natgillin/translations-raw huggingface dataset:
Consequently, the area of advanced therapies will present a big area of change for the Agency in 2008 and 2009.
Posledično bo na področju naprednih terapij veliko sprememb za Agencijo v letih 2008 in 2009.
This is due to the growing volume of core tasks of the Agency and of its partners in the network, and to the addition of new tasks vested by new legislation (e.g. the implementation of the new paediatric legislation in 2007 and the new legislation on advanced therapies in 2008).
Razlog za to je v vedno večjem številu osnovnih nalog Agencije in njenih partnerjev v mreži in dodajanju novih nalog zaradi novih zakonodaj (npr. izvajanje nove zakonodaje o pediatriji v letu 2007 in nove zakonodaje o naprednih terapijah v letu 2008).
INTRODUCTION BY THE EXECUTIVE DIRECTOR
Uvod izvršnega direktorja
Consequently, the number of new veterinary pharmaceutical medicines for food-producing animals will remain at a low level.
Posledično bo število novih zdravil za uporabo v veterinarski medicini, namenjenih živalim za proizvodnjo živil, ostalo majhno.
These measures will familiarise the national competent authorities with the work performed by the EMEA's scientific committees and their working parties.
Ti ukrepi bodo nacionalnim pristojnim organom dali vpogled v delo, ki ga izvajajo znanstveni odbori EMEA ter njihove delovne skupine.
This will help the Agency to clarify areas of concern to some parts of the industry that were identified in the IFAH Benchmarking survey conducted in 2006.
To bo Agenciji omogočilo, da industriji razjasni nekatere skrb zbujajoče vidike, ki so bili ugotovljeni v anketi primerjalne analize IFAH, izvedene v letu 2006.
Payable initial notifications Total initial notifications Notifications of a change
Plačljiva začetna obvestila Obvestila o spremembi
A wide range of documents are published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Agencija EMEA objavlja širok razpon dokumentov, vključno s sporočili za javnost, splošnimi informativnimi dokumenti, letnimi poročili in delovnimi programi.
More and more clinical trials are conducted in countries outside the EU.
Vse več kliničnih preskušanj se izvaja v državah zunaj EU.
The primary focus in 2008 will be the development of general principles, standards, quality assurance and transparency-related aspects, which subsequently will be applied across the network of these centres.
Glavni poudarek v letu 2008 bo razvoj splošnih načel, standardov, zagotavljanja kakovosti in vidikov preglednosti, ki se bodo nato uvajali po vsej mreži centrov.
Similarly, since the offer by the EMEA to extend MRLs to other species without a fee (by way of extrapolation, provided the scientific criteria are met) was not taken up in 2007, only a small number of such requests for extrapolation are expected in 2008.
Čeprav ponudba agencije EMEA, da MVO brezplačno razširi tudi na druge vrste (z ekstrapolacijo, če so izpolnjeni znanstveni pogoji), leta 2007 ni bila sprejeta, se leta 2008 pričakuje le malo takih zahtevkov za ekstrapolacijo.
Improve the conduct of the Agency's core activities
Izboljšati opravljanje glavnih dejavnosti Agencije
2 Appropriation/Budget 2006 as per final accounts.
Odobrena proračunska sredstva/proračun za leto 2006 kot v zaključnih računih.
The measures include providing free scientific advice as well as administrative and financial assistance similar to that given to SMEs.
Med te ukrepe spada nudenje brezplačnih znanstvenih nasvetov ter administrativne in finančne pomoči, podobno kot pri malih in srednje velikih podjetjih.
The number of arbitrations and referrals remains difficult to predict, but the increasing trend since the introduction of the new legislation is expected to continue.
Število arbitraž in napotitev je še vedno težko napovedati, pričakovati pa je, da se bodo nadaljevale smernice rasti, ki so se začele z uvedbo nove zakonodaje.
The EMEA will also work in the field of environmental risk assessment and will provide support to programmes aimed at reducing animal testing.
EMEA bo delovala tudi na področju ocene okoljskega tveganja ter nudila pomoč programom, katerih cilj je zmanjšati število preizkusov na živalih.
Depending on the outcome, the projects may have an impact on certain aspects of how the Agency evaluates and supervises medicines and delivers its services to its stakeholders.
Glede na končni izid bodo projekti morda vplivali na to, kako Agencija ocenjuje in nadzoruje zdravila ter zagotavlja storitve svojim zainteresiranim stranem.
In 2008, the Agency, in addition to its core activities in the area of parallel distribution, will verify compliance with the mandatory notification procedure by parallel distributors.
V letu 2008 bo Agencija poleg svojih glavnih dejavnosti na področju vzporedne distribucije preverjala, ali vzporedni distributerji spoštujejo obvezni postopek obveščanja.
This trend is in line with the number of innovative reference products reaching the end of the 10-year period of data exclusivity.
To gibanje je skladno s številnimi inovativnimi referenčnimi zdravili, katerih 10-letno obdobje ekskluzivnosti podatkov se izteka.
As part of these initiatives, the EMEA plans to increase transparency in the field of non-product-related activities.
Kot del teh pobud namerava EMEA povečati preglednost na področju dejavnosti, ki niso povezane z zdravili.
The anticipated increase is partly due to the fact that many of the arbitrations relating to applications for generic products also lead to simultaneous Community-interest referrals, as this represents the only way that Member States can address issues relating to safety and efficacy that arise during the procedure.
Pričakovano povečanje je delno pripisano dejstvu, da veliko arbitraž, povezanih z vlogami za generična zdravila, vodi tudi do sočasnih napotitev v interesu Skupnosti, kajti samo tako lahko države članice obravnavajo vprašanja varnosti in učinkovitosti, ki se pojavijo med postopkom.
A number of related guidelines will be further developed and support will be provided to the European Commission to follow up on the 2007 conference on implementation of clinical trials legislation.
Nadaljnje bo razvila številne sorodne smernice in nudila pomoč Evropski komisiji, da bo nadgradila konferenco iz leta 2007 o izvajanju zakonodaje o kliničnih preskušanjih.
General EU contribution EU contribution for SME policy EU contribution for paediatrics policy EU contribution for IT Telematics strategy Special EU contribution for orphan medicinal products
Prispevek EU za pediatrično politiko Prispevek EU za telematsko strategijo IT Posebni prispevek EU za zdravila sirote Prispevek iz EGP
The EMEA will continue to work on a new transitional programme IPA (instrument for pre-accession) for supporting the participation of Croatia, Turkey and the Former Yugoslav Republic of Macedonia as observers in meetings, training courses, and workshops planned by the EMEA.
EMEA bo nadaljevala delo na novem prehodnem programu IPA (predpristopni instrument) za podporo sodelovanju Hrvaške, Turčije in Makedonije kot opazovalk na sejah, usposabljanjih in delavnicah, ki jih načrtuje EMEA.
4 Appropriation/Draft Budget 2008 as adopted by the Management Board on 13 December 2007.
Odobrena proračunska sredstva/predlog proračuna za leto 2008, kot ga je sprejel upravni odbor 13. decembra 2007.
This is due to the fact that more products are authorised and subsequently more variations are submitted.
To gre pripisati dejstvu, da je odobrenih vse več zdravil, in posledično je predloženih več sprememb.
Scientific advice and protocol assistance are key areas of activity for the Agency, in particular with respect to fostering new innovative technologies and therapies and as a means to facilitate and improve earlier availability of medicinal products.
Znanstveno svetovanje in pomoč pri protokolu sta ključni področji dejavnosti Agencije, zlasti z namenom spodbujanja novih inovativnih tehnologij in terapij ter kot način, da se omogoči in izboljša zgodnja dostopnost zdravil.
These will include links between specific therapies such as gene, cell-therapy and tissue-engineered products, and nanomedicines.
Te bodo vključevale povezave med posameznimi terapijami, kot so genska terapija, celična terapija in izdelki, pridobljeni iz človeških tkiv, ter nanozdravila.
Another type of advice relates to the assessment of dossier requirements in relation to products for limited markets.
Druga vrsta svetovanja zadeva oceno zahtev za dosje v zvezi z zdravili za omejene trge.
In addition, the operation of the scientific committees' working parties will be reviewed in order to evaluate whether it may be possible to rationalise the use of resources from the national competent authorities.
Hkrati bo Agencija preučila delovanje delovnih skupin znanstvenih odborov, da bi ocenila, če je mogoče racionalizirati uporabo virov nacionalnih pristojnih organov.
Reinforce the Agency's interaction with patients and healthcare professionals, building on the initiatives undertaken in 2006 and 2007 and taking due account of satisfaction surveys.
Okrepiti stike Agencije z bolniki in zdravstvenimi delavci, nadgrajevati pobude, sprejete leta 2006 in 2007, in upoštevati ankete o zadovoljstvu.
Elements affecting the environment include the adoption of new EU legislation in the field of pharmaceuticals, challenges faced by researchers in the development of new therapies, globalisation of the regulatory environment and steady intensification of work within the Agency's existing areas of responsibility.
Med elemente, ki vplivajo na to okolje, sodijo sprejetje nove EU zakonodaje na področju farmacevtskih izdelkov, izzivi, s katerimi se soočajo raziskovalci pri razvijanju novih terapij, globalizacija regulativnega okolja in vse bolj intenzivne dejavnosti znotraj obstoječih področij odgovornosti Agencije.
In addition to ongoing activities in this field, the Agency will review how to expand its scientific-advice database with information on scientific advice given by national competent authorities.
Poleg tekočih dejavnosti na tem področju bo Agencija ocenila, kako dopolniti svojo podatkovno bazo o znanstvenem svetovanju s podatki o znanstvenem svetovanju, ki ga izvajajo pristojni nacionalni organi.
The authorities will also be involved in the EU telematics programme.
Pristojni organi bodo vključeni tudi v telematski program EU.
The Agency will discuss worksharing and cooperation on all types of inspections with its international partners, as part of efforts to address the increasing demand for international collaboration in this area and to avoid duplication of effort and resources.
Agencija se bo s svojimi mednarodnimi partnerji dogovarjala glede delitve dela in sodelovanja pri vseh vrstah inšpekcijskih pregledov, kar bo del prizadevanj, da bi ji uspelo zadovoljiti vse večje povpraševanje po mednarodnem sodelovanju na tem področju ter bi se izognila podvojevanju truda in vloženih sredstev.
In 2008, the Agency will continue its work to tackle major public- and animal-health threats, including the development of antimicrobial resistance, pandemic influenza, avian influenza and other epizootic diseases such as bluetongue.
V letu 2008 bo Agencija nadaljevala svoje delo na področju boja proti večjim nevarnostim, ki pretijo javnemu zdravju in zdravju živali, vključno z razvojem antimikrobne rezistence, pandemijo gripe, ptičjo gripo in drugimi epizootskimi boleznimi, kot je bolezen modrikastega jezika.
Referrals concerning new indications, new pharmaceutical forms or new routes of administration relating to paediatric use are a new legislative tool.
Napotitve, ki zadevajo nove indikacije, nove farmacevtske oblike in nove poti uporabe v pediatriji, so novo regulativno orodje.
In 2008, the Agency plans to consolidate the outcomes of its two-year process-improvement exercise and will continue to implement measures to optimise key processes, improve cost-effectiveness of the Agency's operations, and achieve higher satisfaction for the Agency's stakeholders.
V letu 2008 namerava Agencija združiti rezultate dveletnega izboljševanja postopkov in nadalje izvajati ukrepe za racionalizacijo ključnih procesov, izboljšanje stroškovne učinkovitosti njenega delovanja in dosego večjega zadovoljstva njenih zainteresiranih straneh.
It is anticipated that the majority of referrals will continue to relate to arbitrations that are due to differences in opinion at the Member State level within the framework of the mutual-recognition or decentralised procedures.
Pričakovati je tudi, da bo večina napotitev še naprej zadevala arbitraže zaradi razlik v mnenjih na ravni držav članic v okviru postopka vzajemnega priznavanja ali decentraliziranega postopka.
The number of clinical trials conducted in countries outside the EU is increasing.
Število kliničnih preskušanj v državah zunaj EU narašča.
Senior medical officer
Visoki zdravstveni uradnik
In the area of information technology, the Agency and its partners will work to increase the use of various IT tools that support collaboration.
Na področju informacijske tehnologije bo Agencija s svojimi partnerji povečala uporabo različnih orodij informacijske tehnologije, ki podpirajo sodelovanje.
In addition, a number of inspections to support plasma-file certification are planned, contributing to about 15% of the total number.
Poleg tega je načrtovanih več inšpekcijskih pregledov za potrditev dokazil o plazemskih dosjejih, kar je 15 % vseh pregledov.
Conduct an assessment of the impact and consistency of the Agency's scientific opinions.
Izvajati oceno vpliva in skladnosti znanstvenih mnenj Agencije.
The Agency will also maintain and further strengthen dialogue with all stakeholders through joint workshops with the European Commission on both the regulatory and scientific aspects of advanced therapy medicinal products.
Agencija bo tudi vzdrževala in še naprej krepila dialog z vsemi zainteresiranimi stranmi na skupnih delavnicah z Evropsko komisijo o regulativnih in znanstvenih vidikih zdravil za napredne terapije.
Improve liaison with the World Health Organization and developing countries' regulatory authorities for the effective use of opinions on medicinal products intended for non-EU markets.
Izboljšati povezavo s Svetovno zdravstveno organizacijo in upravnimi organi držav v razvoju za učinkovito uporabo mnenj o zdravilih, namenjenih trgom zunaj EU;
Over 4,000 experts are used by the EMEA in its scientific evaluation work.
Agencija EMEA pri svojem znanstvenem ocenjevalnem delu sodeluje z več kot 4.000 strokovnjaki.
This activity is strengthened through the peer review of assessment reports, which also includes the review of risk-management plans.
To dejavnost krepijo tudi medsebojni pregledi stanovskih strokovnjakov, s katerimi se pregledajo poročila ocen, ki vključujejo tudi pregled načrtov za obvladovanje tveganja.
As part of the task of implementing the paediatric legislation, the Agency will begin to implement the strategy on the network of paediatric research.
Kot del naloge izvajanja pediatrične zakonodaje bo Agencija začela izvajanje strategije o mreži raziskav v pediatriji.
The Agency will participate in the work relating to studies on off-patent medicinal products used in children, studies on the safety of medicines, and projects on rare diseases.
Agencija bo sodelovala pri delu, ki zadeva študije zdravil za otroke brez patenta, študije o varnosti zdravil in projekte o redkih boleznih.
Summary of the work programme for the European Medicines Agency
Povzetek delovnega programa Evropske agencije za zdravila
With this in mind, the EMEA will conduct a few pilot projects related to benefit-risk assessment, risk communication and scientific memory.
V skladu s tem bo EMEA izvedla nekaj pilotnih projektov, povezanih analizo tveganja in koristi, sporočanjem tveganja ter znanstvenim spominom.
This requirement contributes to the Agency's initiatives in the area of transparency and provision of information.
Ta zahteva prispeva k pobudam Agencije glede preglednosti in posredovanja informacij.
Once implemented, the advice given will facilitate certain aspects of the conduct of clinical trials and may potentially contribute to earlier availability of novel medicines.
Ko se bo začel postopek izvajati, bodo nasveti olajšali nekatere vidike kliničnega preskušanja in morda prispevali k zgodnejši dostopnosti novih zdravil.
In addition to their participation in the work of certain EMEA committees and working parties, patients' representatives will continue to be involved in the review of documents developed for patients and the general public.
Predstavniki bolnikov bodo poleg sodelovanja pri delu določenih odborov in delovnih skupin EMEA še naprej vključeni v pregled dokumentov, pripravljenih za bolnike in splošno javnost.
This includes implementation across all the committees of the electronic system for managing meeting documents and wider implementation of video- and teleconferencing facilities.
To vključuje uporabo elektronskega sistema za upravljanje z gradivi za seje v vseh odborih ter širšo uporabo video in telekonferenčne opreme.
Implement the new legislation on advanced-therapy medicinal products and establish a new Committee for Advanced Therapies.
Izvajati novo zakonodajo o zdravilih za napredne terapije in ustanoviti nov odbor za napredne terapije;
The office aims to facilitate communication with SMEs through dedicated personnel within the Agency who will respond to practical or procedural enquiries, monitor applications, and organise workshops and training sessions for SMEs.
Namen urada je olajšati komunikacijo z malimi in srednje velikimi podjetji s specializiranim osebjem na Agenciji, ki bo odgovarjalo na praktične ali postopkovne poizvedbe, spremljalo vloge ter organiziralo delavnice in usposabljanja za mala in srednje velika podjetja.
Integrated quality management and audit
Integrirano upravljanje kakovosti in revizija
Care will be taken to ensure that a new system, if introduced, will promote cooperation and exchange of resources in the network.
Če bo nov sistem vpeljan, bo posebna pozornost namenjena temu, da bo ta sistem spodbujal sodelovanje in izmenjavo sredstev znotraj mreže.
The Agency's focus in 2008 in the area of variations will be on the establishment of a new procedure for variations of generic and similar biological medicinal products in order to allow the implementation of changes to the product information subsequent to changes to the reference product, hence ensuring consistency.
Agencija se bo na področju sprememb v letu 2008 osredotočila na uvajanje novega postopka za spremembe generičnih in biološko podobnih zdravil, da bi omogočila izvajanje sprememb v informacijah o zdravilih po spremembi referenčnih zdravil in s tem zagotovila skladnost.
Based on the initial experience during 2007, there is a clear trend for an increase in referral procedures in the context of the suspension or revocation of marketing authorisations as a result of the evaluation of pharmacovigilance data.
Na podlagi začetnih izkušenj iz leta 2007 je mogoče videti jasne smernice rasti števila napotitvenih postopkov v okviru umika ali preklica dovoljenja za promet kot posledice ovrednotenja podatkov o farmakovigilanci.
The Agency also expects to receive some referrals relating to harmonisation within the Community of the conditions of authorisation of already authorised products, to Community interests, and to other safety-related issues.
Agencija pričakuje, da bo prejela tudi nekaj napotitev v zvezi z usklajevanjem pogojev dovoljenj za že odobrena zdravila znotraj Skupnosti ter v zvezi z interesi Skupnosti in drugimi vprašanji, povezanimi z varnostjo.
The EMEA plans to set up a new procedure for advice on biomarkers.
Agencija EMEA namerava uvesti nov postopek za svetovanje o bioloških označevalcih.
The legislation requires the Agency to provide access to EudraVigilance data by its stakeholders.
Zakonodaja zahteva, da Agencija svojim zainteresiranim stranem omogoči dostop do podatkov sistema EudraVigilance.
Sampling and testing
2.7 Vzorčenje in preskušanje
Another large area of activity will relate to the provision of support to small and medium-sized enterprises (SMEs) developing medicines for human and veterinary use.
Nadaljnje obsežno področje dejavnosti bo zadevalo zagotavljanje podpore malim in srednje velikim podjetjem, ki razvijajo zdravila za uporabo v humani in veterinarski medicini.
The Agency will develop the next phase of the EudraPharm database (EU telematics projects), introducing multilingual navigation and content, advanced search capability and better-structured product information.
Agencija bo razvila naslednjo fazo podatkovne baze EudraPharm (EU telematski projekt) in predstavila večjezikovno navigacijo in vsebino, napredne možnosti iskanja ter bolje zasnovane informacije o izdelkih.
Among these, the Agency will participate in discussions regarding Ayurvedic and traditional Chinese medicines.
Tako bo Agencija sodelovala v razpravah o ajurvedskih in tradicionalnih kitajskih zdravilih.
In order to review and improve the process for producing Community herbal monographs and entries to the aforementioned list, the EMEA will explore the possibility of involving academia alongside the resources made available by the European medicines network.
Da bi EMEA pregledala in izboljšala postopek oblikovanja monografij rastlin Skupnosti in vnosov v omenjeni seznam, bo preučila možnosti vključevanja akademikov poleg virov, ki jih omogoča Evropska mreža zdravil.
The graph below demonstrates that this activity has experienced strong growth over the years.
V spodnjem grafu je prikazano, da se je v preteklih letih ta dejavnost zelo povečala.
The number of extensions has remained low over recent years, despite the initiatives taken by the CVMP to facilitate the authorisation of products for minor uses and minor species.
Število razširitev je v zadnjih letih ostalo majhno, kljub pobudam, ki jih je dal CVMP za lažje izdajanje dovoljenj za promet z zdravili za manj pomembne uporabe in vrste.
In order to address the pressures on scientific resources, the Agency and its partners will work to ensure long-term availability of top-quality scientific expertise (through establishment of an inventory of available expertise, and through various training and competence-development activities) and to develop further the common workload-planning practices.
V odgovor na pritiske na znanstvene vire bodo Agencija in njeni partnerji delali na tem, da zagotovijo dolgoročno dostopnost najkakovostnejšega znanstvenega strokovnega znanja (z uvedbo popisa obstoječih strokovnih znanj in z različnimi usposabljanji ter dejavnostmi za razvijanje znanja) ter nadalje razvijejo splošno prakso načrtovanja delovne obremenitve.
GMP inspection numbers will continue their steep growth, with a further 30% increase expected compared to 2007.
Število inšpekcijskih pregledov dobre proizvodne prakse (GMP) se bo še naprej strmo povečevalo, v primerjavi z letom 2007 pričakujemo nadaljnjo 30-odstotno rast.
The EMEA/CHMP working group with healthcare professionals' organisations will finalise recommendations that will improve these interactions.
Delovna skupina EMEA/CHMP bo s sodelovanjem z organizacijami zdravstvenih delavcev dokončno oblikovala predloge, ki bodo te stike še izboljšali.
Focus on the international issues related to inspections, in particular with regard to avoiding where possible the duplication of inspections internationally; ensure consistency of standards for manufacture of active substances and finished products, and consistency of ethical standards for the conduct of clinical trials outside the EU.
Osredotočiti se na mednarodne zadeve glede inšpekcijskih pregledov, zlasti glede preprečevanja podvojevanja inšpekcijskih pregledov na mednarodni ravni, kadar je to mogoče; zagotoviti skladnost standardov za izdelavo zdravilnih učinkovin in končnih izdelkov ter skladnost etičnih standardov za izvajanje kliničnih preskušanj zunaj EU;
The strategy helps the partners to optimise the efficiency in the EU regulatory network for veterinary pharmacovigilance of all medicinal products authorised in the Community.
Omenjena strategija omogoča partnerjem racionaliziranje učinkovitosti v regulativni mreži EU za farmakovigilanco za vsa zdravila z dovoljenjem v Skupnosti.