natgillin/translations-raw huggingface dataset:
In 1986 he joined the University of Bordeaux and was involved in various research areas in public health, including epidemiology, clinical research, pharmacovigilance, tropical and infectious diseases, health economy and health education.
Leta 1986 se je pridružil Univerzi v Bordeauxu in se začel ukvarjati z raziskovanjem javnega zdravja, vključno z epidemiologijo, kliničnimi raziskavami, farmakovigilanco, tropskimi in nalezljivimi boleznimi, zdravstveno ekonomijo in zdravstvenim izobraževanjem.
Monitor the assessment procedures for PMFs and VAMFs, and review the procedures on the basis of experience gained
Spremljati postopke presoje za PMF in VAMF ter preverjati postopke na podlagi pridobljenih izkušenj.
This includes making multilingual navigation possible and improving presentation, user friendliness and search tools
To vključuje možnost večjezične navigacije ter izboljšanje predstavitve, da bo bolj prijazna do uporabnikov, in iskalnih orodij.
The Agency will continue to work closely with the relevant European institutions in the field of veterinary medicinal products, particularly the European Commission, and will work to increase the level of collaboration already established with the European Food Safety Authority during the previous year.
Institucije EU in regulativne zadeve Agencija bo še naprej tesno sodelovala s pristojnimi evropskimi institucijami na področju veterinarskih zdravil, zlasti z Evropsko komisijo, in si prizadevala za zvišanje ravni sodelovanja, ki je bilo vzpostavljeno z Evropsko agencijo za varno hrano v preteklem letu.
Increase in number of requests for protocol assistance in line with an increase in the number of designated orphan medicinal products and on the basis of the recommendation to seek protocol assistance made by the COMP at the time of designation
Povečevanje števila zahtevkov za pomoč pri protokolu v skladu z večjim številom zdravil, določenih za zdravila sirote, in na podlagi priporočila, da naj se med postopkom določitve poišče pomoč pri protokolu, ki ga je dal COMP.
Once completed, the EuroPharm database will help healthcare professionals, patients and the general public to access up-to-date and reliable information about medicinal products available on the EU market.
Zbirka podatkov EuroPharm bo, ko bo dokončno oblikovana, omogočila zdravstvenim strokovnjakom, bolnikom in javnosti dostop do posodobljenih in zanesljivih podatkov o zdravilih, ki so na voljo na trgu EU.
Continued development of the EuroPharm database to increase access to information on medicines available in the European Union
Stalno razvijanje zbirke podatkov EuroPharm, da se poveča dostop do informacij o zdravilih, ki so na voljo v Evropski uniji.
New legislation requires that Member States agree within the coordination group on a list of medicinal products for which harmonised summaries of product characteristics shall be prepared to promote harmonisation of veterinary medicines authorised in the EU.
Nova zakonodaja zahteva, da se države članice strinjajo s skupino za usklajevanje glede seznama zdravil, za katera se pripravijo usklajeni povzetki glavnih značilnosti izdelka, da se spodbuja usklajevanje veterinarskih zdravil, ki imajo dovoljenje za promet v EU.
To this end, the CHMP has already established a Scientific Advice Working Party (SAWP) that has the sole remit of providing scientific advice to undertakings.
V ta namen je Odbor za zdravila za uporabo v humani medicini (Committe for Medicinal Products for Human Use, CHMP) že ustanovil Delovno skupino za znanstveno svetovanje (SAWP), katere izključna naloga je znanstveno svetovanje podjetjem.
Strengthen the concept of lifecycle management and scientific consistency
Krepitev koncepta upravljanja življenjskega cikla in znanstvene doslednosti.
To contribute to the promotion of harmonisation of authorisation of veterinary medicines in the EU
Prispevati k spodbujanju uskladitve izdajanja dovoljenj za veterinarska zdravila v EU.
Preparatory work in the area of procedures to be established in relation to the provision to Member States and European institutions of the best scientific opinion on questions related to herbal medicinal products, as well as to the adoption of opinions at the request of the Committee for Medicinal Products for Human Use
Pripravljalno delo na področju postopkov, ki jih je treba vzpostaviti, da se državam članicam in evropskim institucijam zagotovi najboljše znanstveno mnenje v zvezi z vprašanji o zeliščnih zdravilih in za sprejetje mnenj na zahtevo Odbora za zdravila za uporabo v humani medicini.
Management and reinforcement of the procedure, introduced in 2004, for the handling of safety concerns, both pre- and post-authorisation, for centrally processed applications
Upravljanje in krepitev postopka, uvedenega leta 2004, za obravnavanje varnostnih vprašanj, tako pred izdajo dovoljenja kot po njej, za centralno obravnavane vloge.
Further actions necessary to meet the Agency's long-term objectives will be included in future work programmes, with a view to full implementation of the Road Map by 2010.
Dodatni ukrepi, potrebni za izpolnitev dolgoročnih ciljev Agencije, bodo vključeni v prihodnje delovne programe, zato da se usmeritveni načrt ("Road Map")
The Agency will cooperate more actively with the WHO and will provide opinions on medicinal products intended exclusively for markets outside the EU.
Agencija bo dejavneje sodelovala s Svetovno zdravstveno organizacijo in dajala mnenja o zdravilih, namenjenih izključno trgom zunaj EU.
In 1984 Dr Korteweg created the regulatory compliance/quality assurance audit department for the European pharmaceutical R&D division of BristolMyers Squibb, later becoming director of worldwide regulatory compliance (auditing).
Leta 1984 je dr. Kortewegova ustanovila oddelek za revizijo regulativne skladnosti/zagotavljanja kakovosti za Divizijo R&R evropskih farmacevtskih izdelkov pri Bristol-Myers Squibb in kasneje postala direktorica svetovne regulativne skladnosti (za revizijo).
Standing and temporary working parties
Stalne in začasne delovne skupine
The time for communication of opinion to the European Commission has been decreased considerably, which requires substantial review of the processes following the opinion of the scientific committee.
Evropski komisiji je bil občutno skrajšan, kar zahteva poglobljen pregled postopkov ob upoštevanju mnenja znanstvenega odbora.
The EMEA will continue to support the European Commission in the updating and further development of the Notice to Applicants, providing advice on the centralised procedure and regulatory guidance for issues affecting the CHMP and its standing and temporary working parties
EMEA bo še naprej podpirala Evropsko komisijo pri posodabljanju in nadaljnjem razvijanju obvestila vlagateljem, pri svetovanju glede centraliziranega postopka in regulativnih smernic za vprašanja, ki vplivajo na CHMP ter na njegove stalne in začasne delovne skupine.
Dr Lyngvig has 12 years' private-sector experience in the transport and consultancy industries and was appointed chief executive officer of the Danish Medicines Agency in 2000.
Dr. Lyngvigova ima 12-letne izkušnje iz zasebnega sektorja, kjer je delala na področju transporta in svetovanja, leta 2000 pa je bila imenovana za glavno izvršno direktorico danske Agencije za zdravila.
The Agency plans to review its organisational structure to be able to carry out its expanded responsibilities in the areas of medical information and provision of support and incentives to small and medium-sized enterprises.
Agencija namerava spremeniti svojo organizacijsko strukturo, da bi bila sposobna izvajati svoje razširjene odgovornosti na področjih obveščanja o zdravilih ter zagotavljanja podpore in spodbud majhnim in srednje velikim podjetjem.
Implementation of an action plan for collaboration between the EMEA and the US Food and Drug Administration under the confidentiality arrangements, and close monitoring of all actions contained in this plan
Izvajanje akcijskega načrta za sodelovanje med EMEA in Upravo za hrano in zdravila ZDA na podlagi dogovorov o zaupnosti ter tesno spremljanje vseh ukrepov iz tega načrta.
Press office Press officer
Tiskovno predstavništvo Tiskovni predstavnik
Infrastructure Services at the EMEA
Infrastrukturne storitve v EMEA
It is forecast that there will be some 1,700 ICSRs from the EU received electronically through the EudraVigilance post-authorisation module in 2005.
Predvidoma naj bi v letu 2005 elektronsko po modulu EudraVigilance za fazo po izdaji dovoljenja prejeli približno 1700 ICSR iz EU.
To implement the new legislative requirements in the area of initial evaluation
Izvajati nove zakonske zahteve na področju začetnega vrednotenja.
Development of a Conference Guide for EMEA staff, external delegates and experts, linked to the meeting management system and containing all relevant information surrounding conferences
Razviti konferenčni priročnik za osebje EMEA, zunanje delegate in strokovnjake, ki bo povezan s sistemom za vodenje sestankov in bo vseboval vse pomembne informacije o konferencah.
He has been a member of the EMEA management board since 1995.
Od leta 1995 je član upravnega odbora EMEA.
Provisions regarding small and medium-sized enterprises are applicable in the field of veterinary medicinal products as well, and the Agency will need to provide support to veterinary companies with limited markets and to those licensing products for diseases with regional distribution.
Določbe, ki se nanašajo na majhna in srednje velika podjetja, se uporabljajo tudi na področju veterinarskih zdravil, Agencija pa bo morala zagotoviti podporo veterinarskim podjetjem z omejenimi trgi in veterinarskim podjetjem z dovoljenjem za promet z zdravili za regionalno
Electronic reporting of Adverse Drug Reactions for all veterinary medicines will be initiated under EudraVigilance Veterinary on 1 January 2005
Elektronsko poročanje o neželenih učinkih zdravil za vsa veterinarska zdravila bo uvedeno na podlagi EudraVigilance za veterino 1. januarja 2005.
She is also in charge of issues relating to medicines used in children and has been acting head of sector for safety & efficacy since October 2004.
Odgovorna je tudi za vprašanja v zvezi z zdravili, ki se uporabljajo pri otrocih, od oktobra 2004 pa je tudi vršilka dolžnosti vodje Sektorja za varnost in učinkovitost.
Applications for designation are expected to include more complex emerging therapies
Vloge za določitev naj bi predvidoma vključevale zahtevnejše nove terapije.
The attainment of these objectives will be measured against delivery of the systems on time, within budget, and to specification
Doseganje teh ciljev se bo merilo po pravočasnih dostavah sistemov v okviru proračuna in po specifikacijah.
With the steady increase in products being authorised through the centralised procedure, the rise in adverse reaction reports and periodic safety update reports continues, with approximately 400 of the former and over 50 of the latter forecast for 2005
S stalnim naraščanjem števila izdelkov, odobrenih po centraliziranem postopku, bo še naprej naraščalo število poročil o neželenih učinkih zdravila in periodično dopolnjenih poročil o varnosti; za leto 2005 se predvideva približno 400 prvih in več kot 50 drugih.
After a three-year stay in Prague, Czech Republic, where she worked as a consultant on European pharmaceutical matters as well as continuing her work with EFPIA, she joined the pharmaceuticals unit of the European Commission in September 1998.
Po triletnem bivanju v Pragi, Češka republika, kjer je delala kot svetovalka za evropske farmacevtske zadeve in nadaljevala svoje delo v okviru EFPIA, se je septembra 1998 pridružila Enoti Evropske komisije za farmacevtske izdelke.
Building on the experience obtained in 2004, the CHMP will strengthen its interaction with patients through a further development of the activities undertaken at the level of the EMEA/CHMP Working Group with Patients' Organisations.
CHMP bo na podlagi izkušenj, pridobljenih leta 2004, krepil vzajemno delovanje z bolniki na podlagi nadaljnjega razvijanja dejavnosti, prevzetih na ravni Delovne skupine EMEA/CHMP za sodelovanje z organizacijami bolnikov.
Number of videoconferences and reimbursed meetings
Število videokonferenc in sestankov s povrnjenimi stroški
CPMP Guideline on parametric release Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2 (in collaboration with GMP inspectors)
CPMP Guideline on parametric release Možna revizija po stabiliziranju pobud ICH za Q8 in Q9, v fazi 2 (v sodelovanju z inšpektorji dobre proizvodne prakse)
The Agency has been given significant new responsibilities for the provision of information to patients and healthcare professionals.
Agenciji so bile dane pomembne nove odgovornosti za zagotavljanje informacij bolnikom in zdravstvenim strokovnjakom.
Review of audiovisual and interpretation equipment in the meeting rooms
Pregled avdiovizualne opreme in opreme za tolmačenje v sejnih sobah.
Interim and other support persons
Začasno in drugo podporno osebje
The special Community fund (‘orphan drug fund') supports additional new applications and protocol assistance, as well as the post-authorisation activities that are necessary due to the increasing number of orphan medicinal products with Community marketing authorisations.
Poseben sklad Skupnosti ("sklad za zdravila sirote") podpira dodatne nove vloge in pomoč pri protokolu ter dejavnosti po izdaji dovoljenja za promet z zdravilom, ki so potrebne zaradi vse večjega števila zdravil sirot, ki imajo dovoljenje za promet v Skupnosti.
Ensure high-quality functioning of core activities through effective management of the increasing workload and adherence to reduced regulatory timelines for pre and post-authorisation activities
Zagotavljanje visoke kakovosti izvajanja osnovnih dejavnosti z učinkovitim upravljanjem vse večje delovne obremenitve in upoštevanjem krajših predpisanih rokov za dejavnosti pred izdajo dovoljenja za promet in po njej.
Regulatory and procedural advice is provided to the pharmaceutical industry during the lifecycle of medicinal products, from pre-submission meetings with applicants through to annual meetings with marketing authorisation holders.
Regulativno in postopkovno svetovanje je farmacevtski industriji zagotovljeno med življenjskim ciklom zdravil, od sestankov z vlagatelji pred oddajo vloge do letnih sestankov z imetniki dovoljenja za promet.
Facilitation of liaison with other scientific working groups and with interested parties
spodbujanje povezave z drugimi znanstveno delovnimi skupinami in zainteresiranimi stranmi;
To maintain and develop financial and budgetary accounting systems and reporting tools, including security and helpdesk components
Vodenje in razvijanje finančnih in proračunskih računovodskih sistemov ter orodij za poročanje, vključno z elementoma varnosti in pomoči za uporabnike.
The scope is broadened by the possibility of increased eligibility for the centralised procedure to include any veterinary medicine having importance for animal health throughout the Community.
Področje uporabe je razširjeno z možnostjo večje upravičenosti do centraliziranega postopka, ki vključuje vsa veterinarska zdravila, pomembna za zdravje živali v vsej Skupnosti.
4.3 Mutual recognition agreements
4.3 Sporazumi o vzajemnem priznavanju
Development of the EU transparency and communication strategies together with the Heads of Medicines Agencies
Razvoj strategij EU za preglednost in obveščanje v sodelovanju z vodji agencij za zdravila.
3.8 International activities
3.8 Mednarodne dejavnosti
Development of scientific advice procedures in line with the new legislation, including procedures for particular support for small and medium-sized enterprises and emerging therapies
Razvoj postopkov znanstvenega svetovanja v skladu z novo zakonodajo, vključno s postopki za posebno podporo majhnim in srednje velikim podjetjem, in novimi terapijami.
To provide timely information on MRLs to the public in accordance with agreed timelines
Zagotavljati pravočasne informacije o MRL-jih javnosti v skladu z dogovorjenimi roki.
Increased electronic reporting both for ICSRs (individual case safety reports) and SUSARs (suspected unexpected serious adverse reactions) into the EudraVigilance database for all medicinal products, irrespective of the licensing route
Povečan obseg elektronskega poročanja tako za varnostna poročila o posameznih primerih (individual case safety report, ICSR) kot za resne nepričakovane neželene učinke oziroma sum nanje (suspected unexpected serious adverse reactions, SUSAR) v zbirko podatkov EudraVigilance za vsa zdravila, ne glede na način pridobitve dovoljenja.
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organization.
EMEA izdaja potrdila o zdravilu v skladu z dogovori, ki jih je določila Svetovna zdravstvena organizacija.
Implementation of the EU telematics strategy for the pharmaceutical sector
Izvajanje telematske strategije EU za farmacevtski sektor
Career to date: Mr Le Cam has 19 years of professional experience, and personal commitment, in non-governmental health and medical research organisations in France, Europe and the United States in the fields of cancer, HIV/AIDS and genetic diseases.
Dosedanja poklicna pot: G. Le Cam ima 19 let poklicnih izkušenj, ki jih je dobil v zdravstvenih in medicinsko raziskovalnih nevladnih organizacijah v Franciji, Evropi in Združenih državah, ki se ukvarjajo z rakom, hiv/aidsom in genetskimi boleznimi, katerim je osebno zavezan.
Completion of the internal evaluation work with new Member States in the context of the Canadian mutual recognition agreement
Dokončanje mednarodnega ocenjevalnega dela z novimi državami članicami v okviru kanadskega sporazuma o medsebojnem priznavanju.
He joined the EMEA in May 1999 and one of his major activities in recent years was the establishment of orphan drug designation and protocol assistance in the EMEA.
EMEA se je pridružil maja 1999, ena njegovih glavnih nalog v zadnjih letih pa je bila vzpostavitev določitve zdravila sirote in pomoči pri protokolu v EMEA.
Variations to marketing authorisations can be either minor (type IA or IB) or major (type II) changes.
Spremembe dovoljenj za promet z zdravilom so lahko manjše (tip IA ali IB) ali večje (tip II).
Temporary working parties on new emerging therapies and new technologies, i.e. pharmacogenetics, gene therapy and cell therapy, will continue to meet in 2005 as the Agency is likely to receive applications in relation to emerging therapies.
Začasne delovne skupine za nove terapije in tehnologij, kot so farmakogenetika, gensko zdravljenje, celično zdravljenje, se bodo leta 2005 še naprej sestajale, saj bo Agencija verjetno prejela vloge, povezane z novimi oblikami terapij.
Provision of secretariat support to the scientific advice working party and support to potential applicants
Zagotavljanje pisarniške podpore delovni skupini za znanstveno svetovanje in podpora možnim prosilcem.
Development and implementation of an EU benchmarking system, development of quality assurance systems for scientific committees and an improved peer review system
Razvoj in izvajanje sistema EU za primerjalne analize, razvoj sistemov zagotavljanja kakovosti za znanstvene odbore ter izboljšani sistem medsebojnih pregledov.
The working party will develop a technical guidance document prepared in cooperation with Member States and industry to facilitate implementation of the CVMP/VICH guideline.
Delovna skupina bo v sodelovanju z državami članicami in panogo pripravila pisna tehnična navodila, ki bodo omogočila izvajanje smernice CVMP/VICH.
During this time he also worked as contributing editor for a European affairs publication and as Brussels correspondent for an American pharmaceutical journal.
V tem času je bil tudi pomožni urednik objav v zvezi z evropskimi zadevami in bruseljski dopisnik ameriške farmacevtske revije.
Implementation of an action plan for revision of the sampling and testing programme for centrally authorised products, in cooperation with EDQM, to streamline activities and focus resources taking a risk-based approach.
Izvajanje akcijskega načrta za revizijo programa vzorčenja in preizkušanja centralno odobrenih izdelkov v sodelovanju z EDQM, da se s pristopom, ki temelji na nevarnosti, poenostavijo dejavnosti in usmerijo viri.
Career to date: Miss Leivers worked for the Milk Marketing Board for England and Wales (MMB) as a liaison chemist for five years, prior to being appointed assistant director of the MMB/Federation of Agricultural Cooperatives office in Brussels, representing all sectors of agricultural cooperation to the European institutions.
Dosedanja poklicna pot: Gospodična Leiversova je pet let delala za Odbor za trženje mleka v Angliji in Walesu (MMB) kot kemičarka za zvezo, preden je bila imenovana za pomočnico direktorja MMB/ Urada Zveze kmetijskih zadrug v Bruslju, ki zastopa vse sektorje kmetijskega sodelovanja v evropskih institucijah.
Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2
Možna revizija po stabiliziranju pobud ICH za Q8 in Q9, v fazi 2
3.9 Coordination group
3.9 Skupina za usklajevanje
From 1974 to 1985, he was an audit manager in Spain with Ernst and Young and from 1985 to 1995 he was financial controller at Johnson Wax Española.
Od 1974 do 1985 je bil v Španiji vodja revizorjev pri Ernst and Young, od 1985 do 1995 pa finančni nadzornik pri Johnson Wax Española.
The EMEA checks compliance of such products distributed in parallel with the appropriate terms of the Community marketing authorisation.
EMEA preverja skladnost takšnih izdelkov, ki so v vzporedni distribuciji z ustreznimi pogoji Skupnosti za izdajo dovoljenja za promet z zdravilom.
This encompasses making available topquality scientific expertise and a robust quality assurance system
To vključuje razpoložljivost vrhunskega znanstvenega strokovnega znanja in izkušenj ter stabilen sistem zagotavljanja kakovosti.
In 1986 he joined the Austrian drug regulatory authority; since 2003 he has been deputy head of the drug authorisation department of the Austrian Ministry of Health and Women.
Leta 1986 se je priključil avstrijskemu regulativnemu organu za zdravila, od leta 2003 je namestnik vodje oddelka za izdajo dovoljenj za promet z zdravilom pri avstrijskem Ministrstvu za zdravje in ženske.
New legislation in the fields of paediatric medicines and tissue engineering is also under development, and the Agency contributes to and monitors its development in anticipation of its future adoption.
Pripravlja se tudi nova zakonodaja na področju zdravil za otroke in inženiringa tkiv, pri čemer Agencija sodeluje, spremlja njen razvoj in pričakuje njeno sprejetje v prihodnosti.
The target is to provide 95 % of responses within the timeline
Cilj je v roku zagotoviti 95 % odgovorov.
He was reelected chairman of the Committee on Orphan Medicinal Products in May 2003.
Maja 2003 je bil ponovno izvoljen za predsednika Odbora za zdravila sirote.
Development of meeting broadcasting and wider implementation of video- and teleconferencing to facilitate communication and reduce the number of reimbursed meetings
Razvijati prenašanje sestankov in širše izvajati video- in telekonference, da se olajša komuniciranje in zmanjša število sestankov s povrnjenimi stroški.
Management and organisation of the CVMP
Upravljanje in organizacija CVMP
Conduct joint planning to manage the resource implications arising from the new pharmaceutical legislation, the advent of new technologies and the increase in the number of scientific resource providers
Izvajanje skupnega načrtovanja za obvladovanje potreb po virih, ki izhajajo iz nove farmacevtske zakonodaje, pojava novih tehnologij in povečanega števila ponudnikov strokovnega znanja in izkušenj.