FrancophonIA/ELRC3.0 huggingface dataset:
English: Implementation of an action plan for revision of the sampling and testing programme for centrally authorised products, in cooperation with EDQM, to streamline activities and focus resources taking a risk-based approach.
Slovenian: Izvajanje akcijskega načrta za revizijo programa vzorčenja in preizkušanja centralno odobrenih izdelkov v sodelovanju z EDQM, da se s pristopom, ki temelji na nevarnosti, poenostavijo dejavnosti in usmerijo viri.
English: Career to date: Miss Leivers worked for the Milk Marketing Board for England and Wales (MMB) as a liaison chemist for five years, prior to being appointed assistant director of the MMB/Federation of Agricultural Cooperatives office in Brussels, representing all sectors of agricultural cooperation to the European institutions.
Slovenian: Dosedanja poklicna pot: Gospodična Leiversova je pet let delala za Odbor za trženje mleka v Angliji in Walesu (MMB) kot kemičarka za zvezo, preden je bila imenovana za pomočnico direktorja MMB/ Urada Zveze kmetijskih zadrug v Bruslju, ki zastopa vse sektorje kmetijskega sodelovanja v evropskih institucijah.
English: Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2
Slovenian: Možna revizija po stabiliziranju pobud ICH za Q8 in Q9, v fazi 2
English: 3.9 Coordination group
Slovenian: 3.9 Skupina za usklajevanje
English: From 1974 to 1985, he was an audit manager in Spain with Ernst and Young and from 1985 to 1995 he was financial controller at Johnson Wax Española.
Slovenian: Od 1974 do 1985 je bil v Španiji vodja revizorjev pri Ernst and Young, od 1985 do 1995 pa finančni nadzornik pri Johnson Wax Española.
English: The EMEA checks compliance of such products distributed in parallel with the appropriate terms of the Community marketing authorisation.
Slovenian: EMEA preverja skladnost takšnih izdelkov, ki so v vzporedni distribuciji z ustreznimi pogoji Skupnosti za izdajo dovoljenja za promet z zdravilom.
English: This encompasses making available topquality scientific expertise and a robust quality assurance system
Slovenian: To vključuje razpoložljivost vrhunskega znanstvenega strokovnega znanja in izkušenj ter stabilen sistem zagotavljanja kakovosti.
English: In 1986 he joined the Austrian drug regulatory authority; since 2003 he has been deputy head of the drug authorisation department of the Austrian Ministry of Health and Women.
Slovenian: Leta 1986 se je priključil avstrijskemu regulativnemu organu za zdravila, od leta 2003 je namestnik vodje oddelka za izdajo dovoljenj za promet z zdravilom pri avstrijskem Ministrstvu za zdravje in ženske.
English: New legislation in the fields of paediatric medicines and tissue engineering is also under development, and the Agency contributes to and monitors its development in anticipation of its future adoption.
Slovenian: Pripravlja se tudi nova zakonodaja na področju zdravil za otroke in inženiringa tkiv, pri čemer Agencija sodeluje, spremlja njen razvoj in pričakuje njeno sprejetje v prihodnosti.
English: The target is to provide 95 % of responses within the timeline
Slovenian: Cilj je v roku zagotoviti 95 % odgovorov.
English: He was reelected chairman of the Committee on Orphan Medicinal Products in May 2003.
Slovenian: Maja 2003 je bil ponovno izvoljen za predsednika Odbora za zdravila sirote.
English: Development of meeting broadcasting and wider implementation of video- and teleconferencing to facilitate communication and reduce the number of reimbursed meetings
Slovenian: Razvijati prenašanje sestankov in širše izvajati video- in telekonference, da se olajša komuniciranje in zmanjša število sestankov s povrnjenimi stroški.
English: Management and organisation of the CVMP
Slovenian: Upravljanje in organizacija CVMP
English: Conduct joint planning to manage the resource implications arising from the new pharmaceutical legislation, the advent of new technologies and the increase in the number of scientific resource providers
Slovenian: Izvajanje skupnega načrtovanja za obvladovanje potreb po virih, ki izhajajo iz nove farmacevtske zakonodaje, pojava novih tehnologij in povečanega števila ponudnikov strokovnega znanja in izkušenj.
English: 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.
Slovenian: 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.
English: These readability requirements will also be applicable to package inserts.
Slovenian: Te zahteve za razumljivost se bodo uporabljale tudi pri navodilih za uporabo.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: To provide timely and quality opinions arising from arbitration and referral procedures
Slovenian: Pravočasno zagotavljati kakovostna mnenja, ki izhajajo iz arbitražnih postopkov in postopkov predložitve.
English: Operation, maintenance, support and further development of five EU telematics projects: EudraNet, EudraVigilance, EudraCT, EuroPharm and e-Submission
Slovenian: Izvajanje, vzdrževanje, podpiranje in nadaljnji razvoj petih telematskih projektov EU: EudraNet, EudraVigilance, EudraCT, EuroPharm in elektronsko pošiljanje.
English: 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.
Slovenian: 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.
English: Concurrent administration of IVMPs in view of determining day X to be 14 days and consequent revision of the SPC guideline for immunologicals
Slovenian: Concurrent administration of IVMPs in view of determining day X to be 14
English: Update the EMEA guidance to parallel distributors taking into account the experience gathered
Slovenian: Posodabljati smernice EMEA za vzporedne distributerje na podlagi pridobljenih izkušenj.
English: 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
Slovenian: 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.
English: Develop tools for the provision of information to patients and healthcare professionals, and strengthen interaction with the Agency's stakeholders
Slovenian: Razvoj orodij za obveščanje bolnikov in zdravstvenih strokovnjakov ter krepitev povezanosti z zainteresiranimi stranmi Agencije.
English: 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.
Slovenian: 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.
English: Similarly, the EMEA coordinates pharmacovigilance inspections requested by the scientific committees and inspections of blood establishments within the Plasma Master File (PMF) certification framework.
Slovenian: Podobno EMEA usklajuje inšpekcijske preglede farmakovigilance, ki jih zahtevajo znanstveni odbori, in inšpekcijske preglede zavodov za kri v okviru certificiranja glavnega dosjeja plazme (PMF).
English: 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
Slovenian: 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.
English: 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
Slovenian: 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.
English: Trends:
Slovenian: Trendi:
English: Management and monitoring of EudraVigilance Veterinary for its effective implementation of methodology for data analysis supported by automated signal detection
Slovenian: Upravljanje in spremljanje EudraVigilance za veterino zaradi njenega učinkovitega izvajanja metodologije za analiziranje podatkov, podprte s samodejnim odkrivanjem signalov.
English: Executive master of business administration from the Centre de Perfectionnement aux Affaires at HEC-CPA, in Jouy-en-Josas, France, in 2000.
Slovenian: Leta 2000 magisterij iz poslovne administracije na Centre de Perfectionnement aux Affaires na HEC-CPA v Jouy-en-Josas v Franciji.
English: 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.
Slovenian: 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.
English: Clarification of applicability to welldefined active substances
Slovenian: Pojasni se uporabnost za točno določene aktivne snovi
English: Certificat de Hautes Etudes Européennes (economics) from the College of Europe, Bruges.
Slovenian: Certificat de Hautes Etudes Européennes (ekonomija) Evropskega kolidža v Brugesu.
English: This harmonisation work will include the development of GMP guidelines on products used as gene and cell therapies.
Slovenian: To usklajevalno delo bo vključevalo razvoj smernic dobre proizvodne prakse za izdelke, ki se uporabljajo za gensko in celično zdravljenje.
English: Preparation of communication strategy, including annual report on pharmacovigilance for centralised products, for release to the Commission and Member States
Slovenian: Priprava strategije sporočanja, vključno z letnim poročilom o farmakovigilanci za centralizirane izdelke, zato da se sporoči Komisiji in državam članicam.
English: 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
Slovenian: 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.
English: Endorse the EMEA transparency and communication strategies and related policies
Slovenian: Odobril strategiji EMEA o preglednosti in obveščanju ter s tem povezane politike.
English: 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
Slovenian: V EU izvesti pregled farmacevtske zakonodaje, zlasti glede okrepljene usklajevalne vloge EMEA na področju farmakovigilance in zagotavljanja informacij o varnostnih vidikih.
English: The consequences of the new pharmaceutical legislation:
Slovenian: Posledice nove farmacevtske zakonodaje:
English: 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.
Slovenian: 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.
English: 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
Slovenian: Na takšno povečanje bodo vplivali revidirana razvrstitev sprememb in status izvajanja nove zakonodaje Skupnosti o certificiranju glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov.
English: VICH Target animal safetypharmaceuticals
Slovenian: VICH Target animal safety pharmaceuticals
English: The biggest impact on future workload estimated for 2005 will be the implementation and management of new invoicing and financial accounting systems.
Slovenian: Predvidoma bo na prihodnjo delovno obremenitev v letu 2005 najbolj vplivalo izvajanje in upravljanje novih računovodskih sistemov za izdajanje računov in finance.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Establish scientific advisory groups, in particular for mandatory therapeutic fields of the centralised procedure
Slovenian: Ustanovitev znanstveno svetovalnih skupin, zlasti za obvezna terapevtska področja centraliziranega postopka.
English: The Paediatrics Working Party will be consulted at an early stage of the drafting of guidelines which are relevant to paediatric population developed by any CHMP working parties
Slovenian: The Paediatrics Working Party will be consulted at an early stage of the drafting of guidelines, which are relevant to paediatric population,
English: 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.
Slovenian: 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.
English: 10 March
Slovenian: 10. marec
English: 4.2 Implementation of the Clinical Trials Directive
Slovenian: 4.2 Izvajanje direktive o kliničnem preizkušanju
English: 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
Slovenian: Izvajanje naloge zgodnjega obveščanja in sodelovanje z Evropskim direktoratom za kakovost zdravil pri programu vzorčenja in preizkušanja centralno odobrenih zdravil.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Znanstveno svetovanje je za EMEA prednostno področje in se zagotavlja za vse vidike raziskav in razvoja, povezane s kakovostjo, varnostjo ali učinkovitostjo zdravil.
English: Undertake the initial phase of the implementation plan for the EMEA Road Map to 2010 in relation to human medicines
Slovenian: Uvedba prve faze izvedbenega načrta za usmeritveni načrt EMEA do 2010 za zdravila za ljudi.
English: Development and implementation of document management, records management and mail registration policies will be undertaken in 2005.
Slovenian: Leto 2005 se bo začelo z razvojem in izvajanjem vodenja dokumentacije, vodenja poročil in politik registriranja pošte.
English: 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.
Slovenian: 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.
English: To provide timely and understandable product information to users and interested parties
Slovenian: Zagotavljati pravočasne in razumljive informacije o izdelkih uporabnikom in zainteresiranim stranem.
English: 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.
Slovenian: Pričakujejo se vloge v okviru sodelovanja s Svetovno znanstveno organizacijo, kjer se EMEA lahko zaprosi za mnenje o zdravilih, namenjenih izključno trgom zunaj Skupnosti.
English: 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
Slovenian: Leta 2005 se bo Agencija usmerila k pripravi na začetek popolne veljavnosti nove zakonodaje v zadnji polovici leta.
English: She was appointed integrated quality management adviser in January 2004.
Slovenian: Januarja 2004 je bila imenovana za svetovalko za integrirano upravljanje kakovosti.
English: Establish procedures and a dedicated structure to provide support for small and medium-sized enterprises
Slovenian: Vzpostavitev postopkov in namenske organiziranosti za zagotavljanje podpore majhnim in srednje velikim podjetjem.
English: Enhancement of the activity-based budgeting system
Slovenian: Povečanje proračunskega sistema, utemeljenega na dejavnostih.
English: To implement the new legislative requirements in the area of scientific advice
Slovenian: Izvajati nove zakonske zahteve na področju znanstvenega svetovanja.
English: The operation of the Mutual Recognition Facilitation Group (MRFG) will continue to be supported by the EMEA at its monthly meetings.
Slovenian: Recognition facilitation Group, MRFG) na njenih mesečnih zasedanjih.
English: To prepare for provision of incentives to small and medium-sized enterprises
Slovenian: Pripraviti se na zagotavljanje spodbud za majhna in srednje velika podjetja.
English: Implementation of transparency initiatives in the designation procedure in liaison with patients' organisations
Slovenian: Izvajanje pobud za preglednost postopka za določitev v povezavi z organizacijami bolnikov.
English: Activities in relation to plasma and vaccine antigen master files and to medical devices containing biotechnology and blood-derived medicinal products will develop further
Slovenian: 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.