natgillin/translations-raw huggingface dataset:
Core summary of product characteristics for Hepatitis B immunoglobulin Revision of core summary of product characteristics for human normal immunoglobulin for intravenous use – addition of indication for treatment of parvovirus B19 infection Revision of core summary of product characteristics for human plasma derived factor VII products and human plasma prothrombin complex Revision of core summary of product characteristics for factor VIII inhibitor bypassing fraction Warning on transmissible agents for patient leaflets and summary of product characteristics Revision of core summary of product characteristics for human anti-D immunoglobulin for intravenous and/ or intramuscular use (CPMP/ BPWG/ 574/ 99)
Core summary of product characteristics for Hepatitis B immunoglobulin Revision of core summary of product characteristics for human normal immunoglobulin for intravenous use – addition of indication for treatment of parvovirus B19 infection Revision of core summary of product characteristics for human plasma derived factor VII products and human plasma prothrombin complex Revision of core summary of product characteristics for factor VIII inhibitor bypassing fraction Warning on transmissible agents for patient leaflets and summary of product characteristics Revision of core summary of product characteristics for human anti- D immunoglobulin for intravenous and/ or intramuscular
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Efficacy Working Party
47/ 64 Asiakirjan nimi use (CPMP/ BPWG/ 574/ 99)
 EMEA 2002 Page 45/ 62
CPMP: n tehokkuustyöryhmä
Note for guidance on clinical investigation of medicinal products for treatment of peripheral arterial occlusive disease Concept paper on the revision of the Note for guidance on evaluation of new anti-bacterial medicinal product (CPMP/ EWP/ 558/ 95) and the Note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial products Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Asiakirjan nimi Note for guidance on clinical investigation of medicinal products for the treatment of diabetes mellitus Note for guidance on clinical investigation of anti- depressive agents Note for guidance on clinical investigation of medicinal products for pain treatment Position paper on new modified formulations of acetyl salicylic acid in the secondary prevention of cardiovascular events Note for guidance on clinical investigation of medicinal products for treatment of peripheral arterial occlusive disease Concept paper on the revision of the Note for guidance on evaluation of new anti- bacterial medicinal product (CPMP/ EWP/ 558/ 95) and the Note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial products Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Adjustment for baseline covariates Points to consider on the clinical investigation of medicinal products in the treatment of asthma Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women Note for guidance on the evaluation of medicinal products for treatment of migraine Appendix to the CPMP Note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction Addendum on acute cardiac failure to the CPMP Note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia Points to consider on clinical investigation of slow-acting anti-rheumatic medicinal products in rheumatoid arthritis Points to consider on irritable bowel syndrome Points to consider document on the evaluation of new anti-fungal agents for invasive fungal infections Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Adjustment for baseline covariates Points to consider on the clinical investigation of medicinal products in the treatment of asthma Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women Note for guidance on the evaluation of medicinal products for treatment of migraine Appendix to the CPMP Note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction Addendum on acute cardiac failure to the CPMP Note for guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia Points to consider on clinical investigation of slow- acting anti- rheumatic medicinal products in rheumatoid arthritis Points to consider on irritable bowel syndrome Points to consider document on the evaluation of new anti- fungal agents for invasive fungal infections Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Choice of delta Points to consider on the requirements for clinical documentation for metered dose inhalers Addenda for neuropathic pains to be considered Clinical investigation of hypnotic medicinal products Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder, Panic Disorder and Obsessive-compulsive DisorderRevision Note for guidance on Anthiarrhythmics Note for guidance on Clinical investigation of steroid contraceptives in women Clinical Investigation of Corticosteroids Intended for use on the Skin.
Choice of delta Points to consider on the requirements for clinical documentation for metered dose inhalers Addenda for neuropathic pains to be considered Clinical investigation of hypnotic medicinal products Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder, Panic Disorder and Obsessive- compulsive DisorderRevision Note for guidance on Anthiarrhythmics Note for guidance on Clinical investigation of steroid contraceptives in women Clinical Investigation of Corticosteroids Intended for use on the Skin.
Note for guidance on Pharmacokinetic Studies in man Points to consider on Live attenuated influenza vaccines Guidance on requirements for pharmaceutical/ clinical documentation for Cell culture influenza vaccines Points to consider on xenogeneic cell therapy Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance Note for guidance on the use of medicinal products during pregnancy: need for post-marketing data Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling Revision of the Note for guidance on harmonisation of requirements for influenza vaccines
Note for guidance on Pharmacokinetic Studies in man Points to consider on Live attenuated influenza vaccines Guidance on requirements for pharmaceutical/ clinical documentation for Cell culture influenza vaccines Points to consider on xenogeneic cell therapy Note for guidance on comparability of medicinal products containing biotechnology- derived proteins as active substance Note for guidance on the use of medicinal products during pregnancy: need for post- marketing data Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling Revision of the Note for guidance on harmonisation of requirements for influenza vaccines
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Safety Working Party
48/ 64 CPMP: n turvallisuustyöryhmä
Document title Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
Asiakirjan nimi Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
63) Note for guidance on photosafety testing Points to consider document on the need for assessment of reproductive toxicity of human insulin analogues Discussion paper on environmental risk assessments of non-GMO containing medicinal products for human use Non-clinical documentation of medicinal products with ‘ well-established use’ Note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals Discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man Note for guidance on specification limits for residues for heavy metal catalysts in medicinal products Points to consider on xenogeneic cell therapy Note for guidance on comparability of biotechnology products pre-clinical and clinical issues
63) Note for guidance on photosafety testing Points to consider document on the need for assessment of reproductive toxicity of human insulin analogues Discussion paper on environmental risk assessments of non- GMO containing medicinal products for human use Non- clinical documentation of medicinal products with ‘ well- established use ’ Note for guidance on the need for non- clinical testing of pharmaceuticals in juvenile animals Discussion paper on the non- clinical safety studies to support single low dose clinical screening studies in man Note for guidance on specification limits for residues for heavy metal catalysts in medicinal products Points to consider on xenogeneic cell therapy Note for guidance on comparability of biotechnology products pre- clinical and clinical issues Points to consider on the assessment of the potential for QT interval prolongation by non- cardiovascular medicinal products Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
CVMP Efficacy Working Party
CVMP: n tehokkuustyöryhmä
Document title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Asiakirjan nimi Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
CPMP Pharmacovigilance Working Party
CPMP: n lääkevalvonnan työryhmä
Document title Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy:
Asiakirjan nimi Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy:
Need for post-marketing data Contribution to CPMP Points to consider document on xenogeneic cell therapy Proposals for revision to Standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
Need for post- marketing data Contribution to CPMP Points to consider document on xenogeneic cell therapy Proposals for revision to Standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
Document title Harmonisation requirements for low and high potency and batch consistency of vaccines Harmonisation requirements for low and high potency and batch consistency of vectored vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products Revision: transmissible spongiform encephalopathy Revision: compliance with the European Pharmacopoeia Revision: equine influenza Revision: claims for veterinary vaccines VICH:
Asiakirjan nimi Harmonisation requirements for low and high potency and batch consistency of vaccines Harmonisation requirements for low and high potency and batch consistency of vectored vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products Revision: transmissible spongiform encephalopathy Revision: compliance with the European Pharmacopoeia Revision: equine influenza Revision: claims for veterinary vaccines VICH:
Biologicals: testing of residual moisture EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CVMP Pharmacovigilance Working Party
Biologicals: testing of residual moisture
 EMEA 2002 Page 47/ 62
49/ 64 CVMP: n lääkevalvonnan työryhmä
Document title VICH:
Asiakirjan nimi VICH:
Document title Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Asiakirjan nimi Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Pre-approval information for registration of new medicinal products for food producing animals with respect to antimicrobial resistance VICH:
Pre- approval information for registration of new medicinal products for food producing animals with respect to antimicrobial resistance VICH:
Carcinogenicity testing Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Carcinogenicity testing Pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Document title In-use stability testing of veterinary medicinal products Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Asiakirjan nimi In- use stability testing of veterinary medicinal products Use of near infrared spectroscopy by the pharmaceutical industry Modified oral and transdermal dosage forms Revision:
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 4 EMEA contact points
50/ 64 Liite 4 EMEA: n yhteystiedot
The constant monitoring of the safety of medicines after authorisation (‘ pharmacovigilance’) is an important part of the work of the national competent authorities and EMEA.
Tärkeä osa kansallisten toimivaltaisten viranomaisten ja EMEAn työtä on myyntiluvan saaneiden lääkevalmisteiden turvallisuuden jatkuva seuranta (lääkevalvonta).
For matters relating to pharmacovigilance for medicinal products for human use
Ihmisten käyttöön tarkoitettujen lääkevalmisteiden lääketurvatoimintaa koskevat asiat:
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
Noël Wathion Suora puhelinnumero (+44- 20) 74 18 85 92 Sähköposti: noel. wathion@ emea. eu. int
For matters relating to pharmacovigilance for medicinal products for veterinary use
Eläinten käyttöön tarkoitettujen lääkevalmisteiden lääketurvatoimintaa koskevat asiat:
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
Barbara FREISCHEM Suora puhelinnumero (+44- 20) 74 18 85 81 Sähköposti: barbara. freischem@ emea. eu. int
For product defect and other quality-related matters
Valmistevikoja ja muut laatua koskevat asiat:
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: francisco. penaranda@emea. eu. int
Francisco PEÑARANDA FERNANDEZ Faksinumero, johon voi heti ilmoittaa (44- 20) 74 18 85 90 Sähköposti: francisco. penaranda@ emea. eu. int
These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Todistukset vahvistavat lääkevalmisteiden myyntiluvan ja hyvän valmistustavan EU: ssa, ja niillä pyritään tukemaan myyntilupien hakemista Euroopan unionin ulkopuolisissa maissa ja vientiä niihin.
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Keskitetyn myyntiluvan saaneita ihmisille tai eläimille Jonna SUNELL- HUET tarkoitettujen lääkkeiden todistuksia koskevat tiedustelut:
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
Suora puhelinnumero (+44- 20) 74 18 84 65 Sähköposti: certificate@ emea. eu. int
A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
EMEA on julkaissut monenlaisia julkaisuja, kuten lehdistötiedotteita, yleisiä tietoesitteitä, vuosikertomuksia ja työohjelmia.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
Nämä ja muita asiakirjoja on saatavilla www- osoitteessa http: // www. emea. eu. int ja seuraavasta postiosoitteesta:
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
51/ 64 Tilauspalvelusta saa kaikkia EMEAn julkisia asiakirjoja sekä sähköisessä muodossa että paperilla.
Further information can be obtained from the Iro MAVROPOULOS
Lisätietoja saa edellä esitetystä tai tästä osoitteesta:
above address or from Direct telephone (44-20) 74 18 85 E-mail: subscriptions@emea. eu. int
Iro MAVROPOULOS Suora puhelinnumero (+44- 20) 74 18 85 82 Sähköposti: subscriptions@ emea. eu. int
Requests for general information packs should be sent to
Yleisiä tietopaketteja koskevat pyynnöt tulisi lähettää
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
Amanda BOSWORTH Suora puhelinnumero (+44- 20) 74 18 84 08 Sähköposti: amanda. bosworth@ emea. eu. int
European experts lists
EU: n asiantuntijoiden luettelo
The list of European experts is available for examination on request at the EMEA offices.
Luettelo EU: n asiantuntijoista on saatavissa tarkastuksia varten EMEAn toimistosta.
Human medicines’ experts list
Ihmisille tarkoitettujen lääkkeiden asiantuntijaluettelo
human_experts@emea. eu. int
human_ experts@ emea. eu. int
Veterinary medicines ’ experts list
Eläinlääkeasiantuntijoiden luettelo
vet_experts@emea. eu. int
vet_ experts@ emea. eu. int
Inspectors ’ experts list
Tarkastusasiantuntijaluettelo
inspectors_experts@emea. eu. int
inspectors_ experts@ emea. eu. int
Press officer
Tiedotusvastaava
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eu. int
Martin HARVEY Suora puhelinnumero (+44- 20) 74 18 84 27 Sähköposti: martin. harvey@ emea. eu. int
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 5 Profiles of EMEA personalities
52/ 64 Liite 5 EMEA: n vastuuhenkilöiden esittely
Keith Jones, Chairman of the Management Board, b.
Keith Jones, hallintoneuvoston puheenjohtaja, s.
British
14. lokakuuta 1937, Yhdistynyt kuningaskunta
He then trained as a toxicologist in the agrochemical industry.
Sittemmin hän on hankkinut toksikologin koulutuksen agrokemian teollisuudessa.
Dr Jones went on to spend 22 years in industry as Head of the Medical Department at Fisons Agrochemical Divisions, Head of Safety Assessment and Clinical Pharmacology at Beecham Pharmaceuticals and Executive Director, Medical Affairs at Merck Sharp and Dohme in the USA.
Tri Jones on toiminut 22 vuotta teollisuudessa Fisons Agrochemical Divisionsin lääketieteellisen jaoston johtajana, Beecham Pharmaceuticalsin turvallisuusarviointi - ja kliinisen farmakologian jaoston päällikkönä sekä lääketieteellisten asioiden johtajana Merkc Sharp and Dohmella Yhdysvalloissa.
In 1991 Dr Jones was appointed Chief Executive of the UK Medicines Control Agency, and is presently the UK delegate to the EU Pharmaceutical and Standing Regulatory Committees, and a member of the EU Scientific Steering Committee within the European Commission Directorate-General for Public health and consumer protection.
Vuonna 1991 Jones nimitettiin Yhdistyneen kuningaskunnan lääkevalvontaviraston johtajaksi, ja tällä hetkellä hän on Yhdistyneen kuningaskunnan edustaja EU: n lääkekomiteassa ja pysyvässä sääntelykomiteassa sekä Euroopan komission terveys - ja kuluttaja - asioiden pääosaston tieteellisen ohjauskomitean jäsen.
He is currently visiting Professor of Pharmacology at the School of Pharmacy University of London and has published widely.
Hän on myös Lontoon yliopiston lääkeopin tiedekunnan vieraileva professori ja hän on laatinut runsaasti julkaisuja.
Dr Jones joined the EMEA Management Board in 1995 and was elected chairman of the Board in 2001.
Vuonna 1991 tri Jonesista tuli EMEAn hallintoneuvoston jäsen, ja vuonna 2001 hänet valittiin sen puheenjohtajaksi.
Gerhard Josef Kothmann, Vice-Chairman of the Management Board, b.
Gerhard Kothmann, hallintoneuvoston varapuheenjohtaja, s.
German
23. heinäkuuta 1943, Saksa
After a period of general veterinary practice, Dr Kothmann joined the German Federal Research Centre for Animal Virus Diseases in 1970 and the veterinary administrative service for Lower Saxony in 1972.
Toimittuaan eläinlääkärinä tri Kothmann siirtyi Saksan liittovaltion eläinten virustautien tutkimuskeskuksen palvelukseen vuonna 1970 ja sieltä Ala- Saksin eläinlääkintävirastoon vuonna 1972.
He moved to the German Federal Ministry for Health in 1975 where he has served in various posts, including in the division responsible for veterinary pharmaceutical sector, and in 1990 he collaborated in the reconstruction of the veterinary services in the new federal Länder.
Vuonna 1990 hän osallistui eläinlääkintävirastojen uudistamiseen uusissa osavaltioissa.
He was appointed Chief Veterinary Officer in 1991.
Hänet nimitettiin ylieläinlääkärin virkaan vuonna 1991.
Dr Kothmann joined the EMEA Management Board in 1996 and was elected vice-chairman in 2000.
Tri Kothmann nimitettiin EMEAn hallintoneuvoston jäseneksi vuonna 1996 ja valittiin sen varapuheenjohtajaksi vuonna 2000.
Post-graduate studies in management and health economics.
Korkeakouluopintoja hallinnossa ja terveydenhuollon taloudessa.
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.
Tänä aikana hänen vastuualuettaan olivat luonnonlääkkeet, kosmetiikka, lääketieteelliset laitteet, huumausaineet ja ehkäisyvälineet.
He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994.
Vuosina 1982– 1994 hän toimi Ruotsin terveydenhoidon yhteistyöohjelmassa Vietnamissa vanhempana lääkeaineopin konsulttina.
He joined the Swedish Medicinal Products Agency in 1990, serving as Director of Operations and later as Deputy Director-General.
Vuonna 1990 hän tuli Ruotsin lääkevalmisteviraston palvelukseen, jossa työskenteli toiminnanjohtajana ja myöhemmin varajohtajana.
He is Executive Director of the EMEA since January 2001.
Hän on toiminut EMEAn johtajana tammikuusta 2001.
 EMEA 2002 Page 51/ 62
53/ 64 EMEAn tieteelliset komiteat
Daniel Brasseur, Chairman of the CPMP, b.
Daniel Brasseur, CPMP: n puheenjohtaja, s.
Belgian
7. kesäkuuta 1951, Belgia
Qualified medical doctor from the Free University of Brussels.
Valmistunut lääkäriksi Brysselin vapaasta yliopistosta.
Post-graduate degree in paediatrics and a PhD in nutrition.
Jatkotutkinto lastentautiopissa ja filosofian tohtorin tutkinto ravitsemustieteessä.
From 1976 to 1986 Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Vuosina 1976– 1986 tri Brasseur toimi lastenlääkärinä Sint Pieterin yliopistollisessa sairaalassa Brysselissä.