FrancophonIA/ELRC3.0 huggingface dataset:
English: The working parties and scientific advisory groups will support the CVMP with its provision of scientific input to the Commission and other Community institutions on request, with regard to animal health issues of concern to the Community.
Slovenian: Delovne in znanstveno svetovalne skupine bodo na zahtevo podprle CVMP pri njegovem zagotavljanju znanstvenih prispevkov Komisiji in drugim institucijam Skupnosti v zvezi z vprašanji zdravja živali, ki se nanašajo na Skupnost.
English: Implementation of the projects in 2005 will advance the Agency towards the goal of collecting all information about adverse drug reactions electronically and conducting automatic signal detection.
Slovenian: Izvajanje projektov v letu 2005 bo Agencijo približalo cilju, ki je elektronsko zbiranje vseh informacij o neželenih učinkih zdravil in izvajanje samodejnega odkrivanja signalov.
English: Need for revision of the current SPC guideline to give precise recommendation on prudent use and restrictions based on resistance data evolving from the SPC guideline
Slovenian: guideline to give precise recommendation on prudent use and restrictions based on resistance data evolving from the SPC guideline
English: Postgraduate studies include a PhD in socio-economic planning.
Slovenian: Podiplomski študij vključuje doktorat iz socialno-ekonomskega načrtovanja.
English: In 1987, she joined the German Environmental Agency as scientific administrator involved in risk assessment of industrial chemicals.
Slovenian: Leta 1987 se je pridružila nemški Agenciji za okolje kot znanstvena administratorka za oceno tveganja industrijskih kemikalij.
English: 9 Particular attention will be given to the implementation of provisions reinforcing the safety of medicines, accelerating the availability of medicines to EU patients and creating the right environment to stimulate research.
Slovenian: Posebna pozornost bo namenjena izvajanju določb, ki krepijo varnost zdravil, pospešujejo njihovo dostopnost bolnikom v EU in ustvarjajo ustrezno okolje za spodbujanje raziskovalnega dela.
English: He was appointed head of sector on 1 May 2002.
Slovenian: 1. maja 2002 je bil imenovan za vodjo Sektorja.
English: 2.10 Provision of information to healthcare professionals and patients
Slovenian: 2.10 Zagotavljanje informacij zdravstvenim strokovnjakom in bolnikom
English: ICH E14 the clinical evaluation of QT/QTs interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs
Slovenian: ICH E14 the clinical evaluation of QT/QTs interval prolongation and proarrhythmic potential for non antiarrhythmic drugs
English: The Agency will capitalise on its previously successful initiatives to maintain contacts and exchanges with interested parties, and aims to fulfil its obligations in accordance with new legislation to facilitate greater communication and dialogue on matters of common interest.
Slovenian: Agencija bo izkoristila svoje prvotne uspešne pobude za ohranitev stikov in izmenjav z zainteresiranimi stranmi ter namerava izpolniti svoje obveznosti v skladu z novo zakonodajo, da se omogoči boljše obveščanje in dialog o zadevah skupnega interesa.
English: In 1986 he joined the University of Bordeaux and was involved in various research areas in public health, including epidemiology, clinical research, pharmacovigilance, tropical and infectious diseases, health economy and health education.
Slovenian: Leta 1986 se je pridružil Univerzi v Bordeauxu in se začel ukvarjati z raziskovanjem javnega zdravja, vključno z epidemiologijo, kliničnimi raziskavami, farmakovigilanco, tropskimi in nalezljivimi boleznimi, zdravstveno ekonomijo in zdravstvenim izobraževanjem.
English: Monitor the assessment procedures for PMFs and VAMFs, and review the procedures on the basis of experience gained
Slovenian: Spremljati postopke presoje za PMF in VAMF ter preverjati postopke na podlagi pridobljenih izkušenj.
English: This includes making multilingual navigation possible and improving presentation, user friendliness and search tools
Slovenian: To vključuje možnost večjezične navigacije ter izboljšanje predstavitve, da bo bolj prijazna do uporabnikov, in iskalnih orodij.
English: The Agency will continue to work closely with the relevant European institutions in the field of veterinary medicinal products, particularly the European Commission, and will work to increase the level of collaboration already established with the European Food Safety Authority during the previous year.
Slovenian: Institucije EU in regulativne zadeve Agencija bo še naprej tesno sodelovala s pristojnimi evropskimi institucijami na področju veterinarskih zdravil, zlasti z Evropsko komisijo, in si prizadevala za zvišanje ravni sodelovanja, ki je bilo vzpostavljeno z Evropsko agencijo za varno hrano v preteklem letu.
English: Increase in number of requests for protocol assistance in line with an increase in the number of designated orphan medicinal products and on the basis of the recommendation to seek protocol assistance made by the COMP at the time of designation
Slovenian: Povečevanje števila zahtevkov za pomoč pri protokolu v skladu z večjim številom zdravil, določenih za zdravila sirote, in na podlagi priporočila, da naj se med postopkom določitve poišče pomoč pri protokolu, ki ga je dal COMP.
English: Once completed, the EuroPharm database will help healthcare professionals, patients and the general public to access up-to-date and reliable information about medicinal products available on the EU market.
Slovenian: Zbirka podatkov EuroPharm bo, ko bo dokončno oblikovana, omogočila zdravstvenim strokovnjakom, bolnikom in javnosti dostop do posodobljenih in zanesljivih podatkov o zdravilih, ki so na voljo na trgu EU.
English: Continued development of the EuroPharm database to increase access to information on medicines available in the European Union
Slovenian: Stalno razvijanje zbirke podatkov EuroPharm, da se poveča dostop do informacij o zdravilih, ki so na voljo v Evropski uniji.
English: New legislation requires that Member States agree within the coordination group on a list of medicinal products for which harmonised summaries of product characteristics shall be prepared to promote harmonisation of veterinary medicines authorised in the EU.
Slovenian: Nova zakonodaja zahteva, da se države članice strinjajo s skupino za usklajevanje glede seznama zdravil, za katera se pripravijo usklajeni povzetki glavnih značilnosti izdelka, da se spodbuja usklajevanje veterinarskih zdravil, ki imajo dovoljenje za promet v EU.
English: To this end, the CHMP has already established a Scientific Advice Working Party (SAWP) that has the sole remit of providing scientific advice to undertakings.
Slovenian: V ta namen je Odbor za zdravila za uporabo v humani medicini (Committe for Medicinal Products for Human Use, CHMP) že ustanovil Delovno skupino za znanstveno svetovanje (SAWP), katere izključna naloga je znanstveno svetovanje podjetjem.
English: Strengthen the concept of lifecycle management and scientific consistency
Slovenian: Krepitev koncepta upravljanja življenjskega cikla in znanstvene doslednosti.
English: To contribute to the promotion of harmonisation of authorisation of veterinary medicines in the EU
Slovenian: Prispevati k spodbujanju uskladitve izdajanja dovoljenj za veterinarska zdravila v EU.
English: Preparatory work in the area of procedures to be established in relation to the provision to Member States and European institutions of the best scientific opinion on questions related to herbal medicinal products, as well as to the adoption of opinions at the request of the Committee for Medicinal Products for Human Use
Slovenian: Pripravljalno delo na področju postopkov, ki jih je treba vzpostaviti, da se državam članicam in evropskim institucijam zagotovi najboljše znanstveno mnenje v zvezi z vprašanji o zeliščnih zdravilih in za sprejetje mnenj na zahtevo Odbora za zdravila za uporabo v humani medicini.
English: Management and reinforcement of the procedure, introduced in 2004, for the handling of safety concerns, both pre- and post-authorisation, for centrally processed applications
Slovenian: Upravljanje in krepitev postopka, uvedenega leta 2004, za obravnavanje varnostnih vprašanj, tako pred izdajo dovoljenja kot po njej, za centralno obravnavane vloge.
English: Further actions necessary to meet the Agency's long-term objectives will be included in future work programmes, with a view to full implementation of the Road Map by 2010.
Slovenian: Dodatni ukrepi, potrebni za izpolnitev dolgoročnih ciljev Agencije, bodo vključeni v prihodnje delovne programe, zato da se usmeritveni načrt ("Road Map")
English: The Agency will cooperate more actively with the WHO and will provide opinions on medicinal products intended exclusively for markets outside the EU.
Slovenian: Agencija bo dejavneje sodelovala s Svetovno zdravstveno organizacijo in dajala mnenja o zdravilih, namenjenih izključno trgom zunaj EU.
English: In 1984 Dr Korteweg created the regulatory compliance/quality assurance audit department for the European pharmaceutical R&D division of BristolMyers Squibb, later becoming director of worldwide regulatory compliance (auditing).
Slovenian: Leta 1984 je dr. Kortewegova ustanovila oddelek za revizijo regulativne skladnosti/zagotavljanja kakovosti za Divizijo R&R evropskih farmacevtskih izdelkov pri Bristol-Myers Squibb in kasneje postala direktorica svetovne regulativne skladnosti (za revizijo).
English: Standing and temporary working parties
Slovenian: Stalne in začasne delovne skupine
English: The time for communication of opinion to the European Commission has been decreased considerably, which requires substantial review of the processes following the opinion of the scientific committee.
Slovenian: Evropski komisiji je bil občutno skrajšan, kar zahteva poglobljen pregled postopkov ob upoštevanju mnenja znanstvenega odbora.
English: The EMEA will continue to support the European Commission in the updating and further development of the Notice to Applicants, providing advice on the centralised procedure and regulatory guidance for issues affecting the CHMP and its standing and temporary working parties
Slovenian: EMEA bo še naprej podpirala Evropsko komisijo pri posodabljanju in nadaljnjem razvijanju obvestila vlagateljem, pri svetovanju glede centraliziranega postopka in regulativnih smernic za vprašanja, ki vplivajo na CHMP ter na njegove stalne in začasne delovne skupine.
English: Dr Lyngvig has 12 years' private-sector experience in the transport and consultancy industries and was appointed chief executive officer of the Danish Medicines Agency in 2000.
Slovenian: Dr. Lyngvigova ima 12-letne izkušnje iz zasebnega sektorja, kjer je delala na področju transporta in svetovanja, leta 2000 pa je bila imenovana za glavno izvršno direktorico danske Agencije za zdravila.
English: The Agency plans to review its organisational structure to be able to carry out its expanded responsibilities in the areas of medical information and provision of support and incentives to small and medium-sized enterprises.
Slovenian: Agencija namerava spremeniti svojo organizacijsko strukturo, da bi bila sposobna izvajati svoje razširjene odgovornosti na področjih obveščanja o zdravilih ter zagotavljanja podpore in spodbud majhnim in srednje velikim podjetjem.
English: Implementation of an action plan for collaboration between the EMEA and the US Food and Drug Administration under the confidentiality arrangements, and close monitoring of all actions contained in this plan
Slovenian: Izvajanje akcijskega načrta za sodelovanje med EMEA in Upravo za hrano in zdravila ZDA na podlagi dogovorov o zaupnosti ter tesno spremljanje vseh ukrepov iz tega načrta.
English: Press office Press officer
Slovenian: Tiskovno predstavništvo Tiskovni predstavnik
English: Infrastructure Services at the EMEA
Slovenian: Infrastrukturne storitve v EMEA
English: It is forecast that there will be some 1,700 ICSRs from the EU received electronically through the EudraVigilance post-authorisation module in 2005.
Slovenian: Predvidoma naj bi v letu 2005 elektronsko po modulu EudraVigilance za fazo po izdaji dovoljenja prejeli približno 1700 ICSR iz EU.
English: To implement the new legislative requirements in the area of initial evaluation
Slovenian: Izvajati nove zakonske zahteve na področju začetnega vrednotenja.
English: Development of a Conference Guide for EMEA staff, external delegates and experts, linked to the meeting management system and containing all relevant information surrounding conferences
Slovenian: Razviti konferenčni priročnik za osebje EMEA, zunanje delegate in strokovnjake, ki bo povezan s sistemom za vodenje sestankov in bo vseboval vse pomembne informacije o konferencah.
English: He has been a member of the EMEA management board since 1995.
Slovenian: Od leta 1995 je član upravnega odbora EMEA.
English: Provisions regarding small and medium-sized enterprises are applicable in the field of veterinary medicinal products as well, and the Agency will need to provide support to veterinary companies with limited markets and to those licensing products for diseases with regional distribution.
Slovenian: Določbe, ki se nanašajo na majhna in srednje velika podjetja, se uporabljajo tudi na področju veterinarskih zdravil, Agencija pa bo morala zagotoviti podporo veterinarskim podjetjem z omejenimi trgi in veterinarskim podjetjem z dovoljenjem za promet z zdravili za regionalno
English: Electronic reporting of Adverse Drug Reactions for all veterinary medicines will be initiated under EudraVigilance Veterinary on 1 January 2005
Slovenian: Elektronsko poročanje o neželenih učinkih zdravil za vsa veterinarska zdravila bo uvedeno na podlagi EudraVigilance za veterino 1. januarja 2005.
English: She is also in charge of issues relating to medicines used in children and has been acting head of sector for safety & efficacy since October 2004.
Slovenian: Odgovorna je tudi za vprašanja v zvezi z zdravili, ki se uporabljajo pri otrocih, od oktobra 2004 pa je tudi vršilka dolžnosti vodje Sektorja za varnost in učinkovitost.
English: Applications for designation are expected to include more complex emerging therapies
Slovenian: Vloge za določitev naj bi predvidoma vključevale zahtevnejše nove terapije.
English: The attainment of these objectives will be measured against delivery of the systems on time, within budget, and to specification
Slovenian: Doseganje teh ciljev se bo merilo po pravočasnih dostavah sistemov v okviru proračuna in po specifikacijah.
English: With the steady increase in products being authorised through the centralised procedure, the rise in adverse reaction reports and periodic safety update reports continues, with approximately 400 of the former and over 50 of the latter forecast for 2005
Slovenian: S stalnim naraščanjem števila izdelkov, odobrenih po centraliziranem postopku, bo še naprej naraščalo število poročil o neželenih učinkih zdravila in periodično dopolnjenih poročil o varnosti; za leto 2005 se predvideva približno 400 prvih in več kot 50 drugih.
English: After a three-year stay in Prague, Czech Republic, where she worked as a consultant on European pharmaceutical matters as well as continuing her work with EFPIA, she joined the pharmaceuticals unit of the European Commission in September 1998.
Slovenian: Po triletnem bivanju v Pragi, Češka republika, kjer je delala kot svetovalka za evropske farmacevtske zadeve in nadaljevala svoje delo v okviru EFPIA, se je septembra 1998 pridružila Enoti Evropske komisije za farmacevtske izdelke.
English: Building on the experience obtained in 2004, the CHMP will strengthen its interaction with patients through a further development of the activities undertaken at the level of the EMEA/CHMP Working Group with Patients' Organisations.
Slovenian: CHMP bo na podlagi izkušenj, pridobljenih leta 2004, krepil vzajemno delovanje z bolniki na podlagi nadaljnjega razvijanja dejavnosti, prevzetih na ravni Delovne skupine EMEA/CHMP za sodelovanje z organizacijami bolnikov.
English: Number of videoconferences and reimbursed meetings
Slovenian: Število videokonferenc in sestankov s povrnjenimi stroški
English: CPMP Guideline on parametric release Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2 (in collaboration with GMP inspectors)
Slovenian: CPMP Guideline on parametric release Možna revizija po stabiliziranju pobud ICH za Q8 in Q9, v fazi 2 (v sodelovanju z inšpektorji dobre proizvodne prakse)
English: The Agency has been given significant new responsibilities for the provision of information to patients and healthcare professionals.
Slovenian: Agenciji so bile dane pomembne nove odgovornosti za zagotavljanje informacij bolnikom in zdravstvenim strokovnjakom.
English: Review of audiovisual and interpretation equipment in the meeting rooms
Slovenian: Pregled avdiovizualne opreme in opreme za tolmačenje v sejnih sobah.
English: Interim and other support persons
Slovenian: Začasno in drugo podporno osebje
English: The special Community fund (‘orphan drug fund') supports additional new applications and protocol assistance, as well as the post-authorisation activities that are necessary due to the increasing number of orphan medicinal products with Community marketing authorisations.
Slovenian: Poseben sklad Skupnosti ("sklad za zdravila sirote") podpira dodatne nove vloge in pomoč pri protokolu ter dejavnosti po izdaji dovoljenja za promet z zdravilom, ki so potrebne zaradi vse večjega števila zdravil sirot, ki imajo dovoljenje za promet v Skupnosti.
English: Ensure high-quality functioning of core activities through effective management of the increasing workload and adherence to reduced regulatory timelines for pre and post-authorisation activities
Slovenian: Zagotavljanje visoke kakovosti izvajanja osnovnih dejavnosti z učinkovitim upravljanjem vse večje delovne obremenitve in upoštevanjem krajših predpisanih rokov za dejavnosti pred izdajo dovoljenja za promet in po njej.
English: Regulatory and procedural advice is provided to the pharmaceutical industry during the lifecycle of medicinal products, from pre-submission meetings with applicants through to annual meetings with marketing authorisation holders.
Slovenian: Regulativno in postopkovno svetovanje je farmacevtski industriji zagotovljeno med življenjskim ciklom zdravil, od sestankov z vlagatelji pred oddajo vloge do letnih sestankov z imetniki dovoljenja za promet.
English: Facilitation of liaison with other scientific working groups and with interested parties
Slovenian: spodbujanje povezave z drugimi znanstveno delovnimi skupinami in zainteresiranimi stranmi;
English: To maintain and develop financial and budgetary accounting systems and reporting tools, including security and helpdesk components
Slovenian: Vodenje in razvijanje finančnih in proračunskih računovodskih sistemov ter orodij za poročanje, vključno z elementoma varnosti in pomoči za uporabnike.
English: The scope is broadened by the possibility of increased eligibility for the centralised procedure to include any veterinary medicine having importance for animal health throughout the Community.
Slovenian: Področje uporabe je razširjeno z možnostjo večje upravičenosti do centraliziranega postopka, ki vključuje vsa veterinarska zdravila, pomembna za zdravje živali v vsej Skupnosti.
English: 4.3 Mutual recognition agreements
Slovenian: 4.3 Sporazumi o vzajemnem priznavanju
English: Development of the EU transparency and communication strategies together with the Heads of Medicines Agencies
Slovenian: Razvoj strategij EU za preglednost in obveščanje v sodelovanju z vodji agencij za zdravila.
English: 3.8 International activities
Slovenian: 3.8 Mednarodne dejavnosti
English: Development of scientific advice procedures in line with the new legislation, including procedures for particular support for small and medium-sized enterprises and emerging therapies
Slovenian: Razvoj postopkov znanstvenega svetovanja v skladu z novo zakonodajo, vključno s postopki za posebno podporo majhnim in srednje velikim podjetjem, in novimi terapijami.
English: To provide timely information on MRLs to the public in accordance with agreed timelines
Slovenian: Zagotavljati pravočasne informacije o MRL-jih javnosti v skladu z dogovorjenimi roki.
English: Increased electronic reporting both for ICSRs (individual case safety reports) and SUSARs (suspected unexpected serious adverse reactions) into the EudraVigilance database for all medicinal products, irrespective of the licensing route
Slovenian: Povečan obseg elektronskega poročanja tako za varnostna poročila o posameznih primerih (individual case safety report, ICSR) kot za resne nepričakovane neželene učinke oziroma sum nanje (suspected unexpected serious adverse reactions, SUSAR) v zbirko podatkov EudraVigilance za vsa zdravila, ne glede na način pridobitve dovoljenja.
English: The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organization.
Slovenian: EMEA izdaja potrdila o zdravilu v skladu z dogovori, ki jih je določila Svetovna zdravstvena organizacija.
English: Implementation of the EU telematics strategy for the pharmaceutical sector
Slovenian: Izvajanje telematske strategije EU za farmacevtski sektor
English: Career to date: Mr Le Cam has 19 years of professional experience, and personal commitment, in non-governmental health and medical research organisations in France, Europe and the United States in the fields of cancer, HIV/AIDS and genetic diseases.
Slovenian: Dosedanja poklicna pot: G. Le Cam ima 19 let poklicnih izkušenj, ki jih je dobil v zdravstvenih in medicinsko raziskovalnih nevladnih organizacijah v Franciji, Evropi in Združenih državah, ki se ukvarjajo z rakom, hiv/aidsom in genetskimi boleznimi, katerim je osebno zavezan.
English: Completion of the internal evaluation work with new Member States in the context of the Canadian mutual recognition agreement
Slovenian: Dokončanje mednarodnega ocenjevalnega dela z novimi državami članicami v okviru kanadskega sporazuma o medsebojnem priznavanju.
English: He joined the EMEA in May 1999 and one of his major activities in recent years was the establishment of orphan drug designation and protocol assistance in the EMEA.
Slovenian: EMEA se je pridružil maja 1999, ena njegovih glavnih nalog v zadnjih letih pa je bila vzpostavitev določitve zdravila sirote in pomoči pri protokolu v EMEA.
English: Variations to marketing authorisations can be either minor (type IA or IB) or major (type II) changes.
Slovenian: Spremembe dovoljenj za promet z zdravilom so lahko manjše (tip IA ali IB) ali večje (tip II).
English: Temporary working parties on new emerging therapies and new technologies, i.e. pharmacogenetics, gene therapy and cell therapy, will continue to meet in 2005 as the Agency is likely to receive applications in relation to emerging therapies.
Slovenian: Začasne delovne skupine za nove terapije in tehnologij, kot so farmakogenetika, gensko zdravljenje, celično zdravljenje, se bodo leta 2005 še naprej sestajale, saj bo Agencija verjetno prejela vloge, povezane z novimi oblikami terapij.
English: Provision of secretariat support to the scientific advice working party and support to potential applicants
Slovenian: Zagotavljanje pisarniške podpore delovni skupini za znanstveno svetovanje in podpora možnim prosilcem.
English: Development and implementation of an EU benchmarking system, development of quality assurance systems for scientific committees and an improved peer review system
Slovenian: Razvoj in izvajanje sistema EU za primerjalne analize, razvoj sistemov zagotavljanja kakovosti za znanstvene odbore ter izboljšani sistem medsebojnih pregledov.
English: The working party will develop a technical guidance document prepared in cooperation with Member States and industry to facilitate implementation of the CVMP/VICH guideline.
Slovenian: Delovna skupina bo v sodelovanju z državami članicami in panogo pripravila pisna tehnična navodila, ki bodo omogočila izvajanje smernice CVMP/VICH.
English: During this time he also worked as contributing editor for a European affairs publication and as Brussels correspondent for an American pharmaceutical journal.
Slovenian: V tem času je bil tudi pomožni urednik objav v zvezi z evropskimi zadevami in bruseljski dopisnik ameriške farmacevtske revije.