FrancophonIA/ELRC3.0 huggingface dataset:
English: Sylvie Bénéfice, Head of Sector for meeting management and conferences, b. 28 December 1954, n. French
Estonian: Sylvie Bénéfice, koosolekute halduse ja konverentside sektori juhataja, sünd.
English: Work to be continued in 2005
Estonian: Töö jätkub 2005. aastal
English: 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.
Estonian: kõrvaltoimete elektrooniline aruandlus veterinaarsektoris algab pädevatel ametiasutustel 2005. aasta jaanuaris, millega kasvab ka müügiloa hoidjate elektrooniline aruandlus; jätkuv vastutus ühise veterinaariaalase rakendusrühma töö korraldamise ja abistamise, koolituse koordineerimise, EudraVigilance'i kasutajate registreerimistaotluste haldamise, samuti andmete kogumise, analüüsi, aruandluse ning alates 1. jaanuarist 2005 elektrooniliselt laekuvatest kõrvaltoimete aruannetest teavitamise osas suurendab märkimisväärselt veterinaariasektori väikese ravimiohutuse järelevalve rühma koormust.
English: He joined the French medicines agency in 1994 as director of pharmacotherapeutic evaluation, a post he holds today.
Estonian: 1994. aastal asus ta tööle Prantsusmaa Ravimiameti direktorina farmakoterapeutilise hindamise alal ja töötab sellel ametikohal praeguse ajani.
English: The area of infrastructure services at the EMEA covers a wide range of services, including security, telecommunications, reception, switchboard, archiving, mail, reprographics, technical assistance to meeting rooms, confidential waste, health & safety, fire and emergency plans, business continuity planning, inventory, office equipment and supplies, maintenance, refurbishment and fitting out, and management of the catering facilities.
Estonian: side, vastuvõtt, lülituspult, arhiveerimine, post, reprograafia, tehniline abi koosolekuruumidele, konfidentsiaalsed paberjäätmed, töötervishoid ja tööohutus, tuleohutuse ja hädaolukorra kavad,
English: 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.
Estonian: Senine teenistuskäik: Dr Pittner töötas aastail 1972-1985 farmaatsiatööstuses, kus ta avastas beeta 1
English: The implementation of an improved activity-based budgeting database and budgetary planning
Estonian: täiustatud tegevuspõhise eelarvestusandmebaasi ja eelarve planeerimise rakendamine; uue pädevuse arendamise poliitika rakendamine.
English: She was appointed head of sector for safety and efficacy of medicines in January 2001.
Estonian: 2001. aasta jaanuaris määrati ta ravimite ohutuse ja efektiivsuse sektori juhatajaks.
English: Jytte Lyngvig, Vice-Chairman of the Management Board, b.13 October 1953, n. Danish
Estonian: Jytte Lyngvig, haldusnõukogu aseesimees, sünd.
English: 27-28 January
Estonian: 27.-28. jaanuar
English: The further development and implementation of EudraVigilance will relate to appropriate methodologies for data analysis, including data warehousing and data mining supporting signal detection, as well as the coordination and provision of training to the EMEA's business partners
Estonian: EudraVigilance'i edasiarendamine ja rakendamine on seotud asjakohaste andmeanalüüsi meetoditega, sealhulgas signaalide tuvastamist toetav andmelaondus ja andmekaevandamine,
English: Communication and action by Member States in response to suspected quality defects relating to centrally authorised medicines are also coordinated by the EMEA.
Estonian: EMEA koordineerib ka liikmesriikide kommunikatsiooni ja meetmeid reageerimisel kahtlustele tsentraliseeritud müügiloaga ravimite kvaliteedis.
English: David Drakeford, Head of Sector for information technology, b. 4 December 1957, n. Irish
Estonian: David Drakeford, infotehnoloogia sektori juhataja, sünd.
English: Vincenzo Salvatore, Head of Legal Sector, b. 8 August 1963, n. Italian
Estonian: Vincenzo Salvatore, õigusküsimuste sektori juhataja, sünd.
English: Sara Mendosa, Head of Sector for infrastructure services, b. 23 January 1950, n. British
Estonian: Sara Mendosa, infrastruktuuriteenuste sektori juhataja, sünd.
English: Setting-up of procedures for the assessment and re-evaluation of products five years from designation and/or removal from the Community register
Estonian: Põhilised algatused nende eesmärkide saavutamiseks: nimetamismenetluse pidev täiustamine; menetluste kehtestamine ravimite hindamiseks ja uuesti hindamiseks viie aasta möödumisel nende nimetamisest ja/või väljaarvamisest ühenduse registrist;
English: 22-23 March
Estonian: 22.-23. märts
English: 18-20 October
Estonian: 18.-20. oktoober
English: Riccardo Ettore, Deputy Head of Sector for information technology, b. 8 April 1953, n. Italian
Estonian: Riccardo Ettore, infotehnoloogia sektori juhataja asetäitja, sünd.
English: Other staff-related expenditure
Estonian: Muud personaliga seotud kulud 1. jaotis kokku
English: He undertook long-term assignments as a management consultant until January 1997, when he joined the EMEA.
Estonian: Kuni EMEA-sse tööleasumiseni 1997. aasta jaanuaris tegi ta pikaajalisi töid juhtimiskonsultandina.
English: Post-authorisation activities relate to variations, line extensions and transfers of marketing authorisation.
Estonian: Müügiloa järgsed tegevused on seotud müügilubade muudatustega, tooterühma laiendamisega ja müügilubade ülekandmisega.
English: • by fax to (44-20) 7418 8670
Estonian: • faksi teel, kui saata päring (44-20) 7418 8670
English: Frances Nuttall, Head of Sector for personnel and budget, b. 11 November 1958, n. Irish
Estonian: Frances Nuttall, personali- ja eelarve sektori juhataja, sünd.
English: Services attached to the Executive Director
Estonian: Tegevdirektori talitused
English: Concept paper for preparation of guideline to be developed
Estonian: Töötatakse välja põhimõtteline taust suunise koostamiseks
English: 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.
Estonian: Pärast kolmeaastast viibimist Tšehhi Vabariigis Prahas, kus ta töötas konsultandina Euroopa farmaatsiaküsimuste alal,
English: Guideline on the investigation of mitochondrial toxicity of HIVtherapeutics in vitro
Estonian: Guideline on the investigation of mitochondrial toxicity of HIV
English: 6.3 EMEA document management and publishing
Estonian: 6.3 EMEA dokumendihaldus ja kirjastamine
English: 4-6 October
Estonian: 4.-6. oktoober
English: EU Comments in preparation of ICH Guideline
Estonian: EL märkused ICH suunise koostamiseks
English: John Purves, Head of Sector for quality of medicines, b. 22 April 1945, n. British
Estonian: John Purves, ravimite kvaliteedi sektori juhataja, sünd.
English: Core SPC for human plasma derived and recombinant coagulation Factor VIII products
Estonian: Core SPC for human plasma derived and recombinant coagulation Factor
English: Education: Qualified in medicine from Sheffield University in 1983.
Estonian: 18. septembril 1956, britt Haridus: Lõpetanud Sheffieldi Ülikooli 1983. aastal meditsiini erialal.
English: Status studies in the safety evaluation of new medicinal products in animals
Estonian: Pharmacokinetics and metabolic studies in the safety evaluation of new medicinal products in animals
English: 2-4 March
Estonian: 2.-4. märts
English: It should be noted that pharmacovigilance is a priority area for the Agency and that, as a consequence, the EMEA will continue and further strengthen its efforts in order to ensure the safe use of products licensed in accordance with the centralised procedure.
Estonian: mistõttu EMEA jätkab ja tugevdab veelgi jõupingutusi litsentseeritud ravimite ohutu kasutamise tagamiseks kooskõlas tsentraliseeritud menetlusega.
English: Finalisation of recommendations under development by the EMEA/CHMP Working Party with Patients' Organisations
Estonian: EMEA inimtervishoius kasutatavate ravimite komitee patsientide organisatsioonide töörühma poolt koostatavate soovituste lõplik vormistamine;
English: Annex 1 EMEA establishment plan 2003-2005
Estonian: 1. lisa EMEA ametikohtade loetelu 2003-2005
English: Josep Torrent i Farnell, Chairman of the COMP, b. 2 May 1954, n. Spanish
Estonian: Josep Torrent i Farnell, harva kasutatavate ravimite komitee (COMP) esimees, sünd.
English: Work to be considered in 2005
Estonian: Tööd kaalutakse 2005. aastal
English: Unit for Veterinary medicines and inspections
Estonian: Veterinaarravimite ja kontrolli üksus
English: A continuous increase in the number of both type I and type II variations is anticipated due to the cumulative increase in the number of marketing authorisations granted.
Estonian: väljastatud müügilubade arvu kumulatiivse kasvu tõttu on ette näha nii I kui ka II tüüpi muudatuste arvu pidevat kasvu.
English: In addition, the centralised procedure is open to any other product that constitutes a significant innovation or for which there is a Community interest.
Estonian: mis on oluliselt uuenduslikud või mis pakuvad huvi kogu ühenduse ulatuses.
English: These estimates relate to centrally authorised products
Estonian: Need hinnangud puudutavad tsentraliseeritud müügiloaga ravimeid;
English: 20-23 June
Estonian: 20.-23. juuni
English: Andreas Pott, Head of Unit, b. 14 April 1949, n. German
Estonian: Andreas Pott, üksuse juhataja, sünd.
English: Annex 5 Profiles of EMEA personalities
Estonian: 5. lisa EMEA ametiisikute lühielulood
English: Possible revision once the ICH initiatives on Q8 and Q9 have been stabilised, at step 2
Estonian: algatuste stabiliseerumist Q8 ja Q9
English: Implementation of Directive 2001/20/EC and of the Commission Directive on GCP at EU level will require continued support to the development of harmonised procedures within the ad hoc group of GCP inspection services
Estonian: nõukogu direktiiv inimtervishoius kasutatavate ravimite kliiniliste uuringute läbiviimise kohta jõustus 1. mail 2004; direktiivi 2001/20/EÜ ja komisjoni hea kliinilise tava direktiivi rakendamine EL tasandil nõuab pidevat abistamist ühtlustatud korra väljatöötamisel hea kliinilise tava kontrollimise talituse ajutises töörühmas.
English: Preparation of transparency and communication strategies and related policies that set out what, how and when information will be published
Estonian: läbipaistvuse- ja kommunikatsioonistrateegiate ja -poliitikate koostamine, milles nähakse ette,
English: 14-16 June
Estonian: 14.-16. juuni
English: Beatrice Fayl, Head of Sector for document management and publishing, b. 9 October 1959, n. Danish
Estonian: Beatrice Fayl, dokumendihalduse ja kirjastamise sektori juhataja, sünd.
English: Opinions adopted (Output)
Estonian: Vastuvõetud arvamused (väljastamised)
English: Cooperation with other public-health-oriented scientific and regulatory institutions and agencies at European Union level will develop further as a result of the increased responsibilities given to the Agency by the new European pharmaceutical legislation
Estonian: Suundumused: ametile uute Euroopa farmaatsiaalaste õigusaktidega pandud kasvavate ülesannete tõttu areneb edasi koostöö teiste Euroopa Liidu tasandil tegutsevate teadus- ja regulatiivasutustega, mille tegevus on suunatud rahvatervisele; Euroopa Liidu arvatav laienemine 2007. aastal;
English: He was reelected chairman of the Committee on Orphan Medicinal Products in May 2003.
Estonian: 2003. aasta mais valiti ta tagasi harva kasutatavate ravimite komitee esimeheks.
English: Melanie Leivers, Deputy Head of Sector for veterinary marketing authorisation procedures, b. 1 December 1958, n. British
Estonian: Melanie Leivers, veterinaarravimite müügilubade korra sektori juhataja asetäitja, sünd.
English: Career to date: From 1978 to 1982, Dr Keller worked as a research and teaching assistant at the Institute for Pharmacognosy and Analytical Phytochemistry of the University of Saarbrücken.
Estonian: Senine teenistuskäik: Aastail 1978-1982 töötas dr Keller Saarbrückeni Ülikooli Farmakognoosia ja Analüütilise Fütokeemia Instituudi teadus- ja õppeassistendina.
English: EU Comments in preparation of revised VICH Guideline
Estonian: EL märkused muudetud VICH suunise koostamiseks
English: Kornelia Grein, Head of Sector for safety of veterinary medicines, b. 24 July 1952, n. German
Estonian: Kornelia Grein, veterinaarravimite ohutuse sektori juhataja, sünd.
English: Parallel distribution
Estonian: Paralleelse turustamise teated,
English: The performance indicator for this objective is the percentage of applications evaluated within the 90-day timeline.
Estonian: Selle eesmärgi saavutamise näitaja on 90-päevase tähtaja jooksul hinnatud taotluste protsent.
English: Further develop the EMEA risk management strategy, in particular as regards the concept of risk management plans and further implementation of the EudraVigilance project, including the reporting of adverse drug reactions in clinical trials
Estonian: EMEA riskijuhtimisstrateegia edasiarendamine, eelkõige seoses riskijuhtimiskavade kontseptsiooni ja projekti EudraVigilance edasise rakendamisega, sealhulgas teatamine ravimite kõrvaltoimetest kliinilistes uuringutes; vahendite väljatöötamine patsientide ja tervishoiutöötajate teavitamiseks ning sidemete tugevdamiseks ameti huvirühmadega;
English: Consultation ended 16 Dec. 04, under revision by PhVWP- V for adoption in 1Q 2005
Estonian: Arutelu lõppes 16. detsembril 2004, muutmisel PhVWP-V poolt vastuvõtmiseks 2005. aasta I kvartalis
English: 2-4 February
Estonian: 2.-4. veebruar
English: 17-20 January
Estonian: 17.-20. jaanuar
English: 12-15 December
Estonian: 12.-15. detsember
English: Contribution (see SWP)
Estonian: Panus (vt ohutuse töörühm)
English: To be incorporated in revised Volume 9 (see above)
Estonian: Lülitatakse muudetud 9. köitesse (vt eespool)
English: Early cooperation with regulatory authorities in the accession countries prior to the historic enlargement of the European Union in 2004 contributed greatly to their smooth integration into the European medicines network.
Estonian: Varane koostöö ühinevate riikide regulatiiv ametiasutustega enne Euroopa Liidu ajaloolist laienemist
English: Administration Unit
Estonian: Haldusüksus
English: Concurrent development work on all EU telematics projects will have to be carried out, and five of the EU telematics systems - EudraNet, EudraVigilance, EudraCT, EuroPharm and eSubmission - will have to be operated, supported and maintained
Estonian: telemaatikasüsteemi - EudraNet, EudraVigilance, EudraCT, EuroPharm ja e-Submission - tuleb käigus hoida, toetada ja hooldada.
English: Tim Buxton, Head of Sector for project management, b. 27 February 1959, n. British
Estonian: Tim Buxton, projektijuhtimise sektori juhataja, sünd.
English: Interaction with the US Food and Drug Administration will be further developed through enhanced cooperation in the context of the confidentiality arrangements, e.g. in the fields of orphan medicinal products, scientific advice requests, new applications, pharmacovigilance, development of guidelines and the exchange of trainees and experts
Estonian: Põhilised algatused: suhteid USA Toidu- ja Ravimiametiga arendatakse edasi tihendades koostööd konfidentsiaalsuslepingute raames, nt harva kasutatavate ravimite, teadusliku nõustamise taotluste, uute taotluste, ravimiohutuse järelevalve, suuniste väljatöötamise ning praktikantide ja ekspertide vahetamise alal; suhted Kanada ja Jaapani ja teiste regulatiivasutustega jätkuvad EMEA külalisekspertide programmi raames;
English: 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.
Estonian: (CVM) ja USA Põllumajandusministeeriumiga praktilise korra kehtestamiseks USA ja EL vahel 2004.
English: Work to start in 2005
Estonian: Töö algab 2005. aastal
English: Preparation of draft Community herbal monographs for herbal medicinal products with a wellestablished use
Estonian: ühenduse taimemonograafiate projektide koostamine laialdaselt kasutatavate taimsete ravimite kohta;
English: Operational expenditure Meetings
Estonian: Tegevuskulud
English: 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.
Estonian: Senine teenistuskäik: Pr Nuttall töötas mitmel ametikohal Iiri tsiviilteenistuses, nimelt
English: The performance indicator for this objective is the percentage of applications evaluated within the 120-day timeline.
Estonian: Selle eesmärgi saavutamise näitaja on 120-päevase tähtaja jooksul hinnatud taotluste protsent.
English: 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)
Estonian: algatuste stabiliseerumist Q8 ja Q9 kohta, 2. astmel (koostöös hea tootmistava inspektoritega)
English: 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
Estonian: ameti koordineeriva rolli edasine tugevdamine ravimiohutuse järelevalve alal ühenduse uute õigusaktide rakendamise tulemusena; kasvav elektrooniline aruandlus andmebaasi EudraVigilance nii individuaalsete juhtumite ohutusaruannete (ICSR) kui ka kahtlustatavate ootamatute raskete kõrvaltoimete (SUSAR) osas kõigi ravimite kohta, olenemata nende litsentseerimisviisist;
English: Guideline to be developed after consultation of concept paper
Estonian: Suunis töötatakse välja pärast põhimõttelise tausta arutelu
English: Mr Lönngren was with the National Board of Health and Welfare, Sweden, from 1978 to 1990, during which time he was responsible for herbal medicines, cosmetics, medical devices, narcotics and contraceptives.
Estonian: Rootsi Tervishoiu ja Hoolekande Ametis, mil tema vastutusalasse kuulusid taimsed ravimid, kosmeetikavahendid, meditsiiniseadmed, narkootikumid ja rasestumisvastased vahendid.
English: To be adopted in 1/2Q 2005
Estonian: Võetakse vastu 2005. aasta I/II kvartalis
English: Martin Harvey Allchurch, Head of Executive Support, b. 20 October 1966, n. British
Estonian: Martin Harvey Allchurch, täitevtugi talituse juhataja, sünd.
English: To conduct quality orphan medicinal product designations and related activities and adhere to regulatory timelines
Estonian: viia läbi heatasemelisi harva kasutatavate ravimite nimetamismenetlusi ja seonduvaid tegevusi ning pidada kinni kehtestatud tähtaegadest.
English: • by writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB UK
Estonian: Canary Wharf London E14 4HB UK
English: Provision of appropriate support to rapporteurs and co-rapporteurs
Estonian: vajaliku abi osutamine ettekandjatele ja kaasettekandjatele;
English: The European Union Telematics strategy for pharmaceuticals is agreed between Member States, the EMEA and the European Commission.
Estonian: Liikmesriigid, EMEA ja Euroopa Komisjon on kokku leppinud Euroopa Liidu telemaatikastrateegias farmaatsiatoodete suhtes.
English: Isabelle Moulon, Head of Sector for medical information, b. 9 March 1958, n. French
Estonian: Isabelle Moulon, meditsiiniteabe sektori juhataja, sünd.
English: Type I variation opinions Type II variation opinions Line extension opinions
Estonian: Arvamused tooterühma laiendamiste kohta Arvamused II tüüpi muudatuste kohta Arvamused I tüüpi muudatuste kohta
English: To maintain and develop financial and budgetary accounting systems and reporting tools, including security and helpdesk components
Estonian: finants- ja eelarvestussüsteemide ja aruandlusvahendite, sealhulgas turva- ja tugiteenuste komponentide käigushoidmine ja arendamine; täpse ja õigeaegse finantsteabe esitamine juhtkonnale;
English: From 1993 to 1997, she was seconded to the European Commission (DG XII) as scientific secretary for COST actions in the field of chemistry, with responsibility for coordination of research networks and organisation of scientific conferences and workshops in Europe.
Estonian: meetmetega keemia alal; tema ülesandeks oli uurimisvõrgustike tegevuse koordineerimine ning teaduskonverentside ja seminaride korraldamine Euroopas.
English: 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
Estonian: tsentraliseeritud menetlusega seotud aruandlus ja tagasiside liikmesriikidele, huvitatud osapooltele ja üldsusele ravimiohutuse järelevalve küsimustes; jätkuv vastutus ühise veterinaariaalase rakendusrühma koolituse ja EudraVigilance'i kasutajate taotluste koordineerimise, samuti andmekogumise, analüüsi, aruandluse ning kõrvaltoimete aruannete teavitamise osas, mis alates 1. jaanuarist 2005 laekuvad elektrooniliselt.
English: 14-17 February
Estonian: 14.-17. veebruar
English: The initial evaluation phase covers a number of EMEA activities ranging from pre-submission discussions with future applicants, through the evaluation by the Committee for Medicinal Products for Human Use (CHMP), to the granting by the European Commission of the product authorisation.
Estonian: Algse hindamise etapp hõlmab mitmesuguseid EMEA tegevusi alates esitamiseelsetest aruteludest tulevaste taotlejatega ja aruteludest inimtervishoius kasutatavate ravimite komitees kuni ravimile
English: In 1994, she joined the UK Veterinary Medicines Directorate as senior veterinary assessor in the pharmaceuticals and feed additives team.
Estonian: Veterinaarravimite Direktoraadi veterinaarravimite vanemhindajana farmaatsiatoodete ja toidulisandite rühmas.
English: It is forecast that there will be some 1,700 ICSRs from the EU received electronically through the EudraVigilance post-authorisation module in 2005.
Estonian: prognooside kohaselt esitatakse 2005. aastal EudraVigilance'i müügiloa järgse mooduli kaudu
English: E-mail: europeanexperts@emea.eu.int
Estonian: E-post: europeanexperts@emea.eu.int
English: Peter Jones, Head of Unit, b. 9 August 1947, n. British
Estonian: Peter Jones, üksuse juhataja, sünd.
English: Education: Doctorate in natural sciences (applied physics and materials science) from Saarbrücken University; diploma in physics from Tübingen University; master of arts (mathematics) from the University of Cambridge, UK.
Estonian: Ülikoolist, diplom füüsika alal Tübingeni Ülikoolist, magistrikraad (matemaatika) Ühendkuningriigi Cambridge'i Ülikoolist.
English: Education: Graduated in pharmacology from King's College London.
Estonian: Haridus: Lõpetanud Londoni Ülikooli Kings College'i farmakoloogia erialal.
English: ICH-E2D: Post-Approval Safety Management: Definitions and Standards for Expedited Reporting and Good Case Management Practices
Estonian: ICH-E2D: Post-Approval Safety
English: To conduct quality assessments of MRL applications and related activities, and adhere to regulatory timelines
Estonian: jääkide piirnormide taotluste kvaliteedi hindamine ja sellega seotud tegevused ning kehtestatud tähtaegadest kinnipidamine.
English: 12-14 April
Estonian: 12.-14. aprill
English: Education: Bachelor of law from the University of Birmingham, qualified as a member of the Institute of Chartered Accountants in England and Wales.
Estonian: 27. veebruaril 1959, britt Haridus: Bakalaureusekraad Birminghami Ülikoolist õigusteaduse alal, Inglismaa ja Walesi Audiitorite Instituudi liige.
English: The ad hoc group of GCP inspection services will meet four times in 2005.
Estonian: Hea kliinilise tava kontrollimise talituste ajutisel töörühmal toimub 2005. aastal neli koosolekut.