natgillin/translations-raw huggingface dataset:
The number of initial applications for a marketing authorisation is expected to stabilise in 2005.
Število začetnih vlog za izdajo dovoljenja za promet z zdravilom se bo predvidoma v letu 2005 ustalilo.
Postgraduate diploma in European Community law from King's College London.
Dokončala podiplomski študij iz zakonodaje Evropske skupnosti na Kraljevem kolidžu v Londonu.
9 To provide for safe use of medicinal products, the Agency will reinforce its activities in the area of pharmacovigilance, in particular the EudraVigilance database and the implementation of the EMEA risk management strategy for medicines for human use.
Agencija bo za zagotovitev varne uporabe zdravil okrepila svoje dejavnosti na področju farmakovigilance, zlasti pri zbirki podatkov EudraVigilance in izvajanju strategije obvladovanja tveganja pri zdravilih za uporabo v humani medicini.
He was appointed acting deputy head of sector for scientific advice and orphan drugs in October 2004.
Oktobra 2004 je bil imenovan za vršilca dolžnosti namestnika vodje Sektorja za znanstveno svetovanje in zdravila sirote.
Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b. 12 December 1961, n. Irish
Tony Humphreys, vodja Sektorja za regulativne zadeve in organizacijsko podporo, roj. 12. decembra 1961, po narodnosti Irec
Implementation of the EU risk management strategy
Izvajanje strategije EU za obvladovanje tveganja.
The achievement of these objectives will be monitored through key performance indicators, such as systems availability, response times and on-time delivery, within budget and to specifications, for new or improved information systems
Doseganje teh ciljev bodo pri novih ali izboljšanih informacijskih sistemih spremljali ključni kazalniki uspeha, kot so dostopnost sistemov, odzivni čas in pravočasna dostava v okviru proračuna in po specifikacijah.
The legislative basis of pharmacovigilance inspections is now provided.
Zakonska podlaga inšpekcijskih pregledov farmakovigilance je zdaj zagotovljena.
Career to date: Ms Cooke worked in a number of positions within the Irish pharmaceutical industry before joining the Irish Medicines Board as a pharmaceutical assessor in 1988.
Cooke je imela več služb v irski farmacevtski industriji, preden se je 1988 pridružila Irskemu odboru za zdravila kot ocenjevalka farmacevtskih izdelkov.
From 1990 to 1994, he was technical counsellor in clinical evaluation and pharmacology at the Spanish Ministry of Health, a member of the CPMP Efficacy Working Party and involved in the Efficacy Group of the ICH.
do 1994 je bil tehnični svetovalec za klinično ocenjevanje in farmakologijo pri španskem Ministrstvu za zdravje, član Delovne skupine CPMP za učinkovitost, sodeloval je tudi pri Skupini ICH za učinkovitost.
Priorities for medicines for human use in 2005:
Prednostne naloge zdravil za uporabo v humani medicini v letu 2005:
Category & Grade
Skupina in stopnja
Education: Qualified pharmacist and degree in medicine and surgery from the University of Barcelona, as well as postgraduate courses in pharmacology and toxicology, public health and European institutions.
Izobrazba: Diplomiral iz farmacije ter medicine in kirurgije na Univerzi v Barceloni, podiplomski študij iz farmakologije in toksikologije, javnega zdravja in evropskih institucij.
The legislative basis for pharmacovigilance inspections is now provided.
Zakonska podlaga za inšpekcijske preglede farmakovigilance je zdaj zagotovljena.
Dr Pittner joined the Herbal Medicinal Products Working Party (HMPWP) in 1999 and was vice-chairman of the HMPWP from 2002 until 2004.
1999 pridružil Delovni skupini za zeliščna zdravila (HMPWP) in bil od 2002 do 2004 njen podpredsednik.
The performance indicator for this objective is the percentage of applications evaluated within the 30, 60 or 90-day timeline (depending on the procedure).
Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v 30-, 60- ali 90-dnevnem roku (odvisno od postopka).
Josep Torrent i Farnell, Chairman of the COMP, b. 2 May 1954, n. Spanish
Josep Torrent i Farnell, predsednik COMP, roj. 2. maja 1954, po narodnosti Španec
Education: Qualified as a medical doctor in Rome in July 1978.
Izobrazba: Diplomirala iz splošne medicine julija 1978 v Rimu.
To provide timely and understandable product information to patients and healthcare professionals
Zagotavljati pravočasne in razumljive informacije o izdelkih bolnikom in zdravstvenim strokovnjakom.
Miss Leivers joined the EMEA in February 1996 and was appointed deputy head of sector in June 2001.
Gospodična Leiversova se je EMEA pridružila februarja 1996 in bila junija 2001 imenovana za namestnico vodje Sektorja.
Enhancement of liaison with working parties of CHMP and scientific advisory groups
Okrepitev povezovanja z delovnimi skupinami CHMP in znanstveno svetovalnimi skupinami.
He has been a CVMP member since 1997; he was elected vice-chairman of the CVMP in 2001.
Član CVMP je od leta 1997, leta 2001 je bil izvoljen za njegovega podpredsednika.
He moved briefly to the pharmaceutical industry from 1986 to 1987, before returning to clinical work at the Queen Fabiola Children's University Hospital in Brussels as head of the nutrition and pharmacodynamics unit, a post he continues to hold today.
preden se je vrnil h kliničnemu delu v Univerzitetni otroški bolnišnici kraljice Fabiole v Bruslju kot vodja enote za prehrano in farmakodinamiko; na tem delovnem mestu je še danes.
To be finalised following end of consultation, the revision and update of 3AQ10a
Dokončno se oblikuje po zaključenem posvetovanju, revizija in posodobitev
As a result of the initiatives in the area of transparency and communication, patients, healthcare professionals, academia, learned societies, the pharmaceutical industry and other stakeholders will have faster, easier access to a wider range of information regarding the activities of the Agency and the network.
akademski sveti, poklicna združenja, farmacevtska industrija in druge zainteresirane strani hitrejši in enostavnejši dostop do večjega obsega informacij o dejavnostih Agencije in mreži.
He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Leta 1997 se je pridružil farmacevtskemu inšpektoratu belgijskega ministrstva za javno zdravje kot vodja ocenjevalcev zdravil.
25-28 July
25.-28. julij
Publication of summaries of opinion at the time of adoption by the CVMP Regular updating of EPARs in the post-authorisation phase for procedural and scientific aspects
Redno posodabljanje poročil EPAR v fazi po izdaji dovoljenja zaradi postopkovnih in znanstvenih vidikov.
He joined the EMEA as head of the legal sector in November 2004.
EMEA se je pridružil novembra 2004 kot vodja Pravnega sektorja.
Martin Harvey Allchurch, Head of Executive Support, b. 20 October 1966, n. British
Martin Harvey Allchurch, vodja izvršne podpore, roj. 20. oktobra 1966, po narodnosti Britanec
In addition to general harmonisation work on approaches to GCP inspection, focus will be on consolidation of procedures to support the implementation of the Clinical Trials Directive and the Commission directive on GCP.
Osrednja pozornost bo usmerjena k splošnemu usklajevalnemu delu pri pristopih inšpekcije za dobro klinično prakso in h konsolidaciji postopkov, da se podpre izvajanje direktive o kliničnem preizkušanju in direktive Komisije odobri klinični praksi.
Core SPC released for 6 months' consultation in 2003 and to be finalised in early 2005
Osnovni SPC dan v 6-mesečno posvetovanje leta 2003 in dokončno oblikovan predvidoma na začetku leta
3.6 Arbitration and Community referrals
3.6 Arbitraža in predložitve Skupnosti
Education: Graduated in veterinary medicine from the faculty of veterinary science at Liverpool University and is a member of the Royal College of Veterinary Surgeons of the United Kingdom.
Izobrazba: Diplomiral iz veterinarske medicine na Veterinarski fakulteti Univerze v Liverpoolu, je član Kraljevske akademije veterinarjev Združenega kraljestva.
Variations to marketing authorisations can be either minor (type I) or major (type II) changes.
Spremembe dovoljenj za promet z zdravilom so lahko manjše (tipa I) ali večje
He served on the management board of the French National Agency for Health Evaluation and Hospital Accreditation (ANAES) from 2000 to 2004, and on its executive committee from 2002 to 2004.
Med letoma 2000 in 2004 je bil član upravnega odbora francoske Nacionalne agencije za vrednotenje zdravil in bolnišnično akreditacijo (ANAES), od 2002 do 2004 pa je bil tudi v njenem izvršnem odboru.
Postgraduate studies in cardiology and endocrinology.
Podiplomski študij iz kardiologije in endokrinologije.
Peter Jones, Head of Unit, b. 9 August 1947, n. British
Peter Jones, vodja enote, roj. 9. avgusta 1947, po narodnosti Britanec
The summarised comparative budget statements for 2003 to 2005 are as follows: (Amounts expressed in euro)
Povzetek primerjalnih proračunskih poročil za obdobje 2003-2005 je, kot sledi:
Career to date: From 1977 to 1990, Professor Torrent i Farnell worked in internal medicine and clinical pharmacology in Spain and was assistant professor of pharmacology at the UAB.
Dosedanja poklicna pot: Prof. Torrent i Farnell je od leta 1977 do 1990 delal na področju interne medicine in klinične farmakologije v Španiji in bil profesor asistent farmakologije na UAB.
Continuing responsibility for Veterinary Joint Implementation Group coordination of training and applications for EudraVigilance, as well as data collection, analysis, reporting and communication of electronic adverse reactions received from 1 January 2005
Stalna odgovornost za podporo Veterinarski skupini za skupno izvajanje na področju usklajevanja usposabljanja, vlog za EudraVigilance, zbiranja podatkov, analiziranja, sporočanja in obveščanja o neželenih učinkih, prejetih v elektronski obliki po 1. januarju 2005.
Frances Nuttall, Head of Sector for personnel and budget, b. 11 November 1958, n. Irish
Frances Nuttall, vodja Sektorja za osebje in proračun, roj. 11. novembra 1958, po narodnosti Irka
Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisations.
Dejavnosti po izdaji dovoljenja se nanašajo na spremembe, podaljšanje rokov in prenose dovoljenj za promet z zdravilom.
Emer Cooke, Head of Sector for inspections, b. 9 April 1961, n. Irish
Emer Cooke, vodja Sektorja za inšpekcijske preglede, roj. 9. aprila 1961, po narodnosti Irka
The target is 90 % of summaries published at the time of the press release o percentage of European public assessment reports published within two weeks after Commission decision.
Cilj je 90 % povzetkov, objavljenih hkrati s sporočilom za javnost; o odstotek evropskih javnih poročil o oceni, objavljen v dveh tednih po odločitvi
Noël Wathion, Head of Unit, b. 11 September 1956, n. Belgian
Noël Wathion, vodja enote, roj. 11. septembra 1956, po narodnosti Belgijec
These initiatives include implementation of the concept of risk management plans, expansion of the scope of medicines to be authorised through the centralised procedure, establishment of the accelerated assessment, conditional authorisation and compassionate use procedures, as well as procedures for authorisation of biosimilar and generic products, and support to small and medium-sized enterprises 9 High importance will be attributed to initiatives aimed at increased communication and provision of information to patients, healthcare professionals and the general public
Te pobude vključujejo izvajanje koncepta načrtov za obvladovanje tveganja, razširitev obsega tistih zdravil, katerim se izda dovoljenje za promet po centraliziranem postopku, vzpostavitev postopkov za pospešeno oceno, izdajo pogojnega dovoljenja in sočutno uporabo ter postopkov za izdajo dovoljenja za promet z biološko podobnimi in generičnimi izdelki ter podporo majhnim in srednje velikim podjetjem.
Performance indicators for this objective are: o percentage of summaries of opinion published at the time of publication of the press release following the CVMP meeting.
Kazalnika uspešnosti za ta cilj sta: o odstotek povzetkov mnenj, objavljenih hkrati z objavo sporočila za javnost, ki sledi zasedanju CVMP.
Plasma master files (PMFs) and vaccine antigen master files (VAMFs) are separate documents from the dossier for a marketing authorisation.
Glavni dosje plazme (PMF) in glavni dosje virusnih antigenov (VAMF) sta dokumenta, ločena od dokumentacije za izdajo dovoljenja za promet z zdravilom.
These include activities related to pharmacovigilance information (adverse drug reaction reports and periodic safety update reports).
Sem spadajo dejavnosti, ki se nanašajo na informacije o farmakovigilanci (poročila o neželenih učinkih zdravil (ADR) in periodiočno dopolnjena poročila o varnosti (PSUR)).
Opinions adopted (Output)
Sprejeta mnenja (Izhodni podatek)
She acted as scientific secretary of the Biotechnology Working Party until December 2000.
je bila znanstvena sekretarka Delovne skupine za biotehnologijo.
Revision expected to be released by mid 2005
Revizija se sprosti predvidoma do sredine leta 2005
Career to date: From 1977 to 1986, Dr Le Courtois worked as a general practitioner and as director of a medical centre in Paris.
Dosedanja poklicna pot: Od 1977 do 1986 je dr. Le Courtois delal kot splošni zdravnik in direktor zdravstvenega centra v Parizu.
Work on Concept paper to be continued in 2005
Delo na idejnem dokumentu se nadaljuje leta 2005
The target is to publish 80 % of EPARs within the timeline
Cilj je v roku objaviti 80 % EPAR-ov.
Education: Qualified as a pharmacist from Heriot-Watt University, Edinburgh.
Izobrazba: Diplomirani farmacevt z Univerze Heriot-Watt v Edinburghu.
Career to date: From 1976 to 1986, Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Dosedanja poklicna pot: Od leta 1976 do 1986 je dr. Brasseur delal kot pediater v Univerzitetni bolnišnici Sint Pieter v Bruslju.
He worked also as research assistant in international law at the University of Pavia from 1992 to 1999, as associate professor of international law at the University of Insubria (Varese) from 1999 to 2003, and as chair professor of international law at the same University since 2004.
Delal je tudi kot asistent raziskovalec na področju mednarodnega prava na Univerzi v Pavii od 1992 do 1999, izredni profesor mednarodnega prava na Univerzi v
Kornelia Grein, Head of Sector for safety of veterinary medicines, b. 24 July 1952, n. German
Kornelia Grein, vodja Sektorja za varnost veterinarskih zdravil, roj. 24. julija 1952, po narodnosti Nemka
Safety Working Party
Prispevek delovne skupine za varnost
To be finalised following end of public consultation
Dokončno se oblikuje po zaključenem javnem posvetovanju
The legislation provides for compliance with GMP requirements by manufacturers of active substances and for the establishment of a database containing information on GMP certificates and on manufacturing authorisations.
Zakonodaja predpisuje, da morajo izdelovalci zdravilnih učinkovin upoštevati zahteve zadobro proizvodno prakso, ter vzpostavitev zbirke podatkov, ki bo vsebovala informacije o potrdilih dobre proizvodne prakse in dovoljenjih za izdelavo.
Requests should be sent in writing to the EMEA or to
Pisni zahtevki se pošljejo EMEA
Education: Business studies and languages at Loughborough Polytechnic Career to date: From 1975 to 1990, Mrs Mendosa held a number of posts at the European Commission in Luxembourg, including the Conference Service, the Office for Official Publications and the Statistical Office.
Dosedanja poklicna pot: Od 1975 do 1990 je ga. Mendosa opravljala različne službe v Evropski komisiji v Luksemburgu, med drugim v konferenčni službi, Uradu za javne objave in v Statističnem uradu.
Hannes Wahlroos, Chairman of the Management Board, b. 7 July 1952, n. Finnish
Hannes Wahlroos, predsednik upravnega odbora, roj. 7. julija 1952, po narodnosti Finec
Career to date: From 1976 to 1978, lecturer at the University of Uppsala.
Dosedanja poklicna pot: Od leta 1976 do 1978 predavatelj na Univerzi v Uppsali.
6.3 EMEA document management and publishing
6.3 Vodenje in objavljanje dokumentacije EMEA
She was appointed head of sector for safety and efficacy of medicines in January 2001.
Januarja 2001 je bila imenovana za vodjo Sektorja za varnost in učinkovitost zdravil.
He joined the EMEA in May 1996 and was appointed head of sector for regulatory affairs and operational support in January 2001.
EMEA se je pridružil maja 1996 in bil januarja 2001 imenovan za vodjo Sektorja za regulativne zadeve in operativno podporo.
The performance indicator for this objective is the percentage of products evaluated within the regulatory timeline of 210 days.
Kazalnik uspešnosti za ta cilj je odstotek izdelkov, ovrednotenih v predpisanem roku 210 dni.
Gerard O'Malley, Head of Sector for accounting, b. 14 October 1950, n. Irish
Gerard O'Malley, vodja računovodskega sektorja, roj. 14. oktobra 1950, po narodnosti
60 % increase in the reimbursement of meeting expenses to delegates, national authorities and suppliers
60-odstotno povečanje pri povračilu stroškov, ki so ji imeli v zvezi s sestankom delegati,
Revenue and expenditure overview 2003-2005 Guidelines and working documents in 2005 EMEA contact points
Načrt delovnih mest EMEA za obdobje 2003-2005 Pregled prihodkov in odhodkov v obdobju 2003-2005 Smernice in delovni dokumenti za leto 2005 Kontaktne osebe EMEA
CVMP Pharmacovigilance Working Party (PhVWP-V)
Delovna skupina CVMP za farmakovigilanco (PhVWP-V) Referenčna številka
If revision is needed, revision expected to be released for consultation in 2005 and finalised in 2006
Če se zahteva revizija, se da v posvetovanje predvidoma leta 2005 in zaključi 2006
Career to date: Since qualifying in 1983, Mr Humphreys has worked in the area of development pharmaceutics for a national branded generics manufacturer and an international research and development company.
Dosedanja poklicna pot: Po končanem šolanju leta 1983 je g. Humphreys delal na področju razvoja farmacevtike za izdelovalca generičnih zdravil z nacionalno blagovno znamko ter mednarodno raziskovalno in razvojno družbo.
Provision of accurate and timely financial information to management Implementation of inventory accounting system
Zagotavljanje točnih in pravočasnih finančnih informacij vodstvu.
Preparation of transparency and communication strategies and related policies that set out what, how and when information will be published
Priprava strategij preglednosti in obveščanja ter s tem povezanih politik, v katerih bo določeno,
She participated as UK CVMP member from 1996 until joining the EMEA in July
Bila je predstavnica Združenega kraljestva v CVMP od 1996 do svoje pridružitve EMEA julija 1997.
To be revised as per PhVWP-V work programme for 2005 (VEDDRA subgroup to meet May 05, adoption by PhVWP July 05 & CVMP Sept. 05)
Revidira se v skladu z delovnim programom PhVWP-V za leto 2005 (podskupina VEEDRA, ki naj bi se sestala maja 2005, sprejme pa ga
Communication and action by Member States in response to suspected quality defects relating to centrally authorised medicines are also coordinated by the EMEA.
EMEA usklajuje tudi obveščanje in ukrepanje držav članic kot odgovor na domnevne kakovostne pomanjkljivosti centralno odobrenih zdravil.
PhD in pharmaceutical microbiology from the University of Strathclyde, Glasgow.
Doktoriral je iz farmacevtske mikrobiologije na Univerzi Strathclyde v Glasgowu.
Further to the restructuring of the Human Medicines Evaluation Unit in 2001, he was appointed head of unit for the pre-authorisation evaluation of medicines for human use, in March
Po preoblikovanju Enote za vrednotenje zdravil za ljudi leta 2001 je bil marca 2001 imenovan za vodjo Enote za vrednotenje zdravil za uporabo v humani medicini pred izdajo dovoljenja za promet.
The initial evaluation phase covers a number of EMEA activities ranging from pre-submission discussions with future applicants, through the evaluation by the CVMP, to the granting by the European Commission of the product marketing authorisation.
Faza začetne ocene zajema številne dejavnosti EMEA, ki segajo od razprav z bodočimi vlagatelji pred oddajo vloge, ovrednotenja s strani CVMP do dovoljenja za promet z izdelkom, ki ga izda Evropska komisija.
The Management Board will meet four times in 2005:
Upravni odbor se bo leta 2005 sestal štirikrat: Zasedanja upravnega odbora leta 2005
A pilot implementation of the data warehouse and business intelligence applications for EudraVigilance
Pilotsko izvajanje podatkovnega skladišča in vloge poslovne inteligence za EudraVigilance.
The implementation of a new competence-development policy
izvajanje politike za razvoj novih pristojnosti.
She joined the EMEA as head of sector for inspections in July 2002.
EMEA se je pridružila julija 2002 kot vodja Sektorja za inšpekcijske preglede.
Yann Le Cam, Vice-Chairman of the COMP, b. 15 July 1961, n. French
Yann Le Cam, podpredsednik COMP, roj. 15. julija 1961, po narodnosti Francoz
In 1998 he was coordinator-director for the creation of the Spanish Medicines Agency and executive director of the Spanish Medicines Agency from 1999 to 2000.
Leta 1998 je bil direktor koordinator za ustanovitev španske Agencije za zdravila, od
Career to date: From 1988 to 1992, Dr Brosch worked as an assistant professor at the department of pharmacology and toxicology at the University of Vienna, where she specialised in electrophysiology.
Dosedanja poklicna pot: Od leta 1988 do 1992 je dr. Broscheva delala kot profesorica asistentka na Oddelku za farmakologijo in toksikologijo Univerze na Dunaju, kjer je specializirala iz elektrofiziologije.
Jill Ashley-Smith, Head of Sector for veterinary marketing authorisation procedures, b. 18 December 1962, n. British
Jill Ashley-Smith, vodja Sektorja za postopke za izdajo dovoljenja za promet z veterinarskimi zdravili, roj. 18. decembra 1962, po narodnosti Britanka
To provide high-quality service, including extended helpdesk facilities, of EU telematics to the EMEA's partners on an ongoing basis.
Stalno zagotavljati visoko kakovostno storitev telematike EU partnerjem EMEA, vključno s povečanimi zmogljivostmi za pomoč uporabnikom.
Eric Abadie, Vice-Chairman of the CHMP, b. 14 July 1950, n. French
Eric Abadie, podpredsednik CHMP, roj. 14. julij 1950, po narodnosti Francoz
27-28 January
27.-28. januar
Increase in workload as a result of the EU enlargement (handling of product information in 20 EU languages and possibility for additional referral procedures) and Commission decisions which involve specific commitments (pre-clinical trials, clinical trials, PSURs, post-marketing studies, registries) that need adequate follow-up
EU in možnost dodatnih postopkov za predložitev) in sklepov Komisije, ki vključujejo posebne zahteve (predklinično preizkušanje, klinično preizkušanje, PSUR-i, študije po izdaji dovoljenja za promet, registri), ki jih je treba spremljati.
Board-certified specialist in pharmacology and toxicology (Bavarian Chamber of Physicians).
Specialist s certifikatom iz farmakologije in toksikologije (Bavarska zdravniška zbornica).
CVMP Scientific Advisory Group on Antimicrobials
Znanstveno svetovalna skupina CVMP za protimikrobna sredstva Referenčna številka
The EMEA publishes a European public assessment report (EPAR) once the Commission decision has been taken.
Ko Komisija sprejme svojo odločitev, EMEA objavi evropsko javno poročilo o oceni zdravila (EPAR).
Sylvie Bénéfice, Head of Sector for meeting management and conferences, b. 28 December 1954, n. French
Sylvie Bénéfice, vodja Sektorja za vodenje sestankov in konferenc, roj. 28. decembra 1954, po narodnosti Francozinja
Adopted by EWP in October 04, under discussion at CVMP
Sprejel jo je EWP oktobra 2004 po razpravi v CVMP
Vincenzo Salvatore, Head of Legal Sector, b. 8 August 1963, n. Italian
Vincenzo Salvatore, vodja Pravnega sektorja, roj. 8. avgusta 1963, po narodnosti
Key initiatives to meet the objectives:
Ključne pobude za izpolnitev ciljev:
17-20 January
17.-20. januar
Riccardo Ettore, Deputy Head of Sector for information technology, b. 8 April 1953, n. Italian
Riccardo Ettore, namestnik vodje Sektorja za informacijsko tehnologijo, roj. 8. aprila 1953, po narodnosti Italijan
3.2 Initial evaluation
3.2 Začetna ocena