natgillin/translations-raw huggingface dataset:
This includes ensuring best practice in document and records management; verifying the quality of all published documents; providing staff with the most effective access to internal and external information needed to perform their professional duties; verifying the accuracy of translations; and organising and supporting Agency exhibitions.
To vključuje zagotavljanje najboljše prakse s področja vodenja dokumentacije in poročil, preverjanje vseh objavljenih dokumentov, zagotavljanje najučinkovitejšega dostopa do notranjih in zunanjih informacij osebju, ki jih potrebuje za opravljanje svojih poklicnih nalog; preverjanje točnosti prevodov ter organiziranje in podporo razstav Agencije.
These readability requirements will also be applicable to package inserts.
Te zahteve za razumljivost se bodo uporabljale tudi pri navodilih za uporabo.
Dr Pittner was also a CPMP delegate from 1995 to 1997 and from 2001 until April 2004; since May 2004 Dr Pittner has been a CHMP delegate.
Poleg tega je bil dr. Pittner delegat CPMP od 1995 do 1997 ter od 2001 do aprila 2004, od maja 2004 pa je delegat CHMP.
The Agency is preparing for its new responsibility for the provision of secretarial support to the newly created coordination group, established according to the new legislation in 2005.
Agencija se pripravlja na nove odgovornosti pri zagotavljanju pisarniške podpore na novo oblikovani skupini za usklajevanje, ki bo leta 2005 ustanovljena v skladu z novo zakonodajo.
Establish a scientific memory database for centrally authorised medicinal products to underpin the quality and consistency of scientific assessment within the CVMP, thereby reinforcing the risk/benefit analysis prior to authorisation of new veterinary medicines
Vzpostavitev zbirke podatkov znanstvenega pomnilnika za centralno odobrena zdravila, da se podpre kakovost in doslednost znanstvenega vrednotenja v okviru CVMP, s čimer se okrepi analiza med tveganji in koristmi pred izdajo dovoljenja za nova veterinarska zdravila.
The objective for 2005 in the area of document management and publishing is to support the Agency's full compliance with all regulatory and quality requirements in the areas of records and document management and to ensure the application of best practice.
Cilj za leto 2005 na področju vodenja in objavljanja dokumentacije je podpreti Agencijo pri njenem polnem upoštevanju vseh regulativnih in kakovostnih zahtev na področju vodenja dokumentacije in poročil ter zagotoviti uporabo najboljše prakse.
To provide timely and quality opinions arising from arbitration and referral procedures
Pravočasno zagotavljati kakovostna mnenja, ki izhajajo iz arbitražnih postopkov in postopkov predložitve.
Operation, maintenance, support and further development of five EU telematics projects: EudraNet, EudraVigilance, EudraCT, EuroPharm and e-Submission
Izvajanje, vzdrževanje, podpiranje in nadaljnji razvoj petih telematskih projektov EU: EudraNet, EudraVigilance, EudraCT, EuroPharm in elektronsko pošiljanje.
In 1990 he joined the pharmacy directorate of the French Ministry of Health and in 1993 joined the French Medicines Agency as CPMP rapporteur, was head of unit for European procedures and from January 1995 was a French CPMP delegate.
Leta 1990 se je pridružil Direktoratu za farmacijo pri francoskem Ministrstvu za zdravje, leta 1993 pa francoski Agenciji za zdravila kot poročevalec CPMP, vodja Enote za evropske postopke in od januarja 1995 kot francoski delegat CPMP.
Update the EMEA guidance to parallel distributors taking into account the experience gathered
Posodabljati smernice EMEA za vzporedne distributerje na podlagi pridobljenih izkušenj.
Provide support to all 25 Member States to optimise compliance with Community requirements in relation to GMP and GCP and Pharmacovigilance, and cooperate on planning initiatives to secure the allocation of sufficient resources for the conduct of inspections throughout the EU and in third countries
Zagotavljanje podpore vsem 25 državam članicam za čim boljšo uskladitev z zahtevami Skupnosti za dobro proizvodno prakso in dobro klinično prakso ter farmakovigilanco in za sodelovanje pri načrtovanju pobud, da se zagotovi dodelitev zadostnih virov za izvajanje inšpekcijskih pregledov v vsej EU in tretjih državah.
Develop tools for the provision of information to patients and healthcare professionals, and strengthen interaction with the Agency's stakeholders
Razvoj orodij za obveščanje bolnikov in zdravstvenih strokovnjakov ter krepitev povezanosti z zainteresiranimi stranmi Agencije.
The Executive Director is responsible for setting up administrative structures and procedures in consultation with scientific committees allowing the development of advice for undertakings, particularly regarding new therapies, on the conduct of the various tests and trials necessary to demonstrate the quality, safety and efficacy of medicinal products.
Izvršni direktor je pristojen, da po posvetovanju z znanstvenimi odbori vzpostavi upravno organiziranost in postopke, ki bodo omogočali razvoj svetovanja za podjetja, zlasti glede novih terapij, o izvajanju različnih preizkušanj in testiranj, potrebnih, da se dokaže kakovost, varnost in učinkovitost zdravil.
Similarly, the EMEA coordinates pharmacovigilance inspections requested by the scientific committees and inspections of blood establishments within the Plasma Master File (PMF) certification framework.
Podobno EMEA usklajuje inšpekcijske preglede farmakovigilance, ki jih zahtevajo znanstveni odbori, in inšpekcijske preglede zavodov za kri v okviru certificiranja glavnega dosjeja plazme (PMF).
Proposal to the Management Board to approve an extension to the provision of free scientific advice to include products intended for use in minor uses and minor species that meet agreed criteria
Priprava predloga upravnemu odboru za potrditev razširitve brezplačnega znanstvenega svetovanja, da se vključijo izdelki, namenjeni manjšim uporabam in manj pomembnim vrstam, ki izpolnjujejo dogovorjena merila.
The EMEA will support the development of biosimilar medicinal products through the activities of the Comparability Working Party and the Biotechnology Working Party with the development of specific product guidelines
EMEA bo podpirala razvoj biološko podobnih zdravil v okviru dejavnosti Delovne skupine za primerljivost in Delovne skupine za biotehnologijo s pripravo smernic za posebna zdravila.
Trends:
Trendi:
Management and monitoring of EudraVigilance Veterinary for its effective implementation of methodology for data analysis supported by automated signal detection
Upravljanje in spremljanje EudraVigilance za veterino zaradi njenega učinkovitega izvajanja metodologije za analiziranje podatkov, podprte s samodejnim odkrivanjem signalov.
Executive master of business administration from the Centre de Perfectionnement aux Affaires at HEC-CPA, in Jouy-en-Josas, France, in 2000.
Leta 2000 magisterij iz poslovne administracije na Centre de Perfectionnement aux Affaires na HEC-CPA v Jouy-en-Josas v Franciji.
The area of infrastructure services at the EMEA covers a wide range of services, including security, telecommunications, reception, switchboard, archiving, mail, reprographics, technical assistance to meeting rooms, confidential waste, health & safety, fire and emergency plans, business continuity planning, inventory, office equipment and supplies, maintenance, refurbishment and fitting out, and management of the catering facilities.
Področje infrastrukturnih storitev v EMEA zajema širok razpon storitev, vključno z varnostjo, telekomunikacijami, sprejemanjem, posredovalnim mestom, arhiviranjem, pošto, reprografiko, tehnično pomočjo za sejne sobe, posebnimi odpadki, zdravjem in varnostjo, načrtom gašenja in ukrepov v sili, načrtovanjem zveznosti poslovanja, zalogami, pisarniško opremo in materialom, vzdrževanjem, obnavljanjem in opremljanjem ter upravljanjem zmogljivosti za pripravo in dostavo hrane.
Clarification of applicability to welldefined active substances
Pojasni se uporabnost za točno določene aktivne snovi
Certificat de Hautes Etudes Européennes (economics) from the College of Europe, Bruges.
Certificat de Hautes Etudes Européennes (ekonomija) Evropskega kolidža v Brugesu.
This harmonisation work will include the development of GMP guidelines on products used as gene and cell therapies.
To usklajevalno delo bo vključevalo razvoj smernic dobre proizvodne prakse za izdelke, ki se uporabljajo za gensko in celično zdravljenje.
Preparation of communication strategy, including annual report on pharmacovigilance for centralised products, for release to the Commission and Member States
Priprava strategije sporočanja, vključno z letnim poročilom o farmakovigilanci za centralizirane izdelke, zato da se sporoči Komisiji in državam članicam.
To handle effectively and in a timely manner adverse reaction reports and PSURs for centralised products, in conjunction with rapporteur and co-rapporteur, for review by the CVMP, and to communicate information to the Commission, the Member States and the general public
Učinkovito in pravočasno obravnavati poročila o neželenih učinkih in PSUR-je za centralizirane izdelke v povezavi s poročevalcem in soporočevalcem, da jih pregleda CVMP in da se informacije sporočijo Komisiji, državam članicam in javnosti.
Endorse the EMEA transparency and communication strategies and related policies
Odobril strategiji EMEA o preglednosti in obveščanju ter s tem povezane politike.
To implement the EU review of pharmaceutical legislation, in particular as regards the reinforced coordinating role for the EMEA in the area of pharmacovigilance and provision of information on safety aspects
V EU izvesti pregled farmacevtske zakonodaje, zlasti glede okrepljene usklajevalne vloge EMEA na področju farmakovigilance in zagotavljanja informacij o varnostnih vidikih.
The consequences of the new pharmaceutical legislation:
Posledice nove farmacevtske zakonodaje:
The new legislation, in addition, introduces requirements to provide information on withdrawals of applications by applicants prior to opinion and on refusals of marketing authorisations, to prepare summaries of European public assessment reports in a manner that is understandable to the public, and to distribute appropriate pharmacovigilance information.
Nova zakonodaja uvaja tudi zahteve za zagotavljanje informacij o umiku vlog s strani vlagateljev pred izdajo mnenja ter o zavrnitvah izdaje dovoljenja za promet, da se pripravi povzetke evropskih javnih poročil o oceni na način, ki je razumljiv javnosti, in širi ustrezne informacije o farmakovigilanci.
Such increase will be influenced by the revised classification of variations and the status of implementation of new Community legislation on certification of plasma master files and vaccine antigen master files
Na takšno povečanje bodo vplivali revidirana razvrstitev sprememb in status izvajanja nove zakonodaje Skupnosti o certificiranju glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov.
The biggest impact on future workload estimated for 2005 will be the implementation and management of new invoicing and financial accounting systems.
Predvidoma bo na prihodnjo delovno obremenitev v letu 2005 najbolj vplivalo izvajanje in upravljanje novih računovodskih sistemov za izdajanje računov in finance.
She was appointed deputy head of sector for safety and efficacy of medicines in January 2001, and since then has been in charge of EMEA activities in the field of innovation, emerging therapies & technologies, and the coordination of scientific training.
Januarja 2001 je bila imenovana za vršilko dolžnosti vodje Sektorja za varnost in učinkovitost zdravil in od takrat naprej je odgovorna za dejavnosti EMEA na področju inovacij, novih oblik zdravljenja in tehnologij ter za usklajevanje znanstvenega usposabljanja.
These projects have been agreed as being EudraNet, EudraVigilance, the EuroPharm database, electronic submissions, implementation of the Clinical Trials Directive and the good manufacturing practice database.
Dogovorjeno je bilo, da so to projekti EudraNet, EudraVigilance, zbirka podatkov EuroPharm, elektronsko pošiljanje, izvajanje direktive o kliničnem preizkušanju in zbirka podatkov o dobri proizvodni praksi.
Development and implementation of methodologies and tools for data analysis supporting signal detection; provision of adequate training to all users of the EudraVigilance system, including the new SUSAR component
Razvijanje in izvajanje metodologij in orodij za analiziranje podatkov v podporo odkrivanju signalov, zagotavljanje ustreznega usposabljanja za vse uporabnike sistema EudraVigilance, vključno z novim elementom SUSAR.
He was later appointed to the Pharmaceutical Inspectorate (Ministry of Social Affairs and Public Health) in Brussels as a chief inspector, acting as the secretary of the Belgian Medicines Commission.
Nato je bil dodeljen farmacevtskemu inšpektoratu (Ministrstvo za socialne zadeve in javno zdravje) v Bruslju kot glavni inšpektor, ki je deloval kot sekretar Belgijske komisije za zdravila.
Establish scientific advisory groups, in particular for mandatory therapeutic fields of the centralised procedure
Ustanovitev znanstveno svetovalnih skupin, zlasti za obvezna terapevtska področja centraliziranega postopka.
She worked at the Danish Environment Ministry from 1979 to 1985, first as a consultant and later as an official, before moving to the City of Copenhagen Environment Protection Agency until 1988.
Od leta 1979 do 1985 je delala na danskem Ministrstvu za okolje, najprej kot svetovalka in kasneje kot njegova uslužbenka, preden se je do leta 1988 preselila v Kopenhagen na Agencijo za varstvo okolja.
4.2 Implementation of the Clinical Trials Directive
4.2 Izvajanje direktive o kliničnem preizkušanju
Implementation of the early information function and cooperation with the European Directorate for the Quality of Medicines on the sampling and testing programme for centrally authorised products
Izvajanje naloge zgodnjega obveščanja in sodelovanje z Evropskim direktoratom za kakovost zdravil pri programu vzorčenja in preizkušanja centralno odobrenih zdravil.
In addition, EU regulators will have instant access to information about ongoing clinical trials in Europe and information about the status of GMP certificates and manufacturing authorisations.
Poleg tega bodo imeli zakonodajalci EU takojšen dostop do informacij o kliničnih preizkušanjih, ki potekajo v Evropi, ter informacij o statusu potrdil o dobri proizvodni praksi in dovoljenj za izdelavo.
Scientific advice is a priority area for the EMEA and is provided on any aspect of research and development relating to quality, safety or efficacy of medicinal products.
Znanstveno svetovanje je za EMEA prednostno področje in se zagotavlja za vse vidike raziskav in razvoja, povezane s kakovostjo, varnostjo ali učinkovitostjo zdravil.
Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to human medicines
Uvedba prve faze izvedbenega načrta za usmeritveni načrt EMEA do 2010 za zdravila za ljudi.
Development and implementation of document management, records management and mail registration policies will be undertaken in 2005.
Leto 2005 se bo začelo z razvojem in izvajanjem vodenja dokumentacije, vodenja poročil in politik registriranja pošte.
Career to date: Six years of clinical experience in UK hospitals, five years as director of pharmacovigilance and regulatory affairs at Astra Pharmaceuticals in the UK and a total of seven years at the UK Medicines Control Agency.
Dosedanja poklicna pot: Šest let kliničnih izkušenj v angleških bolnišnicah, pet let kot direktor za farmakovigilanco in regulativne zadeve pri Astra Pharmaceuticals v Združenem kraljestvu in skupaj sedem let pri angleški Agenciji za nadzorovanje zdravil.
To provide timely and understandable product information to users and interested parties
Zagotavljati pravočasne in razumljive informacije o izdelkih uporabnikom in zainteresiranim stranem.
Applications are expected in the context of cooperation with the WHO where the EMEA may be asked to provide an opinion on medicinal products intended exclusively for markets outside the Community.
Pričakujejo se vloge v okviru sodelovanja s Svetovno znanstveno organizacijo, kjer se EMEA lahko zaprosi za mnenje o zdravilih, namenjenih izključno trgom zunaj Skupnosti.
9 In 2005 the Agency will focus on preparation for the full entry into force of the new legislation in the last part of the year
Leta 2005 se bo Agencija usmerila k pripravi na začetek popolne veljavnosti nove zakonodaje v zadnji polovici leta.
She was appointed integrated quality management adviser in January 2004.
Januarja 2004 je bila imenovana za svetovalko za integrirano upravljanje kakovosti.
Establish procedures and a dedicated structure to provide support for small and medium-sized enterprises
Vzpostavitev postopkov in namenske organiziranosti za zagotavljanje podpore majhnim in srednje velikim podjetjem.
Enhancement of the activity-based budgeting system
Povečanje proračunskega sistema, utemeljenega na dejavnostih.
To implement the new legislative requirements in the area of scientific advice
Izvajati nove zakonske zahteve na področju znanstvenega svetovanja.
The operation of the Mutual Recognition Facilitation Group (MRFG) will continue to be supported by the EMEA at its monthly meetings.
Recognition facilitation Group, MRFG) na njenih mesečnih zasedanjih.
To prepare for provision of incentives to small and medium-sized enterprises
Pripraviti se na zagotavljanje spodbud za majhna in srednje velika podjetja.
Implementation of transparency initiatives in the designation procedure in liaison with patients' organisations
Izvajanje pobud za preglednost postopka za določitev v povezavi z organizacijami bolnikov.
Activities in relation to plasma and vaccine antigen master files and to medical devices containing biotechnology and blood-derived medicinal products will develop further
Dejavnosti, povezane z glavnima dosjejema plazme in virusnih antigenov ter medicinskimi pripomočki, ki vsebujejo biotehnološka zdravila in zdravila iz krvi, se bodo razvijale še naprej.
Develop procedures for more systematic and repeated use of scientific advice and protocol assistance during the development of products, particularly for rare diseases and new therapies
Razvoj postopkov za bolj sistematično in večkratno uporabo znanstvenega svetovanja in pomoč pri protokolu med razvojem zdravil, zlasti za redke bolezni in nove terapije.
Delivery of first production versions of the EuroPharm medicines information system, the EudraVigilance data warehouse and pharmacointelligence tools, and the product information management system (PIM), plus completion of phase 2a of the European Clinical Trials registration database system (EudraCT).
Dostaviti prve proizvodne različice informativnega sistema EuroPharm za zdravila, podatkovnega skladišča EudraVigilance in orodij farmakointeligence in sistema upravljanja informacij o izdelkih, ter zaključiti fazo 2a sistema zbirke podatkov o registraciji evropskih kliničnih preizkušanj (EudraCT).
Interaction with the US Food and Drug Administration will be further developed through enhanced cooperation in the context of the confidentiality arrangements, e.g. in the fields of orphan medicinal products, scientific advice requests, new applications, pharmacovigilance, development of guidelines and the exchange of trainees and experts
Vzajemno delovanje z Upravo za hrano in zdravila ZDA se bo še naprej razvijalo z okrepljenim sodelovanjem v okviru dogovorov o zaupnosti, npr. na področju zdravil sirot, zahtevkov za znanstveno svetovanje, novih vlog, farmakovigilance, pripravi smernic ter izmenjavi udeležencev usposabljanja in strokovnjakov.
Line extensions are likely to increase, with eight applications foreseen for 2005.
Število vlog za podaljšanje rokov bo verjetno naraščalo, za leto 2005 se predvideva osem vlog.
He currently holds the positions of director and professor at the Federal Institute for Drugs and Medical Devices.
Trenutno je direktor in profesor na Zveznem inštitutu za zdravila in medicinske pripomočke.
2.12 Coordination group
2.12 Skupina za usklajevanje
She was editor for the ICH GCP guideline from February 1992 until its adoption in May 1996.
Bila je urednica smernice ICH za dobro klinično prakso od februarja 1992 do njenega sprejetja maja 1996.
Invitation by the CVMP, its working parties or scientific advisory groups to interested parties on specific technical/scientific issues
povabilo CVMP, njegovih delovnih ali znanstveno svetovalnih skupin zainteresiranih strani k skupnemu reševanju posebnih tehničnih/znanstvenih vprašanj;
This includes the organisation of meetings, travel and hotel arrangements for delegates and hosts, reception of visitors, the reimbursement of delegates' expenses, and the payment of suppliers' invoices, as well as the preparation and follow-up of meeting room facilities.
Sem spadajo organiziranje sestankov in potovanj ter hotelske nastanitve delegatov in gostov, sprejem obiskovalcev, vračilo stroškov delegatom, plačilo računov dobaviteljev ter priprava in spremljanje naprav v sejnih sobah.
The trend in the number of generic applications which began in 2004 is anticipated to continue in
Trend glede števila generičnih vlog, ki se je začel leta 2004, se bo leta 2005 predvidoma nadaljeval.
To improve the availability of information in relation to Community referral procedures
Izboljšati dostopnost informacij o postopkih za predložitev Skupnosti.
Establish new procedures necessary to implement the new pharmaceutical legislation (conditional approval, accelerated assessment, compassionate use, opinions for medicinal products not marketed in the EU (in collaboration with the WHO), scientific advisory groups, extended scope of the centralised procedure, etc.)
Vzpostavitev novih postopkov, potrebnih za izvajanje nove farmacevtske zakonodaje (pogojna odobritev, pospešena ocena, sočutna uporaba, mnenja o zdravilih, ki se v EU ne tržijo (v sodelovanju s Svetovno zdravstveno organizacijo), znanstveno svetovalne skupine, razširjeno področje uporabe centraliziranega postopka itd.).
Monitor use of resources by the Agency as well as implementation of EU telematics and other information technology initiatives
Spremljal, kako Agencija uporablja vire ter izvaja telematske in druge pobude EU na področju informacijske tehnologije.
The working party on Environmental Risk Assessment will advise the CVMP on implementation of specific requirements in the new legislation concerning any risk of undesirable effects on the environment resulting from the use of veterinary medicinal products.
Delovna skupina za oceno tveganja za okolje bo CVMP seznanila z izvajanjem posebnih zahtev iz nove zakonodaje, ki se nanašajo na kakršno koli nevarnost neželenih učinkov na okolje, ki bi bila
Need for comments in the light of experience to be considered in 2005
Potrebne so pripombe glede na izkušnje, ki se preučijo leta 2005
Service quality will be measured by a number of performance indicators, such as systems availability, helpdesk response times and problem resolution times
Kakovost storitve se bo merila s številnimi kazalniki uspešnosti, kot so dostopnost sistemov, odzivni čas pomoči za uporabnike in porabljeni čas za rešitev težave.
Continuous improvement of the designation procedure
Stalno izboljševanje postopka za določitev.
The activities in the administration area relate to a number of functions, which include managing revenue, expenditure and accounts according to existing rules and regulations, conducting recruitment procedures, and managing and administering staff and seconded personnel, as well as providing and running the necessary infrastructure services for effective functioning of the Agency.
Dejavnosti na področju upravljanja se nanašajo na številne naloge, ki vključujejo vodenje prihodkov in odhodkov ter računov v skladu z veljavnimi pravili in predpisi, vodenje zaposlitvenih postopkov, vodenje in upravljanje zaposlenega in začasno dodeljenega osebja ter zagotavljanje in vodenje potrebnih infrastrukturnih storitev za učinkovito delovanje Agencije.
3.7 Regulatory activities
3.7 Regulativne dejavnosti