.
Pričakuje se, da bo do leta 2007 na voljo več kot 70 proizvodov z dovoljenjem, izdanim po centraliziranem postopku.
To address these trends, the EMEA, together with the national competent authorities, will work to strengthen the network of excellence and will cooperate to further develop resource-planning and work-sharing practices.
EMEA bo, z namenom obravnave teh trendov, skupaj s pristojnimi nacionalnimi organi okrepila mrežo odličnosti ter s sodelovanjem še bolj razvila prakso načrtovanja virov in delitve dela.
− Continue to apply a proactive approach to safety of medicines by initiating early assessment of the safety prior to authorisation, by monitoring implementation of risk-management plans after marketing authorisation, and by supervising the updating of such plans throughout the lifecycle of the product;
− nadaljnji proaktivni pristop k varnosti zdravil z izvajanjem zgodnjega ocenjevanja varnosti pred izdajo dovoljenja, spremljanjem izvajanja načrtov za obvladovanje tveganj po izdaji dovoljenja in nadzorovanjem posodabljanja takih načrtov skozi življenjski cikel zdravila;
Requests should be sent in writing to the EMEA or to
Pisne zahtevke pošljite na naslov EMEA ali na
A renomination of the majority of the CHMP, CVMP and HMPC members will take place in May 2007, following completion of their three-year term.
Maja 2007 bo po koncu triletnega mandata potekal ponoven izbor večine članov CHMP, CVMP in HMPC.
EU telematics strategy
Telematska strategija EU
Additional efforts will focus on addressing the impact of legal and procedural requirements on various inspection areas, on integration of certain ICH concepts (quality risk-management, design space, etc.) in assessment and inspection areas, and on analysis of GMP, PMF inspection and quality-defect findings in previous years.
Dodatna prizadevanja bodo usmerjena v obravnavanje vpliva pravnih in postopkovnih zahtev na različna področja inšpekcijskih pregledov, v povezovanje določenih konceptov Mednarodne konference o usklajevanju (ICH) (obvladovanje tveganj na področju kakovosti, načrtovalski prostor (design space) itd.) pri oceni in na področjih inšpekcijskih pregledov ter v analizo GMP, inšpekcijskih pregledov PMF in ugotovitev o pomanjkljivi kakovosti iz prejšnjih let.
− Implement the new regulation on medicinal products for paediatric use, including the establishment of a new Paediatric Committee, delivering opinions and decisions on paediatric investigation plans and waivers, and providing information on paediatric clinical trials.
− izvajanje nove uredbe o zdravilih za pediatrično uporabo, vključno z ustanovitvijo novega Odbora za pediatrijo, izdajanje mnenj in odločitev o načrtih pediatričnih raziskav in opustitvah ter zagotavljanje informacij o pediatričnih kliničnih preizkušanjih.
The Agency expects to complete the implementation of the full scope of the GMP Annex with EC-Japan MRA and maintenance arrangements.
Agencija pričakuje dokončno uresničitev celotnega obsega priloge o GMP sporazuma o medsebojnem priznavanju med ES in Japonsko ter vzdrževalnih ureditev.
14 Socio-medical infrastructure 15 Exchange of civil servants and experts 16 Social welfare
11 Aktivno zaposleno osebje 13 Stroški službenih potovanj 14 Socialno-zdravstvena infrastruktura 15 Izmenjava javnih uslužbencev in strokovnjakov 16 Socialno varstvo
The Agency will take part in the work of the Pharmaceutical Forum, and will continue the development of the EudraPharm database, containing information about centrally authorised products.
Agencija bo sodelovala pri delu Farmacevtskega foruma in nadaljevala razvoj zbirke podatkov EudraPharm, ki vsebuje podatke o zdravilih, odobrenih po centraliziranem postopku.
It will continue to implement the policy on micro, small and medium-sized enterprises (SMEs), which are often innovative companies working in the field of new technologies and emerging therapies; will continue to provide high-quality scientific advice to companies developing medicinal products; will support the development of orphan medicinal products; and will actively participate in the Innovative Medicines Initiative.
Še naprej bo izvajala politiko v zvezi z mikro, malimi in srednje velikimi podjetji (MSP), ki so pogosto inovativna na področju novih tehnologij in terapij, zagotavljala bo visoko kakovost znanstvenega svetovanja podjetjem, ki razvijajo zdravila, podpirala bo razvoj zdravil sirot in dejavno sodelovala v pobudi za inovativna zdravila (Innovative Medicines Initiative).
7 Good clinical practice (GCP).
7 Dobra klinična praksa (Good clinical practice, GCP).
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.
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.
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.
Cilj tega izboljševanja je racionalizacija ključnih procesov v Agenciji, izboljšanje stroškovne učinkovitosti njenega delovanja, izboljšanje uspešnosti ter povečanje zadovoljstva strank in interesnih skupin.
5 Good manufacturing practice (GMP).
5 Dobra proizvodna praksa (Good manufacturing practice, GMP).
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.
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.
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.
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.
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.
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.
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.
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.
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.
Načrtovane so do tri sprostitve v uporabo, ki uresničujejo povečanja funkcionalnosti na področju slovarja proizvoda, prvega dela signalnega sledenja in dostopa posebnih uporabnikov.
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.
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.
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.
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.
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.
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.
1.2 Transparency, communication and provision of information
1.2 Preglednost, obveščanje in zagotavljanje informacij
− 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.
− 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.
The EMEA PMF/VAMF certification process is an assessment of the PMF/VAMF application dossier.
Certifikacijski postopek EMEA za PMF/VAMF je ocena dokumentacije za vlogo za PMF/VAMF.
The Agency expects that the overall number of applications for veterinary medicinal products will remain at around 14 applications in 2007.
Agencija pričakuje, da bo v letu 2007 celotno število vlog za veterinarska zdravila ostalo pri približno 14 vlogah.
Similar biological products
Zdravila s podobnimi biološkimi lastnostmi
The EMEA Paediatric Committee will conduct assessment of, agreement on, and verification of compliance with, paediatric investigation plans and waivers.
Odbor za pediatrijo EMEA bo vodil ocenjevanje, sprejemanje dogovora in potrjevanje skladnosti s načrti pediatričnih raziskav in sistemom opustitev.
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.
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.
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.
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.
The Agency will focus on ensuring the quality of opinions arising from arbitration and referral procedures, and will work to adhere to regulatory timelines.
Agencija se bo osredotočila na zagotavljanje kakovosti mnenj, ki izhajajo iz postopkov arbitraže in napotitve, ter si prizadevala za izpolnjevanje zakonskih rokov.
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.
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.
The Agency will review the effectiveness of the procedures and will reinforce the link between scientific advice and marketing authorisation application phases.
Agencija bo preverila učinkovitost postopkov in okrepila povezavo med fazo znanstvenega svetovanja in fazo izdaje dovoljenja za promet z zdravilom.
The Agency expects an 18% increase in the number of certificate requests due to the increasing number of approved marketing authorisations.
Agencija pričakuje, da se bo zaradi povečanega števila odobrenih dovoljenj za promet število zahtevkov za potrdila povečalo za 18 %.
1.1 European medicines network
1.1 Evropska mreža zdravil
2.5 Post-authorisation activities
2.5 Dejavnosti po izdaji dovoljenja
This will be coupled with further developments in document management, records management (including retention policies) and mail registration activities.
Temu bo sledil nadaljnji razvoj na področju vodenja dokumentacije, vodenja evidenc (vključno s politikami hranjenja) in registriranja pošte.
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.
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.
− 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;
− 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;
This intensification must be supported by improved cost-effectiveness of the Agency's operations and further improvement of its quality assurance systems.
Zaradi večje intenzivnosti je treba izboljšati stroškovno učinkovitost delovanja Agencije in še naprej izboljševati sistem zagotavljanja kakovosti.
− 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.
− 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.
Good laboratory practice (GLP).
Dobra laboratorijska praksa (Good laboratory practice, GLP).
EMEA/MB/442095/2006
EMEA/119323/2007
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.
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.
Applications for designation (input) Opinions on designation (output)
Zahtevki za določitev (vhodni podatek) Mnenja o določitvi (izhodni podatek)
Another trend is the advent of new technologies and emerging therapies, for which the Agency and the network will begin preparations.
Poleg tega se pojavljajo tudi nove tehnologije in terapije, zato se bosta Agencija in mreža začeli pripravljati nanje.