natgillin/translations-raw huggingface dataset:
Education: Qualified pharmacist from the University of Uppsala Faculty of Pharmacy.
Izobrazba: Diplomirani farmacevt s Fakultete za farmacijo Univerze v Uppsali.
Panos Tsintis, Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b. 18 September 1956, n. British
Panos Tsintis, vodja Sektorja za farmakovigilanco, varnost in učinkovitost zdravil po izdaji dovoljenja za promet, roj. 18. septembra 1956, po narodnosti Britanec
Special EU contribution for orphan medicinal products Contribution from EEA Contribution from EU programmes p.m.
Prispevek iz EGP Prispevek iz programov EU
He joined the EMEA in February 1997.
EMEA se je pridružil februarja 1997.
Parallel distribution notifications received/forecast (Input)
Število prejetih/predvidenih obvestil o vzporedni distribuciji (Vhodni podatek)
The performance indicator for this objective is the percentage of applications evaluated within the 120-day timeline.
Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v roku 120-ih dni.
14-17 February
14.-17. februar
Follow-up on initiatives to improve transparency and provide clear and understandable information to patients, healthcare professionals and the public
2003 in priporočilom G10; spremljanje pobud za boljšo preglednost in zagotavljanje jasnih in razumljivih informacij bolnikom, zdravstvenim strokovnjakom in javnosti; krepitev mednarodnega sodelovanja Agencije.
CVMP meetings in 2005
Zasedanja CVMP leta 2005
CVMP member since 1998 and chairman of the CVMP ad hoc group for environmental risk assessment.
in predsednik njegove ad hoc skupine za oceno tveganja za okolje.
Education: Master of science in economics and bachelor of science in public administration from Trinity College Dublin.
Izobrazba: Magisterij iz ekonomije in diploma iz javne uprave na Trinity Collegu v Dublinu.
Education: Bachelor of law from the University of Birmingham, qualified as a member of the Institute of Chartered Accountants in England and Wales.
Izobrazba: Diplomirani pravnik z Univerze v Birminghamu, član Združenja revizorjev v Angliji in
Work to start in 2005
Delo se začne leta 2005
Education: Bachelor of commerce from University College Dublin.
Izobrazba: Diplomirani komercialist Univerzitetnega kolidža v Dublinu.
Education: Doctorate of science in physical sciences; qualification in research management; PhD in physical organic chemistry; master's degree in physical organic chemistry; degree in biochemistry.
Doktorat iz fizikalne organske kemije; Magisterij iz fizikalne organske kemije; Diploma iz biokemije.
CHMP Biotechnology Working Party
Delovna skupina CHMP za biotehnologijo Referenčna številka
12-14 January
12.-14. januar
Career to date: After 10 years of fundamental prostaglandin research she joined the pharmaceutical industry in 1981 as a clinical research associate.
Dosedanja poklicna pot: Po desetletnem osnovnem raziskovanju prostaglandina se je leta 1981
Conduct analysis of adverse reaction reports and periodic safety update reports in a timely manner
Pravočasno analiziranje poročil o neželenih učinkih in periodično dopolnjenih poročil o varnosti Zagotavljanje ustrezne podpore poročevalcem in soporočevalcem.
She joined the EMEA in April 1996.
EMEA se je pridružila aprila 1996.
E-mail: silvia.domingo@emea.eu.int
E-naslov: silvia.domingo@emea.eu.int
E-mail: ragini.shivji@emea.eu.int
E-naslov: ragini.shivji@emea.eu.int
These include implementation of the concept of risk management plans, as well as accelerated assessment,
Ti vključujejo izvajanje koncepta načrtov za obvladovanje tveganja ter postopke za pospešeno oceno, pogojno izdajo dovoljenja in sočutno uporabo.
To implement the new legislation in the fields of GMP, in particular with respect to active substances
Izvajati novo zakonodajo na področjihdobre proizvodne prakse, zlasti za zdravilne učinkovine.
Deadline for comments March
Zadnji rok za pripombe marec 2005
The integration of delegates, staff and experts from the new Member States, and the extension of the Agency's office and conference space to accommodate new staff, delegates and experts following the entry into force of the new legislation
spremenjeno delovno okolje po pregledu uredbe o ustanovitvi Agencije; izvajanje nove uredbe o pristojbinah; izvajanje novega računovodskega sistema; vključevanje delegatov, osebja in strokovnjakov iz novih držav članic ter povečanje pisarniškega in konferenčnega prostora Agencije za namestitev novega osebja, delegatov in strokovnjakov po začetku veljavnosti nove zakonodaje; izvajanje izboljšane proračunske zbirke podatkov, utemeljene na dejavnostih, in proračunskega načrtovanja;
EU Comments in preparation of VICH Guideline
Pripombe EU k pripravi smernice VICH
Consultation ended 16 Dec. 04, under revision by PhVWP- V for adoption in 1Q 2005
2004, pod revizijo PhVWP-V za sprejetje v 1. četrt.
Concept paper for preparation of guideline to be developed
Idejni dokument, ki se sestavi za pripravo smernice
He has a continuing teaching appointment for pharmacology and toxicology at the University of Würzburg.
Stalno delovno mesto ima kot predavatelj farmakologije in toksikologije na Univerzi v Wuerzburg.
In 1979 he joined the National Board of Health, where he acted as senior pharmaceutical inspector and head of the pharmaceuticals department.
Nacionalnemu odboru za zdravje, kjer je bil višji farmacevtski inšpektor in vodja Oddelka za farmacevtske izdelke.
Education: Qualified medical doctor from the University of Würzburg, Germany.
Izobrazba: Diplomiral iz splošne medicine na Univerzi v Wuerzburgu, Nemčija.
Scientific Advice Requests received/forecast (Input)
Prejeti/predvideni zahtevki za znanstveno svetovanje (Vhodni podatek)
Preparatory work for the establishment of the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
Pripravljalno delo za določitev seznama zeliščnih snovi, pripravkov in njihovih kombinacij za uporabo v tradicionalnih zeliščnih zdravilih.
Career to date: After a traineeship with the European Commission, from 1991 to 1992, Martin Harvey Allchurch worked as a European affairs consultant in Brussels, from 1992 to 1995.
Allchurch delal od 1992 do 1995 kot svetovalec za evropske zadeve v Bruslju.
To conduct quality orphan medicinal product designations and related activities and adhere to regulatory timelines
Izvajati kakovostno določanje zdravil sirot in s tem povezanih dejavnosti ob upoštevanju predpisanih rokov.
Patrick Le Courtois, Head of Unit, b. 9 August 1950, n. French
Enota za vrednotenje zdravil za ljudi pred izdajo dovoljenja za promet Patrick Le Courtois, vodja enote, roj. 9. avgusta 1950, po narodnosti Francoz
Joint CHMP/CVMP Quality Working Party Working party on Environmental Risk Assessment Scientific advisory group on Antimicrobials Scientific Advice Working Party
Delovna skupina za oceno tveganja za okolje Znanstveno svetovalna skupina za protimikrobna sredstva Delovna skupina za znanstveno svetovanje
Career to date: From 1976 to 1981, Dr Grein held a position at the Free University of Berlin in Germany teaching and conducting research.
Dosedanja poklicna pot: Od 1976 do 1981 je dr. Greinova predavala in vodila raziskave na
The target is to have 90 % of applications evaluated within these timelines
Cilj je 90 % vlog, ovrednotenih v tem roku.
Education: Qualified as a pharmacist, BSc (Pharm) and was granted a master's degree in pharmaceutics in the research area of microencapsulation from Trinity College Dublin.
Izobrazba: Diplomiral iz farmacije, magistriral iz farmacevtike za raziskovalno področje mikroinkapsulacije na Trinity Collegu v Dublinu.
• by writing to: EMEA Documentation service European Medicines Agency 7 Westferry Circus Canary Wharf London E14 4HB UK
Canary Wharf London E14 4HB
In 1995 she returned to Germany to the Ministry for Environment as scientific administrator.
Ministrstvo za okolje kot znanstvena administratorka.
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.
Zaradi naraščanja skupnega števila izdanih dovoljenj za promet z zdravilom se pričakuje stalno naraščanje števila sprememb tipa I in II.
Education: PhD (Chemistry) and PhD (Biochemistry), University of Ghent, Belgium.
Izobrazba: Doktorat iz kemije in doktorat iz biokemije na Univerzi v Ghentu, Belgija.
14-17 March
14.-17. marec
The performance indicator for this objective is the percentage of applications evaluated within the 90-day timeline.
Kazalnik uspešnosti za ta cilj je odstotek vlog, ovrednotenih v roku 90-ih dni.
Scientific advice and protocol assistance finalised (Output)
Izvedena strokovno svetovanje in pomoč pri protokolu (Izhodni podatek)
Further to the restructuring of the Human Medicines Evaluation Unit in 2001, he was appointed head of unit for the post-authorisation evaluation of medicines for human use.
Po preoblikovanju te enote je bil imenovan za vodjo Enote za vrednotenje zdravil za uporabo v humani medicini po izdaji dovoljenja za promet.
Definition of criteria of eligibility for extension of data exclusivity as provided in the new pharmaceutical legislation
Opredelitev meril o izpolnjevanju pogojev za podaljšanje izključne pravice do uporabe podatkov,
The trend for referral of issues resulting from pharmacovigilance reporting at Member State level to the CVMP will continue to grow, requiring the Committee's opinion for further actions to be taken as appropriate
CVMP, bo še naraščal, pri čemer bo potrebno mnenje odbora o nadaljnjih ukrepih, ki bi jih bilo treba sprejeti.
Clarification of the status of guidance prepared by the Herbal Medicinal Products Working Party between 1997 and 2004
Pojasnitev statusa smernic, ki jih je pripravila Delovna skupina za zeliščna zdravila med letoma
She joined the EMEA in October 1994.
EMEA se je pridružila oktobra 1994.
To implement new legislative mechanisms to optimise drug safety
Izvajati mehanizme, da se čim bolj poveča varnost zdravil v novi zakonodaji.
Revision 3 expected in 1Q 2005
Revizija 3 predvidena za 1. četrt.
Discussion of interested parties with working parties and/or ad hoc groups on specific technical/scientific issues
predstavitve visokih predstavnikov zainteresiranih strani; razprave o delovnih programih delovnih in znanstveno svetovalnih skupin CVMP; izmenjava stališč med zainteresiranimi stranmi glede smernic; razprava zainteresiranih strani z delovnimi in/ali ad hoc skupinami o posebnih tehničnih/znanstvenih vprašanjih;
EU Comments in preparation of revised VICH Guideline
Pripombe EU k pripravi revidirane smernice VICH
Organisation of individual implementation meetings with each national competent authority (NCA) to further facilitate the electronic transmission of adverse reaction data between the NCAs and the EMEA
da se še bolj olajša elektronski prenos podatkov glede neželenih učinkov med njimi in EMEA.
8-10 March
8.-10. marec
Also, the time for communication of the CVMP opinion on medicinal products for veterinary use has been decreased to 15 days.
Zakonodaja odborom omogoča ustanovitev znanstveno svetovalnih skupin za ocenjevanje posebnih vrst farmacevtskih izdelkov ali postopkov, rok za posredovanje mnenja CVMP o zdravilih za veterinarsko uporabo pa je bil skrajšan na 15 dni.
Education: Qualified chemist and pharmacist from the Free University of Berlin.
Izobrazba: Diplomirala iz kemije in farmacije na Neodvisni univerzi v Berlinu.
Concept paper to be transmitted to CHMP by Q4 2005
Idejni dokument se pošlje CHMP do 4.
12-14 July
12.-14. julij
Concept paper to be transmitted to CHMP by Q2 2005
Idejni dokument se pošlje CHMP do 2.
HMPC meetings in 2005
Zasedanja HMPC leta 2005
Associate professor for pharmacology and toxicology in the University of Würzburg.
Izredni profesor farmakologije in toksikologije na Univerzi v Wuerzburgu.
Guidance documents focusing on the key steps of the centralised procedure, as well as on issues of quality, safety and efficacy of medicinal products, are continuously developed and updated by the EMEA.
EMEA stalno razvija in posodablja usmeritvene dokumente, usmerjene h ključnim fazam centraliziranega postopka ter vprašanjem kakovosti, varnosti in učinkovitosti zdravil.
Education: Law degree from the University of Dundee, UK. Master's degree in European and international law from the Free University of Brussels, Belgium.
Magisterij iz evropskega in mednarodnega prava na Vrije Universiteit Brussel, Belgija.
Profiles of EMEA personalities
Osnovni podatki o osebju EMEA
Note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)
Note for guidance on the clinical investigation of human normal immunoglobulin for intravenous
Revision to be considered in 2005
Revizija se preuči v letu 2005
E-mail: europeanexperts@emea.eu.int
E-naslov: europeanexperts@emea.eu.int
Applications for designation are expected to remain stable at the pre-2004 level with 85 applications in 2005
Trendi: Predvidoma naj bi leta 2005 znašalo število vlog za določitev zdravil 85, kar pomeni ohranitev ravni pred letom 2004.
Work to be considered in 2005
Delo se preuči leta 2005
To be released for consultation in 3Q
V posvetovanje se da v 3. četrt.
Studies and consultants Publications
Prevajanje Študije in svetovalci Objavljanje Programi EU
Career to date: From 1982 to 1986, Dr Bénéfice was a researcher at the University of Montpellier, France.
Dosedanja poklicna pot: Dr. Bénéfice je bila od 1982 do 1986 raziskovalka na Univerzi v
To be finalised in 2005
Dokončno se oblikuje leta 2005
COMP meetings in 2005
Zasedanja COMP leta 2005
Postgraduate degree in pharmacology; associate professor in pharmacology and toxicology at the University of Vienna.
Podiplomski študij iz farmakologije, izredni profesor farmakologije in toksikologije na Univerzi na Dunaju.
She joined the EMEA in September 1997.
EMEA se je pridružila septembra 1997.
Paediatrics Working Party
Pediatrična delovna skupina Referenčna številka
Periodic safety update reports received/forecast (Input)
Prejeta/predvidena periodično dopolnjena poročila o varnosti (Vhodni podatek)
Consultation ended 18 Oct 04, under revision by SWP-V for adoption in 1Q 2005
2004, pod revizijo delovna skupina za varnost SWP-V za sprejetje v 1. četrt.
She joined the EMEA in May 1995.
EMEA se je pridružila maja 1995.
Doctorate in clinical pharmacology from the Autonomous University of Barcelona (UAB).
Doktoriral iz klinične farmakologije na Avtonomni univerzi v
Position paper to be developed
Pripravi se dokument o stališču
Career to date: Dr Wagner was a research and teaching assistant at Saarbrücken University from 1976 to 1981.
Dosedanja poklicna pot: Dr. Wagner je bil od 1976 do 1981 asistent raziskovalec in predavatelj na
Career to date: Worked as a clinical endocrinologist in a French hospital until 1987 and then joined the directorate of pharmacy at the French Ministry of Health.
Dosedanja poklicna pot: Do leta 1987 je delala kot klinična endokrinologinja v francoski bolnišnici,
To develop a database on manufacturing authorisations and GMP certificates
Razvoj zbirke podatkov o dovoljenjih za izdelavo in potrdilih o dobri proizvodni praksi.
EU Comments in preparation of ICH Guideline
Pripombe EU k pripravi smernice ICH
Development of GCP inspection-related procedures and guidelines
Razvijati postopke in smernice za inšpekcijske preglede dobre klinične prakse.
Career to date: After several years in general veterinary practice in the United Kingdom and Canada, Dr Jones joined the pharmaceutical industry in the animal health sector.
Dosedanja poklicna pot: Dr. Jones se je po več letih opravljanja splošne veterinarske prakse v
Conduct of recruitment procedures
Vodenje zaposlitvenih postopkov.
He joined the EMEA in June 1995, and was appointed head of the veterinary unit in December of the same year, and took on responsibility for the inspections sector in January 2002.
Veterinarske enote, januarja 2002 pa je prevzel odgovornost za Sektor inšpekcijskih pregledov.
Revision 2 expected in 1Q 2005
Revizija 2 predvidena za 1. četrt.
Total Title 3 TOTAL EXPENDITURE 84,179,000
84,179.000 EUR 99,089.103 EUR 110,160.000 EUR
CHMP meetings in 2005
Zasedanja CHMP leta 2005
Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: press@emea.eu.int
Martin HARVEY ALLCHURCH Direktni telefon (44-20) 74 18 84 27
He joined the EMEA in May 2000.
EMEA se je pridružil maja 2000.
Between 1974 and 1996 he held posts in the UK Medicines Division and the Medicines Control Agency, including those of inspector of pharmaceutical manufacture, reviewer of dossiers, and manager of the biotechnology and biological unit.
Med letoma 1974 in 1996 je delal v Diviziji za zdravila Združenega kraljestva in Agenciji za nadzorovanje zdravil,
He joined the EMEA in April 1995.
EMEA se je pridružil aprila 1995.
CVMP Efficacy Working Party
Delovna skupina CVMP za učinkovitost Referenčna številka
CVMP Safety Working Party
Delovna skupina CVMP za varnost Referenčna številka
Education: Master's degree in pharmacy and doctor of natural sciences degree in pharmacology from the University of Vienna.
Izobrazba: Magisterij iz farmacije in doktorat naravoslovnih znanosti iz farmakologije na Univerzi na
Education: Honours degree in experimental physics and MSc in electronic engineering from Trinity College Dublin.
Izobrazba: Častna diploma iz eksperimentalne fizike in magisterij iz elektronskega inženiringa s
Consultation ends 18 Apr. 2005 subsequent revision by PhVWP-V
Posvetovanje se zaključi 18. apr. 2005,
Education: Qualified medical doctor from the University of Paris.
Izobrazba: Diplomiral iz splošne medicine na Univerzi v Parizu.
Pharmacovigilance Working Party Biotechnology Working Party Joint CHMP/CVMP Quality Working Party Blood Products Working Party Efficacy Working Party (plenary) Safety Working Party (plenary)
Delovna skupina za izdelke iz krvi Delovna skupina za učinkovitost (plenarna) Delovna skupina za varnost (plenarna) Skupina EMEA/CHMP za sodelovanje z organizacijami bolnikov Pediatrična delovna skupina Delovna skupina za cepiva
Development of the database on manufacturing authorisations and GMP certificates
Razvijati zbirke podatkov o dovoljenjih za izdelavo in potrdilih odobri proizvodni praksi.
The EMEA anticipates that interest in seeking such advice will continue and grow with the establishment of a new Scientific Advice Working Party for veterinary medicines Nine applications for scientific advice are expected this year Only a few applications for free scientific advice for products intended for minor uses/minor species have been received - for food animals
EMEA pričakuje, da se bo zanimanje za takšno svetovanje nadaljevalo in naraščalo z ustanovitvijo nove Delovne skupine za znanstveno svetovanje o veterinarskih zdravilih.
The target is 90 % of summaries published at the time of the press release o percentage of European public assessment reports published within 14 days after Commission decision.
o odstotek evropskih javnih poročil o oceni, objavljenih v 14 dneh po odločitvi Komisije.
Under development by SWP-V
Pripravlja jih delovna skupina za varnost SWP-V
CVMP Immunologicals Working Party
Delovna skupina CVMP za imunološke izdelke Referenčna številka
Provision of dedicated and up-to-date information on procedures for emerging therapies and technologies
Zagotavljanje namenskih in dopolnjenih informacij o postopkih za nove terapije in tehnologije Izvajanje uvrstitvenega postopka za mejne izdelke.
PhD in organic chemistry from the Free University of Berlin.
Na Neodvisni univerzi v Berlinu je doktorirala iz organske kemije.
To be released for consultation in 1/2Q
V posvetovanje se da v 1./2.
Draft to be transmitted to CHMP by Q2
Osnutek se pošlje CHMP do 2. četrt.
Inspection requests received/forecast (Input)
Prejeti/predvideni zahtevki za potrdilo (Vhodni podatek)
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
EU - EudraNet, EudraVigilance, EudraCT, EuroPharm in elektronsko pošiljanje - pa bo treba začeti izvajati, podpirati in vzdrževati.
4.4 Certificates
4.4 Potrdila
Revision to start in 2005
Začetek revizije leta 2005
Draft revision 2 to be released for consultation in 1/2Q 2005
Osnutek revizije 2 se da v posvetovanje v 1./2.
To be released for consultation in 4Q
V posvetovanje se da v 4. četrt.
He was nominated press officer in September 2001 and appointed head of executive support in January
EMEA se je pridružil septembra 1995. Septembra 2001 je bil imenovan za tiskovnega predstavnika, januarja 2004 pa za vodjo Izvršne podpore.
CHMP Efficacy Working Party
Delovna skupina CHMP za učinkovitost Referenčna številka
CHMP Vaccine Working Party
Delovna skupina CHMP za cepiva Referenčna številka
Heribert Pittner, Vice-Chairman of the HMPC, b. 19 January 1948, n. Austrian
Heribert Pittner, podpredsednik HMPC, roj. 19. januarja 1948, po narodnosti Avstrijec Izobrazba: Diplomiral iz splošne medicine na Univerzi v Gradcu.
CVMP working parties and ad hoc groups in 2005 Number of meetings Immunologicals Working Party
Delovne in ad hoc skupine CVMP v letu 2005
2004 final
1997 in 2004.
The target is to have 100 % of applications evaluated within this time
Cilj je ovrednotiti 100 % vlog v tem roku.
Medicines for human use
zdravila za uporabo v humani medicini
The Agency will improve handling of referral procedures to provide faster opinions on questions related to safety of medicines 9 The Agency will remain committed to managing effectively and efficiently its increased tasks and responsibilities, ensuring that patients and users of medicines have access to safe and effective medicinal products within the timelines laid down in the legislation 9 The Agency will work for greater transparency of its operations and activities 9 EMEA will further extend its capacity to provide scientific advice and the quality of that advice 9 It will strive to increase availability of veterinary medicines intended for minor uses and minor species
Agencija bo še naprej predano, smotrno in učinkovito vodila svoje povečane naloge in pristojnosti ter zagotavljala, da bodo imeli bolniki in uporabniki zdravil dostop do varnih in učinkovitih zdravil v rokih, predpisanih v zakonodaji.
Draft revision 1 to be released for consultation in 1/2Q 2005
Osnutek revizije 1 se da v posvetovanje v 1./2.
Draft revision 1 to be released for consultation in 2/3Q 2005
Osnutek revizije 1 se da v posvetovanje v 2./3.
Renewal of efforts to ensure availability of the best scientific expertise for evaluation of medicinal products, taking steps to reinforce areas where expertise is insufficient, especially with regard to future technologies, thus strengthening the European medicines network and increasing the overall quality and efficiency of its operation
Ukrepi spadajo na več področij in vključujejo: revizijo sedanjega postopkovnega okvira za vrednotenje zdravil, zagotavljanje kakovosti ter višjo raven strokovne podpore, ki jo zagotavlja Agencija; krepitev vloge Agencije na področju nadzora in varnosti zdravil; obnovitev prizadevanj za zagotavljanje dostopnosti najboljšega strokovnega znanja in izkušenj za vrednotenje zdravil, sprejetje ukrepov za okrepitev področij, kjer so to znanje in izkušnje nezadostne, zlasti v zvezi s prihodnjimi tehnologijami, kar bo okrepilo Evropsko mrežo zdravil ter izboljšalo celotno kakovost in učinkovitost njihovega delovanja; spodbujanje raziskav in inovacij na področju zdravil, novih terapij in tehnologij kot podpora lizbonski strategiji za gospodarsko, socialno in okoljsko prenovo, sklepom Sveta o konkurenčnosti z dne 22. septembra 2003, resolucijam Sveta o zdravju z dne 1. in 2. decembra
CHMP Safety Working Party
Delovna skupina CHMP za varnost Referenčna številka
To be finalised in 2/3Q 2005
Dokončno se oblikuje v 2./3.
Opinions on designation (Output)
Mnenja o določitvi zdravila (Izhodni podatek)
Education: Qualified medical doctor from the Free University of Brussels.
Izobrazba: Diplomiral iz splošne medicine na neodvisni univerzi v Bruslju.