natgillin/translations-raw huggingface dataset:
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
46/ 62 CPMP- arbejdsgruppe vedrørende sikkerhed
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Safety Working Party
Titel på dokumentet Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
Document title 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 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
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
Titel på dokumentet Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Document title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Titel på dokumentet 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:
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:
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
Titel på dokumentet 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:
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:
Biologicals: testing of residue formaldehyde VICH:
Biologicals: testing of residue formaldehyde VICH:
Biologicals: testing of residual moisture
Biologicals: testing of residual moisture EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CVMP Pharmacovigilance Working Party
47/ 62 CVMP- arbejdsgruppe vedrørende lægemiddelovervågning
 EMEA 2002 Page 47/ 62
Titel på dokumentet VICH:
Document title VICH:
Management of adverse event reports VICH:
Management of adverse event reports VICH:
Management of periodic summary update reports VICH:
Management of periodic summary update reports VICH:
Controlled list of terms Processing of renewals in the centralised procedure
Controlled list of terms Processing of renewals in the centralised procedure
Titel på dokumentet Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Document title 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
Titel på dokumentet 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:
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:
European Drug Master File
European Drug Master File
48/ 62 Bilag 4 EMEA' s kontaktpunkter
 EMEA 2002 Page 48/ 62
Den fortløbende overvågning af lægemidlers sikkerhed efter udstedelse af tilladelse (‘ lægemiddelovervågning ’) er en vigtig del af de nationale kompetente myndigheders og EMEA’ s arbejde.
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.
EMEA modtager både EU- interne og EU- eksterne sikkerhedsrapporter, som vedrører lægemidler godkendt via den centraliserede procedure, og koordinerer indsatsen for lægemidlers sikkerhed og kvalitet.
The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Spørgsmål om lægemiddelovervågning af humanmedicinske lægemidler
For matters relating to pharmacovigilance for medicinal products for human use
(direkte nummer) (44- 20) 74 18 85 92 E- mail: noel. wathion@ emea. eu. int
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
Spørgsmål om lægemiddelovervågning af veterinærlægemidler
For matters relating to pharmacovigilance for medicinal products for veterinary use
(direkte nummer) (44- 20) 74 18 85 81 E- mail: barbara. freischem@ emea. eu. int
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
Spørgsmål om produktionsfejl og andre kvalitetsrelaterede spørgsmål
For product defect and other quality-related matters
Francisco PEÑARANDA FERNANDEZ Faxnr. vedrørende produktionsfejl i tilfælde af hurtig varsling (44- 20) 74 18 85 90 E- mail: francisco. penaranda@ emea. eu. int
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: francisco. penaranda@emea. eu. int
Forespørgsler om certifikater for human - eller veterinærmedicinske lægemidler, der er godkendt via den centraliserede procedure
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
(direkte nummer) (44- 20) 74 18 84 65 E- mail: certificate@ emea. eu. int
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
Dokumentation
Documentation services
EMEA har nu udgivet en bred vifte af dokumenter, herunder pressemeddelelser, generelt informationsmateriale, årsberetninger og arbejdsprogrammer.
A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Disse og andre dokumenter findes på internettet på følgende adresse: http: // www. emea. eu. int eller kan rekvireres ved skriftlig henvendelse til:
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4HB
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4H
49/ 62 Der kan abonneres på alle EMEA' s offentliggjorte dokumenter, enten i elektronisk udgave eller i papirformat.
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.
Yderligere oplysninger kan fås ved henvendelse til ovennævnte adresse eller til
 EMEA 2002 Page 49/ 62
Iro MAVROPOULOS Tlf.:
Further information can be obtained from the Iro MAVROPOULOS
(direkte nummer) (44- 20) 74 18 85 82 E- mail: subscriptions@ emea. eu. int
above address or from Direct telephone (44-20) 74 18 85 E-mail: subscriptions@emea. eu. int
Anmodninger om mapper med generelt Informationsmateriale sendes til
Requests for general information packs should be sent to
(direkte nummer) (44- 20) 74 18 84 08 E- mail: amanda. bosworth@ emea. eu. int
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
Lister over europæiske eksperter
European experts lists
Listerne over europæiske eksperter kan efter anmodning besigtiges i EMEA.
The list of European experts is available for examination on request at the EMEA offices.
Skriftlige anmodninger kan sendes til EMEA eller til følgende e- mail- adresser:
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
Listen over humanmedicinske eksperter
Human medicines’ experts list
human_ experts@ emea. eu. int
human_experts@emea. eu. int
Listen over veterinærmedicinske eksperter
Veterinary medicines ’ experts list
vet_ experts@ emea. eu. int
vet_experts@emea. eu. int
Listen over tilsynsførende eksperter
Inspectors ’ experts list
inspectors_ experts@ emea. eu. int
inspectors_experts@emea. eu. int
(direkte nummer) (44- 20) 74 18 84 27 E- mail: martin. harvey@ emea. eu. int
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eu. int
50/ 62 Bilag 5 Profiler af EMEA' s ledende medarbejdere
 EMEA 2002 Page 50/ 62
Keith Jones, formand for bestyrelsen, født 14. oktober 1937, britisk statsborger
British
Keith Jones er uddannet i medicin og har beklædt forskellige stillinger inden for klinisk medicin og forskning ved britiske universitetshospitaler.
Dr Jones is qualified in medicine and has held posts in clinical medicine and research at UK teaching hospitals.
Yderligere uddannelse inden for toksikologi inden for den agrokemiske industri.
He then trained as a toxicologist in the agrochemical industry.
Er britisk medlem af EU' s Lægemiddeludvalg og Stående Forskriftsudvalg samt medlem af EU' s Videnskabelige Styringsudvalg under Europa - Kommissionens GD for Sundhed og Forbrugerbeskyttelse.
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.
Gerhard Kothmann, næstformand i bestyrelsen, født 23. juli 1943, tysk statsborger
German
Uddannet som veterinærkirurg ved Hannover Universitet.
Qualified veterinary surgeon from the University of Hanover.
Kothmann i 1970 ansat i det tyske Forskningscenter for Virussygdomme hos Dyr og dernæst - i 1972 - i veterinærforvaltningen for Niedersachsen.
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.
Kothmann trådte ind i EMEA' s bestyrelse i 1996 og blev valgt til næstformand i 2000.
Dr Kothmann joined the EMEA Management Board in 1996 and was elected vice-chairman in 2000.
Thomas Lönngren blev ansat i den svenske Lægemiddelstyrelse i 1990, først som direktør for operationelle anliggender og dernæst som vicegeneraldirektør.
He joined the Swedish Medicinal Products Agency in 1990, serving as Director of Operations and later as Deputy Director-General.
Har været administrerende direktør i EMEA siden januar 2001.
He is Executive Director of the EMEA since January 2001.
51/ 62 EMEA' s videnskabelige udvalg
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 EMEA scientific committees
Daniel Brasseur, formand for CPMP, født 7. juni 1951, belgisk statsborger
Belgian
Uddannet som læge ved Det Frie Universitet i Bruxelles.
Qualified medical doctor from the Free University of Brussels.
Universitetsgrad efter kandidateksamen i pædiatri og en PhD i ernæring.
Post-graduate degree in paediatrics and a PhD in nutrition.
Brasseur som pædiater ved universitetshospitalet Sint Pieter i Bruxelles.
From 1976 to 1986 Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Arbejdede dernæst en kort periode inden for medicinalindustrien 1986- 1987, indtil han vendte tilbage til en klinisk stilling ved Dronning Fabiolas Universitetshospital for Børn i Bruxelles som leder af afdelingen for ernæring og farmakodynamik, en stilling, han stadig beklæder.
He moved briefly to the pharmaceutical industry from 1986 to 1987, before returning to clinical work at the Queen Fabiola Children’ s University Hospital in Brussels as head of the nutrition and pharmacodynamics unit, a post he continues to hold today.
Eric Abadie, næstformand i CPMP, født 14. juli 1950, fransk statsborger
French
Uddannet som læge ved Paris Universitet.
Qualified medical doctor from the University of Paris.
Uddannelse efter kandidateksamen inden for intern medicin, endokrinologi, diabetologi og kardiologi.
Post-graduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Steve Dean, formand for CVMP, født 2. august 1951, britisk statsborger
British
Gérard Moulin, næstformand i CVMP, født 18. oktober 1958, fransk statsborger
French
PhD i mikrobiologi fra Lyon Universitet.
PhD in Microbiology from the University of Lyon Career to date:
Karriereforløb:
From 1981 to 1984, Dr Moulin worked in the Bovine Pathology Laboratory in Lyon.
52/ 62 Josep Torrent i Farnell, formand for COMP, født 2. maj 1954, spansk statsborger
Spanish
Uddannet i farmaci, medicin og kirurgi ved Barcelona Universitet og har desuden taget kurser efter kandidateksamen i farmakologi og toksikologi, folkesundhed og europæiske institutioner.
Qualified Pharmacist and Degree in medicine and surgery from the University of Barcelona as well as postgraduate courses in pharmacology and toxicology, public health and
Doktorgrad i klinisk farmakologi ved Barcelonas Autonome Universitet (UAB).
Doctorate pharmacology from the Autonomous University of Barcelona (UAB).
1977- 1990 arbejdede prof.
From 1977-1990, Prof.
Torrent i Farnell inden for intern medicin og klinisk farmakologi i Spanien og var desuden ansat som docent i farmakologi ved UAB.
Torrent i Farnell worked in internal medicine and clinical pharmacology in Spain and was Assistant Professor of Pharmacology at UAB.
1990- 1994 var han teknisk rådgiver inden for klinisk vurdering og farmakologi i det spanske sundhedsministerium, medlem af CPMP' s arbejdsgruppe vedrørende virkninger og engageret i arbejdet i gruppen om virkninger under ICH.
From 1990 to 1994, he was Technical Counsellor in Clinical Evaluation and Pharmacology at the Spanish Ministry of Health, Member of the CPMP Efficacy Working Party and involved in the Efficacy Group of the ICH.
I 1992 blev han professor i klinisk farmakologi og behandling og direktør for master/ diplom - uddannelsen i europæisk registrering af lægemidler (UAB).
In 1992, he became Professor of Clinical Pharmacology and Therapeutics and Director of the Masters/ Diploma course on European Registration of Medicinal Products (UAB).
Ansat i EMEA som ledende videnskabelig fuldmægtig i 1995 og i perioden 1996- 1998 leder af sektionen for nye kemiske stoffer.
He joined the EMEA in 1995 as Principal Scientific Administrator and from 1996 to 1998 he was Head of Sector for new chemical substances.
Administrerende direktør for samme lægemiddelstyrelse 1999- 2000.
In 1998 he was coordinator Director for the creation of the Spanish Medicines Agency and Executive Director of the Spanish Medicines Agency from 1999-2000.
Valgt til formand for Udvalget for Lægemidler til Sjældne Sygdomme i maj 2000.
He was elected Chairperson of the Committee for Orphan Medicinal Products in May 2000.
Yann Le Cam, næstformand i COMP, født 15. juli 1961, fransk statsborger
French
Uddannet i virksomhedsledelse ved Institut Supérieur de Gestion i Paris.
He is a graduate in business administration from the Institut Supérieur de Gestion in Paris.
Har desuden en MBA fra Centre de Perfectionnement aux Affaires, Groupe HEC- CPA, 2000, Jouy- en- Josas i Frankrig.
He also holds an MBA from the Centre de Perfectionnement aux Affaires, Groupe HEC-CPA, 2000, Jouy-en-Josas, France.