FrancophonIA/ELRC3.0 huggingface dataset:
English: 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
Slovenian: Razvoj postopkov za bolj sistematično in večkratno uporabo znanstvenega svetovanja in pomoč pri protokolu med razvojem zdravil, zlasti za redke bolezni in nove terapije.
English: 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).
Slovenian: 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).
English: 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
Slovenian: 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.
English: Line extensions are likely to increase, with eight applications foreseen for 2005.
Slovenian: Število vlog za podaljšanje rokov bo verjetno naraščalo, za leto 2005 se predvideva osem vlog.
English: He currently holds the positions of director and professor at the Federal Institute for Drugs and Medical Devices.
Slovenian: Trenutno je direktor in profesor na Zveznem inštitutu za zdravila in medicinske pripomočke.
English: 2.12 Coordination group
Slovenian: 2.12 Skupina za usklajevanje
English: She was editor for the ICH GCP guideline from February 1992 until its adoption in May 1996.
Slovenian: Bila je urednica smernice ICH za dobro klinično prakso od februarja 1992 do njenega sprejetja maja 1996.
English: Invitation by the CVMP, its working parties or scientific advisory groups to interested parties on specific technical/scientific issues
Slovenian: povabilo CVMP, njegovih delovnih ali znanstveno svetovalnih skupin zainteresiranih strani k skupnemu reševanju posebnih tehničnih/znanstvenih vprašanj;
English: 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.
Slovenian: 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.
English: The trend in the number of generic applications which began in 2004 is anticipated to continue in
Slovenian: Trend glede števila generičnih vlog, ki se je začel leta 2004, se bo leta 2005 predvidoma nadaljeval.
English: To improve the availability of information in relation to Community referral procedures
Slovenian: Izboljšati dostopnost informacij o postopkih za predložitev Skupnosti.
English: 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.)
Slovenian: 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.).
English: Monitor use of resources by the Agency as well as implementation of EU telematics and other information technology initiatives
Slovenian: Spremljal, kako Agencija uporablja vire ter izvaja telematske in druge pobude EU na področju informacijske tehnologije.
English: 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.
Slovenian: 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
English: Need for comments in the light of experience to be considered in 2005
Slovenian: Potrebne so pripombe glede na izkušnje, ki se preučijo leta 2005
English: Service quality will be measured by a number of performance indicators, such as systems availability, helpdesk response times and problem resolution times
Slovenian: Kakovost storitve se bo merila s številnimi kazalniki uspešnosti, kot so dostopnost sistemov, odzivni čas pomoči za uporabnike in porabljeni čas za rešitev težave.
English: Continuous improvement of the designation procedure
Slovenian: Stalno izboljševanje postopka za določitev.
English: Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for foodproducing animals with respect to antimicrobial resistance (CVMP/VICH/644/01)
Slovenian: Further guidance on interpretation of the data from guideline CVMP-VICH GL27, guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
English: 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.
Slovenian: 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.
English: 3.7 Regulatory activities
Slovenian: 3.7 Regulativne dejavnosti
English: The Committee on Herbal Medicinal Products The Committee on Herbal Medicinal Products (HMPC) will meet six times in 2005.
Slovenian: Odbor za zeliščna zdravila (Committe on Herbal Medicinal Poducts, HMPC) se bo leta 2005 sestal šestkrat.
English: Contribution to the activities initiated by the Directorate-General for Research relating to emerging therapies and medicinal products for rare diseases and for developing countries
Slovenian: Prispevek k dejavnostim, ki jih je uvedel Generalni direktorat za raziskave in se nanašajo na nove terapije in zdravila za redke bolezni ter za države v razvoju.
English: Further strengthening and maintenance of the quality assurance system in relation to the management of procedures and CHMP activities
Slovenian: Nadaljnja krepitev in vzdrževanje sistema zagotavljanja kakovosti za vodenje postopkov in dejavnosti CHMP.
English: Key initiatives in this area:
Slovenian: Ključne pobude na tem področju:
English: The Agency is in the process of revising its practices to make such information more understandable and accessible for both patients and healthcare professionals.
Slovenian: Agencija izvaja revizijo svojih postopkov, da bi bile takšne informacije razumljivejše ter dostopnejše bolnikom in zdravstvenim strokovnjakom.
English: Dr Brasseur has held a number of teaching posts and is currently professor of nutrition and nutrition-related diseases at the Free University of Brussels.
Slovenian: Dr. Brasseur je tudi veliko poučeval in je trenutno profesor prehrane in z njo povezanih bolezni na Neodvisni univerzi v Bruslju.
English: Implementation of the guideline on the provision of scientific opinions in the context of cooperation with the WHO
Slovenian: Izvajanje smernic za zagotavljanje znanstvenih mnenj v okviru sodelovanja s Svetovno zdravstveno organizacijo.
English: He co-founded the International Alliance of Patient Organisations (IAPO) based in London, and served as vice-chairman from 1997 to 2000.
Slovenian: Bil je soustanovitelj Mednarodne zveze organizacij bolnikov (IAPO) s sedežem v Londonu in bil od leta 1997 do 2000 njen podpredsednik.
English: This relates to the provision of scientific advice to sponsors during the research and development of medicinal products.
Slovenian: To se nanaša na zagotavljanje znanstvenega svetovanja sponzorjem med raziskavami in razvojem zdravil.
English: Requests for GCP and pharmacovigilance inspections are not expected to increase from their 2004 level as the rise in number for that year was already significant
Slovenian: Število zahtevkov za inšpekcijske preglede dobre klinične prakse in farmakovigilance se predvidoma ne bo povečalo ter bo ostalo na ravni iz leta 2004, saj se je že v tem letu zelo povečalo.
English: To improve scientific and regulatory consistency of opinions, adhere to regulatory timelines, and continue strengthening the operation of the initial evaluation procedure
Slovenian: Izboljšati znanstveno in regulativno skladnost mnenj, ob upoštevanju predpisanih rokov, in nadaljevati s krepitvijo delovanja postopka začetnega vrednotenja.
English: Further develop the EMEA risk management strategy, in particular as regards the concept of risk management plans and further implementation of the EudraVigilance project, including the reporting of adverse drug reactions in clinical trials
Slovenian: Nadaljnji razvoj strategije EMEA za obvladovanje tveganja, zlasti v zvezi s konceptom načrtov obvladovanja tveganja in nadaljnjim izvajanjem projekta EudraVigilance, vključno s poročanjem o neželenih učinkih zdravila med kliničnim preizkušanjem.
English: Preparatory work to provide access to dedicated information contained in the EudraVigilance database to healthcare professionals, marketing authorisation holders and the public.
Slovenian: Pripravljalno delo, ki naj zagotovi dostop do namenskih informacij iz zbirke podatkov EudraVigilance zdravstvenim strokovnjakom, imetnikom dovoljenja za promet z zdravilom in javnosti.
English: To further implement the EMEA risk management strategy, as part of the EU risk management strategy
Slovenian: Nadaljevati izvajanje strategije EMEA za obvladovanje tveganja kot sestavnega dela strategije
English: Guidelines for consultation on the possible adaptation of data requirements for testing medicinal products for minor uses and minor species to facilitate their further authorisation will be drafted
Slovenian: Pripravili se bodo osnutki smernic za posvetovanje o možni prilagoditvi podatkovnih zahtev za preizkušanje zdravil za manjše uporabe in manj pomembne vrste, da se omogoči nadaljnje izdajanje dovoljenj.
English: Impact of new approach to WHO cooperation in the context of the certification scheme
Slovenian: Vpliv novega pristopa k sodelovanju s Svetovno zdravstveno organizacijo v okviru certifikacijskega sistema.
English: 50 % of fees for post-authorisation applications and annual fees
Slovenian: 50 % pristojbin za vloge po izdaji dovoljenja za promet in letne pristojbine.
English: In 1992, he became professor of clinical pharmacology and therapeutics and director of the masters/diploma course on European registration of medicinal products (UAB).
Slovenian: Leta 1992 je postal profesor klinične farmakologije in terapevtike ter direktor magistrskega/diplomskega študija Evropska registracija zdravil (UAB).
English: To consider new and innovative ways of applying technological solutions to conducting meetings, including promoting greater use of videoconferencing and web streaming
Slovenian: Preučiti nove in inovativne načine uporabe tehnoloških rešitev pri vodenju sestankov, vključno s spodbujanjem večje uporabe prenašanja prek videokonference in neprekinjenega pretoka po spletu.
English: 50 % of fees for initial applications for marketing authorisations and inspections
Slovenian: 50 % pristojbin za začetne vloge za izdajo dovoljenja za promet in nadzor,
English: Emphasis is put on transparency, communication and information on pharmacovigilance issues.
Slovenian: Poudarjeni so preglednost, sporočanje in obveščanje o vprašanjih farmakovigilance.
English: Establishment of a working party with the Heads of Medicines Agencies to address transparency and communication policy issues of the network
Slovenian: Ustanovitev delovne skupine iz vodij agencij za zdravila, ki bo obravnavala vprašanja, povezana s politiko preglednosti in obveščanja v mreži.
English: In 1984, he joined the Veterinary Medicines Laboratory in Fougères where he was assessor and rapporteur for marketing authorisation dossiers.
Slovenian: Leta 1984 se je pridružil Laboratoriju za veterinarska zdravila v Fougèresu, kjer je bil ocenjevalec in poročevalec za dokumentacijo za izdajo dovoljenja za promet z zdravilom.
English: To process parallel distribution notifications in accordance with the EMEA procedure and adhering to regulatory timelines
Slovenian: Obravnavati obvestila o vzporedni distribuciji v skladu s postopkom EMEA in ob upoštevanju predpisanih rokov.
English: The goal is to shorten the procedure time for safety referrals
Slovenian: Cilj je skrajšati čas postopka za predložitve v zvezi z varnostnimi vprašanji.
English: Considerations of the Scientific group to be prepared during 2005
Slovenian: Premisleki Znanstvene skupine se pripravijo v letu 2005
English: Reporting and feedback on pharmacovigilance issues relating to centralised procedures to the Member States, interested parties and the public
Slovenian: Poročanje in povratne informacije o vprašanjih farmakovigilance, ki se nanašajo na centralizirane postopke, za države članice, zainteresirane skupine in javnost.
English: Specialist in endocrinology and metabolic diseases.
Slovenian: Specialistka za endokrinologijo in metabolične bolezni.
English: The Agency plans to re-engineer and reinforce its processes related to meeting management.
Slovenian: Agencija namerava preoblikovati in okrepiti svoj postopek vodenja sestankov.
English: Prior to his appointment as unit manager in pharmacovigilance, he held a number of positions in both pre- and post-authorisation areas, and was also the UK delegate to the CPMP Pharmacovigilance Working Party.
Slovenian: Pred imenovanjem za vodjo Enote za farmakovigilanco je opravljal več služb na področju dejavnosti pred in po izdaji dovoljenja za promet z zdravilom ter bil tudi delegat Združenega kraljestva v Delovni skupini CPMP za farmakovigilanco.
English: Career to date: From 1987 to 1994, Dr Ashley-Smith was employed in the veterinary pharmaceutical industry, first as a technical adviser and subsequently as a registration manager.
Slovenian: Dosedanja poklicna pot: Od leta 1987 do 1994 je bila dr. Ashley-Smithova zaposlena v farmacevtski industriji veterinarskih zdravil, najprej kot tehnična svetovalka in nato kot vodja registracije.
English: Possible revision in 2005
Slovenian: Možna revizija v letu 2005
English: Interaction between the CHMP and healthcare professionals and learned societies will be further developed.
Slovenian: Vzajemno delovanje med CHMP ter zdravstvenimi strokovnjaki in znanstvenimi združenji se bo še naprej razvijalo.
English: EU telematics strategy and information technology
Slovenian: Telematska strategija EU in informacijska tehnologija
English: The further development and implementation of EudraVigilance will relate to appropriate methodologies for data analysis, including data warehousing and data mining supporting signal detection, as well as the coordination and provision of training to the EMEA's business partners
Slovenian: Nadaljnji razvoj in izvajanje EudraVigilance se bosta nanašala na razvoj ustreznih metodologij za analizo podatkov, tudi podatkov, ki se shranijo, in podatkov, ki zavirajo odkrivanje podpornega signala, ter na usklajevanje in zagotavljanje usposabljanja za poslovne partnerje EMEA.
English: Objective:
Slovenian: Cilj:
English: Following the implementation of the confidentiality arrangements with the US Food and Drug Administration, discussions will continue with the FDA regarding specific issues on the development of medicinal products
Slovenian: Po začetku izvajanja dogovorov o zaupnosti, sklenjenih z Upravo za hrano in zdravila ZDA, se bodo z njo nadaljevale razprave v zvezi s posebnimi vprašanji glede razvoja zdravil.
English: He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994.
Slovenian: Od leta 1982 do 1994 je bil višji farmacevtski svetovalec za švedski program zdravstvenega sodelovanja v Vietnamu.
English: The new scope encompasses medicines intended for self-medication, generic products of centrally authorised medicinal products, and biosimilar medicinal products.
Slovenian: Nov obseg zajema zdravila, namenjena za samozdravljenje, generična zdravila, odobrena po centraliziranem postopku, in biološko podobna zdravila.
English: Introduction of the following new procedures foreseen in the new legislation: conditional marketing authorisation, accelerated assessment and compassionate use
Slovenian: Uvedba naslednjih novih postopkov, ki jih predvideva nova zakonodaja: pogojna izdaja dovoljenja za promet z zdravilom, pospešena ocena in sočutna uporaba.
English: Career to date: From 1971 to 1974, Mr O'Malley completed articles in Dublin.
Slovenian: Dosedanja poklicna pot: Od 1971 do 1974 je g. O'Malley opravljal pripravništvo v Dublinu.
English: Postgraduate qualifications in internal medicine (FRCP) and pharmaceutical medicine (FFPM).
Slovenian: Podiplomski študij iz interne medicine (FRCP) in farmacevtske medicine (FFPM).
English: From 1984 to 1994, as medical director at the pharmaceutical department of the Italian Ministry of Health, she was in charge of the Operative Centre for Community Procedures, was the Italian member of the former Committee for Proprietary Medicinal Products (CPMP), and was also involved in ICH activities.
Slovenian: Od 1984 do 1994 je bila kot zdravstvena direktorica na farmacevtskem oddelku italijanskega Ministrstva za zdravje odgovorna za Operativni center za postopke Skupnosti in je kot italijanska članica bivšega Odbora za lastniška zdravila sodelovala tudi pri dejavnostih ICH.
English: Preparation of EPAR summaries that are written so they are understandable to the public, and coordination with applicants to ensure package leaflets are similarly written in a manner comprehensible to the lay person
Slovenian: Priprava povzetkov EPAR, napisanih tako, da so razumljivi javnosti, ter usklajevanje z vlagatelji, da se zagotovi, da so tudi navodila za uporabo napisana tako, da jih razumejo tudi nestrokovnjaki.
English: 1.3 EMEA Road Map to 2010
Slovenian: 1.3 Usmeritveni načrt ("Road Map") EMEA do 2010
English: He joined the Swedish Medicinal Products Agency in 1990, serving as director of operations and later as deputy director-general.
Slovenian: Leta 1990 se je pridružil švedski Agenciji za zdravila, kjer je bil poslovni direktor in kasneje namestnik generalnega direktorja.
English: Consequently, growing demands from the public and interested parties for access to the documents held by the Agency will have procedural and resource implications.
Slovenian: Zato bo povečano povpraševanje javnosti in zainteresiranih strani po dostopu do dokumentov, ki jih ima Agencija, vplivalo na postopke in vire.
English: Revision to be released for public consultation by April 2005
Slovenian: Revizija se da v javno posvetovanje do aprila 2005
English: Establishment of a dedicated forum which would include the EMEA and Member State competent authorities, as well as the Agency's stakeholders, to discuss and propose the optimal way forward in providing information to patients and healthcare professionals from the European medicines network
Slovenian: Vzpostavitev namenskega pristojnega mesta, ki bi vključeval EMEA in pristojne organe držav članic ter zainteresirane strani Agencije, za razpravljanje in predlaganje najboljšega možnega prihodnjega načina za zagotavljanje informacij bolnikom in zdravstvenim strokovnjakom prek Evropske mreže zdravil.
English: Postgraduate studies in nutrition, statistics and methodology.
Slovenian: Podiplomski študij iz prehrane, statistike in metodologije.
English: He is the head of the ‘Particular therapies' division, which is in charge of the pharmaceutical und clinical assessment of herbal, homeopathic and anthroposophic products.
Slovenian: "posebne oblike zdravljenja", ki je pristojen za farmacevtsko in klinično ocenjevanje zeliščnih, homeopatskih in antropozofskih izdelkov.
English: Note for guidance on the clinical investigation of recombinant Factor VIII and IX products (CPMP/BPWG/1561/99) and the Note for guidance on the clinical investigation of human plasma derived Factor VIII and IX products
Slovenian: VIII and IX products (CPMP/BPWG/1561/99) and the Note for guidance on the clinical investigation of human plasma derived Factor VIII and IX products
English: The new requirements include the establishment of procedures for conditional marketing authorisations, accelerated assessment, compassionate use and for opinions on medicinal products intended for markets exclusively outside the EU (in collaboration with the WHO).
Slovenian: Nove zahteve vključujejo vzpostavitev postopkov za izdajo pogojnih dovoljenj za promet z zdravili, pospešene ocene, sočutne uporabe ter za mnenja o zdravilih, namenjenih izključno trgom zunaj EU (v sodelovanju s Svetovno zdravstveno organizacijo).
English: Revision of the safety referral process in order to shorten the timeframe for finalisation of safety referral procedures
Slovenian: Revizija postopka za predložitev v zvezi z varnostnimi vprašanji, da se skrajša časovni okvir za dokončanje postopkov za predložitev v zvezi z varnostnimi vprašanji.
English: 2.9 Regulatory activities
Slovenian: 2.9 Regulativne dejavnosti
English: He has three daughters, the eldest of whom is affected by cystic fibrosis.
Slovenian: najstarejša ima cistično fibrozo.
English: Dr Korteweg joined the EMEA in August 1997 and has acted as EMEA quality manager since July 1998.
Slovenian: Dr. Kortewegova se je EMEA pridružila avgusta 1997 in je od julija 1998 njena direktorica za kakovost.
English: The amount of work in post-authorisation activities such as variations and line extensions will increase steadily in line with the total number of marketing authorisations.
Slovenian: Obseg dela na področju dejavnosti po izdaji dovoljenja za promet z zdravilom, kot so spremembe in podaljšanje rokov, bo stalno naraščal v skladu s skupnim številom izdanih dovoljenj.
English: For enquiries concerning VAMF certificates
Slovenian: Za vprašanja o potrdilih VAMF
English: The trend in applications through the centralised procedure continues, ensuring a steady supply of new and innovative medicines for veterinarians and animal owners throughout the Community
Slovenian: Trendi: Pri vlogah se nadaljuje trend po centraliziranem postopku, kar zagotavlja stalno oskrbo veterinarjev in lastnikov živali z novimi in inovativnimi zdravili po vsej Skupnosti.
English: Career to date: Ms Fayl held various positions as a documentalist in several European countries, the latest from 1988 to 1995, setting up and running the documentation service at the European Commission Delegation in Norway.
Slovenian: Faylova je imela več služb kot dokumentalistka v več evropskih državah, zadnjo od leta 1988 do 1995, ko je vzpostavila in vodila dokumentacijsko službo delegacije