natgillin/translations-raw huggingface dataset:
Document title Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products CPMP recommendations on vCJD and plasma derived medicinal products – CPMP recommendations on transmissible agents and urinary derived medicinal products Note for guidance on the use of bovine serum used in the manufacture of human biological medicinal products Note for guidance on the production and quality control of animal immunoglobins and immunosera for human use Cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines EU recommendations for the influenza vaccine composition for the season 2002/ 2003 Plasma master file:
Dokumenttitel Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products CPMP recommendations on vCJD and plasma derived medicinal products – CPMP recommendations on transmissible agents and urinary derived medicinal products Note for guidance on the use of bovine serum used in the manufacture of human biological medicinal products Note for guidance on the production and quality control of animal immunoglobins and immunosera for human use Cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines EU recommendations for the influenza vaccine composition for the season 2002/ 2003 Plasma master file:
CPMP Blood Products Working Party
CPMP: s arbetsgrupp för blodprodukter
Document title Note for guidance on the clinical investigation of plasma derived antithrombin products Core summary of product characteristics for plasma-derived antithrombin products Note for guidance on the clinical investigation of human normal immunoglobulin for intramuscular and subcutaneous use Core summary of product characteristics for human normal immunoglobulin for intramuscular and subcutaneous use Note for Guidance on the clinical investigation of plasma derived fibrin sealants Core summary of product characteristics for plasma derived fibrin sealants Note for guidance on the clinical investigation of von Willebrand factor Core summary of product characteristics for von Willebrand factor Note for guidance on the clinical investigation of alpha1 antitrypsin Core summary of product characteristics for alpha1 antitrypsin Core summary of product characteristics for the following specific immunoglobulins:
Dokumenttitel Note for Guidance on the Clinical investigation of plasma derived antithrombin products Core summary of product characteristics for plasma- derived antithrombin products Note for guidance on the clinical investigation of human normal immunoglobulin for intramuscular and subcutaneous use Core summary of product characteristics for human normal immunoglobulin for intramuscular and subcutaneous use Note for Guidance on the clinical investigation of plasma derived fibrin sealants Core summary of product characteristics for plasma derived fibrin sealants Note for guidance on the clinical investigation of von Willebrand factor Core summary of product characteristics for von Willebrand factor Note for guidance on the clinical investigation of alpha1 antitrypsin Core summary of product characteristics for alpha1 antitrypsin Core summary of product characteristics for the following specific immunoglobulins:
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 use (CPMP/ BPWG/ 574/ 99)
 EMEA 2002 Page 45/ 62
45/ 62 CPMP: s arbetsgrupp för läkemedelseffekt (EWP)
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:
Dokumenttitel 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 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:
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
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 woman 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
 EMEA 2002 Page 46/ 62
46/ 62 CPMP: s arbetsgrupp för säkerhet (SWP)
Document title Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
Dokumenttitel Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
CVMP Efficacy Working Party
CVMP: s arbetsgrupp för läkemedelseffekt (EWP)
Document title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Dokumenttitel Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
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:
Dokumenttitel 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:
CVMP Immunologicals Working Party
CVMP: s arbetsgrupp för immunologiska läkemedel (IWP)
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:
Dokumenttitel 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:
 EMEA 2002 Page 47/ 62
47/ 62 CVMP: s arbetsgrupp för biverkningsbevakning
Document title VICH:
Dokument titel VICH:
CVMP Safety Working Party
CVMP: s arbetsgrupp för säkerhet
Document title Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Dokumenttitel Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
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:
Revision:
 EMEA 2002 Page 48/ 62
48/ 62 Bilaga 4 EMEA: s kontaktpunkter
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.
Den löpande övervakningen av läkemedels säkerhet efter det att de godkänts för försäljning (” biverk - ningsbevakning ”) är en viktig del av det arbete som utförs av de behöriga nationella myndigheterna och EMEA.
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.
EMEA får in säkerhetsrapporter om centralt godkända läkemedel från EU- länderna och andra länder och samordnar den verksamhet som rör läkemedels säkerhet och kvalitet.
For matters relating to pharmacovigilance for medicinal products for human use
Frågor rörande biverkningsbevakning avseende humanläkemedel
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
Noël WATHION Tfn direkt (44- 20) 74 18 85 92 E- post: noel. wathion@ emea. eu. int
For matters relating to pharmacovigilance for medicinal products for veterinary use
Frågor rörande biverkningsbevakning avseende veterinärmedicinska läkemedel
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
Barbara FREISCHEM Tfn direkt (44- 20) 74 18 85 81 E- post: barbara. freischem@ emea. eu. int
For product defect and other quality-related matters
Produktdefekter och andra kvalitetsfrågor
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: francisco. penaranda@emea. eu. int
(44- 20) 74 18 85 90 E- post: francisco. penaranda@ emea. eu. int
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
I enlighet med WHO: s regler utfärdar EMEA läkemedelscertifikat där godkännande för försäljning och GMP- status i EU intygas.
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Frågor rörande certifikat för centralt godkända humanläkemedel och veterinärmedicinska läkemedel
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
Jonna SUNELL- HUET Tfn direkt (44- 20) 74 18 84 65 E- post: 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 har nu publicerat ett stort antal dokument, bl. a. pressmeddelanden, allmän information, årsrapporter och arbetsprogram.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
Dessa och andra dokument finns på webbplatsen http: // www. eudra. org/ emea. html eller kan rekvireras skriftligen från:
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4H
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf London E14 4HB Storbritannien
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.
49/ 62 Det finns en prenumerationstjänst för alla offentliga EMEA- dokument.
 EMEA 2002 Page 49/ 62
Distributionen sker elektroniskt eller i pappersform.
Further information can be obtained from the Iro MAVROPOULOS
Mer information kan erhållas från adressen ovan eller från
above address or from Direct telephone (44-20) 74 18 85 E-mail: subscriptions@emea. eu. int
Iro MAVROPOULOS Tfn direkt (44- 20) 74 18 85 82 E- post: subscriptions@ emea. eu. int
Requests for general information packs should be sent to
Informationspaket kan rekvireras från
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
Amanda BOSWORTH Tfn direkt (44- 20) 74 18 84 08 E- post: amanda. bosworth@ emea. eu. int
European experts lists
Förteckningar över europeiska experter
The list of European experts is available for examination on request at the EMEA offices.
Förteckningarna över europeiska experter kan på begäran studeras vid EMEA: s kontor.
Human medicines’ experts list
Experter - humanläkemedel
Veterinary medicines ’ experts list
Experter - veterinärmedicinska läkemedel
Inspectors ’ experts list
Experter - inspektioner
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eu. int
Martin HARVEY Tfn direkt (44- 20) 74 18 84 27 E- post: martin. harvey@ emea. eu. int
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 5 Profiles of EMEA personalities
50/ 62 Bilaga 5 Presentation av befattningshavare vid EMEA
Keith Jones, Chairman of the Management Board, b.
Keith Jones, styrelsens ordförande.
British
Född 371014, brittisk medborgare
Dr Jones is qualified in medicine and has held posts in clinical medicine and research at UK teaching hospitals.
Läkarexamen och olika befattningar inom klinisk medicin och forskning vid brittiska undervisningssjukhus.
He then trained as a toxicologist in the agrochemical industry.
Därefter utbildning till toxikolog inom den jordbrukskemiska branschen.
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.
Utsågs 1991 till verkställande direktör för det brittiska läkemedelsverket (Medicines Control Agency) och är brittisk delegat i EU: s läkemedelskommitté och ständiga regelkommitté samt ledamot i EU: s vetenskapliga ledningskommitté inom Europeiska kommissionens generaldirektorat för hälsa och konsumentskydd.
Gerhard Josef Kothmann, Vice-Chairman of the Management Board, b.
Gerhard Kothmann, styrelsens vice ordförande.
German
Född 430723, tysk medborgare
Qualified veterinary surgeon from the University of Hanover.
Veterinärexamen vid Hannover- universitetet.
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.
Kom 1970, efter en tid som allmänpraktiserande veterinär, till det federala tyska centrumet för forskning om virussjukdomar hos djur och flyttade därefter 1972 till den veterinär - medicinska förvaltningen för Niedersachsen.
Dr Kothmann joined the EMEA Management Board in 1996 and was elected vice-chairman in 2000.
Blev ledamot av EMEA: s styrelse 1996 och valdes 2000 till dess vice ordförande.
MSc in social and regulatory pharmacy.
Fil. mag. i socialfarmaci och regel - och tillsynsfrågor på läkemedelsområdet.
 EMEA 2002 Page 51/ 62
51/ 62 EMEA: s vetenskapliga kommittéer
Daniel Brasseur, Chairman of the CPMP, b.
Daniel Brasseur, ordförande i Kommittén för farmaceutiska specialiteter (CPMP).
Belgian
Född 510607, belgisk medborgare
Qualified medical doctor from the Free University of Brussels.
Läkarexamen vid Fria universitetet i Bryssel.
Post-graduate degree in paediatrics and a PhD in nutrition.
Examen i pediatri och filosofie doktor i nutrition.
From 1976 to 1986 Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Var 1976– 1986 barnläkare vid universitetssjukhuset Sint Pieter i Bryssel.
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.
Arbetade en kortare tid i läkemedelsbranschen 1986– 1987 men återvände därefter till klinisk verksamhet vid Drottning Fabiolas universitetssjukhus för barn i Bryssel som chef för enheten för nutrition och farmakodynamik, en befattning han fortfarande innehar.
Eric Abadie, Vice-chairman of the CPMP, b.
Eric Abadie, vice ordförande i CPMP.
French
Född 500714, fransk medborgare
Qualified medical doctor from the University of Paris.
Läkarexamen vid Paris- universitetet.
Post-graduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Examina i internmedicin, endokrinologi, diabetologi och kardiologi.
British
Född 510802, brittisk medborgare
Gérard Moulin, Vice-chairman of the CVMP, b.
Gérard Moulin, vice ordförande i CVMP.
French
Född 581018, fransk medborgare
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Josep Torrent i Farnell, Chairman of the COMP, b.
52/ 62 Josep Torrent i Farnell, ordförande i Kommittén för särläkemedel (COMP).
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
Apotekarexamen och examen i medicin och kirurgi vid Barcelona- universitetet.
European institutions.
Kurser i farmakologi och toxikologi, folkhälsa och EU: s institutioner.
Doctorate pharmacology from the Autonomous University of Barcelona (UAB).
Doktorsexamen i klinisk farmakologi vid Autonoma universitetet i Barcelona (UAB).
Torrent i Farnell worked in internal medicine and clinical pharmacology in Spain and was Assistant Professor of Pharmacology at UAB.
Arbetade 1977– 1990 i Spanien inom internmedicin och klinisk farmakologi, och var biträdande professor i farmakologi vid UAB.
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.
Var 1990– 1994 teknisk rådgivare i frågor rörande klinisk utvärdering och farmakologi vid det spanska hälsodepartementet, ledamot av CPMP: s arbetsgrupp för läkemedelseffekt och aktiv i ICH: s arbetsgrupp för läkemedelseffekt.
In 1992, he became Professor of Clinical Pharmacology and Therapeutics and Director of the Masters/ Diploma course on European Registration of Medicinal Products (UAB).
Utsågs 1992 till professor i klinisk farmakologi och terapeutik vid UAB med ansvar för magisterkursen i läkemedelsregistrering på EU- nivå.
Yann Le Cam, Vice-chairman of the COMP, b.
Yann Le Cam, vice ordförande i COMP.
French
Född 610715, fransk medborgare