natgillin/translations-raw huggingface dataset:
The Committee on Herbal Medicinal Products The Committee on Herbal Medicinal Products (HMPC) will meet six times in 2005.
Odbor za zeliščna zdravila (Committe on Herbal Medicinal Poducts, HMPC) se bo leta 2005 sestal šestkrat.
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
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.
Further strengthening and maintenance of the quality assurance system in relation to the management of procedures and CHMP activities
Nadaljnja krepitev in vzdrževanje sistema zagotavljanja kakovosti za vodenje postopkov in dejavnosti CHMP.
Key initiatives in this area:
Ključne pobude na tem področju:
The Agency is in the process of revising its practices to make such information more understandable and accessible for both patients and healthcare professionals.
Agencija izvaja revizijo svojih postopkov, da bi bile takšne informacije razumljivejše ter dostopnejše bolnikom in zdravstvenim strokovnjakom.
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.
Dr. Brasseur je tudi veliko poučeval in je trenutno profesor prehrane in z njo povezanih bolezni na Neodvisni univerzi v Bruslju.
Implementation of the guideline on the provision of scientific opinions in the context of cooperation with the WHO
Izvajanje smernic za zagotavljanje znanstvenih mnenj v okviru sodelovanja s Svetovno zdravstveno organizacijo.
He co-founded the International Alliance of Patient Organisations (IAPO) based in London, and served as vice-chairman from 1997 to 2000.
Bil je soustanovitelj Mednarodne zveze organizacij bolnikov (IAPO) s sedežem v Londonu in bil od leta 1997 do 2000 njen podpredsednik.
This relates to the provision of scientific advice to sponsors during the research and development of medicinal products.
To se nanaša na zagotavljanje znanstvenega svetovanja sponzorjem med raziskavami in razvojem zdravil.
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
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.
To improve scientific and regulatory consistency of opinions, adhere to regulatory timelines, and continue strengthening the operation of the initial evaluation procedure
Izboljšati znanstveno in regulativno skladnost mnenj, ob upoštevanju predpisanih rokov, in nadaljevati s krepitvijo delovanja postopka začetnega vrednotenja.
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
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.
Preparatory work to provide access to dedicated information contained in the EudraVigilance database to healthcare professionals, marketing authorisation holders and the public.
Pripravljalno delo, ki naj zagotovi dostop do namenskih informacij iz zbirke podatkov EudraVigilance zdravstvenim strokovnjakom, imetnikom dovoljenja za promet z zdravilom in javnosti.
To further implement the EMEA risk management strategy, as part of the EU risk management strategy
Nadaljevati izvajanje strategije EMEA za obvladovanje tveganja kot sestavnega dela strategije
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
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.
Impact of new approach to WHO cooperation in the context of the certification scheme
Vpliv novega pristopa k sodelovanju s Svetovno zdravstveno organizacijo v okviru certifikacijskega sistema.
50 % of fees for post-authorisation applications and annual fees
50 % pristojbin za vloge po izdaji dovoljenja za promet in letne pristojbine.
In 1992, he became professor of clinical pharmacology and therapeutics and director of the masters/diploma course on European registration of medicinal products (UAB).
Leta 1992 je postal profesor klinične farmakologije in terapevtike ter direktor magistrskega/diplomskega študija Evropska registracija zdravil (UAB).
To consider new and innovative ways of applying technological solutions to conducting meetings, including promoting greater use of videoconferencing and web streaming
Preučiti nove in inovativne načine uporabe tehnoloških rešitev pri vodenju sestankov, vključno s spodbujanjem večje uporabe prenašanja prek videokonference in neprekinjenega pretoka po spletu.
50 % of fees for initial applications for marketing authorisations and inspections
50 % pristojbin za začetne vloge za izdajo dovoljenja za promet in nadzor,
Emphasis is put on transparency, communication and information on pharmacovigilance issues.
Poudarjeni so preglednost, sporočanje in obveščanje o vprašanjih farmakovigilance.
Establishment of a working party with the Heads of Medicines Agencies to address transparency and communication policy issues of the network
Ustanovitev delovne skupine iz vodij agencij za zdravila, ki bo obravnavala vprašanja, povezana s politiko preglednosti in obveščanja v mreži.
In 1984, he joined the Veterinary Medicines Laboratory in Fougères where he was assessor and rapporteur for marketing authorisation dossiers.
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.
To process parallel distribution notifications in accordance with the EMEA procedure and adhering to regulatory timelines
Obravnavati obvestila o vzporedni distribuciji v skladu s postopkom EMEA in ob upoštevanju predpisanih rokov.
The goal is to shorten the procedure time for safety referrals
Cilj je skrajšati čas postopka za predložitve v zvezi z varnostnimi vprašanji.
Considerations of the Scientific group to be prepared during 2005
Premisleki Znanstvene skupine se pripravijo v letu 2005
Reporting and feedback on pharmacovigilance issues relating to centralised procedures to the Member States, interested parties and the public
Poročanje in povratne informacije o vprašanjih farmakovigilance, ki se nanašajo na centralizirane postopke, za države članice, zainteresirane skupine in javnost.
Specialist in endocrinology and metabolic diseases.
Specialistka za endokrinologijo in metabolične bolezni.
The Agency plans to re-engineer and reinforce its processes related to meeting management.
Agencija namerava preoblikovati in okrepiti svoj postopek vodenja sestankov.
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.
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.
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.
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.
Possible revision in 2005
Možna revizija v letu 2005
Interaction between the CHMP and healthcare professionals and learned societies will be further developed.
Vzajemno delovanje med CHMP ter zdravstvenimi strokovnjaki in znanstvenimi združenji se bo še naprej razvijalo.
EU telematics strategy and information technology
Telematska strategija EU in informacijska tehnologija
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
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.
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
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.
He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994.
Od leta 1982 do 1994 je bil višji farmacevtski svetovalec za švedski program zdravstvenega sodelovanja v Vietnamu.
The new scope encompasses medicines intended for self-medication, generic products of centrally authorised medicinal products, and biosimilar medicinal products.
Nov obseg zajema zdravila, namenjena za samozdravljenje, generična zdravila, odobrena po centraliziranem postopku, in biološko podobna zdravila.
Introduction of the following new procedures foreseen in the new legislation: conditional marketing authorisation, accelerated assessment and compassionate use
Uvedba naslednjih novih postopkov, ki jih predvideva nova zakonodaja: pogojna izdaja dovoljenja za promet z zdravilom, pospešena ocena in sočutna uporaba.
Career to date: From 1971 to 1974, Mr O'Malley completed articles in Dublin.
Dosedanja poklicna pot: Od 1971 do 1974 je g. O'Malley opravljal pripravništvo v Dublinu.
Postgraduate qualifications in internal medicine (FRCP) and pharmaceutical medicine (FFPM).
Podiplomski študij iz interne medicine (FRCP) in farmacevtske medicine (FFPM).
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.
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.
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
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.
1.3 EMEA Road Map to 2010
1.3 Usmeritveni načrt ("Road Map") EMEA do 2010
He joined the Swedish Medicinal Products Agency in 1990, serving as director of operations and later as deputy director-general.
Leta 1990 se je pridružil švedski Agenciji za zdravila, kjer je bil poslovni direktor in kasneje namestnik generalnega direktorja.
Consequently, growing demands from the public and interested parties for access to the documents held by the Agency will have procedural and resource implications.
Zato bo povečano povpraševanje javnosti in zainteresiranih strani po dostopu do dokumentov, ki jih ima Agencija, vplivalo na postopke in vire.
Revision to be released for public consultation by April 2005
Revizija se da v javno posvetovanje do aprila 2005
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
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.
Postgraduate studies in nutrition, statistics and methodology.
Podiplomski študij iz prehrane, statistike in metodologije.
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.
"posebne oblike zdravljenja", ki je pristojen za farmacevtsko in klinično ocenjevanje zeliščnih, homeopatskih in antropozofskih izdelkov.
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).
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).
Revision of the safety referral process in order to shorten the timeframe for finalisation of safety referral procedures
Revizija postopka za predložitev v zvezi z varnostnimi vprašanji, da se skrajša časovni okvir za dokončanje postopkov za predložitev v zvezi z varnostnimi vprašanji.
2.9 Regulatory activities
2.9 Regulativne dejavnosti
He has three daughters, the eldest of whom is affected by cystic fibrosis.
najstarejša ima cistično fibrozo.
Dr Korteweg joined the EMEA in August 1997 and has acted as EMEA quality manager since July 1998.
Dr. Kortewegova se je EMEA pridružila avgusta 1997 in je od julija 1998 njena direktorica za kakovost.
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.
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.
For enquiries concerning VAMF certificates
Za vprašanja o potrdilih VAMF
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
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.
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.
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
Implementation of a first production version of the PIM system for 21 November 2005
Začetek izvajanja prve proizvodne različice sistema upravljanja informacij o izdelkih 21. novembra 2005.
2.11 International activities
2.11 Mednarodne dejavnosti
The Veterinary Unit will liaise closely with the Center for Veterinary Medicines (CVM) in the US Food and Drug Administration and with the United States Department of Agriculture to implement practical arrangements for advancing the Confidentiality Arrangements for exchange of information and documents agreed between the US and EU in late 2004.
Veterinarska enota se bo tesno povezala s Centrom za veterinarska zdravila pri Upravi za hrano in zdravila ZDA ter z ameriškim ministrstvom za kmetijstvo pri izvajanju praktičnih rešitev za napredovanje pri dogovorih o zaupnosti za izmenjavo informacij in dokumentov, ki sta jih sklenili
Overall workload to increase compared to 2004
Povečanje celotne delovne obremenitve v primerjavi z letom 2004.
She joined the EMEA Management Board in the same year, was elected vice-chairman in 2003 and re-elected vice-chairman following the EU enlargement in 2004.
V istem letu se je pridružila upravnemu odboru EMEA in bila leta 2003 izvoljena za podpredsednico, leta 2004 po širitvi pa ponovno izvoljena za podpredsednico.
The increase is due in part to inspections in the context of plasma master file and vaccine antigen master file certification, but also to the effect of an increase in applications at the end of 2004
Razlog za povečanje so deloma inšpekcijski pregledi v okviru certificiranja glavnega dosjeja plazme in glavnega dosjeja virusnih antigenov, deloma pa povečanje števila vlog konec leta 2004.
The performance indicator for this activity is the mean time between the start of the procedure and adoption of the advice letter.
Kazalnik uspešnosti za to dejavnost je povprečni čas, ki poteče od začetka postopka do prejema obvestila o svetovanju.
Increase in the number of travel and hotel booking requests to manage
Povečanje števila zahtev za organiziranje potovanj in hotelske rezervacije.
Identification of areas for further improvement and implementation of necessary corrective actions
Določiti področja, na katerih je treba nadaljevati izboljšave in začeti izvajati potrebne popravne ukrepe.
Numbers of certificate requests are expected to continue to increase as the pool of centrally authorised products is growing.
Število zahtevkov za izdajo potrdil se bo predvidoma še naprej povečevalo, hkrati s povečevanjem števila centralno odobrenih izdelkov.
To provide support for the integration of new Member States in the GMP, GCP and GLP work of the Agency and to contribute to international cooperation and harmonisation activities
Zagotavljati podporo pri vključevanju novih držav članic v delo Agencije na področju dobre proizvodne, klinične in laboraorijske prakse ter prispevati k mednarodnemu sodelovanju in dejavnostim usklajevanja.
The new legislation sets out the legal basis and enhanced responsibilities for the Agency in the area of scientific advice.
Nova zakonodaja določa pravno podlago znanstvenemu svetovanju in večje pristojnosti Agencije na tem področju.
The main objective for 2005 is to manage the increased workload and issue certificates according to required timelines.
Glavni cilj za leto 2005 je obvladovati povečano delovno obremenitev in izdajati potrdila v predpisanih rokih.
To perform high-quality activities in the field of pharmacovigilance and adhere to required timelines
Izvajati visoko kakovostne dejavnosti na področju farmakovigilance in upoštevati zahtevane roke.
Requirement to produce financial accounts based on generally accepted accounting principles by
Zahteva, da se z letom 2005 začnejo pripravljati finančna poročila na podlagi splošno sprejetih računovodskih načel.
Authorised for 2004 Requested for 2005
Odobreno za 2004 Zahteve za 2005
Completion of the construction of an EU telematics data centre with high availability, high scalability and good performance
Dokončna izgradnja telematskega podatkovnega centra EU z visoko stopnjo razpoložljivosti,
Interaction and participation through scientific meetings and training with the WHO
Vzajemno delovanje in udeležba v Svetovni zdravstveni organizaciji prek znanstvenih srečanj in usposabljanja.
Support the implementation activities relating to GCP inspections under the Clinical Trials Directive 2001/20/EC for human medicines and the directive on GCP, in particular the implementation of the second phase of the EudraCT database
Podpora izvedbenim dejavnostim, povezanim z inšpekcijskimi pregledi dobre klinične prakse, v skladu z Direktivo 2001/20/ES o kliničnem preizkušanju zdravil za ljudi ter direktivo o dobri klinični praksi, in zlasti izvajanju druge faze zbirke podatkov EudraCT.
Education: Diploma in conference interpretation and translation from Scuola Superiore per Interpreti, Milan.
Izobrazba: Diplomiral iz konferenčnega tolmačenja in prevajanja na Scuoli Superiore per Interpreti v Milanu.
Career to date: From 1972 to 1974, Dr Purves worked in the pharmaceutical industry.
Dosedanja poklicna pot: Od 1972 do 1974 je dr. Purves delal v farmacevtski industriji.
The CHMP will meet 11 times in 2005.
CHMP bo leta 2005 zasedal enajstkrat.
Reinforcement of the scientific advice procedure to better address post-authorisation safetyrelated aspects
Krepitev znanstveno svetovalnega postopka za boljše obravnavanje varnostnih vidikov po izdaji dovoljenja.
Establishment of a database to facilitate scientific memory analysis for all centralised applications submitted in the past 10 years, and for future applications, to allow for greater integrity, scientific quality and consistency of CVMP assessment reports
Vzpostavitev zbirke podatkov zaradi lažjega analiziranja znanstvenega pomnilnika za vse vloge, predložene po centraliziranem postopku v zadnjih desetih letih, in za prihodnje vloge, da se omogoči večja celovitost, znanstvena kakovost in skladnost poročil CVMP o oceni zdravila.
Contribute to EU public health strategies, including those relating to influenza pandemics, tissueengineered products and paediatric medicines
Prispevanje k strategijam EU za javno zdravje, vključno s strategijami za epidemije gripe, izdelke inženiringa tkiv in zdravila za otroke.
Following graduation with an MBA degree in 1991, she joined EFPIA, the European pharmaceutical industry association, as manager of scientific and regulatory affairs.
MBA leta 1991 se je pridružila EFPIA, združenju evropske farmacevtske industrije kot vodja znanstvenih in regulativnih zadev.
In 1995 she joined the French Medicines Agency as head of unit for pharmaco-toxico-clinical assessment.
Leta 1995 se je pridružila francoski Agenciji za zdravila kot vodja Enote za farmako-toksiko-klinično ocenjevanje.
The legislation places emphasis on transparency, communication and provision of information on pharmacovigilance issues.
V zakonodaji so poudarjeni preglednost, sporočanje in obveščanje o vprašanjih farmakovigilance.
The working parties of the EMEA scientific committees responsible for medicinal products for human use are involved in the development and revision of guidelines, in the provision of recommendations and advice on medicinal products for which applications are made, and in marketing authorisation or post-authorisation activities, according to the specific area of responsibility of each group.
Delovne skupine znanstvenih odborov EMEA, pristojne za zdravila za uporabo v humani medicini, so vključene v pripravo in revizijo smernic, zagotavljanje priporočil in nasvetov glede zdravil, za katera so oddane vloge, dejavnosti med pridobivanjem dovoljenja za promet in dejavnosti po izdaji tega dovoljenja, v skladu s posebnim področjem pristojnosti posameznih skupin.
Career to date: From 1978 to 1983, research fellow at the State University of Rome on projects in the area of clinical immunology, oncology and cellular immunology.
Dosedanja poklicna pot: Od leta 1978 do 1983 znanstvena sodelavka na Državni univerzi v Rimu pri projektih s področja klinične imunologije, onkologije in celične imunologije.
Publication of summaries of opinion for those post-authorisation activities which have an important impact on the use of the medicinal product; regular updating of European public assessment reports and publication of press releases regarding major post-authorisation activities
Objava povzetkov mnenj o tistih dejavnostih po izdaji dovoljenja, ki pomembno vplivajo na uporabo zdravila, sprotno dopolnjevanje evropskih javnih poročil o oceni ter objava sporočil za javnost o pomembnih dejavnostih po izdaji dovoljenja.