natgillin/translations-raw huggingface dataset:
Achievement of consensus with the Agency's partners and stakeholders on the most adequate way to provide information on medicines to patients and healthcare professionals
Dosega soglasja s partnerji Agencije in zainteresiranimi stranmi glede najustreznejšega načina zagotavljanja informacij o zdravilih bolnikom in zdravstvenim strokovnjakom.
Establishment of scientific advisory groups in the new mandatory therapeutic areas
Ustanovitev znanstveno svetovalnih skupin na novih obveznih terapevtskih področjih.
To provide targeted, useful and accessible information to patients and healthcare professionals about the medicine-related aspects of the work of the Agency
Zagotavljati bolnikom in zdravstvenim strokovnjakom ciljno naravnane, uporabne in dostopne informacije o vidikih dela Agencije, povezanih z zdravili.
Other TOTAL REVENUE
Drugo PRIHODKI SKUPAJ
The EMEA coordinates the verification of compliance with the principles of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP), and with certain aspects of the supervision of authorised medicinal products in use in the European Community, through inspections requested by the CHMP or CVMP in connection with the assessment of marketing authorisation applications and/or the assessment of matters referred to these committees in accordance with Community legislation.
EMEA usklajuje preverjanje skladnosti z načeli dobre proizvodne prakse, dobre klinične prakse in dobre laboratorijske prakse ter z določenimi vidiki nadzorovanja zdravil, za katera je bilo izdano dovoljenje za promet in se uporabljajo v Evropski skupnosti, z inšpekcijskimi pregledi, ki jih zahtevata CHMP ali CVMP v zvezi z oceno vlog za izdajo dovoljenja za promet in/ali oceno zadev, ki so bile tema odboroma predložene v skladu z zakonodajo Skupnosti.
The major priority for 2005 will be to prepare for the implementation of the pharmaceutical legislative review, in particular the new requirements for GMP for starting materials and the setting-up of a database on manufacturing authorisations and GMP certificates
Najpomembnejša prednostna naloga za leto 2005 bo priprava na izvajanje farmacevtskega zakonodajnega pregleda, zlasti novih zahtev za dobro proizvodno prakso za vhodne snovi ter vzpostavitev zbirke podatkov o dovoljenjih za izdelavo in potrdilih odobri proizvodni praksi.
Postgraduate studies in pharmacology at the Universities of Melbourne and Auckland.
Podiplomski študij iz farmakologije na Univerzi v Melbournu in Aucklandu.
Unit for Veterinary medicines and inspections
Enota za veterinarska zdravila in inšpekcijske preglede
Postgraduate studies in management, leadership and administration.
Podiplomski študij iz managementa, vodenja in upravljanja.
Establishment of a procedure for publication of information on withdrawal of applications and refusal of Community marketing authorisations
Vzpostavitev postopka za objavljanje informacij o umiku vlog in zavrnitvi izdaje dovoljenja Skupnosti za promet z zdravilom.
Priorities for veterinary medicines in 2005:
Prednostne naloge za veterinarska zdravila v letu 2005:
Main CHMP standing and temporary working parties in 2005
Glavne stalne in začasne delovne skupine CHMP v letu 2005
Applications received (non-orphan medicines) Applications received (orphan medicines)
Prejete vloge (za zdravila, ki niso zdravila sirote) Prejete vloge (za zdravila sirote)
Guideline to be developed after consultation of concept paper
Smernica se pripravi po posvetovanju o idejnem dokumentu
Expenditure on data processing Other capital expenditure Postage and communications Other administrative expenditure
Objekti/oprema Najemnina/odhodek Odhodki za obdelavo podatkov Drugi odhodki za naložbe Poštnine in obveščanje Drugi odhodki za poslovanje
Cooperation on the ICH/FDA initiative on quality systems/GMP is expected to build on the need for interaction between GMP inspectors and quality assessors
Sodelovanje pri pobudi ICH/FDA za sisteme kakovosti/dobro proizvodno prakso naj bi predvidoma temeljilo na potrebi po medsebojnem delovanju inšpektorjev za dobro proizvodno prakso in ocenjevalcev kakovosti.
These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports), follow-up measures, specific obligations, annual reassessments and renewal applications.
Sem spadajo dejavnosti, povezane z obveščanjem o farmakovigilanci (poročila o neželenih učinkih zdravil in periodično dopolnjena poročila o njihovi varnosti), nadaljnji ukrepi, posebne obveznosti, vloge za vsakoletno ponovno oceno in podaljšanje.
Postgraduate studies in management and health economics.
Podiplomski študij iz managementa in zdravstvene ekonomike.
The Committee will implement its newly adopted procedure intended to facilitate communication and dialogue between the Committee and interested parties, to fulfil obligations set out in the new legislation by putting in place the necessary arrangements to organise such exchanges and improve transparency as appropriate.
namenjen lažjemu sporazumevanju in dogovarjanju med odborom in zainteresiranimi stranmi, da bo izpolnil obveznosti iz nove zakonodaje s sprejetjem potrebnih dogovorov za organiziranje takšnih izmenjav in ustrezno izboljšanje preglednosti.
Discussion of comments received on revision to be released for public consultation in 2005
Obravnavanje pripomb, prejetih v zvezi z revizijo, ki se da v javno posvetovanje leta 2005
Specialist in internal medicine and clinical pharmacology.
Specialist interne medicine in klinične farmakologije.
Objectives and key initiatives:
Cilji in ključne pobude:
Continuous monitoring of the impact of scientific advice on the outcome of applications for marketing authorisations and analysis as part of the scientific memory and scientific advice databases
Stalno spremljanje vpliva znanstvenega svetovanja na rešitev vlog za izdajo dovoljenja za promet in analiziranje v okviru zbirk podatkov znanstvenega pomnilnika in znanstvenega svetovanja.
From 1993 to 1994 he acted as the vice-chairman of the EFTA Expert Group on Pharmaceuticals and from 1994 to 1995 as the chairman of the Nordic Council on Medicines.
Od leta 1993 do 1994 je bil podpredsednik Izvedenske skupine EFTE za farmacevtske izdelke, od leta 1994 do 1995 pa predsednik Nordijskega sveta za zdravila.
Her responsibilities there included coordination of ICH activities, relations with the FDA, pharmaceutical aspects of mutual recognition agreements, GMP and inspection-related matters, orphan medicinal products, preparatory work on a regulation on paediatric medicinal products and issues relating to EU enlargement.
Njene tamkajšnje odgovornosti so vključevale usklajevanje dejavnosti za ICH, odnose s FDA, farmacevtske vidike sporazumov o medsebojnem priznavanju, dobro proizvodno prakso in zadeve, povezane z inšekcijskimi pregledi, zdravila sirote, pripravljalno delo za pravno ureditev zdravil za otroke ter vprašanja v zvezi s širitvijo
To increase the quality and the regulatory and scientific consistency of the evaluation of applications for line extensions, variations to and transfers of marketing authorisations, and adhere to regulatory timelines
Izboljšati kakovost ter regulativno in znanstveno doslednost pri presojanju vlog za podaljšanje rokov, spremembe in prenose dovoljenj za promet z zdravilom ter upoštevati predpisane roke.
Career to date: Dr Saint Raymond held a position as paediatrician in a teaching paediatric hospital in Paris, followed by a number of years working for a number of pharmaceutical companies.
Dosedanja poklicna pot: Dr. Saint Raymondova je bila pediatrinja v pediatrični poučevalni bolnišnici v Parizu, nato pa je več let delala za številne farmacevtske družbe.
He was first elected chairman of the CVMP in January 2003 and was re-elected in 2004.
Za predsednika CVMP je bil prvič izvoljen januarja 2003, leta 2004 pa je bil izvoljen ponovno.
The legislation also requires the Agency to provide information on withdrawal of an application by an applicant prior to opinion, and on refusal of marketing authorisation.
Zakonodaja od Agencije tudi zahteva, da zagotavlja informacije o umiku vloge s strani vlagatelja pred izdajo mnenja in o zavrnitvi izdaje dovoljenja za promet z zdravilom.
Career to date: From 1981 to 1984, Dr Moulin worked in the Bovine Pathology Laboratory in Lyon.
Dosedanja poklicna pot: Dr. Moulin je od leta 1981 do 1984 delal v patološkem laboratoriju za govedo v Lyonu.
Technical Requirements for Blood and Blood Components (including those used for medicinal products derived from human blood and plasma)
Blood Components (including those used for medicinal products derived
Nine applications for renewal of marketing authorisation are forecast for 2005
Za leto 2005 se predvideva devet vlog za obnovo dovoljenja za promet z zdravilom.
To increase the quality, as well as the regulatory and scientific consistency, of the outcome of the scientific review.
Izboljšati kakovost ter regulativno in znanstveno doslednost ugotovitev strokovne presoje.
Continuous collaboration with the Directorate-General for Enterprise on development of legislation relating to paediatric medicines, tissue engineering and the provision of information to the public
Stalno sodelovanje z Generalnim direktoratom za gospodarstvo pri razvoju zakonodaje za zdravila za otroke in inženiring tkiv ter obveščanju javnosti.
Education: Qualified in medicine from Sheffield University in 1983.
Izobrazba: Diplomiral iz medicine na Univerzi v Sheffieldu leta 1983.
Preparation of draft Community herbal monographs for herbal medicinal products with a wellestablished use
Priprava osnutkov zeliščnih monografij Skupnosti za zeliščna zdravila z dobro uveljavljeno uporabo.
The performance indicator for this objective is the percentage of responses provided within 14 days.
Kazalnik uspešnosti za ta cilj je odstotek odgovorov, zagotovljenih v štirinajstih dneh.
The new legislation sets forth provisions for the implementation of a risk management system as well as the possibility to set up a system of permanent follow-up of the risk/benefit balance.
V novi zakonodaji so navedene določbe za izvajanje sistema obvladovanja tveganja in za možnost vzpostavitve sistema stalnega spremljanja razmerja med tveganji in koristmi.
Priorities for inspections in 2005:
Prednostne naloge inšpekcijskega nadzora v letu 2005:
A*16 A*15 A*14 A*13 A*12 A*11 A*10 A*9 A*8 A*7 A*6 A*5 Total grade A B*11 B*10 B*9 B*8 B*7 B*6 B*5 B*4 B*3 Total grade B C*7 C*6 C*5 C*4 C*3 C*2 C*1 Total grade C D*5 D*4 D*3 D*2 Total grade D Total Staff
A*16 A*15 A*14 A*13 A*12 A*11 A*10
Reimbursed meetings Videoconferences
Sestanki s povrnjenimi stroški Videoconference
To improve transparency and provision of designation-related information to patients and other interested parties
Izboljšati preglednost in zagotavljanje informacij o določitvi bolnikom in drugim zainteresiranim stranem.
3.3 Establishment of maximum residue limits
3.3 Določitev mejne vrednosti ostankov (MRL)
MSc in social and regulatory pharmacy.
Magisterij iz socialne in regulativne farmacije.
In 1994, she joined the UK Veterinary Medicines Directorate as senior veterinary assessor in the pharmaceuticals and feed additives team.
Leta 1994 se je pridružila Direktoratu Združenega kraljestva za veterinarska zdravila kot višja veterinarska ocenjevalka v skupini za farmacevtske izdelke in krmne dodatke.
The EMEA and the CVMP will play an important part in contributing to the drafting of a new regulation and subsequent guidelines on residue control of veterinary medicines in food animals to succeed Council Regulation 2377/90
EMEA in CVMP bosta imela pomembno vlogo pri pripravi osnutka nove uredbe o nadzorovanju ostankov veterinarskih zdravil v živalih za prehrano ter nadaljnjih smernic, ki bodo nasledile Uredbo
Education: Law degree from the University of Pavia, Italy; PhD in European Law from the European University Institute of Florence, Italy; Avvocato, chair professor of international law.
Izobrazba: Diploma iz prava na Univerzi v Pavii, Italija, doktorat iz evropskega prava na Evropskem univerzitetnem inštitutu v Firencah, Italija, Avvocato, redni profesor mednarodnega prava.
Professor Wahlroos had a central role in the pharmaceutical sector in the preparations for the accession of Finland to the EU in 1995.
Prof. Wahlroos je imel osrednjo vlogo na farmacevtskem področju v pripravah na pristop
Professor Wahlroos was appointed director-general of the National Agency for Medicines (NAM) in 1993.
Leta 1993 je bil prof. Wahlroos imenovan za generalnega direktorja Nacionalne agencije za zdravila.
He has been executive director of the EMEA since January 2001.
Izvršni direktor EMEA je od januarja 2001.
Adopt rules for the implementation of the staff regulations
Sprejel pravila za izvajanje kadrovskih predpisov.
To implement the new legislative requirements and increase the quality of assessment of such applications and adhere to regulatory timelines
Izvajati zahteve nove zakonodaje in izboljšati kakovost ocen takšnih vlog ter upoštevati predpisane roke.
Preparation for progressive submission of applications for emerging therapies and new technologies, and for applications for self-medication and generic products
Priprava na postopno predlaganje vlog za nove terapije in tehnologije ter vlog za samozdravljenje in generične izdelke.
Education: Master's degree in political science, history and English from the University of Hamburg.
Izobrazba: Magisterij iz političnih znanosti, zgodovine in angleščine na Univerzi v Hamburgu.
Career to date: Ms Nuttall held several posts in the Irish Civil Service, serving in the Departments of Health, Finance and the Office of Public Works.
Nuttallova je imela več služb v irski državni upravi, delala je na Oddelku za zdravje, finance in v Uradu za javna dela.
The goal is to encourage all applicants in the field of new technologies and therapies to receive scientific advice
Cilj je spodbujati vse vlagatelje k iskanju znanstvenega svetovanja na področju novih tehnologij in terapij.
Establishment of processes for preparation of summaries of EPARs written in a manner that is understandable to the public
Vzpostavitev postopkov za pripravo povzetkov EPAR-ov, napisanih tako, da so razumljivi javnosti.
Career to date: From 1981 to 1983, Dr Abadie held a number of clinical and laboratory positions, before joining the pharmaceutical industry in 1983.
Dosedanja poklicna pot: Dr. Abadie je od 1981 do 1983 delal na različnih delovnih mestih na klinikah in v laboratorijih, preden se je leta 1983 pridružil farmacevtski industriji.
Preparation for inclusion of new mandatory therapeutic areas within the scope of the centralised procedure
Priprava na vključitev novih obveznih terapevtskih področij v obseg uporabe centraliziranega postopka.
Career to date: Dr Pittner worked in the pharmaceutical industry from 1972 to 1985 where he discovered the pharmacological properties of the beta 1 - adrenoceptor antagonist celiprolol.
Dosedanja poklicna pot: Od 1972 do 1985 je dr. Pittner delal v farmacevtski industriji, kjer je odkril farmakološke značilnosti beta 1 - adrenoceptorja antagonista celiprolola.
This relates to the provision of scientific advice and protocol assistance to sponsors during the research and development of medicinal products.
To se nanaša na zagotavljanje znanstvenega svetovanja in pomoči pri protokolu sponzorjem med raziskavami in razvojem zdravil.
He joined the EMEA in 1995 as principal scientific administrator and from 1996 to 1998 he was head of sector for new chemical substances.
1995 kot odgovorni znanstveni administrator, od leta 1996 do 1998 pa je bil vodja sektorja za nove kemične snovi.
Organisation of a dedicated workshop in the field of human medicines to discuss information and communication issues with healthcare professionals
Organiziranje namenske delavnice na področju zdravil za ljudi, da se z zdravstvenimi strokovnjaki obravnavajo vprašanja obveščanja in sporočanja.
Postgraduate degrees in tropical medicine, clinical research and epidemiology.
Podiplomski študij iz tropske medicine, kliničnih raziskav in epidemiologije.
Invented Name Review Group
Skupina za presojo izmišljenih imen
Electronic reporting of adverse reactions in the veterinary sector will begin in January 2005 for the competent authorities, which will see a growth in development of electronic reporting by marketing authorisation holders as well
Januarja 2005 bodo pristojni organi začeli izvajati elektronsko poročanje o neželenih učinkih v veterinarskem sektorju, povečal se bo tudi obseg elektronskega poročanja imetnikov dovoljenj za promet z zdravilom.
Consolidation of the new Staff Regulations
Utrditev novih kadrovskih predpisov.
TEMPORARY POSTS
ZAČASNA DELOVNA MESTA
Type I variations continue to grow in line with total marketing authorisations, with 25 anticipated for 2005.
Število vlog za spremembe tipa I še naprej narašča v skladu s skupnim številom izdanih dovoljenj, za leto 2005 se jih pričakuje 25.
Education: Degree in analytical chemistry from the University of Amsterdam, 1984, followed by a PhD in biochemistry from the University of Amsterdam, 1988.
Izobrazba: Diplomiral iz analitične kemije na Univerzi v Amsterdamu leta 1984, sledil je doktorat iz biokemije na Univerzi v Amsterdamu leta 1988
Postgraduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Podiplomsko usposabljanje iz interne medicine, endokrinologije, diabetologije in kardiologije.
He was director of medical affairs of the French pharmaceutical trade association from 1985 to 1993 and returned to industry until 1994.
Od 1985 do 1993 je bil direktor za zdravstvene zadeve francoskega farmacevtskega panožnega združenja, nato pa se je do leta 1994 vrnil v farmacevtsko industrijo.
Internal guideline to be developed
Pripravi se notranja smernica
Finalisation of recommendations under development by the EMEA/CHMP Working Party with Patients' Organisations
Dokončno oblikovanje priporočil, ki jih razvija Delovna skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov.
To provide support to the implementation of the clinical trials legislation, in particular with respect to GCP inspection
Zagotavljati podporo izvajanju zakonodaje o kliničnem preizkušanju, zlasti v zvezi z inšpekcijskimi pregledi dobre klinične prakse.
To prepare for provision of specialised support to small and medium-sized companies
Pripraviti se na zagotavljanje posebne podpore majhnim in srednje velikim podjetjem.
The continuing responsibility for the organisation and support of the Veterinary Joint Implementation Group, the coordination of training, and the management of registration applications for access to EudraVigilance, as well as data collection, analysis, reporting and communication of electronic adverse reactions received from 1 January 2005, will place significant burdens on the small pharmacovigilance group in the veterinary sector.
Stalna odgovornost za organiziranje in podporo veterinarski skupini za skupno izvajanje, usklajevanje usposabljanja, obravnavanje vlog za registracijo za dostop do EudraVigilance, zbiranje podatkov, analiziranje ter poročanje in obveščanje o neželenih učinkih, prejetih v elektronski obliki po 1. januarju 2005, bo precej obremenila majhno skupino za farmakovigilanco
Work programme for the European Medicines Agency
Delovni program Evropske agencije za zdravila
He joined the EMEA in August 1996 as head of sector for biotechnology and biologicals.
EMEA se je pridružil avgusta 1996 kot vodja Sektorja za biotehnološke in biološke izdelke.
Education: Graduate in chemical engineering from the Technical University of Denmark.
Izobrazba: Diplomirala je iz kemijskega inženiringa na Tehnični univerzi na Danskem.
26 May
26. maj
Member of the UK Royal College of Veterinary Surgeons.
Članica Kraljevske akadenmije veterinarjev v Združenem kraljestvu.
3.5 Pharmacovigilance and maintenance activities
3.5 Farmakovigilanca in vzdrževalne dejavnosti
Therefore, there will be increased follow-up and assessment of designation criteria at the time of marketing authorisation
Zato se bo med izdajanjem dovoljenja za promet bolj spremljalo in ocenjevalo merila za določitev.
Marijke Korteweg, Integrated quality management adviser, b. 29 May 1947, n. Belgian
Marijke Korteweg, svetovalka za integrirano upravljanje kakovosti, roj. 29. maja 1947,
Annex 5 Profiles of EMEA personalities
Priloga 5 Osnovni podatki o osebju EMEA
Career to date: Tim Buxton completed articles with Touche Ross & Co. in London in 1987.
Dosedanja poklicna pot: Tim Buxton je leta 1987 opravil pripravništvo pri Touche Ross & Co v
He is a former Belgian member of both the CPMP and CVMP and representative on the Pharmaceutical Committee, Standing Committee and Notice to Applicants working group.
CPMP in CVMP in predstavnik v Farmacevtskem odboru, Stalnem odboru in Delovni skupini za obvestila vlagateljem.
To be finalised (with SWP) following end of public consultation
Dokončno se oblikuje (skupaj z delovno skupino za varnost) po zaključenem javnem posvetovanju
Core SPC released for further consultation in 2004 and to be finalised in 2005
Osnovni SPC sproščen za nadaljnje posvetovanje leta 2004 in predvidoma dokončno oblikovan leta 2005
Dr Tsintis joined the EMEA as head of sector, pharmacovigilance and post-authorisation safety and efficacy of medicines in March
Dr. Tsintis se je EMEA pridružil kot vodja Sektorja za farmakovigilanco ter varnost in učinkovitost zdravil po izdaji dovoljenja za promet marca 2002.
6.1 Administration
6.1 Upravljanje
He was appointed a member of the CHMP in 1997.
Leta 1997 je bil imenovan za člana CPMP.
As part of this plan: 9 The Agency will carry out additional work to considerably widen the original scope of the EuroPharm database of information on all medicines authorised in the EU.
Agencija bo opravila dodatno delo za precejšnjo razširitev prvotnega obsega zbirke podatkov EuroPharm o informacijah o vseh zdravilih v EU z dovoljenjem za promet.
The certification of these Master Files in a system analogous to the centralised procedure leads to the issuance by the EMEA of a certificate of compliance with Community legislation that is valid throughout the European Community.
Certificiranje teh glavnih dosjejev v sistem, podoben centraliziranemu postopku, vodi k izdaji potrdila o skladnosti z zakonodajo
PhD in public health from the University of Bordeaux.
Doktoriral iz javnega zdravja na Univerzi v Bordeauxu.
Guideline on the clinical requirements for locally applied, locally acting products containing known constituents
Guideline on the clinical requirements for locally applied, locally acting
Key initiatives:
Ključne pobude:
Career to date: From 1973 to 1979, Professor Wahlroos served as a pharmacist and a researcher in several pharmacies, at the University of Helsinki and in the pharmaceutical industry.
Dosedanja poklicna pot: Od 1973 do 1979 je prof. Wahlroos delal kot farmacevt in raziskovalec v več lekarnah, na Univerzi v Helsinkih in farmacevtski industriji.
In anticipation of the EU legislation on paediatric medicines, which could be adopted in 2006, the Agency will continue to support the Paediatric Working Party in its work with individual companies to discuss the development of paediatric formulations and its work on the availability of information on medicines for use in children
Agencija bo v pričakovanju zakonodaje EU za otroška zdravila, ki bi bila lahko sprejeta leta 2006, še naprej podpirala Pediatrično delovno skupino in njeno delo s posameznimi podjetji zaradi
Under discussion in view of revised pharmaceutical legislation
V razpravi zaradi spremenjene farmacevtske zakonodaje
Special EU contribution for IT Telematics strategy
Splošni prispevek EU Posebni prispevek EU za IT in telematsko strategijo
Education: Master's degree in business administration from the Institut Superieur de Gestion in Paris.
Izobrazba: Magisterij iz poslovne administracije na Inštitutu Superieur de Gestion v Parizu.
He joined the EMEA in August 1996 as head of sector for regulatory affairs and pharmacovigilance and was appointed head of the Human Medicines Evaluation Unit in September 2000.
EMEA se je pridružil avgusta 1996 kot vodja Sektorja za regulativne zadeve in farmakovigilanco, septembra 2000 pa je bil imenovan za vodjo Enote za vrednotenje zdravil za ljudi.